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

目的:评价石杉碱甲治疗轻、中度阿尔茨海默病(AD)的有效性和安全性。方法:计算机检索Medline、Embase、Cochrane图书馆临床对照试验资料库及CBMdisc、CNKI,纳入比较石杉碱甲与安慰剂的随机对照试验,对纳入研究的方法学质量进行评价,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(RCT)。Meta分析结果表明,对轻、中度AD患者,石杉碱甲显著提高了简易精神状态检查表(MMSE)的评分,降低了日常生活活动量表(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;其显著提高了韦氏记忆商(MQ)评分,但由于纳入试验数较少,可能存在一定发表偏倚;长谷川痴呆量表(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;有效率比较显示石杉碱甲组较安慰剂组更为有效;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。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AD患者的记忆和认知功能,与安慰剂组比较具有显著性差异,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。

Meta-analysis of Efficacy and Safety of Huperzine A for Mild and Moderate Alzheimer Disease

OBJECTIVE： To evaluate the efficacy and safety of huperzine A for patients with mild and moderate Alzheimer disease（AD）. METHODS： The randomized controlled trials （RCTs） comparing huperzine A with placebo retrieved from Medline, Embase, the Cochrane Library, CBMdisc and CNKI were enrolled. The methodology quality of the included studies was evaluated and a Meta-analysis was performed using RevMan4.2 software. RESULTS： A total of five RCTs were included. The Meta-analysis results showed that as compared with placebo, huperzine A treatment significantly increased the scores of MMSE, decreased the scores of ADL （activities of daily living）, moreover, the associated therapeutic effect increased gradually with the prolonging of the treatment time yet with small publication bias; huperzine A treatment significantly increased the scores of MQ（memory quotient）, but some publication bias might be existed because of the small number of RCTs included. The sensitivity analysis on the comparison of HDS score changes showed that the influence of the quality of the RCTs could reverse the results. The comparison on effective rate showed that huperzine A was more effective than placebo. The comparison on safety showed that huperzine A was more likely to induced side effects than placebo, but the publication bias was big because there was only a few literature included. CONCLUSION： According to the Meta-analysis＇ s results, we think huperzine A is effective in improving memory and cognitive function of AD patients, and there is significant difference in clinical efficacy as compared with placebo, and there is small publication bias. In terms of safety, huperzine A has higher incidence of side effects than placebo, but the side effects are mostly mild and have little impact on the treatment. The above conclusion may serve as reference for clinical medication.