注射用核糖核酸Ⅱ安全性医院集中监测研究

Intensive hospital monitoring of the safety of Ribonucleic Acid for Injection Ⅱ

目的开展注射用核糖核酸Ⅱ上市后安全性再评价研究。方法采用医院集中监测方法,选取我院2016年7月至2017年3月使用注射用核糖核酸Ⅱ的住院患者1 800例,从患者的一般信息、临床诊断、用药信息、不良反应/不良事件(ADR/ADE)信息进行统计分析。结果纳入的1 800例患者中,发生4例ADR,不良反应发生率为0.22%,属于偶见不良反应。临床表现为头晕、心悸、皮疹、恶心等。结论注射用核糖核酸Ⅱ不良反应发生率较低,安全性良好。

Objective To re-evaluate the post-marketing safety of Ribonucleic Acid for Injection Ⅱ. Methods Totally 1 800 inpatients treated with Ribonucleic Acid for Injection Ⅱ were selected from July 2016 to March 2017 in our hospital by intensive hospital monitoring. The general information, clinical diagnosis, medication information, and ADR/ADE information of patients were statistically analyzed. Results In 1 800 patients,adverse reactions occurred in 4 cases, with an incidence of 0. 22% , which belonged to the occasional adverse reaction. Adverse reactions were characterized by dizziness,palpitations,rash and nausea,et al. Conclusion The incidence of adverse reactions of Ribonucleic Acid for Injection Ⅱ is low, and its clinical application is relatively safe.