中医药治疗老年痴呆症的疗效与安全性

Clinical efficacy and safety of oral Chinese herbal medicine for Alzheimer's disease

目的系统评价中医药干预对老年痴呆症患者认知功能症状的改善与安全。方法全面搜集单纯中医药与中西医结合对比西药治疗老年痴呆症的相关随机对照试验(RCT)文献,采用计算机综合检索维普数据库、万方数据库、中国知网及中国生物医学文献数据库、Cochrane Library、EMbase与Pub Med,相关文献检索时间止于2014年8月1日;同时在大学图书馆以手工方式检索期刊资料库,对纳入研究的试验则依据Cochrane Handbook 5.1评估偏倚性风险及文献质量;采用软件Rev Man5.2.6进行相关数据分析,结合软件GRADE profiler对本研究的证据质量进行标化测评。结果本研究共纳入31个RCT临床干预文献,受试者2 583例;Meta分析提示:在有效率评测层面,中西医结合(中医药结合西药)疗效优于单纯西药治疗〔OR=3.35,95%CI(2.17,5.17)〕,单纯中医药与西药的有效率比较差异无统计学意义〔OR=1.20,95%CI(0.95,1.51)〕;在痊愈率评测层面,中西医结合(中医药结合西药)效应优于单纯西药治疗〔OR=1.86,95%CI(1.31,2.63)〕,单纯中医药和西药的痊愈率(临床控制率)比较差异无统计学意义〔OR=1.17,95%CI(0.94,1.46)〕;在MMSE评分层面对单纯中医药与西药进行亚组分析,即干预4 w〔WMD=0.31,95%CI(-0.38,0.99)〕、6 w〔WMD=0.18,95%CI(-0.52,0.89)〕、8 w〔WMD=0.75,95%CI(-0.32,1.83)〕及12 w〔WMD=0.06,95%CI(-0.76,0.88)〕组间评分皆无统计学差异(P>0.05)。中医药(中医药结合西药)治疗老年痴呆患者不良事件的发生率(1.18%)显著低于西药干预(9.61%)。结论中医药作为一种有效的干预措施,相对安全可靠,不良反应较少,与西药干预效应相当。

Objective To systematically evaluate efficacy and adverse events of Chinese herbal medicine( CHM) for the treatment of Alzheimer’s Disease( AD). Methods Randomized controlled trial( RCTs) involving CHM or integrative medicine comparing with routine pharmacotherapy for AD were retrieved and collected from database of VIP,WANFANG,CNKI,CBM,Pub Med,EMbase,and the Cochrane Library. The journals related to the research were also manually searched from college library. The quality of literature was conducted by the risk of bias and quality evaluation based on the Cochrane Handbook 5. 1,while the data analysis was handled by the software Rev Man 5. 2. 6of Cochrane Collaboration. The evidence quality grading evaluation for the system review was operated by the software of ’GRADE profiler’.Results Thirty-one studies involving 2 583 participants were contained in the meta-analysis. The main meta-analysis results indicated relative benefits for the effective rate in six studies( odds ratio〔OR〕3. 35,95% CI 2. 17,5. 17) and the cure( control) rate in six studies( OR1. 86,95% CI 1. 31,2. 63) in favor of the CHM plus routine pharmacotherapy group. For CHM compared with routine pharmacotherapy,no significant difference was revealed in effective rate( OR 1. 20,95% CI 0. 95,1. 51),cure rate( OR 1. 17,95% CI 0. 94,1. 46) and the detailed sub-group of MMSE score at the timing-point of week-4〔weighted mean difference( WMD) 0. 31,95% CI- 0. 38,0. 99 〕,week-6( WMD0. 18,95% CI- 0. 52,0. 89),week-8( WMD 0. 75,95% CI- 0. 32,1. 83),week-12( WMD 0. 06,95% CI- 0. 76,0. 88). The GRADE quality level of this systematic review indicated ' very low'. Compared to the routine pharmacotherapy group( 9. 61%),the incidence of adverse events of CHM( 1. 18%) was much lower. Conclusions As a relative safe intervention method for AD,CHM shows benefits with few adverse reactions and relative better effect of improving cognitive function incorporated with the routine pharmacotherapy; CHM reveales no statistical difference while in contrast with routine pharmacotherapy. Further study of rigorous design is required to conducted and provided reference for the decision-making of clinical practice.