上海地区云南白药胶囊临床安全性监测报告  

Clinical safety monitoring report of Yunnan Baiyao capsules in Shanghai area

作　　者：黄昱[1] 杨铁毅 刘新泉[3] 王秀会 邵擎东[5] 高强 郑春伟 周琦 梅一南 章如新[1] HUANG Yu;YANG Tie-yi;LIU Xin-quan;WANG Xiu-hui;SHAO Qing-dong;GAO Qiang;ZHENG Chun-wei;ZHOU Qi;MEI Yi-nan;ZHANG Ru-xin(East China Hospital Affiliated to Fudan University, Shanghai 200000 , China;Shanghai Pudong New Area Public Hospital,Shanghai 200120,China;Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200000,China;Zhoupu Hospital of Pudong New Area,Shanghai,Shanghai 200120,China;No. 455 Hospital of the Chinese People's Liberation Army,Shanghai 200000,China;Central Hospital of Shanghai Jiading District, Shanghai 201800,China;Shanghai Yangpu District Hospital of Traditional Chinese Medicine, Shanghai 200000,China;Shanghai Qingpu District Hospital of Traditional Chinese Medicine, Shanghai 201700,China)

机构地区：[1]复旦大学附属华东医院,上海200000 [2]上海市浦东新区公立医院,上海200120 [3]上海中医药大学附属龙华医院,上海200000 [4]上海市浦东新区周浦医院,上海200120 [5]中国人民解放军第四五五医院,上海200000 [6]上海市嘉定区中心医院,上海201800 [7]上海市杨浦区中医医院,上海200000 [8]上海市青浦区中医医院,上海201700

出　　处：《中国新药杂志》2019年第6期712-718,共7页Chinese Journal of New Drugs

摘　　要：目的:探究云南白药胶囊在实际临床应用过程中的群体安全性,寻找可能诱发云南白药胶囊不良反应的危险因素,为临床合理用药和降低不良反应的发生率提供依据。方法:通过对2015年6月—2016年12月上海地区8家医院的骨科、消化科、耳鼻喉科、妇科、外科和眼科等科室接受云南白药胶囊治疗的患者共1 496例进行跟踪研究,对云南白药胶囊治疗期间出现的不良事件进行详细记录,并分析其与云南白药胶囊之间的因果关系。结果:整个研究过程中共收集到不良反应事件47例,最终判定出4例与云南白药胶囊有关,包括胃肠道不适2例,恶心呕吐1例,皮肤过敏1例,不良反应发生率为0. 267%,属偶见级别。结论:云南白药胶囊在上海地区8家医院内使用不良反应发生率低、安全性高,值得临床进一步推广使用。Objective : To explore the group safety of Yunnan Baiyao capsules in real clinical application and find out the risk factors to providing basis for using the drug rationally and reducing the incidence of adverse reactions in clinical practice. Methods: A total of 1 496 patients taking Yunnan Baiyao capsules in the departments of orthopedics, digestive , ear-nose-throat, gynaecology, surgery and ophthalmology in 8 hospitals of Shanghai area were tracked during the period of June 2015 to December 2016. The adverse events were recorded in details, and the causality was analyzed. Results: In the whole study, 47 cases of adverse events were collected , and 4 cases of adverse reactions related to Yunnan Baiyao capsules were determined , in eluding 2 cases of gastrointestinal discomfort, 1 cases of nausea and vomiting, 1 cases of skin allergy. The incidence of adverse reactions was 0. 267%, belonging to occasional rank. Conclusion : Yunnan Baiyao capsules had high safety and low incidence of adverse reactions in the 8 hospitals in Shanghai area, which is worthy of further promotion in clinic.

关 键 词：云南白药胶囊 安全性 不良事件 不良反应发生率 

分 类 号：R969.3[医药卫生—药理学]