中医药治疗药物性肝损伤的网状Meta分析

Network Meta-analysis of traditional Chinese medicine in treating drug-induced liver injury

为系统评价中医药治疗药物性肝损伤(DILI)的疗效和安全性。该文通过检索中国知网、万方数据库、维普数据库、PubMed、Web of Science等数据库自建库至2020年5月1日所发表的中医药治疗DILI的随机对照试验(RCTs),对符合纳入排除标准的研究进行偏倚风险评价及Meta分析。最终纳入17项研究,均为RCT,共1 407例患者。试验组均使用中草药汤剂或中成药,共涉及11种药物,对照组均使用常规西药治疗。Meta分析结果显示,治疗有效率方面,茵兰益肝颗粒、舒肝宁、降酶灵胶囊、百丹疏肝方及四逆疏肝汤优于西医常规治疗;降低谷丙转氨酶(ALT)方面,茵兰益肝颗粒、舒肝宁、护肝解毒方、五酯片、五草保肝方及六味五灵片优于西医常规治疗;降低谷草转氨酶(AST)方面,舒肝宁、护肝解毒方、五草保肝方、六味五灵片、四逆疏肝汤均优于西医常规治疗;降低总胆红素(TBiL)方面,茵兰益肝颗粒、舒肝宁、解毒护肝饮、五酯片、五草保肝方、百丹疏肝方、四逆疏肝汤优于西医常规治疗。通过网状Meta分析方法,对纳入研究的药物进行排序。结果显示,降酶灵胶囊、舒肝宁、四逆疏肝汤及百丹疏肝方分别为提升有效率、降低ALT,AST,TBiL的最优药物,相较于常规西医治疗具有一定的优势。在纳入的17项研究中,有8项研究描述了安全性问题,其中3项涉及试验组,均为轻微不良反应,停药或对症处理后消失。由于纳入研究的质量偏低,尚待更多高质量的临床研究进一步验证,从而为中医药干预DILI提供更多的循证医学证据。

To systematically evaluate the efficacy and safety of Chinese medicine in the treatment of drug-induced liver injury(DILI). By searching the randomized controlled trials(RCTs) of the Chinese medicine published in CNKI, WanFang, VIP, PubMed, Web of Science, in a time limit from database establishment to May 1, 2020. The bias risk assessment and Meta-analysis were then conducted for the included studies. Seventeen studies were finally included, all of which were RCTs, including 1 407 patients. The experimental group was treated with Chinese herbal medicine decoction or Chinese patent medicine, involving a total of 11 kinds of drugs, and the control group was treated with conventional Western medicine. Meta-analysis results showed that, in terms of treatment effective rate, Yinlan Yigan Granules, Shuganning, Jiangmeiling Capsules, Baidan Shugan Recipe and Sini Shugan Decoction were all superior to Western medicine treatment. In terms of reducing alanine aminotransferase(ALT), Yinlan Yigan Granules, Shuganning, Hugan Jiedu Recipe, Wuzhi Tablets, Wucao Baogan Recipe and Liuwei Wuling Tablets were superior to Western medicine. In terms of reducing aspartate aminotransferase(AST), Shuganning, Hugan Jiedu Recipe, Wucao Baogan Recipe, Liuwei Wuling Tablets and Sini Shugan Decoction were all superior to Western medicine. In terms of reducing total bilirubin(TBiL), Yinlan Yigan Granules, Shuganning, Jiedu Hugan Yin, Wuzhi Tablets, Wucao Baogan Recipe, Baidan Shugan Recipe and Sini Shugan Decoction were all superior to Western medicine treatment. Combined with network Meta-analysis and probability ranking, it can be seen that, Jiangmeiling Capsules, Shuganning, Sini Shugan Decoction and Baidan Shugan Recipe were most likely to be the best drugs to improve the efficiency and reduce ALT, AST, TBiL, respectively, with certain advantages compared to conventional Western medicine treatment. Of the seventeen studies included, eight studies described safety issues, three of which involved the test group, all of which were minor adverse reactions that disappeared after drug withdrawal or symptomatic treatment. However, due to the low quality of the included studies, more high-quality clinical studies are needed for further verification, thus providing more evidence-based medical evidence for Chinese medicine intervention in DILI.