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目的:探讨药物流行病学在中药上市后安全性研究中的应用,为中药上市后的安全性研究提供参考。方法:结合药物流行病学研究方法与相关实例,概述各种研究方法的特点及在中药上市后安全性研究中的应用。结果与结论:药物流行病学的各种研究方法在中药上市后安全性研究中发挥了重要作用,其中描述性研究是药物上市后研究的起点;分析性研究可以筛选与检验病因假设;实验性研究尤其随机对照试验是评价药物疗效的金标准,但通常不能专门用于药品不良反应的确证;二次研究可用于汇总证据,强化因果关系论证的力度;多种药物流行病学的新方法,在中药上市后安全性研究中具有广阔的应用前景。应灵活运用多种药物流行病学研究方法对中药的安全性实施科学、客观的评价。
Objective: To explore the application of pharmacoepidemiology in the safety research after the listing of traditional Chinese medicine (TCM) and to provide a reference for the safety study after the listing of TCM. Methods: Combining the methods and related examples of drug epidemiology, the characteristics of various research methods and their application in the safety study of Chinese medicines after their listing were summarized. RESULTS AND CONCLUSION: Various research methods of pharmacoepidemiology play an important role in the safety study of traditional Chinese medicine after its launch. Descriptive research is the starting point of post-marketing research. Analytical research can screen and test the cause hypothesis. Experimental In particular, randomized controlled trials are the gold standard for evaluating the efficacy of drugs, but can not usually be used exclusively for the confirmation of adverse drug reactions. Secondary studies can be used to summarize the evidence and reinforce the demonstration of causation. Various new methods of pharmacoepidemiology, It has a broad application prospect in the safety research of Chinese medicine listed. Should be flexible use of a variety of drug epidemiological research methods on the safety of Chinese medicine to implement a scientific and objective evaluation.