The DOI matches its Crossref record; 45 of the 45 references it cites were found in a registry or an index; 4 of the 57 sources its claims cite were checked for support.
Incidence and Etiology of Drug-Induced Liver Injury in Mainland China
Open accessAbstract
BACKGROUND & AIMS: We performed a nationwide, retrospective study to determine the incidence and causes of drug-induced liver injury (DILI) in mainland China. METHODS: We collected data on a total of 25,927 confirmed DILI cases, hospitalized from 2012 through 2014 at 308 medical centers in mainland China. We collected demographic, medical history, treatment, laboratory, disease severity, and mortality data from all patients. Investigators at each site were asked to complete causality assessments for each case whose diagnosis at discharge was DILI (n = 29,478) according to the Roussel Uclaf Causality Assessment Method. RESULTS: Most cases of DILI presented with hepatocellular injury (51.39%; 95% confidence interval [CI] 50.76-52.03), followed by mixed injury (28.30%; 95% CI 27.73-28.87) and cholestatic injury (20.31%; 95% CI 19.80-20.82). The leading single classes of implicated drugs were traditional Chinese medicines or herbal and dietary supplements (26.81%) and antituberculosis medications (21.99%). Chronic DILI occurred in 13.00% of the cases and, although 44.40% of the hepatocellular DILI cases fulfilled Hy's Law criteria, only 280 cases (1.08%) progressed to hepatic failure, 2 cases underwent liver transplantation (0.01%), and 102 patients died (0.39%). Among deaths, DILI was judged to have a primary role in 72 (70.59%), a contributory role in 21 (20.59%), and no role in 9 (8.82%). Assuming the proportion of DILI in the entire hospitalized population of China was represented by that observed in the 66 centers where DILI capture was complete, we estimated the annual incidence in the general population to be 23.80 per 100,000 persons (95% CI 20.86-26.74). Only hospitalized patients were included in this analysis, so the true incidence is likely to be higher. CONCLUSIONS: In a retrospective study to determine the incidence and causes of DILI in mainland China, the annual incidence in the general population was estimated to be 23.80 per 100,000 persons; higher than that reported from Western countries. Traditional Chinese medicines, herbal and dietary supplements, and antituberculosis drugs were the leading causes of DILI in mainland China.
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TL;DR
In a nationwide retrospective study of 25,927 confirmed drug-induced liver injury (DILI) cases from 308 mainland China centers (2012–2014), the estimated annual incidence in the general population was 23.80 per 100,000 (95% CI 20.86–26.74), higher than several Western estimates. Traditional Chinese medicines/herbal and dietary supplements and anti-tuberculosis drugs were the leading implicated single drug classes.
Key findings
- Most cases presented as hepatocellular injury (51.39%; 95% CI 50.76–52.03), followed by mixed (28.30%; 95% CI 27.73–28.87) and cholestatic (20.31%; 95% CI 19.80–20.82); chronic DILI occurred in 13.00%, and 44.40% of hepatocellular cases met Hy’s Law criteria.
- Severe outcomes were uncommon: 280 cases (1.08%) progressed to hepatic failure, 2 (0.01%) underwent liver transplantation, and 102 (0.39%) died; among deaths, DILI was judged primary in 72 (70.59%), contributory in 21 (20.59%), and no role in 9 (8.82%).
- Leading single implicated classes were TCM/HDS (26.81%) and anti-TB drugs (21.99%); other single classes >1% included antineoplastics/immunomodulators (8.34%), anti-infectious agents (6.08%), psychotropics (4.90%), non-sex hormones (3.04%), cardiovascular drugs (2.98%), digestive drugs (2.04%), respiratory drugs (1.47%), and musculoskeletal drugs (1.32%).
- Among 66 centers with complete capture, 13,691 DILI cases occurred among 8,102,732 inpatients (mean proportion 1.69‰; 95% CI 1.66–1.72); annual estimated incidence was 21.37, 23.86, and 26.00 per 100,000 in 2012, 2013, and 2014, averaging 23.80 per 100,000 (95% CI 20.86–26.74).
Methods
- Retrospective multicentric “DILI-R” study at 308 medical centers in mainland China, searching inpatient discharge diagnoses from January 1, 2012 to December 31, 2014; of 29,478 initial DILI discharge cases, 80 with admission date out of range and 2,153 with missing data were excluded, leaving 27,245 with eligible data.
- Causality assessment used RUCAM: cases with scores ≥6 (n=13,555) entered directly; cases with scores <6 (n=13,690) were reviewed by a panel of 3 hepatologists, and those judged probable DILI by at least two (n=12,372) were enrolled, yielding 25,927 eligible DILI cases.
- Clinical type was classified by R value (hepatocellular ≥5.0, cholestatic ≤2.0, mixed 2.0–5.0); incidence was estimated using only the 66 centers with complete event capture as (DILI inpatients in 66 centers annually ÷ total inpatients in 66 centers annually) × (nationwide inpatients annually ÷ general population in mainland China annually), with SAS 9.3 and standard nonparametric/categorical tests.
Limitations
- Paper-stated: only hospitalized patients were included, so the true incidence is likely higher; mild/moderate DILI patients who were unrecognized or managed as outpatients were not considered, and underdeveloped parts of the country not well covered by the survey have higher incidence of diseases requiring hepatotoxic drug treatment, so actual DILI incidence is very likely higher than 23.80 per 100,000.
- Paper-stated: there were no entrance criteria based on liver chemistries, so the cohort may include more relatively mild cases than other registries; enrollment of children and teenagers (<18 years) was relatively low, possibly related to the limited number of pediatric hospitals participating; the panel did not evaluate why RUCAM scores were calculated as below 6 for enrolled cases.
- Evident from design: retrospective discharge-diagnosis searching and incomplete capture at 242 centers may miss DILI cases; extrapolating incidence from 66 complete-capture centers to all mainland China assumes those centers are representative; no hospitals from Hong Kong, Macau, or Taiwan were included.
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Claims the paper makes
4 of 57 cited sources checked · 1 supported · 0 flagged · accuracy not yet measured
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Chronic DILI occurred in 13.00% of the cases”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Strength:plain· not yet calibratedn = 25,927Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Most cases of DILI presented with hepatocellular injury (51.39%; 95% CI, 50.76-52.03),followed by mixed injury (28.30%; 95% CI, 27.73-28.87)and cholestatic injury (20.31%; 95% CI, 19.80-20.82).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Strength:plain· not yet calibratedn = 25,927Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“2 cases underwent liver transplantation (0.01%)”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Strength:plain· not yet calibratedn = 2Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“only 280 cases (1.08%) progressed to hepatic failure”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“44.40% of the hepatocellular DILI cases fulfilled Hy's Law criteria”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The leading single classes of implicated drugs were traditional Chinese medicines or herbal and dietary supplements (26.81%) and anti-tuberculosis medications (21.99%).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Most cases of DILI presented with hepatocellular injury (51.39%; 95% CI, 50.76-52.03),followed by mixed injury (28.30%; 95% CI, 27.73-28.87)and cholestatic injury (20.31%; 95% CI, 19.80-20.82).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Strength:plain· not yet calibratedn = 25,927Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“102 patients died (0.39%)”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Strength:plain· not yet calibratedn = 102Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The leading single classes of implicated drugs were traditional Chinese medicines or herbal and dietary supplements (26.81%) and anti-tuberculosis medications (21.99%).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Most cases of DILI presented with hepatocellular injury (51.39%; 95% CI, 50.76-52.03),followed by mixed injury (28.30%; 95% CI, 27.73-28.87)and cholestatic injury (20.31%; 95% CI, 19.80-20.82).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Strength:plain· not yet calibratedn = 25,927Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes
- Probably not a substantial claim. 23
- It may state two separate claims as one. 30
Every source the paper cites for this claim was checked and supports it.
In the paper
“In the United States, the annual incidence of DILI in the general population has been recently estimated as 2.7 per 100,000 adults, through surveillance in the state of Delaware.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
What the sources say
- Supportedcites [10] Vega, 2017, The incidence of drug- and herbal and dietary supplement-induced liver injury: preliminary findings from gastroenterologist-based surveillance in the population of the State of Delaware, Drug Saf source
The Results report an annual incidence of 2.7 DILI cases per 100,000 adult Delaware residents during the 2014 surveillance period. The Discussion describes this as the first population-based estimate in an American cohort. The paper cautions that gastroenterologist-only surveillance likely underestimated the actual incidence. (LLM, conf=0.93)
Strength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“females have been reported to have increased, 8,26,27,31 unchanged, 9,30 or even decreased 12,21 incidence of DILI (Table 4).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > M A N U S C R I P T A C C E P T E D ACCEPTED MANUSCRIPT
What the sources say
- Not checked — no full text of the sourcecites [8] Bjornsson, 2013, Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland, Gastroenterology source
- Not checked — no full text of the sourcecites [26] Takikawa, 2009, Drug-induced liver injury in Japan: an analysis of 1676 cases between 1997 and 2006, Hepatol Res source
- Could not verifycites [27] Chalasani, 2008, Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States, Gastroenterology sourceExperimental — accuracy not yet measured
The Results (Presenting Features; page unavailable) report that 60% of enrolled DILI patients were women, but do not compare DILI incidence by sex. The Discussion (page unavailable) finds no relationship between female sex and DILI severity and says susceptibility risk factors require comparison with controls. Neither passage establishes increased, unchanged, or decreased incidence in women. (LLM, conf=0.76)
- Not checked — no full text of the sourcecites [31] Lucena, 2009, Phenotypic characterization of idiosyncratic drug-induced liver injury: the influence of age and sex, Hepatology source
- Not checked — no full text of the sourcecites [9] Sgro, 2002, Incidence of drug-induced hepatic injuries: a French population-based study, Hepatology source
- Not checked — no full text of the sourcecites [30] Hartleb, 2002, Drug-induced liver damage—a three-year study of patients from one gastroenterological department, Med Sci Monit
- Not checked — no full text of the sourcecites [12] Zhou, 2013, Epidemiology of drug-induced liver injury in China: a systematic analysis of the Chinese literature including 21,789 patients, Eur J Gastroenterol Hepatol source
- Partly supportedcites [21] Andrade, 2005, Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period, Gastroenterology sourceExperimental — accuracy not yet measured
The Demographic and Clinical Characteristics section reports a similar sex distribution among DILI cases, and the Discussion says there was no difference in sex distribution. This supports the ‘unchanged’ portion of the citing sentence, but the paper does not establish equal sex-specific incidence rates; it reports case distribution rather than incidence by sex. (LLM, conf=0.82)
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Liver injury caused by antineoplastic or immunomodulators includes hepatocyte necrosis, hepatic steatosis, hepatic mitochondrial injury, cholestasis and vascular injury.[42][43][44][45]”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
What the sources say
- Not checked — no full text of the sourcecites [42] Wang, 2012, Non-genetic risk factors and predicting efficacy for docetaxel—drug-induced liver injury among metastatic breast cancer patients, J Gastroenterol Hepatol source
- Partly supportedcites [43] Ridruejo, 2007, Imatinib-induced fatal acute liver failure, World J Gastroenterol sourceExperimental — accuracy not yet measured
The Additional information table (page not provided) reports hepatocyte necrosis and a case with mild cholestasis after imatinib treatment. The Discussion (page not provided) describes hepatic microthrombi in another case, but links them to the patient’s underlying prothrombotic condition; the paper does not report steatosis or mitochondrial injury. It therefore supports only part of the broader list attributed to it. (LLM, conf=0.87)
- Not checked — no full text of the sourcecites [44] Ma, 2002, Acute toxicity of adjuvant doxorubicin and cyclophosphamide for early breast cancer—a retrospective review of Chinese patients and comparison with an historic Western series, Radiother Oncol source
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Traditional Chinese medicines, herbal and dietary supplements, and anti-tuberculosis drugs were the leading causes of DILI in mainland China.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Among deaths, DILI was judged to have a primary role in 72 (70.59%), a contributory role in 21 (20.59%), and no role in 9 (8.82%).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Strength:plain· not yet calibratedn = 102Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“As expected from continuing bone growth, children generally had higher ALP levels than adults (Figure 2).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Effect of age, gender and ethnicity
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Of the 308 involved centers, 66 centers provided all recorded hospitalized DILI cases during the 3-year period of observation, and the other 242 centers just provided DILI cases from some but not all clinical departments.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > M A N U S C R I P T A C C E P T E D ACCEPTED MANUSCRIPT
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In this study, latency period in DILI cases without jaundice was shorter than in cases with jaundice (P < .0001)and in fatal cases (P < .0001)(Supplementary Figure 6).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Of note, few cases progressed to life-threatening outcomes, which included 280 progressing to hepatic failure (1.08%), two undergoing liver transplantation (.01%) and 102 dying (.39%).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Interestingly, we found that the latency period (P <.05) and duration of usage of implicated agents (P < .01)was significantly longer in ethnic minorities than in Han Chinese.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Effect of age, gender and ethnicity
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Also, children had a shorter mean latency period (P <.0001) and duration of usage of implicated agents (P<.0001), and lower peak levels of TBil, DBil, TBA, ALT, AST and GGT than in adults (P<.0001).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Effect of age, gender and ethnicity
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Of note, compared to the DILI cases without jaundice, female gender occupied higher frequencies than that of men, either in cases with jaundice (P < .0001)or in life-threatening DILI (P < .01)(Supplementary Figure 6).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Effect of age, gender and ethnicity
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In addition, our study showed that DILI patients appeared most frequently in departments of internal medicine (41.74%; 95% CI 41.14-42.34)and infectious diseases (32.59%; 95% CI 32.02-33.16),while only 14.42% (95% CI 13.99-14.85)and 3.35% (95% CI 3.13 -3.57) were diagnosed in departments of hepatology and oncology respectively (Table 1).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Demographic features
Strength:plain· not yet calibratedn = 25,927Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The highest proportion of DILI cases were in patients with ages between 40 and 59 years followed by ages 18-39, ages ≥ 60 and ages < 18 years old.”
- Also stated in: § Demographic features · plain
“Thus, DILI in children and teenagers represented the lowest proportion of the subjects enrolled.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Demographic features
Strength:plain· not yet calibratedn = 25,927Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
- Also stated in: § Demographic features · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“We found that the vast majority (25,113 cases, 96.93%) of DILI patients was Han Chinese and only 3.07% (795 cases) were minorities and this is consistent with the overall population composition.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Demographic features
Strength:plain· not yet calibratedn = 25,927Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“TCM or HDS (26.81%) and anti-TB drugs (21.99%) were the two leading classes of implicated agents.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Causes of DILI
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“As shown in Table 1, men with DILI were found slightly more frequently than females.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Demographic features
Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Also, female patients had higher serum TBil (P <.01), DBil (P < .01),TBA (P < .0001),ALT (P < .0001),AST (P < .0001)and ALP (P < .0001)than males.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Effect of age, gender and ethnicity
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The highest proportion of pre-existing liver disease was among the in fatal cases (64.32%), followed by cases with jaundice (29.21%) and cases without jaundice (21.34%) (P < .0001)(Supplementary Figure 6).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > M A N U S C R I P T A C C E P T E D ACCEPTED MANUSCRIPT
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Cases with serum ALT≥ 3×ULN and <5× ULN and cases with serum ALT<3×ULN formed 16.73% (95% CI 16.27-17.17)and 33.81% (95% CI 33.23 -34.39) of the cases respectively (Table 1).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Clinical presentations
Strength:plain· not yet calibratedn = 25,927Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Most DILI cases were hepatocellular injuries (51.39%; 95% CI 50.76 -52.03), following by mixed injury (28.30%; 95% CI 27.73 -28.87) and cholestatic injury (20.31%; 95% CI 19.80-20.82)(Table 1).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Clinical presentations
Strength:plain· not yet calibratedn = 25,927Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Of 102 death cases, DILI was judged to have had a primary role in 72 (70.59%), a contributory role in 21 (20.59%), and no role in 9 (8.82%) (Table 1).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“It was noteworthy that the higher proportions of hepatocellular DILI were found in fatal cases (65.67%,P<.0001) and in cases with jaundice (65.09%,P<.0001) than in non-fatal cases or in the absence of jaundice (48.53%) (Supplementary Figure 6).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Comparison of demographic and clinical features among DILI cases without jaundice (W/O jaundice, n=20,938), DILI cases with jaundice (W/ jaundice, n=4,605) and life-threatening (”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Additional information
Strength:plain· not yet calibratedn = 20,938Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“A total of 7, 594 cases were diagnosed as tuberculosis, in which gender information of 132 cases was missing or unknown.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Additional information
Strength:plain· not yet calibratedn = 7,594Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Life-threatening DILI cases included 280 cases of progression to hepatic failure, 2 liver transplantations and 102 deaths.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Additional information
Strength:plain· not yet calibratedn = 384Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Only hospitalized patients were included in this analysis, so the true incidence is likely to be higher.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
In the paper
“Also, the most common causative drugs were anti-infectious agents, anti-TB drugs and natural herbal medicines across various registries.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
What the sources say
- Not checked — no full text of the sourcecites [11] Leise, 2014, Drug-induced liver injury, Mayo Clin Proc source
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“Two population-based studies conducted in France and Iceland estimated the annual incidences of DILI to be approximately 13.9/100,000 and 19.1/100,000 respectively.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
What the sources say
- Not checked — no full text of the sourcecites [8] Bjornsson, 2013, Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland, Gastroenterology source
- Not checked — no full text of the sourcecites [9] Sgro, 2002, Incidence of drug-induced hepatic injuries: a French population-based study, Hepatology source
Strength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In the west, the incidence of DILI has been estimated to be 1/100,000-20/100,000 in the general population.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
What the sources say
- Not matchedcites 2,[4][5][6][7]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Strength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Not matched
None of the sources cited for this claim have been checked yet.
In the paper
“which was still higher than that estimated in Iceland (19.1/100,000) 7 , France (13.9/100,000), 9 the United states (2.7/100,000), 10 Spain (3.42/100,000) 21 and Sweden (2.4/100,000) 22 (Table 4).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D Discussion
What the sources say
- Not checked yetcites [7] Bjornsson, 2010, Review article: drug-induced liver injury in clinical practice, Aliment Pharmacol Ther source
Checked before — its earlier verdict is held back until a new check runs.
- Not checked — no full text of the sourcecites [9] Sgro, 2002, Incidence of drug-induced hepatic injuries: a French population-based study, Hepatology source
- Not checked yetcites [10] Vega, 2017, The incidence of drug- and herbal and dietary supplement-induced liver injury: preliminary findings from gastroenterologist-based surveillance in the population of the State of Delaware, Drug Saf source
Checked before — its earlier verdict is held back until a new check runs.
Strength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
- Not checked yet
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Cases with scores greater than or equal to 6 (”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“Drug-induced liver injury (DILI) is a common adverse drug reaction (ADR), and it can lead to liver failure and even death.[1][2][3]”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Abstract
What the sources say
- Not checked — no full text of the sourcecites [1] Kaplowitz, 2005, Idiosyncratic drug hepatotoxicity, Nat Rev Drug Discov source
- Not checked — no full text of the sourcecites [2] Navarro, 2006, Drug-related hepatotoxicity, N Engl J Med source
- Not checked — no full text of the sourcecites [3] Chalasani, 2014, ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury, Am J Gastroenterol source
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Cases judged by at least two of the three hepatologists as probable DILI (n=12,372) were enrolled in the study.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > M A N U S C R I P T A C C E P T E D ACCEPTED MANUSCRIPT
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
None of the sources cited for this claim have been checked yet.
In the paper
“Though females are suggested to have a higher risk of idiosyncratic DILI than males in many retrospective studies, 8,[27][28][29][30]”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > M A N U S C R I P T A C C E P T E D ACCEPTED MANUSCRIPT
What the sources say
- Not checked — no full text of the sourcecites [8] Bjornsson, 2013, Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland, Gastroenterology source
- Not checked yetcites [27] Chalasani, 2008, Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States, Gastroenterology source
Checked before — its earlier verdict is held back until a new check runs.
- Not checked — no full text of the sourcecites [28] Suk, 2012, A prospective nationwide study of drug-induced liver injury in Korea, Am J Gastroenterol source
- Not checked — no full text of the sourcecites [29] De Valle, 2006, Drug-induced liver injury in a Swedish University hospital out-patient hepatology clinic, Aliment Pharmacol Ther source
- Not checked — no full text of the sourcecites [30] Hartleb, 2002, Drug-induced liver damage—a three-year study of patients from one gastroenterological department, Med Sci Monit
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“No hospitals from Hong Kong, Macau or Taiwan were included in this study.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Estimation of incidence of DILI
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Owing to the retrospective analysis of existing administrative and clinical data, the requirement to obtain informed patient consent was waived by the institutional review board.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A three-year retrospective multicentric study ("DILI-R")
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Each patient was given a unique number allowing identification of multiple visits to different centers or readmissions during the 3-year period and thereby avoiding duplication.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In summary, female and older DILI patients tended to have more severe DILI than male and younger individuals.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > Effect of age, gender and ethnicity
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The protocol for the present study was reviewed and approved by the institutional review board at Renji Hospital of Shanghai JiaoTong University, Shanghai, China (ClinicalTrials.govIdentifier: NCT02407964).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A three-year retrospective multicentric study ("DILI-R")
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“Investigators at each site were asked to complete causality assessment scoring for each case whose diagnosis at discharge was DILI (n=29,478) according to the Roussel Uclaf Causality Assessment Method (RUCAM).”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
What the sources say
- Not checked — no full text of the sourcecites [14] Danan, 1993, Causality assessment of adverse reactions to drugs—I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries, J Clin Epidemiol source
- Not checked — no full text of the sourcecites [15] Benichou, 1993, Causality assessment of adverse reactions to drugs—II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge, J Clin Epidemiol source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“In our study, we had no entrance criteria based on liver chemistries so may have included more relatively mild cases than in other registries.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Of the 308 involved centers, only 66 centers provided all recorded hospitalized DILI cases during 3-year observation (red dots).Thus, DILI cases from these 66 centers were used to assess the diagnostic rate of DILI in this study, since all inpatients were screened for the occurrence of DILI.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > M A N U S C R I P T A C C E P T E D
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Additionally, our relatively low enrollment of children and teenagers (<18 years old) may be related to the relatively limited number of pediatric hospitals participating in the study.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“As reported by the western studies, acute liver failure was most associated with use of non-steroidal anti-inflammatory drugs (NSAIDs), anti-infective drugs, and herbs and dietary supplements (HDS).13,33,34”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
What the sources say
- Not checked yetcites [13] Yu, 2017, CSH guidelines for the diagnosis and treatment of drug-induced liver injury, Hepatol Int source
Checked before — its earlier verdict is held back until a new check runs.
- Not checked — no full text of the sourcecites [33] Russo, 2004, Liver transplantation for acute liver failure from drug induced liver injury in the United States, Liver Transpl source
- Not checked — no full text of the sourcecites [34] Bjornsson, 2005, Fulminant drug-induced hepatic failure leading to death or liver transplantation in Sweden, Scand J Gastroenterol source
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Not checked yet
In the paper
“All these anti-TB drugs have hepatotoxicity potential and could lead to DILI during M A N U S C R I P T ## A C C E P T E D ACCEPTED MANUSCRIPT anti-tuberculosis treatment, which commonly leads to interruption of anti-TB treatment and may promote antibiotic resistance.40”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
What the sources say
- Not checked — no full text of the sourcecites [40] Frieden, 2003, Tuberculosis. Lancet source
Strength:hedged· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
In the paper
“Among TB patients, male to female ratio was 2.1:1.32”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > M A N U S C R I P T A C C E P T E D ACCEPTED MANUSCRIPT
What the sources say
- Not matchedcites [32] 2016
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
- Not matched
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In summary, in the largest registry of its kind, we have provided a complete characterization of DILI in mainland China.”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > A C C E P T E D ACCEPTED MANUSCRIPT
Strength:boosted· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt may state two separate claims as one.
In the paper
“In China, it was estimated that 918,000 individuals suffered from tuberculosis (TB) (including TB co-infected with HIV) with overall incidence of 67/100,000 population, which accounted for 8.65% of the world's reported cases of TB in 2015 (WHO Global tuberculosis report 2016).32”
§ Incidence and Etiology of Drug-Induced Liver Injury in Mainland China > M A N U S C R I P T A C C E P T E D ACCEPTED MANUSCRIPT
What the sources say
- Not matchedcites [32] 2016
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Strength:hedged· not yet calibratedn = 918,000Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Not matched
The authors state this as an assumption.
The proportion of DILI in the entire hospitalized population of China is represented by that observed in the 66 centers where DILI capture was complete.
“Assuming the proportion of DILI in the entire hospitalized population of China was represented by that observed in the 66 centers where DILI capture was complete”
The paper relies on this without support.
The ratio of DILI inpatients to total inpatients in the 66 centers with complete event capture is representative of the ratio in all hospitals in mainland China.
“The incidence of DILI in the general population was evaluated as (number of DILI inpatients in 66 centers annually ÷ total number of inpatients in 66 centers annually) × (number of inpatients nationwide annually ÷ the general population in mainland China annually).”
The paper relies on this without support.
The 25,927 DILI cases collected from 308 medical centers are representative of hospitalized DILI patients in mainland China.
“In this study, a total of 25,927 DILI cases among hospitalized patients were collected from 308 medical centers between January 1, 2012 and December 31, 2014 (Figure 1A).”
The paper relies on this without support.
In mainland China, health care of Chinese inhabitants has been covered by the public medical service system, medical insurance system and the rural cooperative medical system since 2003.
“In mainland China, health care of Chinese inhabitants has been covered by the public medical service system, medical insurance system and the rural cooperative medical system since 2003.”
The paper relies on this without support.
In mainland China, hepatoprotective agents are generally administered to hospitalized patients with DILI.
“In addition, in mainland China, hepatoprotective agents are generally administered to hospitalized patients with DILI.”
The paper relies on this without support.
The 66 centers that provided all recorded hospitalized DILI cases are representative of all hospitals in mainland China for estimating the proportion of DILI among inpatients.
“Of the 308 medical centers that participated in this study, only 66 centers provided all recorded hospitalized DILI cases during the three-year observation period and could therefore be used to estimate the proportion of DILI patients among all inpatients.”
The paper relies on this without support.
The gender distribution ratio among TB patients is the expected ratio among DILI patients due to TB treatments if susceptibility to DILI is not affected by gender.
“Among TB patients, male to female ratio was 2.1:1.32”
The paper relies on this without support.
The 66 centers that provided complete enrollment are representative of all 308 centers and of mainland China for estimating DILI incidence.
“Of the 308 involved centers, only 66 centers provided all recorded hospitalized DILI cases during 3-year observation (red dots).Thus, DILI cases from these 66 centers were used to assess the diagnostic rate of DILI in this study, since all inpatients were screened for the occurrence of DILI.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Herbal drugs and dietary supplements are a major growing concern for liver injury, liver failure, and death or liver transplantation globally.3–6”
From Ashwagandha-induced liver injury—A case series from India and literature review (2023) · cites this paper as [5]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“but it seems that the problems can well be solved in a new, promised prospective study, whereby the use of RUCAM may again be helpful, now applying its updated version.36,102–105”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The cited problems focused, among others, on the retrospective design of the study36”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Most commonly implicated medications for idiosyncratic DILI are antimicrobials, immunomodulatory agents, and central nervous system agents.[2,10,12,13]”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [10]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In this study, ALF was defined as INR ≥2, the presence of HE, total bilirubin ≥10 times upper limit of normal or daily elevations ≥1 mg/dL, and the disease duration of <26 weeks, and DILI was the main reason for death in 52 (70.59%) of the patients.”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [10]
Experimental — accuracy not yet measured
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In an observational retrospective study from China conducted between 2012–2014, out of 25,927 patients, 280 (1.08%) patients developed ALF, and of those with ALF, 2 patients (0.01%) underwent LT and 102 (0.30%) died (10).”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [10]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Liver biochemistry in approximately 7-13% of patients may not return to normal or baseline levels 6 months or 1 year after an acute DILI episode, which indicates that acute liver injury may develop into a chronic injury or delayed recovery [8].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [8]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“Some studies included HILI cases not only with highly probable or probable causality gradings but also with a possible causality level based on RUCAM scores ≥3 (Table 1).24,25,27,28,30,36,38”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
The cited source says what the claim attributes to it.
In the citing paper
“In a few instances, publications erroneously mention in their title specifically only DILI, although HILI cases are also presented in the text,24,26,36”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
The cited source says what the claim attributes to it.
In the citing paper
“Instead, some improvements were evident in a more recent report, with the title focusing on incidence and etiology of DILI in mainland China, published in a 2019 issue of Gastroenterology.36”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
The cited source says what the claim attributes to it.
In the citing paper
“In an observational retrospective study from China conducted between 2012–2014, out of 25,927 patients, 280 (1.08%) patients developed ALF, and of those with ALF, 2 patients (0.01%) underwent LT and 102 (0.30%) died (10).”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [10]
In the citing paper
“The RECAM is also not designed nor tested for HDS liver injury which is increasingly reported.20–22”
From A revised electronic version of RUCAM for the diagnosis of DILI (2022) · cites this paper as [22]
In the citing paper
“The proportion of DILI cases attributed to medicinal plants and dietary supplements is increasing worldwide, indicating an evolving trend in the epidemiology of DILI and pointing to the need for greater awareness and regulation [7,8].”
From DILI Differences and Similarities between the US and Europe (2026) · cites this paper as [8]
In the citing paper
“but few combined results of both HILI and DILI cases, causing confusion due to mixed data.24,26,30,36”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
In the citing paper
“Occasionally, RUCAM-based causality gradings, classified initially as possible, had afterwards been upgraded to a probable level through a non-transparent maneuver36”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
In the citing paper
“Under the current conditions, no valid statement is warranted on HILI epidemiology in China.36”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
In the citing paper
“In particular, valid epidemiology data of HILI are not available for the population; although, herbal TCMs are integral constituents of the Chinese health system.”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
In the citing paper
“However, the respective cohorts were grouped under the term of DILI, and represented still not only DILI but also liver injury cases caused by herbal TCM and herbal dietary supplements, representing two different product categories and again providing conditions similar to the shortcomings of the earlier study78 and not allowing for characterization of HILI epidemiology features.36”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
In the citing paper
“At least, it was now recognized that the use of RUCAM, as a valuable diagnostic algorithm, can help assess causality in liver injury cases.36”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
In the citing paper
“Focusing on another report36 and the related Letters to the Editor102–104 by various DILI experts from China,102,104 India,103 and Iceland,103 discussions have emerged around the reported RUCAM-based DILI and HILI cases36”
From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [36]
In the citing paper
“Several risk factors including age, gender, and genetic factors have been suggested for DILI; however, no definite risk factor for all-cause DILI exists.[10]”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [10]
In the citing paper
“HDS constitute the majority of the idiosyncratic DILI in many Asian countries including China and Korea, while they are responsible for the minority of DILI cases in the United States (US).[2,10,14]”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [10]
In the citing paper
“Several risk factors including age, gender, and genetic factors have been suggested for DILI; however, no definite risk factor for all-cause DILI exists.[10]”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [10]
In the citing paper
“In an observational retrospective study from China conducted between 2012–2014, out of 25,927 patients, 280 (1.08%) patients developed ALF, and of those with ALF, 2 patients (0.01%) underwent LT and 102 (0.30%) died (10).”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [10]
In the citing paper
“The most common drugs that cause liver injury in China include TCM, HDS, anti-TB drugs, antineoplastic agents, and immunomodulators [8].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [8]
In the citing paper
“In the United States and China, 10% and 23% of patients with DILI have underlying liver disease, respectively [8,21].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [8]
In the citing paper
“The proportion of patients with fatal adverse clinical outcomes varies from country to country owing to differences in study design, methods, and populations [8].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [8]
Citations
Cites
Danan, G., & Benichou, C. (1993) · Journal of Clinical Epidemiology · doi:10.1016/0895-4356(93)90101-6 · Cited by 1,481
Idiosyncratic drug hepatotoxicity
Kaplowitz, N. (2005) · Nature Reviews Drug Discovery · doi:10.1038/nrd1750 · Cited by 1,054
Features and outcomes of 899 patients with drug-induced liver injury: the DILIN Prospective Study
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Metadata
- Authors
- Shen, T., Liu, Y., Shang, J., Xie, Q., Li, J., Yan, M., Xu, J., Niu, J., Liu, J., Watkins, P. B., Aithal, G. P., Andrade, R. J., Dou, X., Yao, L., Lv, F., Wang, Q., Li, Y., Zhou, X., Zhang, Y., Zong, P., Wan, B., Zou, Z., Yang, D., Nie, Y., Li, D., Wang, Y., Han, X., Zhuang, H., Mao, Y., & Chen, C.
- Affiliations
- Peking University (CN)
- Shenzhen Third People’s Hospital (CN)
- Henan Provincial People's Hospital (CN)
- Shanghai Jiao Tong University (CN)
- Jiangsu Province Hospital (CN)
- Qilu Hospital of Shandong University (CN)
- First Affiliated Hospital of Anhui Medical University (CN)
- First Hospital of Jilin University (CN)
- First Affiliated Hospital of Xiamen University (CN)
- University of North Carolina at Chapel Hill (US)
- Nottingham University Hospitals NHS Trust (GB)
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (ES)
- China Medical University (CN)
- Fujian Medical University (CN)
- Sir Run Run Shaw Hospital (CN)
- Shanxi Medical University (CN)
- Harbin Medical University (CN)
- Xijing Hospital (CN)
- Xinjiang Medical University (CN)
- Jiangxi Chest Hospital (CN)
- Public Health Clinical Center of Chengdu (CN)
- 302 Military Hospital of China (CN)
- Wuhan Union Hospital (CN)
- Guangzhou First People's Hospital (CN)
- Fuzhou General Hospital of Nanjing Military Command (CN)
- Corresponding author
- Mao, Yimin
- Chen, Chengwei
- ORCID
- Shen, Tao
- Liu, Yingxia
- Shang, Jia
- Xie, Qing
- Li, Jun
- Yan, Ming
- Xu, Jianming
- Niu, Junqi
- Liu, Jiajun
- Watkins, Paul B.
- Aithal, Guruprasad P.
- Andrade, Raúl J.
- Dou, Xiaoguang
- Yao, Lvfeng
- Lv, Fangfang
- Wang, Qi
- Li, Yongguo
- Zhou, Xinmin
- Zhang, Yuexin
- Wan, Bin
- Zou, Zhengsheng
- Yang, Dongliang
- Nie, Yuqiang
- Li, Dongliang
- Wang, Yuya
- Zhuang, Hui
- Mao, Yimin
- Chen, Chengwei
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2019-06
- Volume
- 156
- Issue
- 8
- Pages
- 2230-2241.e11
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2914750127
- Cited by
- 615
- References
- 43
- Citations by year
- 2026: 66 · 2025: 89 · 2024: 95 · 2023: 84 · 2022: 91 · 2021: 82 · 2020: 67 · 2019: 41
- FWCI
- 45.62
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Gastroenterology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Repository@Nottingham (University of Nottingham) (acceptedVersion, cc-by-nc-nd)
- Repository@Nottingham (University of Nottingham) (submittedVersion, cc-by-nc-nd)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion, cc-by-nc-nd)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, cc-by-nc-nd)
- UNC Libraries
- Funders
- Shanghai Shenkang Hospital Development Center (16CR2009A)
- School of Medicine, Shanghai Jiao Tong University (DLY201607)
- National Natural Science Foundation of China (81670524)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Keywords
- drug-induced liver injury, incidence, etiology, hepatocyte injury, cholestatic liver injury, traditional Chinese medicine, herbal and dietary supplements, antitubercular agents, liver failure, liver transplantation, Hy's law, RUCAM, hospitalized patients, China, pharmacovigilance, incidence estimation
- MeSH terms
- Acute Disease, Adult, Aged, Cause of Death, China, Chronic Disease, Female, Humans, Liver Function Tests, Male, Middle Aged, Registries, Retrospective Studies, Severity of Illness Index, Cohort Studies, Incidence, Survival Rate, Confidence Intervals, Liver Failure, Acute, Age Distribution, Sex Distribution, Risk Assessment, Young Adult, Chemical and Drug Induced Liver Injury, End Stage Liver Disease
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-11-10, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-11-10 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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