摘要
目的讨论丙戊酸相关血液系统不良反应的总体情况及影响其严重程度的相关因素,为临床安全使用丙戊酸类药物以及出现血液系统不良反应时的处置提供指导。方法调取2004-2017年北京市药品不良反应监测中心接收的丙戊酸相关血液系统不良反应报告数据。首先,对人口学信息、药品和疾病信息以及不良反应情况等进行总体分析,采用均值或中位数以及构成比进行描述。随后,进一步对这些不良反应进行严重程度分级,通过卡方检验或非参数秩和检验分析单因素对严重程度的影响,采用二元Logistic回归进行多因素分析。结果共纳入134例、162例次丙戊酸相关血液系统不良反应,其中包括血小板减少60例次(37.0%)、白细胞减少60例次(37.0%)、中性粒细胞减少24例次(14.8%)和纤维蛋白原减少18例次(11.1%)。不良反应经过停药、减量及对症处理等,多数患者痊愈(36.3%)或好转(49.6%)。不良反应的严重程度与性别(P=0.069)、年龄(P=0.008)和患者原发疾病(P=0.022)相关;多因素分析结果提示,儿童和老年特殊人群(OR=3.198)和男性患者(OR=2.232)是发生严重血液系统不良反应的危险因素。结论丙戊酸导致的血液系统不良反应通常仅表现为实验室检查结果异常,用药期间应注意监测血常规和凝血功能。儿童和老年特殊人群、男性患者易出现严重的血液系统不良反应,对于这些人群出现血液系统检查结果异常时要谨慎处置,避免严重临床事件的发生。
Objective To discuss the general situation of valproic acid-related adverse drug reactions(ADRs) in hematologic system and the related factors of its severity,so as to provide guidance for the safe use of valproic acid drugs and the treatment for hematologic adverse reactions.Methods Data of ADRs related to valproic acid from 2004 to 2017 were obtained from Beijing ADR Monitoring Center.Firstly,demographic information,drug and disease information and adverse drug reactions were analyzed,which were described by mean or median and composition ratio.Subsequently,the severity of these hematologic ADRs was further graded.The influence of single factor on severity was analyzed by chi-square test or non-parametric rank sum test,and multivariate analysis was performed by binary logistic regression.Results Totally 134 reports and 162 cases of valproic acid-related ADRs were included,including 60 cases of thrombocytopenia(37.0%),60 cases of leukopenia(37.0%),24 cases of neutropenia(14.8%) and 18 cases of fibrinogenopenia(11.1%).Most patients were recovered(36.3%) or improved(49.6%) after discontinuation of drugs,dosage reduction and symptomatic treatment.The severity of hematologic ADRs was correlated with gender(P=0.069),age(P=0.008) and patients′ primary diseases(P=0.022).Multivariate analysis showed that children and elderly special population(OR=3.198) and men(OR=2.232) were risk factors for severe hematologic ADRs.Conclusion ADRs of hematologic system caused by valproic acid are usually manifested as abnormal results of laboratory examinations,so we should pay more attention to monitoring blood routine and coagulation function during medication.Children and elderly special population and male patients are prone to serious ADRs of hematologic system.When these people have abnormal results of blood system examination,caution should be exercised to avoid the serious clinical events.
作者
唐静
刘清扬
林京玉
闫素英
TANG Jing;LIU Qing-yang;LIN Jing-yu;YAN Su-ying(Department of Pharmacy,Xuanwu Hospital,Capital Medical University/National Clinical Research Center for Geriatric Disorders,Beijing 100053,China;School of Pharmacy,Capital Medical University,Beijing 100069,China;Beijing Center for ADR Monitoring,Beijing 100035,China)
出处
《实用药物与临床》
CAS
2020年第5期466-470,共5页
Practical Pharmacy and Clinical Remedies
关键词
丙戊酸
不良反应
血液系统
严重程度
Valproic acid
Adverse drug reactions
Hematologic system
Severity
