Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug-induced liver injury: A multicenter, randomized, phase II trial

Tang, Jieting1; Gu, Jin2; Chu, Naihui3; Chen, Yu4; Wang, Yongliang5; Xue, Dongying6; Xie, Qing7; Li, Lei8; Mei, Zaoxian9; Wang, Xiaojin10; Li, Jun11; Chen, Jun12; Li, Yi13; Yang, Changqing14; Wang, Yingxin14; Shang, Jia15; Xie, Wen16; Hu, Peng17; Li, Dongliang18; Zhao, Limin19; Lan, Pei19; Wang, Chen19; Chen, Chengwei10; Mao, Yimin1

2022-05-01

10.1111/liv.15290

LIVER INTERNATIONAL   影响因子和分区

1478-3223

1478-3231

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 (registration no. NCT02944552).

bicyclol drug-induced liver injury randomized clinical trial

SCI

英语

其他

Gastroenterology & Hepatology

Gastroenterology & Hepatology

WOS:000799771100001

WILEY

CLINICAL MEDICINE

Web of Science

1.Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Shanghai Inst Digest Dis,Div Gastroenterol & Hepa, Shanghai 200001, Peoples R China
2.Shanghai Pulm Hosp, Dept TB, Shanghai, Peoples R China
3.Capital Med Univ, Beijing Chest Hosp, Dept TB, Beijing, Peoples R China
4.Henan Infect Dis Hosp, Dept TB, Peoples Hosp Zhengzhou 6, Zhengzhou, Henan, Peoples R China
5.Xinxiang Med Univ, Dept TB, Affiliated Hosp 1, Weihui, Henan, Peoples R China
6.Shanghai Putuo Dist Cent Hosp, Dept Infect Dis, Shanghai, Peoples R China
7.Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Dept Infect Dis, Shanghai, Peoples R China
8.Univ Sci & Technol China, Dept Infect Dis, Affiliated Hosp 1, Hefei, Peoples R China
9.Tianjin Haihe Hosp, Dept TB, Tianjin, Peoples R China
10.Naval 905 Hosp, Liver Dis Ctr, Shanghai 200235, Peoples R China
11.Jiangsu Prov Hosp, Dept Infect Dis, Nanjing, Peoples R China
12.Southern Univ Sci & Technol, Peoples Hosp Shenzhen 3, Dept Liver Dis, Affiliated Hosp 2, Shenzhen, Guangdong, Peoples R China
13.Cent South Univ, Dept Infect Dis, Xiangya Hosp 2, Changshang, Peoples R China
14.Tongji Univ, Dept Gastroenterol, Tongji Hosp, Shanghai, Peoples R China
15.Henan Prov Peoples Hosp, Dept Infect Dis, Zhengzhou, Henan, Peoples R China
16.Capital Med Univ, Beijing Ditan Hosp, Ctr Liver Dis, Beijing, Peoples R China
17.Chongqing Med Univ, Dept Infect Dis, Affiliated Hosp 2, Chongqing, Peoples R China
18.PLAs Joint Logist Support Force, Dept Hepatobiliary Dis, Hosp 900, Fuzhou, Fujian, Peoples R China
19.Beijing Union Pharmaceut Factory, Beijing, Peoples R China

Tang, Jieting,Gu, Jin,Chu, Naihui,et al. Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug-induced liver injury: A multicenter, randomized, phase II trial[J]. LIVER INTERNATIONAL,2022.

Tang, Jieting.,Gu, Jin.,Chu, Naihui.,Chen, Yu.,Wang, Yongliang.,...&Mao, Yimin.(2022).Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug-induced liver injury: A multicenter, randomized, phase II trial.LIVER INTERNATIONAL.

Tang, Jieting,et al."Efficacy and safety of bicyclol for treating patients with idiosyncratic acute drug-induced liver injury: A multicenter, randomized, phase II trial".LIVER INTERNATIONAL (2022).