首页|基于OpenFDA的拉考沙胺相关药物不良反应的流行病学分析

基于OpenFDA的拉考沙胺相关药物不良反应的流行病学分析

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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 10 510 例,其中2018 年起上报数量明显增多;10 510 例拉考沙胺相关ADRs中,绝大多数ADRs的严重程度为"严重"(9 170 例,占 87。25%),"一般"的仅 1 340 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 10 510 例拉考沙胺相关ADRs中,有 1 011 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。
Epidemiological Analysis of Lacosamide-related Adverse Drug Reactions Based on OpenFDA
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 10 510 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"(9 170 patients,87.25%),and only a small number of patients(1 340 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 10 510 patients with lacosamide-related ADRs,the outcomes of 1 011 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.

lacosamideOpenFDAadverse drug reactionepidemiological characteristics

周甜甜、张颖、王录

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郑州市第二人民医院药学部,郑州 450000

拉考沙胺 OpenFDA 药物不良反应 流行病学特点

河南省医学科技攻关计划项目

2018020740

2024

抗感染药学
江苏省苏州市第五人民医院

抗感染药学

影响因子:0.505
ISSN:1672-7878
年,卷(期):2024.21(6)