基于真实世界的12385例使用清开灵注射液患者临床用药特征分析

Analysis of Medication Characteristic in 12 385 Patients Using Qingkailing Injection ( 清 开灵注射液) in the Real World

目的观察清开灵注射液在真实世界中的用药特征。方法收集全国16家三级甲等医院医院信息管理系统(HIS)中住院患者信息,参照集成数据仓库构建模式,整合为清开灵注射液HIS数据仓库,对使用过清开灵注射液的12385例患者的基本信息、住院信息、诊断及中医辨证、合并用药等信息进行描述分析,并与药品说明书进行对比。结果使用清开灵注射液的患者中以45~65岁最多,占35.14%;入院时急、危症患者占42.65%;使用清开灵注射液患者发病和死亡发生率最高的节气前两位是冬至和小寒;符合药品说明书西医诊断的患者占36.84%;符合药品说明书的中医主证占42.35%;49.64%使用清开灵注射液的患者单次剂量是30~40 ml。结论清开灵注射液的使用患者以中老年居多,临床中存在未按照药品说明书推荐剂量及适应症使用情况,普遍存在联合用药现象但可能存在用药风险。

Objective To observe the medication characteristics of Qingkailing Injection（ 清开灵注射液） in the real world. Methods Collected inpatients information in hospital management system（ HIS） of 16 three grade first class hospitals. According to integrated data warehouse construction model,integrated them into the Qingkailing Injection HIS data warehouse. Conducted descriptive analysis on basic information,patient information,diagnosis and syndrome differentiation of Chinese medicine,and drug combination information in 12 385 patients having used Qingkailing Injection. Then compared the information with the drug instructions. Results Patients using Qingkailing Injection were mostly aged 45 ~ 65,accounted for 35. 14%; acute and critical patients in admission accounted for 42. 65%; the top two highest incidence of morbidity and mortality in patients using Qingkailing Injection was in winter solstice and slight cold; patients conforming to western diagnosis in drug instruction accounted for 36. 84%; patients conforming to main symptom of Chinese medicine in drug instruction accounted for 42. 35%; the single dose of 49. 64% patients using Qingkailing Injection was 30 ~ 40 ml. Conclusion Qingkailing Injection is mostly used in middle-aged and elderly patients. Some doctors use drugs not according to the recommended dosage and indications on the instruction. Drug combination is common but there may be drug-induced risk.