4023例使用喜炎平注射液患者真实世界临床应用情况及安全性分析

Real-world Clinical Applications and Safety of Xiyanping Injection(喜炎平注射液) in 4 023 Patients

目的观察喜炎平注射液上市后在真实世界广泛人群中的应用情况及临床安全性。方法采用前瞻性、多中心、大样本、注册登记式医院集中监测的方法,观察2012年9月至2013年10月使用喜炎平注射液的患者,填写《喜炎平注射液临床安全性注册登记式注册登记表》,分析患者的总体情况,包括患者性别、年龄、生命体征等一般情况,患者西医诊断、中医辨证、首次用药时间、用药剂量、疗程、注射期间及注射前后联合用药等医嘱情况,并且分析不良反应(ADR)的发生率、发生特征及可能的原因等。结果 4 023例使用喜炎平注射液患者以儿童居多,疗程以5天内居多,主要用于治疗肺炎、支气管炎及肺部、呼吸道感染等呼吸系统疾病,中医辨证以风热犯肺证、痰热蕴肺证为主。共发生7例ADR占0.17%,6例轻度,1例中度;考虑ADR的发生与生产厂家及批号、滴速、与其他注射剂联合使用及不规范操作有一定的关系。结论喜炎平注射液多用于治疗呼吸系统疾病,中医辨证以风热犯肺、痰热蕴肺为主,偶见不良反应,患有感染性疾病的儿童、老人为易感人群。

Objective To observe the real-world clinical applications and safety of Xiyanping Injection （喜炎平注射液）. Methods Patients injected with Xiyanping Injection （喜炎平注射液） were observed from September 2012 to October 2013 with a prospective, multi-center, large sample and centralized monitoring method. The overall condition of patients, diagnosis, treatment and adverse reactions （ADR） were analyzed. Results Most patients injected with Xiyanping Injection （喜炎平注射液） were children. The treatment course was mostly within five days. The indications were pneumonia, bronchitis, lung infections and respiratory tract infections. The common TCM patterns were syndrome of wind-heat invadi~ the lung and pattern of phlegm-heat brewing in the lung. ARD occurred in 7 patients （0. 17% ）. The occurrence of AI）R was related to the manufacturer, lot number, drip rate, other injections and non- standard operations. Conclusion Xiyanping Injection （ 喜炎平注射液） is commonly used to treat respiratory diseases with syndrome of wind-heat invading the lung or syndrome of phlegm-heat brewing in the lung. ADR is occa- sionally occurred in the elderly or children suffering from infectious diseases.