医院集中监测7189例脑梗死患者使用碟脉灵苦碟子注射液的真实世界用药分析  

Analysis of Diemailing Kudiezi injection use in real world in 7189 patients with cerebral infarction

作　　者：廖星[1] 张寅[1] 谢雁鸣[1] 刘艳[2] 易丹辉[2] 章轶立[1] 陈峰 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国人民大学,北京100872 [3]通化华夏药业有限责任公司,吉林通化134100

出　　处：《中国中药杂志》2016年第23期4442-4450,共9页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金青年基金项目(81202776);中央级公益性科研院所基本业务费项目(Z0406);国家"重大新药创制"科技重大专项(2009ZX09502-030);第七批博士后特别项目(2014T70202)

摘　　要：基于大样本真实世界数据分析脑梗死患者使用碟脉灵苦碟子注射液的真实世界用药情况。采用主动监测方式,碟脉灵苦碟子注射液上市后临床安全性医院集中监测获得7 189例脑梗死患者使用碟脉灵的用药信息。从用药人群基本人口学特征、碟脉灵注射液用药及其联合用药分析等三大方面对该药的使用情况进行了具体的统计描述分析和关联规则分析,分析发现该研究所选取的脑梗死人群分布以中医医院为主,医院级别以三级居多,医院所在地域分布以华北地区为多;对于用药相关指标如单次滴速、配液放置时间、注射持续时间、注射室温均无说明书指导;另外发现有非静脉滴注、>14 d疗程用药、使用非指定溶媒以及>40 m L和<10 m L单次剂量等不符合说明书用药情况。而关联规则分析发现,排在靠前的几种药物除了依拉达奉注射液属于指南推荐用药外,其他几种药物的使用均缺乏现有证据支持。另外,同时使用碟脉灵+阿司匹林+前列地尔的情况最为多见,而非目前临床研究所推崇的"双抗"治疗。该研究通过大样本的数据分析,获得有关碟脉灵真实世界的用药情况,能够为临床医生和研究者提供基本的参考信息。但该研究并没有关注疗效评价,因此不能说明用药疗效相关内容。This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection（ one Chinese herbal medicine injection） in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. The statistical description and association rule analysis were conducted based on patients’ basic demographic characteristics,use of Diemailing injection and combined use of drugs. Sixty-two percent（ 4 437/7 189） of the patients were from traditional Chinese medicine hospitals as compared with 39%（ 2 752/7 189） from western medicine hospitals; 84%（ 6 003/7 189） of the patients were from tertiary hospitals as compared with 16%（ 1 186/7 189） from second-class hospitals. The hospitals were mostly located in north China. Drug related indicators such as a single dripping speed,stash time after allocating transfusion,duration of injection,and injecting room temperature were not noted in instruction manual. It was also found that there were off label use in the practice,for instance,non-intravenous infusion, 〉 14 d treatment course,use of non-designated solvent,and a single dose 〉 40 m L or 〈 10 m L. Analysis of association rules showed that only Edaravone among the most frequent combined drugs was listed in the current guideline in China,and the other three most frequent combined drugs deproteinized calf blood extractive injection,Cinepazide Maleate injection and Alprostadil injection were used with little evidence. Diemailing ＋ Aspirin ＋ Alprostadil was the most common combined use in our study,but the recommended clopidogrel ＋ Aspirin was not found in this study. The drug use situation of Diemailing injection in the real world was obtained by data analysis on large size samples,providing

关 键 词：脑梗死 医院集中监测 碟脉灵苦碟子注射液 联合用药 真实世界 

分 类 号：R277.7[医药卫生—中医学]