Schirm Eric, Tobi Hilde, van Puijenbroek Eugène P, Monster-Simons Margje H, de Jong-van den Berg Lolkje T W
Groningen University Institute for Drug Exploration, University of Groningen, Department of Social Pharmacy, Pharmacoepidemiology and Pharmacotherapy, Groningen, The Netherlands.
Pharmacoepidemiol Drug Saf. 2004 Mar;13(3):159-65. doi: 10.1002/pds.843.
The interpretation of the available studies on adverse drug reactions (ADRs) in children outside the hospital is hampered because none of these studies used a control group. The aim of this study was to describe ADRs in children outside the hospital, controlled for drug use in the paediatric background population.
Using a case-control design, we compared drugs on which a suspected ADR was reported to the Netherlands Pharmacovigilance Centre LAREB, and drugs used in the general paediatric population from the InterAction pharmacy database, both in the year 2001, for children aged 0-16 years.
The main findings are that ADRs were disproportionately more often reported on systemic drugs (OR 3.0; [95%CI: 1.9-4.8]), new drugs (2.4; [1.6-2.7]), anti-infective drugs (1.7; [1.1-2.7]) and nervous system drugs (2.1; [1.3-3.5]), whereas unlicensed drugs (0.1; [0.0-0.4]), frequently used drugs (0.3; [0.2-0.5]) and dermatologicals (0.1; [0.0-0.4]) were less likely to be associated with a reported ADR. Overall, the proportion of off-label prescriptions did not differ between drugs suspected of an ADR and drugs used by children in a general population.
The pattern of drugs associated with a reported ADR could not be solely explained on the basis of drug utilisation patterns in the general population.
由于现有的关于院外儿童药物不良反应（ADR）的研究均未使用对照组，因此对这些研究的解读受到了阻碍。本研究的目的是描述院外儿童的药物不良反应，并对照儿科背景人群的用药情况进行分析。
采用病例对照设计，我们比较了2001年向荷兰药物警戒中心LAREB报告有疑似药物不良反应的药物，以及来自InterAction药房数据库的普通儿科人群使用的药物，研究对象为0至16岁的儿童。
主要发现为，全身用药（比值比3.0；[95%置信区间：1.9 - 4.8]）、新药（2.4；[1.6 - 2.7]）、抗感染药物（1.7；[1.1 - 2.7]）和神经系统药物（2.1；[1.3 - 3.5]）的药物不良反应报告比例过高，而未经许可的药物（0.1；[0.0 - 0.4]）、常用药物（0.3；[0.2 - 0.5]）和皮肤科用药（0.1；[0.0 - 0.4]）与报告的药物不良反应关联较小。总体而言，疑似药物不良反应的药物与普通人群中儿童使用的药物之间，超说明书用药的比例没有差异。
报告的药物不良反应所涉及的药物模式不能仅根据普通人群的药物使用模式来解释。
