56例拖吡酯不良反应文献及临床病例分析

Analysis of 56 Literature and Clinical Cases of Adverse Reactions Induced by Topiramate

目的了解托吡酯致不良反应一般规律及特点,为托吡酯临床安全合理使用提供参考。方法本研究纳入自1999年3月至2018年3月应用托吡酯出现药品不良反应(ADR)并上报至首都医科大学附属北京天坛医院药剂科的患者,同时检索以上时间段中国期刊网全文数据库、万方数据库、维普中文期刊全文数据库、中国生物医学文献数据库中报道的中国患者的文献,按照纳入与排除标准筛选出文献,统计相应的ADR信息,将我院患者及通过文献提取出的病例信息合并后进行归纳分析。结果不良反应多发生在18岁以下患者,原患疾病主要为癫痫,不良反应多发生于用药后1~3个月内,累及系统-器官损害主要为神经系统损害和皮肤及其附件系统损害等,临床表现以认知障碍和出汗减少最为常见,其次为厌食和体重下降,共有10例次严重ADR,其中皮肤及其附件占比最多,其次为泌尿系统损害,无死亡病例,经减、停托吡酯后症状多能痊愈或缓解。结论在应用托吡酯时需关注患者有无过敏史、肾结石家族史等,从小剂量开始,缓慢加量,并监测血常规、肝功能、血氨、电解质、泌尿系B超等,一旦出现ADR表现应尽早诊断及治疗,保障安全用药。

Objective Through investigating the characteristics and mechanism of adverse reactions induced by topiramate,to find its risk factors and provide technical support for safe and rational use of drugs in clinic.Methods The patients who experienced adverse drug reactions(ADRs)induced by topiramate and reported by the department of pharmacy in Beijing Tiantan Hospital from March 1999 to March 2018 were included.At the same time articles in the CNKI database,Wanfang database,VIP Chinese full-text database and CBM database were searched,and the patients in the references which met the inclusion criteria were extracted.Then the ADR information of the patients both from Beijing Tiantan Hospital and the literatures were analyzed together.Results Most of the reactions occurred in patients under the age of 18.The major illness was epilepsy.ADRs occurred more frequently within 1 to 3 months after topiramate treatment.Systems and organs mainly involved in adverse reactions were neurological disorders,skin and appendages disorders,etc.Cognitive disorders and hypohidrosis were the most commonly reported adverse reactions,followed by anorexia and weight decrease.There were ten serious ADRs among which skin and appendages disorders were the most common,and then urinary tract disorders.No case died because of ADRs induced by topiramate,and most ADRs were fully recovered or relieved by stopping or reducing the use of topiramate.Conclusion The family history of nephrocalcinosis and allergy history should be asked before using topiramate.Start using topiramate with a small dose and increase the dose slowly.Blood routine test、liver function、ammonia、electrolyte、urinary system ultrasound test of patients should be monitored.Once ADRs occur,diagnosis and treatment should be carried out as soon as possible to ensure the safe drug use.