施普善治疗阿尔茨海默病疗效和安全性的综合分析

中国临床药理学与治疗学 ›› 2006, Vol. 11 ›› Issue (6): 712-716.

施普善治疗阿尔茨海默病疗效和安全性的综合分析

魏朝晖, 何清波, 王昊, 苏炳华, 陈红专

上海交通大学基础医学院药学系, 上海 200025

收稿日期:2006-03-06 修回日期:2006-04-17 出版日期:2006-06-26 发布日期:2020-12-04
通讯作者: 陈红专,男,教授,博士生导师,研究方向:神经药理。Tel:021-63846590-776450 E-mail:yaoli@shsmu.edu.cn
作者简介:魏朝晖,女,在读博士生,研究方向:临床药理。Tel:021-63846590-776455 E-mail:weizhaohui@ssmustat.com
基金资助:
国家自然科学基金资助项目(No30070860)

Systemic analysis of the efficacy and safety of Cerebrolysin in the treatment of Alzheimer's disease

WEI Zhao-hui, HE Qing-bo, WANG Hao, SU Bing-hua, CHEN Hong-zhuan

Department of Pharmacy, College of Basic Medical Sciences, Shanghai Jiaotong University, Shanghai 200025, China

Received:2006-03-06 Revised:2006-04-17 Online:2006-06-26 Published:2020-12-04

摘要/Abstract

摘要： 目的: 评价施普善治疗轻、中度阿尔茨海默病的临床疗效和安全性。方法: 1) 数据来源:在Medline、Cochrane central Register of controlled trials 和中文生物医学文献等数据库进行联机检索;2) 主题词和关键词:应用“施普善(Cerebrolysin(, 脑活素)”、“随机对照试验”、“痴呆” 等进行全文检索, 检索语种不限。在检索的同时与奥地利依比威大药厂联系, 以了解施普善的临床研究情况;3) 数据合并:获得5 个随机双盲安慰剂对照的临床试验, 基于临床总体印象改善, 以对数优势比[log(OR)] 作为处理效应评价指标, 采用标准的Meta 分析方法合并各临床试验的处理效应, 同时总结施普善临床应用的安全性。结果: 5 个临床研究Meta 分析具有一定的异质性(Q=8.295, P=0.081), 异质性主要来自于Ruether E(1994) 的研究;采用随机效应模型估计合并处理效应, 施普善改善阿尔茨海默病患者临床总体印象的log(OR) 为1.080, 95%可信区间为0.645~1.481, 具有统计学意义, 敏感性分析显示合并效应的估计值对不同模型、不同估计方法是稳定的。施普善在临床应用中, 不良事件的发生率处于2%~7%之间,常表现为轻、中度的眩晕、头痛和头晕。结论: 施普善治疗轻、中度阿尔茨海默病具有一定疗效和良好的安全性。

关键词: 施普善, 阿尔茨海默病, 随机对照临床试验, Meta 分析

Abstract: AIM: To evaluate the efficacy and safety of Cerebrolysin in the treatment of mild to moderate Alzheimer's disease (AD).MOTHODS: Data source: searching the Cochrane Library, Medline, and Chinese Biomedical Literature Analysis and Retrieval System for Compact Disc (CBMDISC) and communicating with EBEWE Pharmaceutical Ltd for the randomized trials comparing Cerebrolysin with placebo in AD.Data extraction: available data on clinical global impression (CGI), cognitive performance and Activities of Daily Living (ADL) were extracted from 5 trails and combined with standard meta-analysis methods.Results: There was some heterogeneity, which was mainly caused by the trial Ruether E (1994), among the 5 clinical trials in this meta-analysis (Q=8.295, P=0.081) Comparing Cerebrolysin with placebo, the estimator of treatment effect (log (OR)) based on the random-effect model was 1.080 (95% IC [0.645, 1.481]).Sensitivity analysis showed that the treatment effect was robust to different models or different estimate methods.In clinical practice, the safety of Cerebrolysin was documented with the incident rate of adverse event as 2%-7%.And the most common adverse events were headaches, dizziness and anxiety.Conclusion: Cerebrolysin is a safe drug that could significantly improve the clinical global impression in patients with mild to moderate AD.

Key words: Cerebrolysin, Alzheimer's disease, Randomized controlled clinical trial, Meta-analysis

中图分类号:

R741

魏朝晖, 何清波, 王昊, 苏炳华, 陈红专. 施普善治疗阿尔茨海默病疗效和安全性的综合分析[J]. 中国临床药理学与治疗学, 2006, 11(6): 712-716.

WEI Zhao-hui, HE Qing-bo, WANG Hao, SU Bing-hua, CHEN Hong-zhuan. Systemic analysis of the efficacy and safety of Cerebrolysin in the treatment of Alzheimer's disease[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(6): 712-716.

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