1170例抗癫痫药单药治疗致药品不良反应分析  

Analysis of 1170 Cases of Adverse Drug Reactions Induced by Antiepileptic Drugs Used in Monotherapy

作　　者：杜延茹 宋秋洁 沈晶赞 郑荣远[1] 徐惠琴[1] DU Yanru;SONG Qiujie;SHEN Jingzan;ZHENG Rongyuan;XU Huiqin(Department of Neurology, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Wenzhou 325035, China;Center for Drug Reevaluation, NMPA, Beijing 100021, China)

机构地区：[1]温州医科大学附属第一医院神经内科,浙江温州325035 [2]国家药品监督管理局药品评价中心,北京100000

出　　处：《中国药物警戒》2019年第2期101-105,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的探讨抗癫痫药单药治疗致药品不良反应的特点和规律,探索药品上市后安全性监测的方法,指导临床合理用药。方法回顾我院癫痫门诊患者随访登记数据库中2003年1月～2015年12月登记的抗癫痫药单药治疗致药品不良反应数据。纳入1 170例病例,涉及2 461例次不良反应,将患者和不良反应的信息进行统计和分析。结果1 170例抗癫痫药单药治疗致药品不良反应的患者中,女性占51.03%,年龄21～40岁有731例(62.48%)。不良反应累及系统-器官主要为神经系统、精神系统和消化系统。卡马西平、丙戊酸钠、拉莫三嗪、奥卡西平、托吡酯和左乙拉西坦均可引起遗忘(记忆力减退)、头晕、头痛和失眠。低、中、高剂量均可出现不良反应。2 461例次不良反应中,服药1个月内和服药1年后出现不良反应的占比分别是33.08%和29.46%。大多数不良反应结局良好,严重不良反应主要为过敏、致畸、肾结石。结论应警惕抗癫痫药单药治疗致药品不良反应,尤其是药物超敏反应、致畸等严重不良反应;应逐步完善药品上市后主动监测体系,重视药品不良反应监测,提高用药安全性。Objective To explore the characteristics and profiles of adverse drug reactions (ADRs) related to antiepileptic drugs (AEDs) used in monotherapies, and explore the method of post-marketing safety surveillance of drugs, so as to guide the rational use of AEDs in clinic. Methods We reviewed the data of ADRs related to AEDs used in monotherapies, which came from the database of outpatients with epilepsy in our hospital from January 2003 to December 2015. Totally, 1 170 cases were included, involving 2 461 ADRs. Data of cases and ADRs was analyzed. Results Among 1 170 cases with ADRs caused by AEDs used in monotherapy, women accounted for 51.03%, and 731 (62.48%) cases aged 21 to 40 years old. The system-organs of nervous system, mental system and digestive system were mainly involved. Carbamazepine, valproate, lamotrigine, oxcarbazepine, topiramate, and levetiracetam could all cause amnesia (poor memory), dizziness, headache, and insomnia. Low, medium and high doses could lead to ADRs. In the 2 461 ADRs, the proportion of ADRs appeared within one month and one year after taking AEDs was 33.08% and 29.46%, respectively. The outcomes of most ADRs came out well. Serious adverse reactions were mainly allergy, fetal abnormalities and renal calculus. Conclusion Clinicians should be alert of ADRs related to AEDs used in monotherapies, especially serious adverse reactions such as hypersensitivity and fetal abnormalities. The post-marketing monitoring system of drugs should be improved gradually to pay attention to ADRs and ensure patients' safety.

关 键 词：抗癫痫药 单药治疗 药品不良反应 药品上市后监测 

分 类 号：R994.11[医药卫生—毒理学]