Wang Yongfeng, Lai Rongtao, Zong Peilan, Xu Qingling, Shang Jia, Zhang Xia, Zhong Wei, Tang Jieting, Han Xi'an, Chen Chengwei, Mao Yimin
Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Department of Infectious Diseases, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
J Int Med Res. 2021 Apr;49(4):3000605211005945. doi: 10.1177/03000605211005945.
To evaluate the efficacy and safety of bicyclol in patients with drug-induced liver injury (DILI) using a nationwide database.
We 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.
The 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.
Bicyclol is a potential candidate for DILI.
利用全国性数据库评估双环醇对药物性肝损伤（DILI）患者的疗效和安全性。
我们回顾性分析了DILI-R数据库中DILI患者的临床资料。进行倾向评分匹配以平衡双环醇组和对照组，并比较两组间丙氨酸氨基转移酶（ALT）的恢复情况。确定与ALT恢复及安全性相关的因素。
分析纳入了25927例患者的数据。双环醇组纳入87例，对照组纳入932例。一对一倾向评分匹配产生了86对匹配病例。双环醇组的ALT正常化率显著高于对照组（50.00%对24.42%），在优效性检验中具有统计学意义。在多变量逻辑回归分析中对基线ALT水平、基线总胆红素水平、性别、年龄、急性或慢性肝病以及可疑药物进行调整后，ALT恢复的主要影响因素包括ALT检测间隔时间（天）和分组因素（双环醇治疗）。两组间肾功能损害或血液异常的比例无差异。
双环醇是治疗DILI的潜在候选药物。
