Ottervanger J P, Valkenburg H A, Grobbee D E, Stricker B H
Netherlands Centre for Monitoring of Adverse Reaction to Drugs, Rijswijk.
J Clin Epidemiol. 1998 Sep;51(9):795-9. doi: 10.1016/s0895-4356(98)00052-3.
Postmarketing surveillance (PMS) studies are frequently based on data from general practitioners (GPs). Patients, however, do not always report to their GP suspected adverse drug reactions.
A postmarketing cohort study on adverse reactions to sumatriptan, performed with assistance of drug dispensing GPs in The Netherlands.
Questionnaires were sent to all drug-dispensing GPs in The Netherlands, as well as to their patients on sumatriptan. To avoid bias, no specific adverse reactions were mentioned in the questionnaires.
Of the GPs, 589 (86%) responded; of the patients, 1202 (70%) responded. The most frequently reported suspected adverse reactions to sumatriptan reported by the GPs were dizziness (1.7%), nausea or vomiting (1.5%), drowsiness or sedation (1.4%), and chest pain (1.3%). The most frequently reported suspected adverse reactions by the patients were paraesthesia (11.7%), dizziness (8.1%), feeling of heaviness (8.0%), and chest pain (7.9%). Neither the GPs nor the patients reported serious adverse reactions.
First, patients experience significantly more suspected adverse reactions than are registered by their GP. In view of this higher frequency of reporting of suspected adverse reactions, postmarketing studies with data from GPs only, may underestimate the cumulative incidence of adverse reactions. Second, we conclude that it is possible to obtain useful additional information about adverse drug reactions from patients by sending them questionnaires via their GP.
上市后监测（PMS）研究通常基于全科医生（GP）提供的数据。然而，患者并不总是向他们的全科医生报告疑似药物不良反应。
在荷兰，一项关于舒马曲坦不良反应的上市后队列研究，在配药全科医生的协助下进行。
向荷兰所有配药全科医生及其使用舒马曲坦的患者发送问卷。为避免偏差，问卷中未提及特定的不良反应。
589名（86%）全科医生回复；1202名（70%）患者回复。全科医生报告的最常见的疑似舒马曲坦不良反应为头晕（1.7%）、恶心或呕吐（1.5%）、嗜睡或镇静（1.4%）以及胸痛（1.3%）。患者报告的最常见的疑似不良反应为感觉异常（11.7%）、头晕（8.1%）、沉重感（8.0%）以及胸痛（7.9%）。全科医生和患者均未报告严重不良反应。
首先，患者经历的疑似不良反应显著多于其全科医生记录的数量。鉴于疑似不良反应报告频率较高，仅基于全科医生数据的上市后研究可能低估不良反应的累积发生率。其次，我们得出结论，通过全科医生向患者发送问卷，可以从患者那里获得有关药物不良反应的有用补充信息。
