基于OpenFDA的拉考沙胺相关药物不良反应的流行病学分析  

Epidemiological Analysis of Lacosamide-related Adverse Drug Reactions Based on OpenFDA

作　　者：周甜甜 张颖[1] 王录 ZHOU Tian-tian;ZHANG Ying;WANG Lu(Department of Pharmacy,Zhengzhou Second Hospital,Zhengzhou 450000,China)

机构地区：[1]郑州市第二人民医院药学部,郑州450000

出　　处：《抗感染药学》2024年第6期577-581,共5页Anti-infection Pharmacy

基　　金：河南省医学科技攻关计划项目(编号:2018020740)。

摘　　要：目的:基于美国食品药品监督管理局公共数据公开项目(OpenFDA)数据库,挖掘拉考沙胺相关药物不良反应(adverse drug reactions,ADRs)的临床特点,为临床拉考沙胺的用药安全提供参考。方法:以“拉考沙胺(lacosamide)”作为检索词,在OpenFDA数据库中检索2004年1月1日—2023年2月1日拉考沙胺相关ADRs的所有信息,分析其流行病学特点。结果:在OpenFDA数据库中共检索到拉考沙胺相关ADRs 10510例,其中2018年起上报数量明显增多;10510例拉考沙胺相关ADRs中,绝大多数ADRs的严重程度为“严重”(9170例,占87.25%)“,一般”的仅1340例(占12.75%);拉考沙胺相关ADRs主要表现为各类神经系统症状,其次为全身性或给药部位的不适或异常和精神类症状;在10510例拉考沙胺相关ADRs中,有1011例的最终结局是死亡,有76例则留有后遗症。结论:拉考沙胺相关ADRs大多表现较为严重,甚至有不少致死的情况,因此临床在使用拉考沙胺进行治疗时应加强用药监护,以避免或减少严重不良结局的发生。Objective:To explore the clinical characteristics of adverse drug reactions(ADRs)related to lacosamide based on OpenFDA,a public database of U.S.Food and Drug Administration,and provide a reference for the clinically safe medication of lacosamide.Methods:All information on lacosamide-related ADRs from January 1,2004 to February 1,2023 was searched in the OpenFDA database using"lacosamide"as the key word to analyze its epidemiological characteristics.Results:A total of 10510 patients with lacosamide-related ADRs were searched from the OpenFDA database,of which,the number of reported patients increased significantly since 2018.Among all lacosamide-related ADRs,most of ADRs were of"serious"(9170 patients,87.25%),and only a small number of patients(1340 patients,12.75%)were of"ordinary".The lacosamide-related ADRs were mainly manifested as various neurological symptoms,followed by systemic or administration site discomforts or abnormalities and psychiatric symptoms.Among 10510 patients with lacosamide-related ADRs,the outcomes of 1011 patients were death and 76 patients had sequelae.Conclusion:Most of the lacosamide-related ADRs are serious,and even cause deaths.Therefore,it is necessary to strengthen the clinical medication monitoring when lacosamide is used for treatment,to avoid or reduce the occurrence of serious adverse outcomes.

关 键 词：拉考沙胺 OpenFDA 药物不良反应 流行病学特点 

分 类 号：R181.35[医药卫生—流行病学] R971.6[医药卫生—公共卫生与预防医学]