左乙拉西坦引起不良反应的相关因素分析

Analysis of influencing factors of the adverse drug reactions associated with levetiracetam

目的探讨左乙拉西坦引起不良反应的相关因素分析。方法回顾性分析2020年1月~2022年12月间,中山市人民医院接受左乙拉西坦治疗的167例癫痫患者的临床资料。运用中山市人民医院病例系统检索患者病历资料,参考《药品不良反应报告和监测管理办法》评价不良反应事件,采用多因素Logistic回归分析左乙拉西坦引起不良反应的危险因素。结果167例患者中共发生48例51起不良反应事件,不良反应发生率为30.54%。所有不良事件均为轻度,其中40例共43起不良反应经判断与左乙拉西坦有关、8例共8起不良反应经判断与左乙拉西坦可能有关,最常见的不良反应为嗜睡(10.78%)、头晕(4.79%)及情绪异常(3.59%)。多因素Logistic回归分析显示,女性、年龄<18岁、病程≥10年、联合用药、合并精神疾病、合并肾脏疾病是不良反应发生的影响因素(P<0.05)。结论左乙拉西坦治疗癫痫的不良反应较轻,多为轻度不良反应,性别、年龄、病程、联合用药、是否合并精神疾病、是否合并肾脏疾病是左乙拉西坦导致不良反应的独立影响因素。

Objective To screen the factors affecting the adverse drug reactions associated with levetiracetam.Methods The clinical data of 167 epileptic patients undergoing monotherapy with levetiracetam in Zhongshan City People's Hospital from January 2020 to December 2022 were retrospectively analyzed.The medical records of patients were retrieved through electronic medical record system of the hospital,and adverse reaction events were evaluated by referring to"Adverse Drug Reaction Reporting and Monitoring Measures".Results Totally 51 adverse events occurred in 48 of 167 patients,with an incidence rate of 30.54%.All adverse events were mild in severity,with 43 adverse reactions occurring in 40 cases judged to be associated with levetiracetam and 8 adverse reactions in 8 cases found to be possibly related to levetiracetam,with the most common adverse reactions being drowsiness(10.78%),dizziness(4.79%)and abnormal mood(3.59%).Multivariate Logistic regression analysis denoted that gender of female,age<18 years,course of disease≥10 years,concomitant medication,presence of mental illness,and presence of kidney disease were the influencing factors for adverse reactions(P<0.05).Conclusion The adverse reactions associated with levetiracetam for epilepsy are mostly mild in severity.Gender,age,duration of disease,concomitant medication,presence of mental illness,and presence of kidney disease are independent influencing factors leading to adverse reactions.