保肝药物预防及治疗抗结核药物性肝损伤的系统评价再评价  

A systematic review on the prevention and treatment of antituberculous drug-induced liver injury by hepatoprotective drugs

作　　者：高悦 江锋[2] 鹿振辉[3] 王冬梅[4] 苏新 薛婧 GAO Yue;JIANG Feng;LU Zhen-hui(Department of Gastroenterology,Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine(Beijing,100700),China;不详)

机构地区：[1]北京中医药大学东直门医院脾胃科,北京100700 [2]北京中医药大学东直门医院消化科 [3]上海中医药大学附属龙华医院呼吸疾病研究所 [4]北京中医药大学东直门医院内科门诊

出　　处：《中西医结合肝病杂志》2024年第4期341-347,350,共8页Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases

基　　金：国家科技重大专项(No.2018ZX10725-509-002)。

摘　　要：目的:对保肝药物预防及治疗抗结核药物性肝损伤(ATB-DILI)的系统评价的方法学质量和证据质量等级进行评价,为临床用药及今后临床研究方向提供一定的参考。方法:通过检索The Cochrane Library、EMBASE、PubMed、中国知网、中国生物医学文献数据库、维普和万方数据库,筛选出符合纳入标准的系统评价类文献,采取主题词与自由词相结合的方式检索,检索时限均从建库至2023年1月30日。采用AMSTAR 2量表评价纳入研究的系统评价文献的方法学质量,运用GRADE工具对纳入研究的结局指标进行证据质量分级。结果:纳入中英文系统评价共12篇,其中6篇比较了抗结核标准治疗中预防性应用保肝药物组与对照组(有或无安慰剂)肝损伤发生的情况。另6篇系统评价比较了ATB-DILI患者治疗性应用某种保肝药物组与对照组(空白对照或其他保肝药物等)的临床疗效。AMSTAR 2质量评级显示11篇为极低质量、1篇为低质量,其中存在较大缺陷的关键条目为2和7,非关键条目为3、15和16。GRADE证据评价显示12篇系统评价所包含的41项结局指标中,中级质量证据8项,低级质量证据16项,极低级质量证据17项,无高级质量证据。结论:现有证据提示,抗结核治疗中预防性应用保肝药物可降低肝损伤的发生,治疗性应用部分西医保肝药物及中药复方可改善ATB-DILI患者的肝功能,疗效明显,短期安全性可。但纳入文献的方法学质量与结论的证据等级均较低,需加强系统评价的方法学质量和证据质量。Objective:To evaluate the methodological quality and outcome indexes of systematic evaluation of anti-tuberculosis drug-induced liver injury(ATB-DILI)prevention and treatment,so as to provide reference for clinical drug use and clinical research.Methods:By searching The Cochrane Library,EMBASE,PubMed,CNKI,CBM VIP and WF databases,systematic review literatures meeting the inclusion criteria were screened.Subject words and free words were used to search,and the search time was from the establishment of the database to January 30,2023.The methodological quality of the included systematic review literature was evaluated using the AMSTAR 2 scale,and the evidence quality of the included outcome indicators was graded using the GRADE tool.Results:A total of 12 systematic reviews in both Chinese and English were included,six of which compared the incidence of liver injury between the prophylactic hepatoprotective drug group and the control group(with or without placebo)during standard anti-tuberculosis therapy.Another six systematic reviews compared the clinical efficacy of therapeutic use of a hepatoprotective drug in patients with ATB-DILI with those of controls(blank control or other hepatoprotective drugs,etc).The AMSTAR 2 quality rating showed that 11 articles were of very low quality and 1 was of low quality,among which the critical items with major defects were 2 and 7,and the non-critical items were 3,15 and 16.GRADE evidence evaluation showed that among 41 outcome indicators included in 12 systematic evaluations,there were 8 evidence of intermediate quality,16 evidence of low quality,17 evidence of very low quality and no evidence of high quality.Conclusion:The existing evidence suggests that prophylacticapplicationof hepatoprotective drugs in anti-tuberculosis therapy can reduce the occurrence of liver injury,and therapeutic application of some Western Medical insurance liver drugs and Chinese herbal compound can improve the liver function of ATB-DILI patients,with obvious efficacy and short-term safety.However,

关 键 词：抗结核药物性肝损伤 保肝药物 系统评价 再评价 AMSTAR 2量表 

分 类 号：R575[医药卫生—消化系统]