摘要
目的以网状Meta分析的方法评价和比较强肝胶囊、壳脂胶囊、当飞利肝宁胶囊(片)、化滞柔肝颗粒、三七脂肝丸和脂必泰胶囊6种中成药治疗非酒精性脂肪性肝病(NAFLD)的有效性和安全性。方法对Pubmed、Embase、Cochrane Library、中国知网(CNKI)、万方数据库(Wanfang)、维普中文期刊(VIP)及中国生物医学文献数据库(SinoMed)进行检索,收集单一应用中成药治疗NAFLD的随机对照试验(Randomized controlled trials,RCTs),时间范围为数据库建库至2022年12月31日。由课题组2名研究人员按照纳入、排除标准进行文献筛选和信息提取,采用Cochrane偏倚风险评估工具对RCTs进行质量评估,并使用Note Express和RevMan 5.3软件进行文献管理和质量评价,最后采用Stata/SE 15.1、R studio 4.1.2软件进行数据分析和制图。结果最终纳入26篇RCTs,共计3017例患者,其中试验组1524例,对照组1493例。网状Meta分析结果显示,与口服化学药物相比,6种中成药单独使用治疗结果如下:临床总有效率累积概率排序前3位分别为脂必泰胶囊、三七脂肝丸、当飞利肝宁胶囊(片);在改善丙氨酸氨基转移酶(ALT)及天门冬氨酸氨基转移酶(AST)方面,脂必泰胶囊效果最佳;在改善总胆固醇(TC)以及甘油三酯(TG)方面,当飞利肝宁胶囊(片)的效果最佳;在安全性方面,除脂必泰胶囊及当飞利肝宁胶囊(片)未见报道相关不良反应,其余4种中成药均有报道,不良反应大多较轻,以消化道症状为主。结论强肝胶囊、壳脂胶囊、当飞利肝宁胶囊(片)、化滞柔肝颗粒、三七脂肝丸以及脂必泰胶囊6种中成药可有效提高NAFLD的临床疗效,在治疗时各有优势,安全性较高,但由于缺少各药间直接对比,且纳入文献总体质量不高,证据强度还需更多的RCTs验证。
Objective To evaluate and compare the efficacy and safety of six Chinese patent medicines,namely Qianggan Capsules,Kezhi Capsules,Dangfei Liganning Capsules(Tablets),Huazhi Rougan Granules,Sanqi Zhigan Pills,and Zhibitai Capsules,in the treatment of nonalcoholic fatty liver disease(NAFLD).Methods A comprehensive search was conducted in databases such as Pubmed,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI),Wanfang Database(Wanfang),VIP Chinese Journals(VIP),and Chinese Biomedical Literature Database(SinoMed)to identify randomized controlled trials(RCTs),concerning patients with NAFLD treated with a proprietary Chinese patent medicine.The search timeframe extended from the inception of the databases to December 31,2022.Two researchers in the research group performed literature screening and data extraction according to the inclusion and excluding criteria.The quality of RCT was assessed using the Cochrane bias risk assessment tool,the management and quality evaluation of literature were conducted by using Note Express and RevMan 5.3 software.Data analysis and visualization were performed using Stata/SE 15.1 and R Studio 4.1.2 software.Results A total of 26 RCTs,involving 3017 patients(1524 in the trial group and 1493 in the control group),were included in the analysis.The network Meta-analysis results revealed the following findings for the six Chinese patent medicines as compared to oral chemical drugs:①The top three ranking in the cumulative probability of the total clinical effective rate were Zhibitai Capsules,Sanqi Zhigan Pills,and Dangfei Liganning Capsules(Tablets).②Zhibitai Capsules showed the most favorable effect on improving alanine aminotransferase(ALT)and aspartate aminotransferase(AST)levels.③Dangfei Liganning Capsules(Tablets)exhibited the best effect on improving total cholesterol(TC)and triglyceride(TG)levels.①No adverse reactions of Zhibitai Capsules and Dangfei Liganning Capsules were reported in terms of safety.The adverse reactions of other Chinese patent medicin
作者
范文
郑垂仰
周旋
孔怡琳
潘丰满
杨钦河
张玉佩
FAN Wen;ZHENG Chuiyang;ZHOU Xuan;KONG Yilin;PAN Fengman;YANG Qinhe;ZHANG Yupei(School of Traditional Chinese Medicine,Jinan University,Guangzhou 510632 Guangdong,China;The Second Affliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510006 Guangdong,China;Yangtze University Health Science Center,Jingzhou 434023 Hubei,China)
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2023年第11期1612-1622,共11页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
国家自然科学基金面上项目(82274393,82374230)
广东自然科学基金面上项目(2021A1515012173,2022A1515011577)
广东省中医药信息化重点实验室开放基金项目(2021B1212040007-2021201)
广东省中医药局项目(20231085)
湖北省卫健委中医药科研项目(ZY2021M099)
国家中医药管理局全国名老中医传承工作室建设项目(国中医药人教函[2022]75号)。
