中国中药杂志

2017, v.42(15) 2883-2888

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30209例舒血宁注射液安全性医院集中监测研究
Intensive hospital monitoring of Shuxuening injection in 30 209 cases

姜俊杰;谢雁鸣;张寅;黎明全;赵玉斌;温泽淮;李学林;易丹辉;张一开;
JIANG Jun-jie;XIE Yan-ming;ZHANG Yin;LI Ming-quan;ZHAO Yu-bin;WEN Ze-huai;LI Xue-lin;YI Dan-hui;ZHANG Yi-kai;Institute of Basic Medical Sciences,Chinese Academy of Traditional Chinese Medicine;Affiliated Hospital of Changchun University of Traditional Chinese Medicine;Shijiazhuang Hospital of Traditional Chinese Medicine;Guangdong Province Traditional Chinese Medical Hospital;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine;College of Statistics,Renmin University

摘要(Abstract):

为获得杏雪~舒血宁注射液的不良反应特征及发生率等安全性信息,采用多中心、大样本医院集中监测的设计方法,在全国27家医疗机构中,以使用舒血宁注射液的住院患者为研究对象,进行用药周期的全程监测。监测主要内容为患者的一般信息、诊断信息、用药信息、不良事件信息。结果共纳入使用舒血宁注射液的患者30 209例,发生不良反应34例,不良反应发生率0.113%,属于偶见不良反应。不良反应发生特征为头痛、头晕、皮肤瘙痒、心悸、恶心等。基于以上结果,说明杏雪舒血宁注射液的安全性良好。
In order to obtain the characteristics and incidence of adverse reactions of Shuxuening injection( Xingxue~ ),the design method of a multi-center,large sample intensive monitoring in the hospitals was adopted. The hospitalized patients with use of Shuxuening injection from 27 medical institutions were enrolled as the research subjects to monitor their entire process of treatment cycle. The main content of monitoring included the patients' general information,diagnostic information,medication information,and adverse event information. A total of 30 209 patients with Shuxuening injection were enrolled; adverse reactions occurred in 34 cases,with an incidence of 0. 113%,which belonged to the rare adverse reactions. Adverse reactions were characterized by headache,dizziness,pruritus,palpitations,nausea,et al. All the above results showed that Xingxue Shuxuening injection had high safety in clinical application.

关键词(KeyWords): 舒血宁注射液;医院集中监测;不良反应;安全性
Shuxuening injection;intensive hospital monitoring;adverse reactions;safety

Abstract:

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基金项目(Foundation): 国家“重大新药创制”科技重大专项(2015ZX09501004-001-002);; 中药上市后安全性监测及报告技术规范项目(ZYYS-2014-03);; 中央级公益性科研院所基本业务费项目(Z0406,PY1303)

作者(Author): 姜俊杰;谢雁鸣;张寅;黎明全;赵玉斌;温泽淮;李学林;易丹辉;张一开;
JIANG Jun-jie;XIE Yan-ming;ZHANG Yin;LI Ming-quan;ZHAO Yu-bin;WEN Ze-huai;LI Xue-lin;YI Dan-hui;ZHANG Yi-kai;Institute of Basic Medical Sciences,Chinese Academy of Traditional Chinese Medicine;Affiliated Hospital of Changchun University of Traditional Chinese Medicine;Shijiazhuang Hospital of Traditional Chinese Medicine;Guangdong Province Traditional Chinese Medical Hospital;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine;College of Statistics,Renmin University

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