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

作　　者：谢敏江 何虎平 黄碧辉[3] 崔顺宇 钟晓[5] 余灵琪 柴勇 夏万俊 XIE Min-jiang;HE Hu-ping;HUANG Bi-hui;CUI Shun-yu;ZHONG Xiao;YU Ling-qi;CHAI Yong;XIA Wan-jun(Chengdu Anorectal Specialist Hospital, Chengdu 610000,China;Yilong County Hospital of Traditional Chinese Medicine, Nanchong 637600 ,China;People's Hospital of Nanbu County Prefecture,Nanchong 637300,China;Mianyang Third People's Hospital, Miartyang 621000,China;First People's Hospital of Ziyang, Ziyang 641300,China;Chengdu Tianfu New District People's Hospital,Chengdu 610000,China;Second People's Hospital of Pengzhou ,Pengzhou 611900,China;An County, Center Health Center of Xiushui Town,An County 622650,China)

机构地区：[1]成都市肛肠专科医院,成都610000 [2]仪陇县中医院,南充637600 [3]南部县人民医院,南充637300 [4]绵阳市第三人民医院,绵阳621000 [5]资阳市第一人民医院,资阳641300 [6]成都市天府新区人民医院,成都610000 [7]彭州市第二人民医院,彭州611900 [8]安县秀水镇中心卫生院,安县622650

出　　处：《中国新药杂志》2019年第6期719-725,共7页Chinese Journal of New Drugs

摘　　要：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.

关 键 词：云南白药胶囊 不良反应类型 不良反应发生率 群体安全性 

分 类 号：R969.3[医药卫生—药理学]