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

作　　者：王俊涛[1] 朱磊[1] 沈戈桢 高圣龙[3] 王福胜[4] 田云虎[5] 张圣魁 杨林青[7] 胡宏伟 赵强[9] 马安军[10] 田向群[11] 郭涛 郭安鹏 徐伟敏[14] 唐敬孝 李军 刘成会 朱喆[18] 王明山[19] 解瑞成 郭兴伟 张诚[22] 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[35] 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

机构地区：[1]山东大学齐鲁医院,济南250000 [2]济南军区总医院,济南250000 [3]莱芜市人民医院,莱芜271100 [4]德州市人民医院,德州253000 [5]潍坊医学院附属医院,潍坊261000 [6]曲阜市中医院,曲阜273100 [7]济宁医学院附属医院,济宁272000 [8]莒县中医院,莒县276500 [9]章丘市人民医院,章丘250200 [10]聊城市第二人民医院,聊城252000 [11]安丘市人民医院,安丘262100 [12]费县人民医院,费县273400 [13]日照市岚山区人民医院,日照276800 [14]桓台县人民医院,日照256400 [15]沂源县人民医院,沂源256100 [16]东平县人民医院,东平271500 [17]济南钢铁总医院,济南250000 [18]枣庄市立医院,枣庄277000 [19]滨州市人民医院,滨州256600 [20]鱼台县人民医院,鱼台272300 [21]临沂罗庄中心医院,临沂276000 [22]东营市胜利油田中心医院,东营257000 [23]莒县人民医院,莒县256500 [24]兰陵县中医院,兰陵200125 [25]滕州市人民医院,滕州277599 [26]日照市中医院,日照256400 [27]烟台市中医医院,烟台264000 [28]威海文登区人民医院,威海264400 [29]临沭县人民医院,临沭276700 [30]临沭县中医院,临沭276700 [31]临沂罗庄区人民医院,临沂276000 [32]山东中医药大学第二附属医院,济南250000 [33]聊城市东昌府区中医院,聊城252000 [34]章丘市中医院,章丘250200 [35]济南市历城区人民医院,济南250000

出　　处：《中国新药杂志》2019年第6期703-711,共9页Chinese Journal of New Drugs

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.

关 键 词：云南白药胶囊 不良事件 不良反应 群体安全性 

分 类 号：R969.3[医药卫生—药理学]