目的 系统评价复方海蛇胶囊联合多奈哌齐治疗阿尔茨海默病的疗效与安全性。方法 计算机检索PubMed、维普中文数据库（VIP）、中国知网（CNKI）、万方医学网及中国生物医学文献数据库（CBM），收集复方海蛇胶囊联合多奈哌齐（试验组）对比单用多奈哌齐（对照组）治疗阿尔茨海默病的随机对照研究（RCT），检索时限2000年1月—2017年2月。筛选文献、提取数据并对纳入RCT进行方法学质量评价，采用RevMan 5.0软件对各效应指标进行Meta分析。结果 共纳入8篇RCT，合计605例患者。Meta分析结果显示：试验组在简易智能精神状态量表评分[P<0.001，MD=2.69，95% CI=（1.46，3.92）]、认知初级量表评分[P<0.001，MD=-4.54，95% CI（-5.64，-3.43）]和日常生活能力量表评分[P<0.001，MD=-3.60，95% CI（-4.53，-2.66）]方面与对照组比较，差异有统计学意义；试验组与对照组不良反应发生率相当[P=0.94，OR=1.02，95% CI（0.63，1.66）]，差异无统计学意义。结论 复方海蛇胶囊联合多奈哌齐治疗阿尔茨海默病的临床疗效优于单用多奈哌齐，且联用未导致不良反应增加。

Objective To evaluate the efficacy and safety of Reinhartdt and Sea Capsule (RSC) combined with donepezil (experimental group) compared with donepezil (control group) in treatment of Alzheimer's disease.Methods The randomized controlled trials (RCT) of reinhartdt and sea capsule combine with donepezil in treatment of Alzheimer's disease were searched from Pubmed, VIP, CNKI, CBM, and Wangfang detabase by computer. Deadline from January 2000 to February 2017. References of included studies were also retrieved, extracted data, and assessed the methodological quality. Then, Meta-analysis was performed using RevMan 5.0 software.Results A total of eight RCTs were included, including 605 patients with insomnia. Meta-analysis results showed that compared with control group, experimental group MMSE score[P<0.001, MD=2.69, 95%CI(1.46, 3.92)], ADAS-Cog score[P<0.001, MD=-4.54, 95%CI(-5.64, -3.43)] and ADL score[P<0.001, MD=-3.60, 95%CI(-4.53, -2.66)], the difference was statistical; There was no signficant difference between two group in the incidences of adverse effect[P=0.94, OR=1.02, 95%CI(0.63, 1.66)].Conclusion RSC combined with donepezil showed better efficacy for Alzheimer's disease, yet without increasing adverse effect rate as compared with donepezil alone.