Drug Safety Reseach Unit, Department of Drug Safety, Bursledon Hall, Blundell Lane, Southampton, UK.
Pharmacoepidemiol Drug Saf. 2011 Jun;20(6):608-18. doi: 10.1002/pds.2105. Epub 2011 Feb 23.
Post-marketing pharmacovigilance is a cornerstone of monitoring and evaluating the safety of medicines in children and adults. However the methods may require modification to detect paediatric signals. The aim of this study was to compare the adverse event (AE) profile of children and adults taking vigabatrin, using modified signal detection methods (SDMs).
Data from the vigabatrin prescription-event monitoring study an observational cohort study (cohort 10,177 patients), stratified into one paediatric (0-17 years) and one adult (≥ 18 years) age group were examined using summary statistics for adverse drug reactions (ADRs), reasons for stopping and deaths. Incidence densities of AEs in children and adults in the first month of treatment were compared to months two to six to examine whether the AE rate was different in these two periods. AE rates in children were compared to those in adults (proportional reporting rates; PRRs and incidence rate ratios), to compare the AE profile between these age groups.
Abnormal behaviour (PRR 5.3) and hyperactivity (PRR 4.5) were more frequently reported in children; confusion (PRR 25.0) and psychosis (PRR 12.5) more frequently in adults. In children 11.8% of ADRs were reported to the regulatory authority compared to 27.3% in adults. A higher proportion of children stopped treatment due to lack of effectiveness (57.7% vs. 47.5%). No deaths were attributed to vigabatrin.
This study demonstrated that modified SDMs can be used to detect differences in the AE profiles between children and adults taking a medicinal product, and also to identify drug safety signals.
上市后药物警戒是监测和评估儿童和成人用药安全性的基石。然而，为了检测儿科信号，这些方法可能需要修改。本研究旨在比较使用改良信号检测方法（SDM）时，接受氨己烯酸治疗的儿童和成人的不良事件（AE）特征。
对氨己烯酸处方事件监测研究的观察队列研究（队列 10177 例患者）的数据进行分析，该研究分为儿童（0-17 岁）和成人（≥18 岁）两个年龄组，使用不良药物反应（ADR）的汇总统计数据、停药原因和死亡情况进行分析。比较治疗的第一个月和第二个至第六个月的儿童和成人的 AE 发生率密度，以检查这两个时期的 AE 发生率是否不同。将儿童的 AE 发生率与成人进行比较（比例报告率；PRR 和发病率比值比），以比较这两个年龄组之间的 AE 特征。
异常行为（PRR5.3）和多动（PRR4.5）在儿童中更常报告；混乱（PRR25.0）和精神病（PRR12.5）在成人中更常报告。在儿童中，有 11.8%的 ADR 报告给监管机构，而在成人中为 27.3%。因无效而停止治疗的儿童比例更高（57.7%比 47.5%）。没有死亡归因于氨己烯酸。
本研究表明，改良 SDM 可用于检测接受药物治疗的儿童和成人之间 AE 特征的差异，还可识别药物安全性信号。
