补肾化痰祛瘀法治疗血管性认知功能障碍随机对照试验的Meta分析

Meta-analysis of Randomized Controlled Trials on Vascular Cognitive Impairment by Method of Invigorating Kidney, Dissipating Phlegm and Removing Blood Stasis

摘要:

目的: 通过对补肾化痰祛瘀法治疗血管性认知功能障碍(VCI)进行文献整理和分析,客观评价其有效性及安全性,为临床提供循证医学证据。 方法: 用Meta分析方法,计算机检索PubMed,Cochrane,生物医学,中国知网,维普及万方等数据库(2001~2011年),两名评价者独立检索、筛选、纳入符合标准的文献,提取有效数据并采用Revman 5.1软件对各研究结果进行系统评价。 结果: 从中医药治疗VCI的569篇文献中,按照纳入标准筛出18篇随机对照试验(RCT)文献。Meta分析结果显示:①补肾化痰祛瘀法干预的治疗组在简易精神状态量表(MMSE),BBS评分方面优于对照组(P＜0.05);②在ADL评分方面两组相似;③安全性方面,经卡方检验,差异没有统计学意义,提示两组不良反应发生率无显著性差异。 结论: 就目前能获得的临床证据表明,补肾化痰祛瘀法治疗VCI有较好疗效,安全性方面两组无显著性差异。鉴于在试验设计和结局指标的选择等方面存在的问题,中医临床试验应具有辨证诊疗过程;制定并采用统一的症状疗效评价标准;推动开展更多的设计合理、执行严格、多中心大样本、随访时间足够、有中医特色的RCT。

Abstract:

Objective:Through screening and analyzing of clinical research literature on vascular cagnitive impairment(VCI), objectively evaluate the efficacy and the safety of the therapy of invigorating kidney, removing phlegm and blood stasis, to provide clinical evidence of evidence-based medicine. Method: With the method of cochrane systematic review, searching randomized controlled trial(RCT) reports of PubMed, Cochrane, CBM, CNKI, VIP, Wanfang (2001-2011), collecting the researches met inclusion criteria by two independent evaluators, analyzing data using Revman 5.1. Result: According to the inclusion criteria, screened out 18 articles of RCT qualified reports from 569 of Chinese medicine treatment of VCI, of which 18 reports had relative high quality. The results showed that: ①The therapy of invigorating kidney and removing phlegm and blood stasis had a better efficacy than the control group by mini-mental state examination(MMSE),BBS(P＜0.05);②There was no significant difference shown by ADL;③ There was no statistical significant difference in safety, indicating that the two groups of incidence of adverse reaction no significant differences by Chi-square test. Conclusion: Available evidences manifests: the therapy has a better efficacy and no significant differences in safety. Due to defects of experimental design and selection of the outcome indexes, should have the process of syndrome differentiation of traditional Chinese medicine(TCM) and make and use unified syndrome curative effect evaluation standard according to syndrome differentiation of TCM, and need to push in more the rational design, the execution strictly, the multi-central and large sample, long time follow-up and has Chinese medicine characteristics double-blind RCT.