288例奥拉西坦致不良反应报告的相关因素分析

Analysis on Correlative Factors of 288 Cases of Reports of Adverse Drug Reactions induced by Oxiracetam Injection

目的:分析奥拉西坦注射剂致药物不良反应(ADR)发生特点和规律,为临床合理用药提供参考。方法:调取上报江苏省药品不良反应监测中心2015年1月1日—2019年2月28日间288例奥拉西坦注射剂致不良反应报告,统计其患者的性别年龄分布、既往ADR史和家族ADR史、疾病分布,ADR类型、累及系统/器官及临床表现、转归及处理措施、给药途径及发生时间、联合用药和严重ADR等因素;分析其ADR发生的特点和关联性。结果:288例ADRs报告中,其中类型为一般的有195例、新的有86例和严重的有5例;涉及女性(146例)略高于男性(142例),在性别分布上无显著差异;奥拉西坦致不良反应发生较多的是中老年人群(93.36%),其中主要发生在>35~60岁间人群;ADR累及系统/器官以皮肤表现为主(60.07%,皮疹最为常见),其次为神经系统表现;ADR发生时间大多在短期内,其中输液时发生例数为最多(93例,32.29%),其次为输液后当天发生(43例,14.93%);关联性评价中"可能"为最多(191例),其次为"很可能"(84例);在疾病分布方面主要为脑血管疾病患者。结论:虽然,奥拉西坦注射剂的ADR并不常见,新的严重的ADR发生率也不高,且通过一些对症处理后大部分症状能好转,但临床仍应加强合理使用,监测ADR的发生,以确保患者用药的安全性和合理性。

Objective:To analyze the characteristics and regularity of adverse drug reaction(ADR)induced by oxiracetam injection,and to provide a reference for clinical rational drug use.Methods:288 reports of adverse reactions caused by oracetam injection from January 1,2015 to February 28,2019 to Jiangsu Adverse Drug Reactions Monitoring Center were extracted.The gender and age distribution,previous and family history of ADR,disease distribution,type of ADR,involved system/organ and clinical manifestations,outcome and treatment measures,route and occurrence time of administration,combined medication and severe ADR of the patients were counted.The characteristics and correlation of ADR were analyzed.Results:Of the 288 cases of ADRs reported,197 cases were of ADR general type,86 were new and 5 were severe.Females(146 cases)were slightly higher than males(142 cases),with no significant difference in gender distribution.The ADR caused by oxiracetam occurred mostly in middle-aged and elderly people(93.36%),mainly people were between 35 and 60 years old.The ADRs involved systems/organs were mainly skin manifestations(60.07%,with rashes were the most common),followed by nervous system manifestations.Most of the ADRs occurred in a short period of time,and the most occurred during infusion(93 cases,32.29%),followed by the most occurred on the day after infusion(43 cases,14.93%).In the correlation evaluation,"likely"was the most(191 cases),followed by"very likely"(84 cases).In terms of disease distribution,patients with cerebrovascular diseases were the main ones.Conclusions:Although oxiracetam injection ADR is not common,the incidence of new severe ADR was not high,and most symptoms could be improved after symptomatic treatment,rational clinical use should be strengthened to monitor the occurrence of ADR,so as to ensure the safety and rationality of drug use in patients.