中医药治疗阿尔茨海默病随机对照试验的系统评价

Systematic review of randomized controlled trials of traditional Chinese medicine in treating Alzheimer's disease

目的:系统评价中医药治疗阿尔茨海默病的临床疗效及安全性。方法:计算机检索Pubmed、CBM、VIP、CNKI检索系统,手工检索相关期刊及灰色文献,纳入中医药治疗阿尔茨海默病的随机对照试验(RCT)。根据随机分配方法、随机方案隐藏、盲法和意向性治疗分析逐个评价纳入研究的质量。2位研究员独立提取资料、评价质量。采用Review Manager 4.3软件进行统计分析。结果:纳入7项符合纳入标准的随机对照试验包括678例患者,均以中文发表。均为低质量试验。结果显示:①总有效率:共纳入7项RCT,中药治疗组总有效率均高于对照组。②MMSE评分:共纳入3项RCT,结果显示,2项RCT研究中药治疗组MMSE评分优于对照组。③ADL评分:共纳入2项RCT,1项RCT显示中药治疗组ADL评分低于对照组。④HDS评分:共纳入3项RCT,2项RCT显示治疗组ADAS-cog评分高于对照组。⑤MQ评分:共纳入1项RCT研究,治疗后MQ评分中药治疗组明显优于对照组。⑥所纳入文献均未发现与中药相关严重的不良反应。结论:中医药可改善阿尔茨海默病患者临床症状、缓解病情,无明显严重不良反应。由于纳入试验的方法学质量普遍偏低,缺乏重要的终点指标,其临床有效性和安全性尚需大量高质量研究支持。

Objective： To evaluate the efficacy and safety of traditional Chinese medicine therapies for Alzheimer＇s disease.Methods： We searched Pubmed Chinese Biomedical Literature（CBM）,VIP,China National Knowledge Infrastruture（CNKI）,and performed a manual search of the RCTs of TCM therapies for AD among periodicals related to TCM.At least two reviewers independently screened the studier for eligibility,evaluated the extracted the data from the eligible literatures with a cross-check to confirm accuracy.Meta-analysis were performed by using Review Manager 4.3 software.Methodological quality of trials was assessed in terms of generation of allocation sequence,allocation concealment,blinding,and intention-to-treat.Results： A total of 7 randomized controlled trials（678 patients） in the Chinese language were identified.The 7 RCTs were low methodological quality.Results showed： ① Total effect： 7 RCTs reported that TCM was more effective than western medicine.② MMSE score： 3 RCTs reported MMSE scores and only 1 RCT indicated that TCM was more higher than western medicine.③ ADL score： 2 RCTs reported ADL scores and only 1 RCT indicated that TCM was more lower than western medicine.④ HDS score： 3 RCTs reported ADAS-cog scores and only 2 RCT indicated that TCM alone was more effective than western medicine.⑤ MQ score： 1 RCTs reported indicated that TCM alone was more effective than western medicine.⑥ No obvious adverse reaction to TCM was reported.Conclusions： TCM therapy may have beneficial effects in improving the clinical symptoms without obvious adverse reaction.Due to the generally low methodological quality of trials included,more high quality of RCTs are required to support the findings.