唑尼沙胺不良反应个案分析  

Adverse Reactions Induced by Zonisamide:A Case Report

作　　者：张涛[1] 王世燕 胡晨吉 樊萍[1] ZHANG Tao;WANG Shiyan;HU Chenji;FAN Ping(Department of Clinical Pharmacy,West China Hospital,Sichuan University,Chengdu,Sichuan,China 610041)

机构地区：[1]四川大学华西医院临床药学部,四川成都610041

出　　处：《中国药业》2024年第14期120-123,共4页China Pharmaceuticals

摘　　要：目的 为临床合理使用唑尼沙胺提供参考。方法 通过检索中国知网、万方、维普、PubMed、Web of Science数据库自建库起至2023年5月收录的唑尼沙胺药品不良反应(ADR)个案报道,提取并分析患者的基本信息及ADR发生特点,利用诺氏评估量表进行关联性评价。结果 共纳入37篇文献,其中中文1篇、英文36篇,涉及患者45例,ADR 47例次。其中男23例,女22例;年龄以50岁及以下多见(39例,86.67%)。37例(82.22%)原患疾病为癫痫或行预防癫痫治疗,且伴多种合并症;用药剂量多在400 mg/d以内(30例,66.67%);31例患者有联合用药记录(联用药物主要为抗癫痫药物、抗肿瘤药物、非甾体抗炎药等)。ADR最常在用药后1个月内发生(26例次,55.32%),主要累及皮肤及软组织系统、泌尿系统、精神系统等。临床表现以精神行为异常、泌尿结石、Stevens-Johnson综合征/中毒性表皮坏死松解症等较多见。关联性评价为“可能有关”8例,“很可能有关”36例,“肯定有关”1例。结论 唑尼沙胺易导致多种严重ADR,临床表现多样。在使用唑尼沙胺期间,应加强对其ADR的监测,并开展癫痫药学服务,从而保障患者用药安全。Objective To provide a reference for the rational use of zonisamide in clinical practice.Methods The case reports of adverse drug reactions(ADRs)induced by zonisamide in the CNKI,WanFang,VIP,PubMed and Web of Science from the inception of each database to May 2023 were searched.The basic information of patients and the characteristics of ADRs were extracted and analyzed,and the correlation of ADRs with zonisamide was evaluated by the Naranjo′s ADR evaluation scale.Results A total of 37 studies were included,among which one was in Chinese and 36 were in English,involving 45 patients(47 case times of ADRs),including 23 males and 22 females,with the majority of 50 years or below(39 cases,86.67%).Thirty-seven cases(82.22%)had a primary disease of epilepsy or received prophylactic treatment for epilepsy,and they were also with multiple comorbidities.Most patients(30 cases,66.67%)used zonisamide at a dosage within 400 mg/d.Thirty-one patients were given combined medication(zonisamide mainly combined with anti-epileptic drugs,anti-tumor drugs,non-steroidal anti-inflammatory drugs,etc.).The ADRs occurred most commonly within one month after medication(26 case times,55.32%),mainly affecting the skin and soft tissue system,urinary system,mental system,etc.The clinical manifestations mainly included mental and behavioral abnormalities,urinary stones,Stevens-Johnson syndrome/toxic epidermal necrolysis,etc.The correlation evaluation showed that the ADRs were possibly,probably and definitely correlated with zonisamide,with eight cases,thirty-six cases and one case,respectively.Conclusion Zonisamide can easily induce various serious ADRs with diverse clinical manifestations.During the use of zonisamide,we should strengthen the monitoring of relevant ADRs and provide pharmaceutical care for epilepsy to ensure the patients′medication safety.

关 键 词：唑尼沙胺 药品不良反应 个案报道 药学监护 

分 类 号：R969.3[医药卫生—药理学]