清热利湿类中成药治疗非酒精性脂肪性肝病的网状Meta分析

Network Meta-analysis of Chinese patent medicine for clearing heat and removing dampness in treatment of non-alcoholic fatty liver disease

目的系统评价7种清热利湿类口服中成药治疗非酒精性脂肪性肝病(non-alcoholic fatty liver disease,NAFLD)的有效性和安全性。方法检索中国知网(CNKI)、中国生物医学文献数据库(SinoMed)、万方(Wanfang)、维普(VIP)以及PubMed、Cochrane Library、Embase数据库自建库至2022年10月1日所发表的7种清热利湿类中成药治疗NAFLD的随机对照试验(randomized controlled trials,RCTs),对符合纳入、排除标准的研究进行文献质量评价及网状Meta分析。结果纳入37项RCTs,共3472例患者。试验组均使用清热利湿类中成药联合常规治疗,对照组均使用常规治疗。网状Meta分析显示,在临床总有效率方面,胆宁片+常规治疗、壳脂胶囊+常规治疗、强肝胶囊+常规治疗、化滞柔肝颗粒+常规治疗、大黄利胆胶囊+常规治疗及当飞利肝宁胶囊+常规治疗均优于常规治疗;在降低血丙氨酸氨基转移酶(alanine aminotransferase,ALT)方面,化滞柔肝颗粒+常规治疗、胆宁片+常规治疗、强肝胶囊+常规治疗、壳脂胶囊+常规治疗均优于常规治疗;在降低血天冬氨酸氨基转移酶(aspartic aminotransferase,AST)方面,化滞柔肝颗粒+常规治疗、胆宁片+常规治疗、强肝胶囊+常规治疗、壳脂胶囊+常规治疗均优于常规治疗;在降低血总胆固醇(total cholesterol,TC)方面,化滞柔肝颗粒+常规治疗、壳脂胶囊+常规治疗、强肝胶囊+常规治疗均优于常规治疗;在降低血三酰甘油(triglyceride,TG)方面,壳脂胶囊+常规治疗、护肝宁片+常规治疗、胆宁片+常规治疗、化滞柔肝颗粒+常规治疗、强肝胶囊+常规治疗均优于常规治疗。累积排序曲线下面积(surface under the cumulative ranking curve,SUCRA)概率排序显示,当飞利肝宁胶囊+常规治疗及壳脂胶囊+常规治疗分别为提升总有效率、降低TG的最佳方案,化滞柔肝颗粒+常规治疗为降低ALT、AST、TC的最佳方案。结论清热利湿类中成药联合常规治疗NAFLD具有明显优势,但由于纳入的研究普遍方法学质量评价偏低,研究结果仍需高质量RCT予以验证。

Objective To systematically evaluate the efficacy and safety of seven oral Chinese patent medicines for clearing heat and removing dampness in the treatment of non-alcoholic fatty liver disease(NAFLD).Methods The randomized controlled trials(RCTs)of seven Chinese patent medicines for clearing heat and removing dampness in the treatment of NAFLD were retrieved from databases including CNKI,Sinomed,Wanfang,VIP,PubMed,Cochrane Library and Embase,and the time range for searching was from the establishment of databases to October 1,2022.The literature quality evaluation and network Meta-analysis were then conducted for the included studies.Results A total of 37 RCTs with 3472 patients were finally included.The experimental group was treated with a combination of Chinese patent medicine for clearing heat and removing dampness and conventional therapy,and the control group was treated with conventional therapy.Network Meta-analysis results showed that,in terms of total effective rate,Danning Tablets(胆宁片)+conventional therapy,Kezhi Capsules(壳脂胶囊)+conventional therapy,Qianggan Capsules(强肝胶囊)+conventional therapy,Huazhi Rougan Granules(化滞柔肝颗粒)+conventional therapy,Dahuang Lidan Capsules(大黄利胆胶囊)+conventional therapy,Dangfei Liganning Capsules(当飞利肝宁胶囊)+conventional therapy were all superior to conventional therapy.In terms of reducing alanine aminotransferase(ALT),Huazhi Rougan Granules+conventional therapy,Danning Tablets+conventional therapy,Qianggan Capsules+conventional therapy,Kezhi Capsules+conventional therapy were all superior to conventional therapy.In terms of reducing aspartate aminotransferase(AST),Huazhi Rougan Granules+conventional therapy,Danning Tablets+conventional therapy,Qianggan Capsules+conventional therapy,Kezhi Capsules+conventional therapy were all superior to conventional therapy.In terms of reducing blood total cholesterol(TC),Huazhi Rougan Granules+conventional therapy,Kezhi Capsules+conventional therapy,Qianggan Capsules+conventional therapy were all superior to conventional therapy.In terms of reducing blood triglycerides(TG),Kezhi Capsule+conventional therapy,Huganning Tablets(护肝宁片)+conventional therapy,Danning Tablets+conventional therapy,Huazhi Rougan Granules+conventional therapy,Qianggan Capsules+conventional therapy were all superior to conventional therapy.The surface under the cumulative ranking curve(SUCRA)probability ranking showed that Dangfei Liganning Capsules+conventional therapy and Kezhi Capsules+conventional therapy were the best regimens to improve the total efficiency and reduce TG respectively,and Huazhi Rougan Granules+conventional therapy was the best regimen to reduce ALT,AST and TC.Conclusion Chinese patent medicines for clearing heat and removing dampness combined with conventional therapy has obvious advantages in the treatment of NAFLD.However,because of the low methodological quality of some included studies,the results of the study still need to be further verified by high-quality RCTs.