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目的 系统评价甘草酸制剂治疗抗结核药物性肝损伤（anti-tuberculosis drug-induced liver injury, AT-DILI）有效性与安全性。方法 检索国内外各大医学文献数据库，选择以AT-DILI为研究对象的甘草酸制剂随机对照试验（randomized controlled trials, RCTs）文献，经过筛查后开展质量评价，采用RevMan 5.3软件开展Meta分析。结果 最终纳入13项RCTs，合计1 435例患者。Meta分析结果发现：异甘草酸镁（magnesium isoglycyrrhizinate, MI）治疗患者的有效率显著高于其它甘草酸制剂治疗患者[OR=4.57,95%CI:2.93～7.12,P=0.000]；而复方甘草酸苷（compound glycyrrhizin, CG）治疗患者的有效率明显低于其它甘草酸制剂治疗患者[OR=0.37,95%CI:0.24～0.57,P=0.000]，亚组分析显示，甘草酸二铵（diammonium glycyrrihizinate, DG）组、复方甘草酸单胺（compound ammonium glycyrrhizin, CAG）组之间治疗有效率差异无统计学意义（P > 0.05）;4种甘草酸制剂治疗有效率比较MI > DG,CAG > CG,DG与CAG接近。肝功能指标方面：MI组能明显降低丙氨酸氨基转移酶和总胆红素水平[均数差=-21.63,95%CI:-32.03～-11.23,P=0.000]、[均数差=-11.07,95%CI:-20.81～-1.34,P=0.030]，但是对天冬氨酸氨基转移酶水平影响不大。各组不良反应发生率差异无统计学意义（P > 0.05）。结论 MI在治疗AT-DILI有效率、降酶量优于其它甘草酸类制剂，安全性相当。4种甘草酸制剂治疗有效率比较MI > DG≈CAG > CG。
Abstract：Objective To systematically evaluate the efficacy and safety of different glycyrrhizin drugs in the treatment of anti-tuberculosis drug-induced liver injury(AT-DILI). Methods Randomized controlled trials(RCTs) investigating glycyrrhizin preparations for AT-DILI were retrieved from domestic and international medical literature databases. After screening the literature, the quality of the studies was evaluated, and a meta-analysis was conducted using RevMan 5.3 software. Results A total of 13 RCTs involving 1,435 patients were included. Meta-analysis showed clinical effective rate in magnesium isoglycyrrhizinate(MI) group was significantly higher than that of other glycyrrhizin agents group [OR=4.57, 95%CI: 2.93-7.12, P=0.000]. Conversely, compound glycyrrhizin(CG) group was significantly lower than other glycyrrhizin drugs group [OR=0.37, 95%CI: 0.24-0.57, P=0.000]. Subgroups analysis showed that no significant differences were found between diammonium glycyrrihizinate(DG) and compound ammonium glycyrrhizin(CAG) group. Comparison of therapeutic efficacy of four glycyrrhizin agents showed MI > DG, CAG > CG, and DG is close to CAG. Regarding liver function indicators, MI significantly reduced alanine aminotransferase(ALT) and total bilirubin levels more than other glycyrrhizin preparations [MD=-21.63, 95%CI:-32.03--11.23), P=0.000], [MD=-11.07, 95%CI:-20.81--1.34), P=0.030], but had no significant effect on aspartate aminotransferase(AST) levels. And there were no significant differences in the incidence of adverse reactions among 4 groups. Conclusions Magnesium isoglycyrrhizinate(MI) demonstrates superior efficacy in terms of treatment response rate and reduction of ALT and TB levels compared to other glycyrrhizin preparations(CG, DG, CAG) for AT-DILI, while exhibiting comparable safety. Comparison of therapeutic efficacy of four glycyrrhizin preparations indicated MI > DG≈CAG > CG.
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基本信息:
DOI：
中图分类号:R595.3;R575
引用信息:
[1]杨晓明,陈海兰,杨艳杰等.甘草酸制剂治疗抗结核药物性肝损伤的疗效和安全性的Meta分析[J].传染病信息,2025,38(04):326-332.
基金信息:
河北省承德市科技计划项目(202303A096)