目的 系統(tǒng)評價(jià)復(fù)方海蛇膠囊聯(lián)合多奈哌齊治療阿爾茨海默病的療效與安全性。方法 計(jì)算機(jī)檢索PubMed、維普中文數(shù)據(jù)庫（VIP）、中國知網(wǎng)（CNKI）、萬方醫(yī)學(xué)網(wǎng)及中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫（CBM），收集復(fù)方海蛇膠囊聯(lián)合多奈哌齊（試驗(yàn)組）對比單用多奈哌齊（對照組）治療阿爾茨海默病的隨機(jī)對照研究（RCT），檢索時(shí)限2000年1月—2017年2月。篩選文獻(xiàn)、提取數(shù)據(jù)并對納入RCT進(jìn)行方法學(xué)質(zhì)量評價(jià)，采用RevMan 5.0軟件對各效應(yīng)指標(biāo)進(jìn)行Meta分析。結(jié)果 共納入8篇RCT，合計(jì)605例患者。Meta分析結(jié)果顯示：試驗(yàn)組在簡易智能精神狀態(tài)量表評分[P<0.001，MD=2.69，95% CI=（1.46，3.92）]、認(rèn)知初級量表評分[P<0.001，MD=-4.54，95% CI（-5.64，-3.43）]和日常生活能力量表評分[P<0.001，MD=-3.60，95% CI（-4.53，-2.66）]方面與對照組比較，差異有統(tǒng)計(jì)學(xué)意義；試驗(yàn)組與對照組不良反應(yīng)發(fā)生率相當(dāng)[P=0.94，OR=1.02，95% CI（0.63，1.66）]，差異無統(tǒng)計(jì)學(xué)意義。結(jié)論 復(fù)方海蛇膠囊聯(lián)合多奈哌齊治療阿爾茨海默病的臨床療效優(yōu)于單用多奈哌齊，且聯(lián)用未導(dǎo)致不良反應(yīng)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.