四川地区云南白药胶囊临床安全性集中监测

Centralized monitoring of clinical safety of Yunnan Baiyao capsules in Sichuan area

目的:通过集中监测云南白药胶囊在临床大样本患者中使用时不良反应的发生类型及发生率,考察云南白药胶囊在临床使用过程中的群体安全性,探索可能诱发云南白药胶囊不良反应的诱因,为指导临床合理用药提供理论依据。方法:采用巢式病例对照研究的方法,收集了2015年6月—2016年12月期间,四川地区8家医院内服用云南白药胶囊的患者进行跟踪监测研究。结果:共收集到病例1 459例,其中有合并用药患者1 347例,仅使用了云南白药胶囊的患者69例。研究期间发生不良事件34例,最终有5例被判定为与云南白药胶囊有关,有4例属于胃肠道不良反应,1例是过敏反应。本研究中云南白药胶囊不良反应发生率为0. 343%。结论:云南白药胶囊在临床使用过程中不良反应发生率较低,临床应用中安全性较高。

Objective: To investigate the group safety of Yunnan Baiyao capsules in clinic through centralized monitoring of the type and incidence of adverse reactions in a large sample population , and explore the causes of the adverse reactions to provide theoretical basis for guiding rational drug use in clinic. Methods: A nested case control study design was adopted, and the patients who used Yunnan Baiyao capsules in 8 hospitals of Sichuan province from June 2015 to December 2016 were followed-up. Results: A total of 1 459 cases were collected, among whom 1347 cases took Yunnan Baiyao capsules with other medications, and 69 cases were treated with Yunnan Baiyao capsules alone. 34 cases of adverse events occurred during the study , and 5 cases were determined to be related to Yunnan Baiyao capsules, including 4 cases of gastrointestinal adverse reactions and 1 case of allergic reaction. The incidence of adverse reaction of Yunnan Baiyao capsules was 0. 343%. Conclusion : The incidence of adverse reactions of Yun nan Baiyao capsules is low , and its safety is high in clin ical application.