6例注射用血栓通(冻干)严重不良反应报告分析

Analysis of 6 cases of severe adverse reactions of Xueshuantong Injection(lyophilized)

目的:对我市使用注射用血栓通(冻干)的6例严重不良反应报告进行回顾性分析,旨在为临床合理用药提供依据。方法:分析2017年至2019年监测网络数据,对不良反应与患者的基本情况、原发疾病、用药原因、溶媒,用药情况的相关性进行研究。结果:6例的严重药品不良反应报告中无50岁以下的年龄患者,≥60岁有5例;6例患者均判定为符合适应证用药:使用注射用血栓通(冻干)后不良反应发生时间≤10min有2例,11-60min有3例,≥2d有1例;4例患者出现了说明书上未载明的新的药品不良反应,如高热、胸痛、面色苍白、心源性休克等。结论:通过主动收集该药近几年出现严重药品不良反应的报告,重点关注该药在临床出现的新的、严重药品不良反应和可能的影响因素,为临床合理用药提供依据,提高患者用药安全性。

Objective:6 cases of severe adverse reaction reports of Xueshuantong Injection(lyophilized) in Haikou were retrospectively analyzed,aiming to provide reference for clinical rational drug use.Method:The monitoring network data ranging from 2017 to 2019 were analyzed,and the correlation between drug adverse reactions and the basic conditions of patients,including primary diseases,causes of medication,solvents,and medication were studied.Result:There were no patients under50 years old and 5 cases over 60 years old in the 6 cases of severe adverse drug reaction reports.All 6 cases were judged as in accordance with the indications.After using Xueshuantong Injection(lyophilized),adverse drug reactions occurred in 2 cases within 10 minutes,3 cases within 11 to 60 minutes,and 1 case more than two days.New adverse reactions which were not stated in the instruction were found in 4 patients,such as hyperpyrexia,chest pain,pallor and cardiogenic shock.Conclusion:By collecting the reports of severe adverse reactions in recent years,we focus on the factors leading to new and severe drug adverse reaction in clinical practice,so as to provide a reference for the clinical rational drug use and improve medication safety in patients.