Efficacy and safety of bicyclol for treating patients with anti-tuberculosis drug-induced liver injury

作者全名："Du, Y.; Gu, J.; Yang, Y.; Chen, Y.; Wang, Y.; Mei, Z.; Li, Y.; Li, L.; Xue, D.; Wang, X.; Li, D.; Hu, P.; Nie, W.; Chu, N."

作者地址："[Du, Y.; Yang, Y.; Nie, W.; Chu, N.] Capital Med Univ, Beijing Chest Hosp, Dept TB, Beijing 101149, Peoples R China; [Gu, J.] Shanghai Pulm Hosp, Dept TB, Shanghai, Peoples R China; [Chen, Y.] Henan Infect Dis Hosp, Peoples Hosp Zhengzhou 6, Dept TB, Zhengzhou, Peoples R China; [Wang, Y.] Xinxiang Med Univ, Affiliated Hosp 1, Dept TB, Weihui, Peoples R China; [Mei, Z.] Tianjin Haihe Hosp, Dept TB, Tianjin, Peoples R China; [Li, Y.] Cent South Univ, Xiangya Hosp 2, Dept Infect Dis, Changsha, Peoples R China; [Li, L.] Univ Sci & Technol China, Affiliated Hosp 1, Dept Infect Dis, Hefei, Peoples R China; [Xue, D.] Shanghai Putuo Dist Cent Hosp, Dept Infect Dis, Shanghai, Peoples R China; [Wang, X.] Naval 905 Hosp, Liver Dis Ctr, Shanghai, Peoples R China; [Li, D.] 900th Hosp PLAs Joint Logist Support Force, Dept Hepatobiliary Dis, Fuzhou, Peoples R China; [Hu, P.] Chongqing Med Univ, Affiliated Hosp 2, Dept Infect Dis, Chongqing, Peoples R China"

通信作者："Nie, W; Chu, N (通讯作者)，Capital Med Univ, Beijing Chest Hosp, Dept TB, Beijing 101149, Peoples R China."

来源：INTERNATIONAL JOURNAL OF TUBERCULOSIS AND LUNG DISEASE

ESI学科分类：IMMUNOLOGY

WOS号：WOS:001222190900013

JCR分区：Q3

影响因子：4

年份：2024

卷号：28

期号：1

开始页：6

结束页：12

文献类型：Article

关键词：randomised clinical trial; anti-tuberculosis drugs; hepatoprotective; hepatotoxicity

摘要："BACKGROUND: Bicyclol was used for treating idiosyncratic acute drug-induced liver injury (DILI) in a phase II trial. This study was aimed at evaluating the efficacy and safety of bicyclol 25 and 50 mg thrice a day (TID) for treating acute DILI caused by anti-TB drugs in the light of the trial results. METHODS: We analysed clinical data of patients with TB drug-induced DILI in the trial database. The primary endpoint was reduction in serum alanine aminotransferase (ALT) levels after 4 weeks of treatment compared to baseline. RESULTS: Overall, 148 patients were included, with respectively 48, 52 and 48 patients included in the control (456 mg polyene phosphatidylcholine TID), high-dose (50 mg bicyclol TID) and low-dose (25 mg bicyclol TID) groups. ALT levels decreased by respectively -149.0 (IQR -299.3 to -98.3 (), -225.5 (IQR -309.3 to -181.8) and -242.5 (IQR -364.8 to -153.8) U/L in the control, high-dose and low-dose groups (P < 0.001). The ALT normalisation rates at weeks 1, 2, 4, 6 and 8 were higher in the high- and low-dose groups, while adverse events and serious adverse events were similar across groups. CONCLUSIONS: Bicyclol (25 and 50 mg TID) is effective and safe in treating anti-TB DILI, and bicyclol 50 mg TID showed higher efficacy."

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