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药物安全性的可靠资料大多来自临床试验报告。由于各种原因,对同一种药物的安全性试验,报告的结果之间存在着一定的差异,因而单项临床试验的结果不足以作为评价用药风险的科学证据。传统的综述方法对众多单项试验结果的合并能力有限,因而系统性综述方法开始被运用到药物安全性评价领域。本文介绍了系统性综述法和定量综述法—荟萃分析(Meta-analysis)的基本概念,详细介绍了实施步骤,对该方法的推广和正确使用有参考价值。
Most reliable data on drug safety come from clinical trial reports. Due to various reasons, there is a certain difference between the safety tests of the same drug and the reported results. Therefore, the results of individual clinical trials are not enough to serve as scientific evidence to evaluate the risk of drug use. Traditional review methods have limited ability to incorporate many individual test results, and systematic reviews have therefore begun to be applied to the field of drug safety evaluation. This paper introduces the basic concepts of systematic review and quantitative review - Meta-analysis. It introduces the implementation steps in detail and provides reference for the promotion and proper use of this method.