辽宁地区云南白药胶囊多中心、前瞻性、大样本临床安全性集中监测统计分析研究  

A multi-center, prospective, large sample statistical analysis of clinical safety of Yunnan Baiyao capsules in Yunnan province by centralized monitoring

作　　者：李福春[1] 高建烨 李殿明 董钧 邵泽丹 王新厚 邢丽 邵立春 范忠义[8] 安良宝 杨波 赵刚[11] 张传家 赵猛 孙玉坤[14] LI Fu-chun;GAO Jian-ye;LI Dian-ming(Shenyang 242 Hospital,Shenyang 110000,China)

机构地区：[1]沈阳二四二医院,110000 [10]阜新市第五人民医院,123000 [11]沈阳市铁西区中心医院,110000 [12]沈阳市德济医院,110000 [13]清原县中医院,113300 [14]武警辽宁总队医院,110000 [2]凌源钢城中心医院,122500 [3]瓦房店中医医院,116000 [4]中国医科大学附属第一医院鞍山医院,114000 [5]丹东市人民医院,118000 [6]东港市骨科医院,118300 [7]沈阳市沈河区人民医院,110000 [8]中国人民解放军第四六三医院,110000 [9]沈阳何氏眼科医院有限公司,110000

出　　处：《中国现代药物应用》2019年第13期149-155,共7页Chinese Journal of Modern Drug Application

摘　　要：目的通过临床集中监测口服云南白药胶囊的患者,发现未知或罕见不良反应及不良反应发生的影响因素,评估云南白药胶囊在真实临床使用中的安全性。方法采用巢式病例对照研究的方法研究分析2019例服用云南白药胶囊患者的临床资料。结果从2019例患者中收集到63例不良事件,最终判定出18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0.644%,属偶见级别。结论云南白药胶囊在临床使用中不良反应发生率低,与其他药物合用相互作用小,使用安全性高,值得临床进一步推广应用。Objective To estimate the safety of Yunnan Baiyao capsule in the real clinical use by clinical centralized monitoring of patients with oraling Yunnan Baiyao capsule,thus finding unknown or rare adverse reactions and the influence factors of adverse reactions.Methods The clinical data of 2019 patients taking Yunnan Baiyao capsule were analyzed by nested case-control study.Results 63 adverse events were collected from 2019 patients,and 18 cases of adverse reactions related to Yunnan Baiyao were finally determined.The incidence of adverse reactions of Yunnan Baiyao combined with other drugs was 0.644%,which belonged to the occasional level.Conclusion Yunnan Baiyao capsule shows low incidence of adverse reactions in clinical use, low interaction with other drugs and high safety,and it is worthy of further clinical promotion and application.

关 键 词：云南白药胶囊 集中监测 不良反应 安全性 

分 类 号：R288[医药卫生—中药学]