药品不良反应监测中的序贯概率比检验方法

Sequential Probability Ratio Analysis in Post-market Drug Safety Surveillance

目的序贯概率比检验方法在美国已被用于多种疫苗上市后实时安全性监测,也是目前药品不良反应信号检测的研究热点。然而,该方法的应用在我国少见报道,本研究对这类方法进行概述。方法通过文献检索,对连续性和成组序贯概率比检验方法的原理进行综述,并比较二者的优缺点,总结该类方法的应用现状,并对该类研究的进一步探索方向进行了展望。结果现有研究表明序贯概率比方法在药品安全性监测过程中有助于信号提炼,目前连续性序贯概率比检验应用较多,但成组序贯概率比方法有很大的发展空间。结论序贯概率比检验方法是一种实时监测药品安全性的可行方法,但仍有许多问题值得进一步探索。

Objective To review currently used sequential probability ratio analysis methods in medical product safety surveillance. Methods The principles of continuous and group sequential probability ratio analysis methods were reviewed.The key features of these two kinds of sequential methods were compared, and the application status was summarized.Meanwhile, we discussed the areas needed further development. Results The use of sequential probability ratio analysis for post-market drug safety surveillance was quickly emerging. Continuous sequential methods were the preferred approach, but group sequential methods were also promising. Conclusion Sequential probability ratio analysis is a feasible method to monitor the drug safety in real time, but methodological development is needed to improve success.