甘草酸二铵制剂治疗药物性肝损害有效性与安全性的系统评价

Meta-analysis of Clinical Efficacy and Safety of Diammonium Glycyrrhizinate in Treatment of Patients with Drug-induced Liver Injury

目的系统评价甘草酸二铵制剂治疗药物性肝损害(drug-inducedliverinjury,DILI)的有效性与安全性。方法检索PubMed、EMBase、Cochrane Library、CNKI、Sinomed、万方数据库和维普数据库公开发表的研究,纳入甘草酸二铵制剂治疗DILI的随机对照试验(randomized controlled trials,RCTs),检索时间从建库到2018年2月,采用Rev Man 5.3统计软件进行meta分析。结果最终纳入24项RCTs,合计2 116例患者。meta分析结果显示:与对照组相比,甘草酸二铵制剂组的治疗有效率更高,RR=1.20,[95%CI(1.12,1.28),P<0.0001]。肝功能指标ALT、AST水平显著下降,WMD_((ALT))=-20.01,[95%CI(-29.00,-11.02),P<0.000 1];WMD_((AST))=-64.36,[95%CI(-92.77,-35.96),P<0.000 1]。且甘草酸二铵组的TBIL和ALT指标复常时间明显快于对照组(P<0.05)。但2组在降低TBIL、ALB、GGT水平和不良反应发生率方面均无统计学意义。结论甘草酸二铵制剂能够有效治疗DILI,不良反应发生率较其他保肝药差异无统计学意义。

OBJECTIVE To system assess the clinical efficacy and safety of diammonium glycyrrhizinate against drug-induced liver injury(DILI). METHODS Studies in Pubmed, EMBase, Cochrane Library, CNKI, Sinomed, Vip and Wanfang database were searched to collect randomized controlled trials(RCTs) regarding the treatment of DILI by diammonium glycyrrhizinate from initial to February 2018. Meta-analysis was conducted by using Rev Man 5.3 statistical software. RESULTS A total of 2 116 patients from 24 RCTs were included. Meta-analysis result showed that compared with control group, diammonium glycyrrhizinate group had higher clinical effective rate, RR=1.20, (95% CI(1.12, 1.28), P<0.000 1)And it was superior in reduction of biochemical indicators such as ALT, AST, WMD(ALT)=-20.01, [95% CI(-29.00,-11.02), P<0.000 1];WMD(AST)=-64.36, (95%CI(-92.77,-35.96), P<0.000 1)Also, it was superior in the recovery time for TBIL and AST compared with control group(P<0.05). But there was no statistical significance in reduction of TBIL, ALB, GGT and the rate of drug adverse reaction. CONCLUSION Diammonium glycyrrhizinate is effective in treatment of DILI patients, there is no statistical significance in the rate of drug adverse reaction compared with other protection drugs.