浙江地区云南白药胶囊多中心、前瞻性、大样本不良反应监测及相关因素研究

A multi-center,prospective,large sample adverse reaction monitoring study and related factors of Yunnan Baiyao capsules in Zhejiang province

目的:全面探索云南白药胶囊在真实世界中不良反应的发生率,找到影响云南白药胶囊临床使用安全性的相关因素。方法:采用巢式病例对照研究的方法,我院联合浙江地区其他11家医院收集了2015年6月至2016年12月期间,服用云南白药胶囊的患者共2 632例的临床资料进行研究分析。结果:从2 632例用药患者中收集到52例不良事件,最终判定出4例与云南白药有关的不良反应。云南白药与其他药物联合使用不良反应发生率为0.181%,属偶见级别。结论:云南白药胶囊在临床使用中不良反应少,与其他药物相互作用小,安全性高,值得临床进一步推广应用。

Objective： To explore comprehensively the incidence of adverse reactions of Yunnan Baiyao capsules in the real world,and find the related factors that affect the safety of Yunnan Baiyao capsules in the clinical application. Methods： Nested case-control study design was adopted. The clinical data of 2 632 patients taking Yunnan Baiyao capsules were collected in our hospital and other 11 hospitals in Zhejiang area from June2015 to December 2016. Results： Totally 52 adverse events were collected from 2 632 patient taking Yunnan Baiyao capsules,among which 4 adverse reactions were ultimately determined to be related to Yunnan Baiyao capsules. The incidence of adverse reactions was 0. 181% when Yunnan Baiyao capsules were combined with other drugs,belonging to occasional rank. Conclusion： Yunnan Baiyao capsules have few adverse reactions,little interaction with other drugs and high safety in clinic. It is worthy of further clinical application.