Bicyclol for the treatment of drug-induced liver injury: a propensity score matching analysis using a nationwide inpatient database

Author:

Wang Yongfeng1,Lai Rongtao2,Zong Peilan3,Xu Qingling4,Shang Jia5,Zhang Xia6,Zhong Wei1,Tang Jieting1,Han Xi’an7,Chen Chengwei8,Mao Yimin1ORCID

Affiliation:

1. Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China

2. Department of Infectious Diseases, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China

3. Chest Hospital of Jiangxi Province, No. 346, Nanchang City, Jiangxi Province, China

4. Department of Liver Disease, Mengchao Hepatobiliary Hospital, Fujian Medical University, Fujian Province, China

5. Department of Infectious Diseases, People’s Hospital of Henan Province, Henan Province, China

6. Department of Tuberculosis, the Second Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing City, China

7. Unimed Scientific Inc., Wuxi, China

8. Liver Disease Center of Naval 905 Hospital, Shanghai, China

Abstract

ObjectiveTo evaluate the efficacy and safety of bicyclol in patients with drug-induced liver injury (DILI) using a nationwide database.MethodsWe retrospectively analyzed the clinical data of DILI patients in the DILI-R database. Propensity score matching was performed to balance the bicyclol and control groups, and alanine aminotransferase (ALT) recovery was compared between the two groups. Factors associated with ALT recovery and safety were identified.ResultsThe analysis included the data of 25,927 patients. Eighty-seven cases were included in the bicyclol group, with 932 cases in the control group. One-to-one propensity score matching created 86 matched pairs. The ALT normalization rate in the bicyclol group was significantly higher than that in the control group (50.00% vs. 24.42%), and statistical significance was found in the superiority test. After adjustment of baseline ALT levels, baseline total bilirubin levels, sex, age, acute or chronic liver diseases, and suspected drugs in the multivariate logic regression analysis, the major influencing factors for ALT recovery included the time interval between ALT tests (days) and the group factor (bicyclol treatment). There were no differences in the proportion of renal function impairment or blood abnormalities between the two groups.ConclusionsBicyclol is a potential candidate for DILI.

Funder

the Clinical Research Center, Shanghai Jiao Tong University School of Medicine

the Shanghai Shenkang Hospital Development Center

the National Natural Science Foundation of China

the Major Project of National Thirteenth Five Plan

the Major Project of National Twelfth Five Plan

Publisher

SAGE Publications

Subject

Biochemistry, medical,Cell Biology,Biochemistry,General Medicine

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