上海地区云南白药胶囊临床安全性监测报告

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英文篇名：Clinical safety monitoring report of Yunnan Baiyao capsules in Shanghai area 作者：黄昱 ; 杨铁毅 ; 刘新泉 ; 王秀会 ; 邵擎东 ; 高强 ; 郑春伟 ; 周琦 ; 梅一南 ; 章如新 英文作者：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 Pudong New Area Public Hospital;Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine;Zhoupu Hospital of Pudong New Area;No.455 Hospital of the Chinese People's Liberation Army;Central Hospital of Shanghai Jiading District;Shanghai Yangpu District Hospital of Traditional Chinese Medicine;Shanghai Qingpu District Hospital of Traditional Chinese Medicine; 关键词：云南白药胶囊 ; 安全性 ; 不良事件 ; 不良反应发生率 英文关键词：Yunnan Baiyao capsule;;safety;;adverse reactions event;;incidence of adverse reactions 中文刊名：ZXYZ 英文刊名：Chinese Journal of New Drugs 机构：复旦大学附属华东医院;上海市浦东新区公立医院;上海中医药大学附属龙华医院;上海市浦东新区周浦医院;中国人民解放军第四五五医院;上海市嘉定区中心医院;上海市杨浦区中医医院;上海市青浦区中医医院; 出版日期：2019-03-30 出版单位：中国新药杂志 年：2019 期：v.28 语种：中文; 页：ZXYZ201906013 页数：7 CN：06 ISSN：11-2850/R 分类号：76-82

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 ofadverse reactions related to Yunnan Baiyao capsules were determined,including 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.

引文

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