北京地区2004~2017年丙戊酸相关不良反应分析

Clinical Analysis of Valproic Acid-related Adverse Reactions in Beijing from 2004 to 2017

目的:分析丙戊酸相关不良反应发生的特点,为安全应用该类药物、有效开展药学监护提供参考。方法:调取2004年至2017年北京市药品不良反应监测中心接收的丙戊酸相关不良反应报告数据,提取患者性别、年龄等人口学信息,丙戊酸剂型、剂量、血药浓度等药品信息,以及不良反应累及系统、出现时间及预后转归等情况,进行统计分析。结果:614例丙戊酸相关不良反应累及系统前三位分别是皮肤和皮下组织(29.5%)、血液淋巴系统(22.1%)、神经和精神系统(17.1%);多数患者不良反应转归为痊愈(30.6%)或好转(48.5%),少部分患者未好转(8.0%),有2例死亡(0.3%)。在71例已知血药浓度的报告中,16例(22.5%)未达到有效血药浓度范围,34例(47.9%)在有效血药浓度范围内,21例(29.6%)超过有效血药浓度范围。结论:皮肤和皮下组织、血液淋巴系统和神经精神系统是丙戊酸相关不良反应常累及的系统,同一患者可同时出现多种或累及多个系统的不良反应;多数患者出现丙戊酸相关不良反应后给予停药、减量或对症处理等措施可以逆转;血药浓度值对于预测丙戊酸用药的安全性仅作参考。

Objective:To analyze the characteristics of valproic acid-related adverse reactions(ADRs),so as to provide reference for safe use and effective pharmaceutical care of valproic acid.Methods:Data of ADRs related to valproic acid reported to Beijing ADR Monitoring Center from 2004 to 2017 were obtained and extracted for demographic information such as gender and age;drug information such as dose form,dosage and serum concentration;ADR information such as the system involved,occurrence time and prognosis.Results:The top three ADR involved systems in 614 patients were skin and subcutaneous tissue(29.5%),hemic and lymphatic system(22.1%)and nervous and mental system(17.1%).Most of the ADRs were cured(30.6%)or improved(48.5%),while a few patients did not improve(8.0%)and 2 died(0.3%).Among the 71 cases reported blood drug concentrations,16 cases(22.5%)were under,34 cases(47.9%)were within and 21 cases(29.6%)were over the range of effective blood drug concentrations.Conclusion:Skin and subcutaneous tissue,hemic and lymphatic system and nervous and mental system are often involved in the ADRs related to valproic acid.One individual may have more than one adverse reaction or have multiple systems involved at the same time.The majority of patients with valproic acid ADRs can be reversed by withdrawal or symptomatic treatment.The serum concentrations of valproic acid can just be a reference for predicting the safety of valproic acid during drug use.