联合异甘草酸镁治疗抗结核药引起的药物性肝损伤疗效与安全性评价  

Meta-analysis and trial sepuential analysis of the efficacy and safety of combined with magnesium isoglycyrrhizinate in the treatment of drug-induced liver injury caused by anti-tuberculosis drugs

作　　者：姚祯 万盼婷[1] 王萍[1] 苏雨 Yao Zhen;Wan Panting;Wang Ping;Su Yu(Department of Pharmacy,the No.2 Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu 210011,China;Collge of Pharmacy,Nanjing Medical University,Nanjing,Jiangsu 210029,China)

机构地区：[1]南京医科大学第二附属医院药学部,江苏南京210011 [2]南京医科大学药学院,江苏南京210029

出　　处：《医药前沿》2020年第3期52-56,共5页Journal of Frontiers of Medicine

摘　　要：目的:系统评价联合异甘草酸镁治疗抗结核药引起的药物性肝损伤疗效与安全性。方法:计算机检索PubMed、EMbase、Cochrane Library、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、万方数字化期刊全文库和维普中文科技期刊全文数据库,收集有关异甘草酸镁治疗抗结核药物引起的肝损伤的随机对照实验(RCTs),检索时间为建库至今。并由2位评价人员独立进行资料提取并评价相关偏倚风险后,采用Rev Man 5.3进行Meta分析,TSA 0.9软件对总有效率进行试验序贯分析。结果:共纳入14个RCTs,合计1169例患者。Meta分析结果显示:(1)联合异甘草酸镁组治疗总有效率高于其它对照组,差异具有统计学意义[OR=5.26,95%CI(3.86,7.18),P<0.00001]。(2)联合异甘草酸镁组治疗后丙氨酸氨基转移酶(ALT)水平[MD=-33.75,95%CI(-40.57,-26.93),P<0.00001]、门冬氨酸氨基转移酶(AST)水平[MD=-31.53,95%CI(-39.33,-23.73),P<0.000015]、总胆红素(TBIL)水平[MD=-8.57,95%CI(-17.21,-0.07),P=0.05],均低于其它治疗组,差异均具有统计学意义。③联合异甘草酸镁组在不良反应发生率上[RR=0.61,95%CI(0.29,1.24,P=0.17]。两组差异无统计学意义。试验序贯分析提示有效率结果可靠。结论:异甘草酸镁治疗抗结核药引起的药物性肝损伤相较其它治疗方法疗效较好,不良反应少。但受纳入研究的质量和数量的影响,尚需更多高质量的研究予以验证。Objective To evaluate the efficacy and safety of combined with magnesium isoglycyrrhizinate in the treatment of druginduced liver injury caused by anti-tuberculosis drugs.Methods Retrieved PubMed,EMbase,Cochrane Library,CBM,CNKI,Wanfang Database,VIP were searched to collect the randomized trials(RCTs)on liver related to anti-tuberculosis drugs treated with magnesium isoglycyrrhizinate.The retrieval time limit ranged from built to date.Meta-analysis was performed using Rev Man 5.3 after two evaluators independently extracted data and assessed the risk of related bias.Trial sequential analysis(TSA)was conducted by usingTSA 0.9 software.Results A total of 14 randomized controlled trials were included,involving 1169 patients.The results of meta-analysis showed that:1.The total effective rate of treatment with magnesium isoglycyrrhizinate was higher than that of other control groups,the difference was statistically significant[OR=5.26,95%CI(3.86,7.18),P<0.00001].2.Alanine aminotransferase(ALT)levels after treatment with magnesium isoglycyrrhizinate[MD=-33.75,95%CI(-40.57,-26.93),P<0.0001],aspartate aminotransferase(AST)level[MD]=-31.53,95%CI(-39.33,-23.73),P<0.00001],Total bilirubin(TBIL)levels[MD=-8.57,95%CI(-17.21,-0.07),P=0.05]were lower than the other control groups,and the differences were statistically significant.3.The incidence of adverse reactions rate[RR=0.61,95%CI(0.29,1.24),P=0.17].The difference were not statistically significant.The results of TSA were reliable.Conclusion Combined with Magnesium isoglycyrrhizinate treatment of drug-induced liver injury caused by anti-tuberculosis drugs is better than other control groups,and less adverse reactions.However,it is needed to more high-quality and large-sample RCTs to support.

关 键 词：异甘草酸镁 抗结核药 药物性肝损伤 META分析 试验序贯分析 

分 类 号：R978.3[医药卫生—药品]