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

作者：Yiqi Du, Jin Gu, Yang Yu, Ying Chen, Ying Wang, Z. Mei, Yun Li, Li Li, D. Xue, Xinhua Wang, Di Li, Peng Hu, Wei Nie, Naihui Chu · 发表于：The International Journal of Tuberculosis and Lung Disease · 年份：2024 · DOI：10.5588/ijtld.23.0038 · 被引用次数：8 · 研究领域：Drug-Induced Hepatotoxicity and Protection、Drug-Induced Ocular Toxicity、Poisoning and overdose treatments

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 â–“149.0 (IQR â–“299.3 to â–“98.3 (), â–“225.5 (IQR â–“309.3 to â–“181.8 ) and â–“242.5 (IQR â–“364.8 to â–“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.