Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China.
West China School of Public Health; Sichuan University, Chengdu 610041, China.
Sci Rep. 2016 Sep 6;6:32649. doi: 10.1038/srep32649.
Alpha-glucosidase inhibitors (AGIs) was reported to be associated with several rare adverse hepatic events, but with inconsistent results. We aimed to investigate the risk of hepatotoxicity associated with the use of AGIs in patients with type 2 diabetes mellitus (T2DM), and performed a systematic review and meta-analysis. Fourteen studies (n = 2881) were eligible, all of which were RCTs. Meta-analysis of data regarding elevation of more than 3-fold the upper limit of normal (ULN) of AST and ALT showed statistically significant differences between AGIs treatment versus control (OR 6.86, 95% CI 2.50 to 18.80; OR 6.48, 95% CI 2.40 to 17.49). Subgroup analyses of elevation of more than 1.8-fold ULN of AST and ALT by dose of AGIs showed differential effects on AST and ALT (AST: OR 0.38 vs 7.31, interaction P = 0.003; ALT: OR 0.32 vs 4.55, interaction p = 0.02). Meta-analysis showed that AGIs might increase the risk of hepatotoxicity, and higher dose appeared to be associated with higher risk of hepatotoxicity. However, the evidence is limited with surrogate measures (i.e. ALT and AST), and no clinically important adverse events were observed.
α-葡萄糖苷酶抑制剂 (AGIs) 与一些罕见的肝不良事件有关,但结果不一致。我们旨在研究 2 型糖尿病 (T2DM) 患者使用 AGIs 与肝毒性相关的风险,并进行了系统评价和荟萃分析。14 项研究(n=2881)符合条件,均为 RCT。关于 AST 和 ALT 超过正常上限 (ULN)3 倍以上升高的数据的荟萃分析显示,AGIs 治疗与对照组之间存在统计学显著差异(OR 6.86,95%CI 2.50 至 18.80;OR 6.48,95%CI 2.40 至 17.49)。按 AGIs 剂量进行的 AST 和 ALT 超过 ULN1.8 倍的亚组分析显示,AST 和 ALT 的影响存在差异(AST:OR 0.38 与 7.31,交互作用 P=0.003;ALT:OR 0.32 与 4.55,交互作用 P=0.02)。荟萃分析表明,AGIs 可能会增加肝毒性的风险,并且较高的剂量似乎与更高的肝毒性风险相关。然而,证据是有限的,且仅使用替代指标(即 ALT 和 AST),未观察到临床上重要的不良事件。