The DOI matches its Crossref record; 6 of the 6 references it cites were found in a registry or an index.
Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug‐induced liver injury: A multicenter, randomized, phase II trial
Abstract
Background and Aims: Evidence for using bicyclol in drug‐induced liver injury (DILI) is limited. This study aimed to explore the efficacy and safety of bicyclol in acute DILI. Methods: This was a multicenter, randomized, double‐blinded, double‐dummy, active‐controlled, superiority and phase II trial. Patients with idiosyncratic acute DILI were randomized 1: 1:1 to low‐dose bicyclol (25 mg times a day [TID]), high‐dose bicyclol (50 mg TID) and polyene phosphatidylcholine (control) groups. The primary endpoint was the decrease from baseline in serum alanine aminotransferase (ALT) levels at post‐treatment for 4 weeks. Results: Overall, 241 patients were included in the full analysis set, with 81, 82 and 78 patients in the low‐dose bicyclol, high‐dose bicyclol, and control groups respectively. ALT levels decreased across groups (−249.2 ± 151.1, −273.6 ± 203.1, and −180.8 ± 218.2 U/L in the low‐dose bicyclol, high‐dose bicyclol and control groups, respectively; both p < .001, the bicyclol‐dependent groups vs. control group). The ALT normalization rates at weeks 1, 2, 4, 6 and 8 were higher in the bicyclol‐dependent groups than in the control group ( p = .002 at week 1 and all p < .001 at weeks 2, 4, 6 and 8 respectively). The median times to ALT normalization in the low‐dose bicyclol, high‐dose bicyclol and control groups were 29, 16 and 43 days respectively. Adverse events, serious adverse events and adverse drug reactions were similar across groups. Conclusions: Bicyclol (25 and 50 mg TID) appeared efficacious and safe for treating idiosyncratic acute DILI, while bicyclol 50 mg TID showed higher efficacy. Trial Registration Number: www.Clinicaltrials.gov (registration no. NCT02944552).
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
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?
In a phase II trial, bicyclol effectively reduced aminotransferase levels in patients with acute DILI and promoted recovery from liver injury when given 25 or 50 mg 3 times a day.
“In a phase II trial, bicyclol effectively reduced level of aminotransferase in patients with acute DILI and promoted recovery from liver injury when given 25 or 50 mg 3 times a day [195].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [195]
Citations
Cites
EASL Clinical Practice Guidelines: Drug-induced liver injury
Andrade, R. J., Aithal, G. P., Björnsson, E. S., Kaplowitz, N., Kullak-Ublick, G. A., Larrey, D., & Karlsen, T. H. (2019) · Journal of Hepatology · doi:10.1016/j.jhep.2019.02.014 · Cited by 1,276
Andrade, R. J., Chalasani, N., Björnsson, E. S., Suzuki, A., Kullak-Ublick, G. A., Watkins, P. B., Devarbhavi, H., Merz, M., Lucena, M. I., Kaplowitz, N., et al. (2019) · Nature Reviews Disease Primers · doi:10.1038/s41572-019-0105-0 · Cited by 924
Björnsson, E. S., Bergmann, O. M., Björnsson, H. K., Kvaran, R. B., & Olafsson, S. (2013) · Gastroenterology · doi:10.1053/j.gastro.2013.02.006 · Cited by 865
Incidence and Etiology of Drug-Induced Liver Injury in Mainland China
Shen, T., Liu, Y., Shang, J., Xie, Q., Li, J., Yan, M., Xu, J., Niu, J., Liu, J., Watkins, P. B., et al. (2019) · Gastroenterology · doi:10.1053/j.gastro.2019.02.002 · Cited by 615
Self-citationACG Clinical Guideline: Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury
Chalasani, N. P., Maddur, H., Russo, M. W., Wong, R. J., Reddy, K. R., & on behalf of the Practice Parameters Committee of the American College of Gastroenterology (2021) · American Journal of Gastroenterology · doi:10.14309/ajg.0000000000001259 · Cited by 430
Drug-induced liver injury: Asia Pacific Association of Study of Liver consensus guidelines
Devarbhavi, H., Aithal, G., Treeprasertsuk, S., Takikawa, H., Mao, Y., Shasthry, S. M., Hamid, S., Tan, S. S., Philips, C. A., George, J., et al. (2021) · Hepatology International · doi:10.1007/s12072-021-10144-3 · Cited by 181
Self-citation
Flagged first, then by citations
Research works printed but not linked: 39
- 10.1016/S1089-3261(05)70097-0 · DOI
- 10.1111/apt.12109 · DOI
- 10.1111/liv.15262 · DOI · Paper page
- 10.7326/M15-2211 · DOI · Paper page
- 10.1007/s12072-017-9793-2 · DOI
- 10.1002/hep.23588 · DOI · Paper page
- 10.1016/j.cgh.2017.05.027 · DOI · Paper page
- 10.1097/COC.0000000000000374 · DOI · Paper page
- 10.1186/s40425-017-0300-z · DOI · Paper page
- 10.14309/ajg.0000000000000398 · DOI
- 10.1016/j.jhep.2018.01.033 · DOI · Paper page
- 10.1016/j.jhep.2018.03.034 · DOI
- 10.1159/000322298 · DOI
- Lee WM, 2009, Intravenous N‐acetylcysteine improves transplant‐free survival in early stage non‐acetaminophen acute liver failure, Gastroenterology, 137, 864.e851
- 10.1016/j.phrs.2020.105404 · DOI · Paper page
- 10.3389/fphar.2020.00463 · DOI
- 10.2174/157340609787049316 · DOI
- 10.5588/ijtld.14.0579 · DOI
- 10.1177/0300060514527058 · DOI
- 10.12659/MSM.904090 · DOI
- 10.1016/0895-4356(93)90101-6 · DOI · Paper page
- 10.1016/0895-4356(93)90102-7 · DOI · Paper page
- 10.1002/hep.23577 · DOI · Paper page
- 10.1038/ajg.2014.131 · DOI · Paper page
- 10.1055/s-0034-1375955 · DOI
- 10.3389/fphar.2019.00853 · DOI · Paper page
- Gundermann KJ, 2016, Essential phospholipids in fatty liver: a scientific update, Clin Exp Gastroenterol, 9, 105
- 10.1136/bmjgast-2019-000341 · DOI
- Cao M, 2016, The effect of polyene phosphatidyl choline intervention on nonalcoholic steatohepatitis and related mechanism, Am J Transl Res, 8, 2325
- Liu YH, 2021, Therapeutic efficacy of polyene phosphatidylcholine in patients with anti‐tuberculosis agents‐induced liver injury, J Prac Hepatol, 24, 228
- 10.1177/03000605211039810 · DOI
- 10.1136/bmjopen-2020-039700 · DOI
- 10.1111/liv.14204 · DOI · Paper page
- 10.1111/j.1365-2125.2004.02133.x · DOI
- 10.1055/s-2002-30105 · DOI
- 10.1016/j.jhep.2021.01.029 · DOI
- 10.1053/j.gastro.2019.07.006 · DOI · Paper page
- 10.1515/med-2017-0012 · DOI
- 10.1053/j.gastro.2015.03.006 · DOI · Paper page
Cited by
Sorted by citations
Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update
Mao, Y., Ma, S., Liu, C., Liu, X., Su, M., Li, D., Li, Y., Chen, G., Chen, J., Chen, J., et al. (2024) · Hepatology International · doi:10.1007/s12072-023-10633-7 · Cited by 62
Self-citation
Metadata
- Authors
- Tang, J., Gu, J., Chu, N., Chen, Y., Wang, Y., Xue, D., Xie, Q., Li, L., Mei, Z., Wang, X., Li, J., Chen, J., Li, Y., Yang, C., Wang, Y., Shang, J., Xie, W., Hu, P., Li, D., Zhao, L., Lan, P., Wang, C., Chen, C., & Mao, Y.
- Venue
- Liver International
- Publisher
- Wiley
- Published
- 2022-05-25
- Volume
- 42
- Issue
- 8
- Pages
- 1803-1813
- ISSN
- 1478-3223
- 1478-3231
- Cited by
- 25
- References
- 6
- Language
- en
- Licence
- Funders
- School of Medicine, Shanghai Jiao Tong University
- National Natural Science Foundation of China (81670524, 81970513)
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.
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 ›
Are you an author, or do you see a problem with this page? Request a review
