湖北地区云南白药胶囊上市后安全性再评价  

Re-Evaluation of Post-Marketing Safety of Yunnan Baiyao Capsules in Hubei Province

作　　者：徐松 吴星火[1] 陆林 叶哲伟[1] 王显勋 李蜀豫 李明辉 姚忠军[4] 余永桂[5] 王洪林 廉凯[6] 陈秀记[6] 胡森懋[7] 阙祥勇[7] 方向明 刘融 田鹏 周宏斌 Xu Song;Wu Xinghuo;Lu Lin;Ye Zhewei;Wang Xianxun;Li Shuyu;Li Minghui;Yao Zhongjun;Yu Yonggui;Wang Honglin;Kang Kai;Chen Xiuji;Hu Senmao;Que Xiangyong;Fang Xiangming;Liu Rong;Tian Peng;Zhou Hongbin(Union Hospital Affiliated to Tongji MedicalCollege of Huazhong University of Science and Technology,Wuhan,Hubei,China 430000;Zhongshan Hospital of Hubei Province,The Third People′s Hospital of Hubei Province,Wuhan,Hubei,China 430000;The Fifth Hospitalin Wuhan,Wuhan,Hubei,China 430000;Shiyan Taihe Hospital,Shiyan,Hubei,China 442000;Shiyan People′s Hospital,Shiyan,Hubei,China 442000;Xiangyang Central Hospital,Xiangyang,Hubei,China 442000;Renhe Hospital Affiliated to Three Gorges University,Yichang,Hubei,China 443000;Wuhan Puren Hospital,Wuhan,Hubei,China 430000;Yiling Hospital of Yichang City,Yichang,Hubei,China 443000)

机构地区：[1]华中科技大学同济医学院附属协和医院,湖北武汉430000 [2]湖北省中山医院.湖北省第三人民医院,湖北武汉430000 [3]湖北省武汉市第五医院,湖北武汉430000 [4]湖北省十堰市太和医院,湖北十堰442000 [5]湖北省十堰市人民医院,湖北十堰442000 [6]湖北省襄阳市中心医院,湖北襄阳442000 [7]三峡大学附属仁和医院,湖北宜昌443000 [8]湖北省武汉市普仁医院,湖北武汉430000 [9]湖北省宜昌市夷陵医院,湖北宜昌443000

出　　处：《中国药业》2018年第24期108-111,共4页China Pharmaceuticals

摘　　要：目的全面评价云南白药胶囊上市后的群体安全性,考察其在临床使用中的不良反应。方法采用巢式病例对照研究方法,收集并分析湖北省9家医院2015年6月至2016年12月服用云南白药胶囊患者的临床资料。结果观察用药患者共1 694例,有合并用药患者1 447例;发生一般不良反应13例,均有合并用药,云南白药胶囊有合并用药的不良反应发生率为0. 898%。结论云南白药胶囊在湖北地区9家参研医院内的不良反应发生类型均为说明书中已载明的可能出现的不良反应类型,研究期间未出现新的和严重的不良反应,且不良反应发生率较低,表明云南白药胶囊在这9家医院的临床应用相对安全。Objective To evaluate the safety among large populations of Yunnan Baiyao Capsules after being marketed,and to investigate their adverse reactions in clinical use. Methods The clinical data of patients treated with Yunnan Baiyao Capsules from June 2015 to December 2016 in 9 hospitals in Hubei Province were collected and analyzed by nested case-control study method. Results A total of 1 694 patients were observed,including 1 447 patients with combined medication,13 patients with general adverse reactions,all of the 13 patients were combined medication,and the incidence rate of adverse reactions caused by combined use of Yunnan Baiyao Capsules was 0. 898%. Conclusion The types of adverse reactions of Yunnan Baiyao Capsules occurred in 9 participating hospitals in Hubei Province are all the possible types of adverse reactions mentioned in the dispensatory. During the period of the investigation,patients treated with Yunnan Baiyao Capsules have low incidence rate of adverse reactions without any new and serious adverse reactions,which indicating that the clinical application of Yunnan Baiyao Capsules in the 9 hospitals was relatively safe.

关 键 词：云南白药胶囊 药品不良反应 不良反应监测 群体安全性 合理用药 

分 类 号：R969.3[医药卫生—药理学] R973.1[医药卫生—药学]