口服中成药治疗血管性痴呆疗效与安全性的贝叶斯网状Meta分析  

Bayesian Network Meta-analysis on the Efficacy and Safety of Oral Chinese Patent Drugs in the Treatment of Vascular Dementia

作　　者：李锋森 刘志勇[2] 乔明亮[2] 成家宏 孟毅[2] Li Fengsen;Liu Zhiyong;Qiao Mingliang;Cheng Jiahong;Meng Yi(Henan University of Traditional Chinese Medicine,Zhengzhou 450003,China;Henan Hospital of Traditional Chinese Medicine)

机构地区：[1]河南中医药大学,郑州450003 [2]河南省中医院

出　　处：《中国药师》2022年第4期655-663,共9页China Pharmacist

基　　金：河南省中医药科学研究专项重点课题(编号:20-21ZY1024)。

摘　　要：目的:基于贝叶斯网状Meta分析方法,探索评价中成药治疗血管性痴呆的临床疗效与安全性。方法:根据2020年中成药治疗血管性痴呆临床应用指南,选取5种口服中成药,即通心络胶囊、银杏叶片、天智颗粒、复方苁蓉益智胶囊、复方丹参片,检索Cochrane Library、PubMed、Web of Science、VIP、CNKI、WanFang Data数据库,搜集关于银杏叶片、天智颗粒、复方苁蓉益智胶囊、通心络胶囊和复方丹参片治疗血管性痴呆的随机对照试验(RCT),检索时限均为建库至2021年3月30日,两名研究人员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,应用R 3.6.2软件进行贝叶斯网状Meta分析,Stata 15.1软件绘制网状证据图、发表偏倚检测的比较-校正漏斗图及预测区间图。结果:共纳入69个RCT,累计6 917例患者,贝叶斯网状Meta分析结果显示:(1)与常规西药治疗比较,中成药及中成药联合常规西药治疗均可显著提高患者的总有效率,总有效率排序:复方丹参片>复方苁蓉益智胶囊>银杏叶片联合常规西药>天智颗粒联合常规西药>通心络胶囊联合常规西药>银杏叶片>通心络胶囊>天智颗粒>常规西药>安慰剂;(2)改善简易智力状态检查表(MMSE)评分排序:通心络联合常规西药>银杏叶片联合常规西药>天智颗粒联合常规西药>通心络胶囊>银杏叶片>天智颗粒>常规西药>复方苁蓉益智胶囊;(3)安全性排序:通心络胶囊>银杏叶片>银杏叶片联合常规西药>常规西药>天智颗粒>复方苁蓉益智胶囊>天智颗粒联合常规西药。结论:口服中成药联合常规西药治疗血管性痴呆疗效显著,推荐临床使用,同时根据患者不同病情特点需求选择适宜的干预措施,其中银杏叶片联合常规西药各方面较优。但鉴于个别中成药干预试验样本量不多,所得结论还需要高质量、大样本的RCT进行进一步验证。Objective:To explore and evaluate the clinical efficacy and safety of Chinese patent drugs in the treatment of vascular dementia based on Bayesian network Meta-analysis.Methods:According to the clinical application guidelines for Chinese patent drugs in the treatment of vascular dementia in 2020,five kinds of oral Chinese patent drugs were selected,namely Tongxinluo capsules,Ginkgo biloba leaves,Tianzhi granule,compound Cistanche Yizhi capsules and compound Danshen tablets.The Cochrane Library,Pubmed,Web of Science,VIP,CNKI and WanFang Data databases were electronically searched to collect the randomized controlled trials(RCTs) on ginkgo biloba,Tianzhi granule,compound Cistanche Yizhi capsules,Tongxinluo capsules and compound Danshen tablets in the treatment of vascular dementia from inception to March 2021.Two reviewers independently screened literature,extracted data,and assessed the risk of bias of included studies,R 3.6.2 software was used for Bayesian network Meta-analysis,and Stata 15.1 software was used to draw reticular evidence map,publication bias correction-comparison funnel chart and prediction interval map.Results:A total of 69 RCTs involving 6 917 patients were included.The results of Bayesian network Meta-analysis showed that:(1) Compared with the conventional western medicine treatment,Chinese patent drugs alone or combined with the conventional western medicine could significantly improve the total effective rate of patients.The order of total effective rate was as follows:compound Danshen tablets > compound Cistanche Yizhi capsules > Ginkgo biloba leaves combined with conventional western medicine > Tianzhi granule combined with conventional western medicine > Tongxinluo capsules combined with conventional western medicine > Ginkgo biloba leaves > Tongxinluo capsules > Tianzhi granule > conventional western medicine > placebo.(2) The order of improving MMSE score was as follows:Tongxinluo combined with western medicine > ginkgo biloba leaves combined with western medicine > Tianzhi granule combi

关 键 词：血管性痴呆 中成药 银杏叶片 天智颗粒 复方苁蓉益智胶囊 通心络胶囊 复方丹参片 网状Meta分析 

分 类 号：R286[医药卫生—中药学]