石杉碱甲治疗轻中度阿尔茨海默病有效性和安全性的meta-分析.doc

石杉碱甲治疗轻中度阿尔茨海默病有效性和安全性的meta-分析 任晓蕾，张海英，李玉珍(北京大学人民医院药剂科,北京100044) 【摘要】目的：通过对治疗前后的简易精神状态检查表（MMSE）、日常生活活动量表（ADL）、长谷川痴呆量表（HDS）、韦氏记忆商（MQ）的评分，及治疗有效率、不良反应发生例数等Medline(1966-2006)，Embase(1989-2000)，Cochrane图书馆临床对照试验资料库（2007年第1期），CBMdisc（1978-2006）及CNKI(1979-2006)，, 并应用RevMan4.2软件进行统计分析。结果：共纳入5个随机对照试验。Meta－分析结果表明，对轻中度AD病人，石杉碱甲显著提高了MMSE的评分，降低了ADL的评分，且合并治疗效应随着治疗时间延长逐步增大，发表偏倚较小。此外，石杉碱甲还显著提高了MQ评分，但由于纳入试验数较少，可能存在一定发表偏倚。对于HDS评分改变的比较，经敏感性分析，试验质量的影响能逆转结果，需扩大样本量进行分析才能得出结论。有效率比较显示石杉碱甲组较对照组更为有效。安全性比较显示石杉碱甲组较安慰剂组更易产生副作用,但由于纳入文献数较少，发表偏倚较大，故需扩大样本量进行比较才能得出正确结论。结论：基于纳入文献的Meta－分析结果，认为石杉碱甲能有效改善和提高轻中度阿尔茨海默病患者的记忆和认知功能，和安慰剂组相比具有显著性差异，发表偏倚影响较小。在药物安全性方面，石杉碱甲组较安慰剂组更易产生一些副作用，但多为轻度不良反应，对治疗影响不大。上述结论对临床用药有一定的参考性。 【关键词】：阿尔茨海默病；石杉碱甲；meta－分析 Meta- analysis of Efficacy and Security of Huperzine A for Mild to Moderate Alzheimer Disease REN Xiaolei，ZHANG Haiying，LI Yuzhen (Department of Pharmacy, People′s Hospital, Peking University, Beijing 100044) evaluate the efficacy and security of Huperzine A on changing the score of MMSE、ADL、HDSMQ, and the rate of side effects of patients with mild to moderate Alzheimer disease. Methods：We searched Medline(1966-2006)Embase(1989-2000),The Cochrane Library ( Issue 1, 2007 ) , CBMdisc（1978-2006）CNKI(1979-2006). The quality of included studies such as randomization, blinding, allocation concealment and loss of follow up was evaluated and meta-analysis was performed by RevMan4.2 software. Results：Five randomized controlled trials (RCTs) were included. The scores of MMSE, ADL, MQ in the treatment group improved more significantly than those in the placebo group. But because of existing some publication bias, we need to extend the amount of samples to compare the score of HDS. Compared witn the placebo group, the huperzine A group is more effective.The rate of side effects of Huperzine A is higher than placebo group, but because the sample quantity is smaller and existing some publication bias, we need to extend the amount of samples to compare. Conclusions：According to the