奥拉西坦制剂安全性分析

Safety Analysis of Oxiracetam Preparation

目的:分析奥拉西坦制剂临床使用的安全性,为药品说明书修订和临床安全用药提供参考和依据。方法:检索国内外文献数据库建库以来关于奥拉西坦制剂致药品不良反应/事件(ADR/ADE)的病例报道,对患者的不良反应/事件发生时间、不良反应/事件表现及累及系统-器官、用法用量等进行回顾性分析,发现奥拉西坦临床ADR/ADE发生规律及特点。结果:按照文献纳入和排除标准,共纳入奥拉西坦制剂文献36篇,病例168例,其中28例详细报道,男性高于女性。原患疾病以脑病为主,主要为脑梗死、脑挫伤、脑肿瘤。患者年龄以50岁以上居多。ADR/ADE以迟发型为主,发生时间在第2~10天居多,发生在30 min内的占22.22%。ADR/ADE主要累及胃肠系统、中枢及外周神经系统和致精神紊乱等,主要表现为恶心、头痛、头晕、睡眠紊乱、失眠、皮疹、瘙痒等。临床用药剂量及溶媒选择能够按照说明书使用。结论:临床使用奥拉西坦制剂过程中应注意加强用药监测,尤其注意速发型ADR/ADE的发生,应定期随访,减少ADR/ADE的发生。

Objective:To analyze the safety of oxiracetam preparation in clinic and to provide reference and basis for the revision of drug instructions and clinical safe.Methods:The case reports of Adverse Drug Reaction/Events(ADR/ADE)caused by oxiracetam preparation were retrieved since the establishment of literature database at home and abroad,and the occurrence time,adverse reaction manifestations,injury system involved,usage and dosage of ADR/ADE were analyzed retrospectively,so as to confirm the occurrence regularity and characteristics of oxiracetam clinical ADR/ADE.Results:According to the inclusion and exclusion criteria,a total of 36 articles were included,including 168 cases of oxiracetam,among which 28 cases were reported in detail.Males was higher than that of females.The original diseases were mainly encephalopathy,mainly cerebral infarction,cerebral contusion and brain tumor.The majority of patients were over 50 years old.ADR/ADE is mainly delayed hair style,which occurs in the 2 nd to 10 th day,also occurs within 30 minutes accounting for 22.22%.ADR/ADE mainly involves gastrointestinal system,central and peripheral nervous system,and causes mental disorders,mainly manifested as nausea,headache,dizziness,sleep disorders,insomnia,rash,pruritus,etc.Clinical dosage and solvent selection can be used in accordance with the instructions.Conclusion:During the clinical use of oxiracetam preparation,attention should be paid to strengthen drug monitoring,especially the occurrence of rapid-type ADR/ADE,regular follow-up to reduce the occurrence of ADR/ADE.