277例吡拉西坦口服制剂不良反应报告分析  

Analysis of 277 cases of adverse reactions of piracetam oral preparation

作　　者：郭会青 黄静 GUO Huiqing;HUANG Jing(Shijiazhuang Food and Drug Inspection Center,Shijiazhuang Adverse Drug Reaction Monitoring Center,Shijiazhuang 050000,China)

机构地区：[1]石家庄市食品药品检验中心,石家庄市药品不良反应监测中心,河北石家庄050000

出　　处：《临床医药实践》2024年第8期596-599,630,共5页Proceeding of Clinical Medicine

基　　金：河北省药品监督管理局科技计划项目(项目编号:2022ZC1051)。

摘　　要：目的:分析吡拉西坦口服制剂不良反应(ADR)发生的特点和规律,为提高临床用药的合理性与安全性提供参考。方法:选取河北省2004年1月1日—2021年8月31日277例吡拉西坦口服制剂ADR报告进行回顾性统计分析。结果:277例吡拉西坦口服制剂ADR报告中男女比为2.15∶1.00,其中45岁以上的中老年患者占比最高;不良反应累及的系统/器官主要为消化系统、神经精神系统、皮肤及皮肤附件;主要的用药原因为脑血管病、记忆力减退、颅内损伤;ADR主要发生在开始用药3 d内,用药当天发生ADR占比最高(41.16%);发生ADR后干预措施以停药为主,停药后51.62%的患者痊愈,33.21%的患者好转。结论:继续关注患者使用吡拉西坦口服制剂发生ADR的性别差异;加强中老年患者用药监护;用药3 d内是吡拉西坦口服制剂ADR的高发期,一旦发生ADR,建议停药,必要时就医治疗;药品上市许可持有人应主动完善药品说明书,以更好地指导临床安全合理用药。Objective:To analyze the characteristics and patterns of adverse drug reactions(ADR)in piracetam oral preparations,and provide reference for improving the rationality and safety of clinical medication.Method:A retrospective statistical analysis was conducted on 277 ADR reports of piracetam oral preparation from January 1,2004 to August 31,2021 in Hebei Province.Results:All 277 ADR reports of piracetam oral preparation were reported,with a male to female ratio of 2.15:1.The proportion of middle-aged and elderly patients aged 45 and above was the highest.Adverse reactions affecting systems/organs mainly include gastrointestinal system damage,neurological damage,mental disorders,skin and skin accessory damage.The main causes of medication are cerebrovascular disease,memory loss,cerebral infarction,and intracranial injury.ADR mainly occurs within 3 days of starting medication,with the highest proportion occurring on the day of medication(41.16%).After the occurrence of ADR,the main intervention measures were discontinuation of medication.51.62%of patients recovered after discontinuation,and 33.21%of patients improved.Conclusion:Continue to pay attention to gender differences in the occurrence of ADR in patients using oral piracetam preparations;strengthen medication monitoring for middle-aged and elderly patients.Within 3 days of medication,it is a high incidence period for ADR in piracetam oral preparations.Once ADR occurs,it is recommended to stop the medication and seek medical treatment if necessary.Holders of drug marketing licenses actively improve drug instructions to better guide clinical safe.

关 键 词：吡拉西坦 口服制剂 不良反应 

分 类 号：R971[医药卫生—药品]