摘要
目的系统评价异甘草酸镁用于治疗药物性肝损伤(drug-induced liver injury,DILI)的有效性及安全性,完善其循证医学证据。方法计算机检索PubMed、The Cochrane Library、CNKI、VIP和WanFang Data数据库,纳入异甘草酸镁用于治疗DILI的随机对照试验(randomized controlled trials,RCT),检索时限2004年1月至2017年12月,筛查文献、提取资料并进行质量评价后,采用Rev Man 5.3统计软件进行Meta分析。结果共纳入20项RCT,纳入DILI患者1 709例。Meta分析结果显示,异甘草酸镁治疗DILI的总有效率及显效率优于对照组[RR=1.15,95%CI(1.08,1.22),P<0.01]及[RR=1.56,95%CI(1.31,1.85),P<0.01],降低DILI患者ALT水平优于对照组[MD=-31.25,95%CI(-38.97,-23.54),P<0.01];异甘草酸镁ADR发生率低于其他甘草酸制剂[RR=0.29,95%CI(0.16,0.52),P<0.01],但对比非甘草酸类药物差异无统计学意义。结论异甘草酸镁治疗DILI的有效性优于其他常用护肝药物,尤其是能够显著降低DILI患者ALT水平,短期应用安全性较好。受纳入研究方法学质量的限制,该结论有待大样本、高质量的RCT进一步验证。
OBJECTIVE To systematically evaluate the efficacy and safety of magnesium isoglycyrrhizinate in the treatment of drug-induced liver injury( DILI). METHODS We searched PubMed,The Cochrane Library,CNKI,VIP and WanFang data from Jan 2004 to Dec 2017 to collect randomized controlled trials( RCT) of magnesium isoglycyrrhizinate for the treatment of drug-induced liver injury( DILI). Two reviewers independently screened literature,extracted data including basic information,demographic data and clinical characteristics,intervention details,outcome indicators,and so on. Assessed the risk of bias of included studies. Then,Metaanalysis was performed using RevMan 5.3 software. RESULTS A total of 20 RCTs involving 1 709 DILI patients were included. The results of Meta-analysis showed that,the overall response rate and normalized rate of magnesium isoglycyrrhizinate for DILI were significantly higher than control [RR = 1. 15,95% CI( 1. 08,1. 22),P < 0. 01] and [RR = 1. 56,95% CI( 1. 31,1. 85),P < 0. 01].Magnesium isoglycyrrhizinate could significantly lower ALT level than control[MD =-31.25,95%CI(-38.97,-23.54),P< 0.01]. The occurrence rate of ADR was significantly lower in the magnesium isoglycyrrhizinate group compared with other glycyrrhizin subgroup[RR= 0. 29,95% CI( 0. 16,0. 52),P < 0. 01] and was not different from non-glycyrrhizin subgroup. CONCLUSION Magnesium isoglycyrrhizinate treating DILI is superior to other common liver-protecting drugs,especially in lowering ALT level and safety in short term. However,limited to the quality of the included trials,clinical trials of bigger sample size and higher quality is needed to validate this result.
作者
张泽伟
谢晓纯
陈佳佳
黄少楷
ZHANG Zewei;XIE Xiaochun;CHEN Jiajia;HUANG Shaokai(Department of Pharmacy, Jieyang Affiliated Hospital, Sun Yat-sen University, Jieyang, Guangdong 522000, China)
出处
《今日药学》
CAS
2019年第7期453-460,共8页
Pharmacy Today
关键词
药物性肝损伤
异甘草酸镁
疗效
药品不良反应
META分析
drug-induced liver injury
magnesium isoglycyrrhizinate
efficacy
adverse drug reaction
Meta-analysis
