复方苁蓉益智胶囊治疗血管性认知障碍的疗效和安全性系统评价及Meta分析  

Systematic review and Meta-analysis of efficacy and safety of Compound Congrong Yizhi Capsules on vascular cognitive impairment

作　　者：苟金 杨昊昕 于姚 郭蓉娟[1] GOU Jin;YANG Hao-xin;YU Yao;GUO Rong-juan(Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]北京中医药大学东方医院,北京100078 [2]北京中医药大学东直门医院,北京100700

出　　处：《中国中药杂志》2020年第8期1924-1932,共9页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金面上项目(81874422);国家重点研发计划项目(2017YFC1307700)。

摘　　要：系统评价复方苁蓉益智胶囊治疗血管性认知障碍的疗效和安全性的Meta分析。计算机检索中国知网数据库(CNKI)、万方数据资源系统、维普中文科技期刊全文数据库(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane图书馆、ClinicalTrials数据库,收集复方苁蓉益智胶囊治疗血管性认知障碍的随机对照试验。由2名研究者独立根据纳排标准筛选文献、资料提取并核对结果,采用Risk of Bias工具进行方法学质量评估,采用RevMan 5.3进行Meta分析。共纳入12篇文献,包含受试者1 279名,治疗组干预措施为单独使用复方苁蓉益智胶囊或联合西药,对照组为西药或空白对照。结果显示,对轻度血管性认知障碍患者,复方苁蓉益智胶囊在改善MoCA量表评分、提高血清NO水平、降低血清ET-1水平方面优于空白对照;对血管性痴呆患者,复方苁蓉益智胶囊联合西药在改善MMSE,MoCA量表评分方面优于单用西药治疗。5项研究报告不良事件,未发现明显不良反应。该研究发现,单独使用复方苁蓉益智胶囊可改善轻度血管性认知障碍患者的早期认知功能损害,联合使用复方苁蓉益智胶囊和西药改善血管性痴呆患者的认知功能损害效果优于单用西药治疗,未见明显不良反应,临床可考虑使用。该结论仍需开展高质量的临床试验进一步加以证实。To analyze the efficacy and safety of Compound Congrong Yizhi Capsules in treatment of vascular cognitive impairment. Databases, such as CNKI, WanFang, VIP, SinoMed, PubMed, Cochrane Library, ClinicalTrials were electronically retrieved for relevant randomized controlled trials about the effect of Compound Congrong Yizhi Capsules in treatment of vascular cognitive impairment. Two researchers independently screened the literatures and extracted data according to the inclusion criteria, and used the risk of bias assessment tool in the Cochrane evaluation manual for quality assessment. The Cochrane systematic evaluation software RevMan 5.3 was used for data analysis. Totally 12 articles including 1 279 patients were included. The intervention measure was Compound Congrong Yizhi Capsules used alone or combined with Western medicine, and the control measure was the Western medicine alone or the blank control. According to the findings, for patients of vascular cognitive impairment no dementia, Compound Congrong Yizhi Capsules was better than the blank control in improving MoCA scale score and serum NO levels and reducing serum ET-1 levels. For vascular dementia patients, Compound Congrong Yizhi Capsules combined with Western medicine was better than Western medicine alone in improving MMSE and MoCA scale score. Five studies reported adverse events, but no significant adverse reaction was found. In conclusion, Compound Congrong Yizhi Capsules alone could alliviate early cognitive impairment in patients of vascular cognitive impairment no dementia;Compound Congrong Yizhi Capsules combined with Western medicine is superior to Western medicine alone in improving cognitive impairment. No obvious adverse reaction was found. Compound Congrong Yizhi Capsules can be recommended in clinical use. This conclusion needs to be further confirmed in high-quality clinical trials in the future.

关 键 词：复方苁蓉益智胶囊 血管性认知障碍 系统评价 META分析 

分 类 号：R285.6[医药卫生—中药学]