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| 105例口服抗癫痫药物致血液系统不良反应分析 |
| Analysis of 105 Cases of Adverse Drug Reactions to the Blood System Induced by Oral Antiepileptic Drugs |
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| DOI： |
| 中文关键词: 抗癫痫药物 血液系统 药品不良反应 药品安全 |
| 英文关键词:Antiepileptic drugs Blood system Adverse drug reactions Drug safety |
| 基金项目:原国家食品药品监督管理总局药品评价中心项目[编号：监测与评价基2016(30)号] |
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| 中文摘要: |
| 摘 要 目的：探讨抗癫痫药物（AEDs）致血液系统不良反应（ADRs）的临床特点，为临床安全用药提供依据。方法：回顾2003～2015年我院癫痫门诊患者随访登记数据库中6种主要AEDs所致血液系统ADRs的105例资料，并对患者性别、年龄， ADRs出现时间、严重程度、ADRs结局，联合用药、AEDs日剂量等指标进行统计分析。 结果：105例AEDs致血液系统ADRs病例中，女性多于男性 (1.56 ∶〖KG-*2〗1)，传统及新型AEDs致血液系统ADR均以21~30岁年龄段最多；传统AEDs卡马西平、丙戊酸钠所占比例分别为32.38%和24.76%，其次为新型AEDs奥卡西平，占17.14%； 白细胞减少症最常见（65.72%）。AEDs致血液系统ADRs在联合治疗时多见，占69.52%；约1/3的ADRs在中等日剂量时出现； 大多数患者的ADRs持续时间不长，结局良好。结论：临床医师充分认识AEDs致血液系统ADRs的临床特点， 可加强药品安全监督，积极预防和早期治疗血液系统ADRs。 |
| 英文摘要: |
| ABSTRACT Objective: To explore the clinical features of adverse drug reactions (ADRs) to the blood system induced by oral antiepileptic drugs (AEDs) and provide evidence for clinical drug safety. Methods:Data of 105 cases of ADRs to the blood system induced by oral AEDs from January 2003 to December 2015 was reviewed and analyzed by gender, age, time of ADRs occurrence, severity, outcome of ADRs, medication combined and daily dosage of AEDs. Results:There were more females than males (1.56:1) in 105 cases of ADRs to the blood system induced by oral AEDs. Traditional and new AEDs were mostly aged from 21 to 30 years. Traditional AEDs carbamazepine (CBZ), valproate (VPA) accounted for a high proportion, 32.38% and 24.76%, respectively; followed by new AEDs oxcarbazepine (OXC) accounting for 17.14%. Leukopenia was the most common ADRs (65.72%). Majority of ADRs to the blood system induced by oral AEDs occurred in combination therapy, accounting for 69.52%. About one third of the ADRs appeared at moderate daily dosage. The ADRs of most patients did not last long time and the outcomes of ADRs were well. Conclusion:Clinicians fully understand the clinical features of ADRs to the blood system induced by oral AEDs, so that the supervision of drug safety strengthens and ADRs to the blood system can be prevent and early treatment. |
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