32546例疏血通注射液医院集中监测研究

32546 intensive hospital monitoring cases of Shuxuetong injection

为了解疏血通注射液的不良反应特征、发生率等安全性信息,该研究采用多中心、大样本医院集中监测的设计方法,在全国54家医疗机构中,以使用疏血通的住院患者为监测对象,进行用药周期的全程监测。监测内容为患者的一般信息、诊断信息、用药信息、不良反应/事件信息等。共纳入32 546例病例,发生不良反应64例,不良反应发生率为0.197%,发生特征主要是皮肤瘙痒、皮疹、感冒状、呼吸困难、心悸、头痛、胸闷等过敏反应;发生不良反应患者以中老年人为主,用药特征基本符合说明书。以上结果说明,疏血通注射液在临床应用中安全性良好。

This study adopted multi-center and large sample design to understand the incidence,characteristics and other information about adverse reaction of Shuxuetong injection. In 54 medical institutions,use of Shuxuetong injection of entire treatment period was monitored,including patients＇ general information,diagnostic information,medication,adverse reaction / event information,etc.Sixty four cases of adverse reactions in 32 546 patients was monitored,adverse rate was 0. 197%,mainly characterized by skin itching,rash,flu-like,dyspnea,palpitations,headache,chest tightness and other allergic reactions. Adverse reaction occurred mainly in elderly patients and medication was consistent with the instruction. Based on these results,safety of Shuxuetong injection in clinical application is excellent.