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山东地区云南白药胶囊临床不良反应集中监测研究

Study on centralized monitoring of clinical adverse reactions of Yunnan Baiyao capsules in Shandong area
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摘要 目的:监测云南白药胶囊在大样本人群中使用的不良反应发生率,全面评价云南白药胶囊在真实临床使用过程中的群体安全性。方法:采用巢式病例对照研究的方法,山东省内36家医院共收集了2015年6月-2016年12月期间服用云南白药胶囊10 183例患者的临床数据进行分析。结果:10 183例服用云南白药胶囊的患者中,发生不良事件患者147例,最终被判定为与云南白药胶囊有关的不良反应共47例,8例为单服云南白药胶囊的患者,39例患者有合并用药,不良反应发生率为0. 462%。结论:云南白药胶囊在山东地区36家参研医院中应用的不良反应发生率较低,不良反应类型均为说明书中已载明的可能出现的不良反应类型。本研究未发现新的和严重的不良反应,说明云南白药胶囊临床应用相对安全,值得临床进一步推广使用。 Objective : To monitor the incidence of adverse reactions of Yunnan Baiyao capsules in large sample population , and comprehensively evaluate the group safety of Yunnan Baiyao capsules in real clinical use. Methods: Nested case-control study was adopted. Thirty-six hospitals in Shandong Province combined to collect the clinical data of 10 183 patients treated with Yunnan Baiyao capsules in the period from June 2015 to December 2016. Results: In 10 183 cases taking Yunnan Baiyao capsules, 147 cases of adverse events were found, and 47 cases of adverse reactions were found to be associated with the Yunnan Baiyao capsules. 8 cases were treated with Yunnan Baiyao capsules alone, and 39 patients had combined use of other drugs. The incidence of adverse reactions was 0. 462%. Conclusion : The incidence of adverse reactions of Yunnan Baiyao capsules was very low in the 36 hospitals in Shandong area, and the types of adverse reactions are all stated in the drug use instructions. New and serious adverse reactions were not found in this study, which indicated that Yunnan Baiyao capsules were relatively safe in the clinical application , and it is worthy of further clinical application.
作者 王俊涛 朱磊 沈戈桢 高圣龙 王福胜 田云虎 张圣魁 杨林青 胡宏伟 赵强 马安军 田向群 郭涛 郭安鹏 徐伟敏 唐敬孝 李军 刘成会 朱喆 王明山 解瑞成 郭兴伟 张诚 厉运收 王学兴 孙建华 王乐新 王东波 赵忠伟 管照广 张士军 李炳森 王东 董兴 韩吉华 孙永峰 WAGN Jun-tao;ZHU Lei;SHEN Yi-zhen;GAO Sheng-long;WANG Fu-sheng;TIAN Yun-hu;ZHANG Sheng-kui;YANG Lin-qing;HU Hong-wei;ZHAO Qiang;MA An-jun;TIAN Xiang-qun;GUO Tao;GUO An-peng;XU Wei-min;TANG Jing-xiao;LI Jun;LIU Cheng-hui;ZHU Zhe;WANG Ming-shan;XIE Rui-cheng;GUO Xing-wei;ZHANG-Cheng;LI Yun-shou;WANG Xue-xing;SUN Jian-hua;WANG Le-xin;WANG Dong-bo;ZHAO Zhong-wei;GUAN Zhao-guang;ZHANG Shi-jun;LI Bing-sen;WANG Dong;DONG Xing;HAN Ji-hua;SUN Yong-feng(Qilu Hospital of Shandong University, Jinnan 250000 , China;Second People's Hospital of Liaocheng, Liaocheng 252000, China;Anqiu People's Hospital,Anqiu 262100,China;Feixian County People's Hospital, Feixian 273400 ,China;People's Hospital of Arashiyama District, Rizhao City, Rizhao 276800 ,China;Huantai County People's Hospital,Rizhao 256400, China;Yiyuan County People's Hospital, Yiyuan 256100,China;Dongping County People's Hospital,Dongping T11500,China;Jinan General Iron and Steel Hospital,Jinan 250000 ,China;Zaozhuang Municipal Hospital,Zaozhuang 277000,China;Binzhou People's Hospital,Binzhou 256600,China;General Hospital of Jinan Military Area,Jinan 250000,China;The People's Hospital of Yutai County, Yutai 272300,China;Central Hospital of Luozhuang, Linyi,Linyi 276000,China;Central Hospital of Shengli Oil Field of Dongying,Dongying 257000,China;Juxian People's Hospital,Juxian 256500,China;Lan Ling County Hospital of Traditional Chinese Medicine,Lanling 200125,China;Tengzhou People's Hospital,Tengzhou 277599,China;Rizhao Hospital of Traditional Chinese Medicine, Rizhao 256400,China;Yantai Hospital of Traditional Chinese Medicine, Yantai 264000, China;People's Hospital of Wendeng District, Weihai, Weihai 264400 ,China;Linshu County People's Hospital, Linshu 276700 , China;Laiwu People's Hospital, Laiwu 271100, China;Linshu County Hospital of Traditional Chinese Medicine, Linshu 276700 , China;People's Hospital of Luozhuang District, Linyi, Linyi 276000 , China;Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250000 ,China;Liaochen
出处 《中国新药杂志》 CAS CSCD 北大核心 2019年第6期703-711,共9页 Chinese Journal of New Drugs
关键词 云南白药胶囊 不良事件 不良反应 群体安全性 Yunnan Baiyao capsule adverse events adverse reactions group safety
作者简介 王俊涛,男,主治医师,主要从事手足显微外科的临床工作的研究.联系电话:(0531)82166571, E-mail:juntaowang@sdu.edu.cn;通讯作者:朱磊,男,主任医师,主要从事手足显微外科的临床工作的研究.联系电话:(0531)82166571,E-mail:zhuleijn@aliyun.com.
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