中国药物警戒 ›› 2012, Vol. 9 ›› Issue (10): 607-614.

• 药械安全性研究 • 上一篇    下一篇

儿童与成人使用拉莫三嗪发生不良事件之比较——英国运用处方事件监测开展儿童上市后药物警戒之介绍

沈璐, 李馨龄, 刘巍, 范燕, 张华, 郭雪, 彭丽丽   

  1. 国家食品药品监督管理局药品评价中心,北京 100045
  • 收稿日期:2012-02-15 出版日期:2012-10-10 发布日期:2015-08-07
  • 作者简介:沈璐,女,硕士,主管药师。

Comparison of the Adverse Event Profiles of Lamotrigine Prescribed to Children and Adults -----the Introduction of Paediatric Postmarketing Pharmacovigilance Using Prescription-Event Monitoring in England

SHEN Lu, LI Xin-ling, LIU Wei, FAN Yan, ZHANG Hua, GUO Xue, PENG Li-li   

  1. Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2012-02-15 Online:2012-10-10 Published:2015-08-07

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摘要： 目的以拉莫三嗪为例,介绍英国运用处方事件监测对上市后儿童药物警戒,以期为我国的药品不良反应监测与评价提供参考。方法对拉莫三嗪处方事件监测（PEM）研究（观察性的队列研究）的数据进行年龄分层,汇总统计药品不良反应（ADR）、停止治疗的原因、死亡及随访信息。将儿童（0~17岁）及成人（18岁以上）第1个治疗月的不良事件（AE）发生密度与第2~6治疗月的发生密度进行比较,以检验在这两个时段中不良事件发生密度是否有差异;同时,还比较了儿童与成人两个年龄组中的AE发生率。结果队列研究包括2 457例儿童及7 379例成人。观察了儿童和成人组中AE的发生情况。儿童中皮疹（PRR=1.2）和Stevens-Johnson 综合征（PRR=4.5）更普遍,成人中更常见精神紊乱（PRR=6.3）。儿童中有33%的ADR报告至监管部门,而成人中则有44%报告至监管部门。儿童中由于疗效缺乏停止治疗的比例更高（儿童45%,成人38%）,无归因于拉莫三嗪的死亡病例。结论该研究显示,信号挖掘方法能够用于检测儿童及成人使用新药发生AE情况的定量和定性差异。

关键词: 拉莫三嗪, 处方事件监测研究, 儿童, 成人, 比较

Abstract: ObjectiveUsing postmarketing pharmacovigilance data collected shortly after market authorization of lamotrigine in the UK, a study was conducted to compare the adverse event(AE) profiles of children and adults taking lamotrigine, using modified signal detection methods. MethodsData from the lamotrigine Prescription Event Monitoring(PEM) study, an observational cohort study, were stratified by age and examined using summary statistics for adverse drug reactions(ADRs), reasons for stopping treatment, deaths and follow-up information. Incidence densities of AEs in children(0-17 years) and adults(≥18 years) in the first month of treatment were compared with months 2-6 to examine whether the AE rates were different in these two periods. AE rates in children were compared with those in adults(proportional reporting ratio[PRR] and incidence rate ratios), to compare the AE profiles between these age groups. ResultsThe cohort included 2457 children and 7379 adults. Differences in the AE profiles between children and adults were observed. Rash(PRR 1.2) and Stevens-Johnson syndrome(PRR 4.5) were more commonly reported in children, and confusion more frequently in adults(PRR 6.3). In children, 33%of ADRs were reported to the Regulatory Authority compared with 44% in adults. A higher proportion of children stopped treatment due to lack of effectiveness(45% vs 38%). No deaths were attributed to lamotrigine. ConclusionThis study demonstrated that signal detection methods can be used to detect quantitative and qualitative differences in the AE profiles between the first children and adults taking a newly licensed drug.

Key words: lamotrigine, PEM study, children, adult, comparison