Prescription-Event Monitoring of 10401 Patients Treated with Fluvoxamine
Prescription-Event Monitoring of 10401 Patients Treated with Fluvoxamine
复制标题
对 10401 名接受氟伏沙明治疗的患者进行处方事件监测
DOI：
10.1192/bjp.164.3.387
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发表时间：
1994
影响因子：
10.5
通讯作者：
G. Pearce
中科院分区：
文献类型：
--
作者：
J. Edwards;W. Inman;L. Wilton;G. Pearce
处方事件监测（PEM）是英国实行的两个国家药物安全监测系统之一。本PEM研究的目的是评估氟伏沙明的安全性，并监测治疗期间不良事件和其他事件的发生。共有10401例患者在全英国接受了药物治疗，并在南安普顿的药物安全性研究中心对数据进行了分析。主要结局指标为每1000例患者事件的总体发生率;治疗第一个月的发生率;治疗第2-6个月的平均发生率;以及这些发生率的比值，作为事件可能与药物相关的信号。最常报告的事件类别为神经精神疾病，而最常报告的个体事件为恶心和呕吐。氟伏沙明被证明是一种安全的药物，没有遇到非预期的或以前未检测到的药物相关事件。胃肠道症状的发生率相对较高，但三环类抗抑郁药治疗期间经常遇到的其他不良反应并不常见。
Prescription-event monitoring (PEM) is one of two national systems of drug safety monitoring practised in Britain. The objective of this PEM study was to assess the safety of fluvoxamine and to monitor the occurrence of untoward and other events during treatment. A total of 10 401 patients treated with the drug in general practices throughout England were studied and data were analysed in the Drug Safety Research Unit, Southampton. The main outcome measures were the overall incidence of events per 1000 patients; the incidence during the first month of treatment; the mean incidence for months 2–6 of treatment; and the ratio of these rates as a signal that an event could be drug related. The most commonly reported category of events was neuropsychiatric while the most commonly reported individual events were nausea and vomiting. Fluvoxamine was shown to be a safe drug and no unexpected or previously undetected drug-related events were encountered. There was a relatively high incidence of gastro-intestinal symptoms, but other adverse reactions often encountered during treatment with tricyclic antidepressants were not frequently reported.