Department of Medical Informatics, Erasmus University Medical Center, Dr, Molewaterplein, Rotterdam, The Netherlands.
BMC Pediatr. 2013 Nov 19;13:192. doi: 10.1186/1471-2431-13-192.
Data on utilization patterns and safety of non-steroidal anti-inflammatory drugs (NSAIDs) in children are scarce. The purpose of this study was to investigate the utilization of NSAIDs among children in four European countries as part of the Safety Of non-Steroidal anti-inflammatory drugs (SOS) project.
We used longitudinal patient data from seven databases (GePaRD, IPCI, OSSIFF, Pedianet, PHARMO, SISR, and THIN) to calculate prevalence rates of NSAID use among children (0-18 years of age) from Germany, Italy, Netherlands, and United Kingdom. All databases contained a representative population sample and recorded demographics, diagnoses, and drug prescriptions. Prevalence rates of NSAID use were stratified by age, sex, and calendar time. The person-time of NSAID exposure was calculated by using the duration of the prescription supply. We calculated incidence rates for serious adverse events of interest. For these adverse events of interest, sample size calculations were conducted (alpha = 0.05; 1-beta = 0.8) to determine the amount of NSAID exposure time that would be required for safety studies in children.
The source population comprised 7.7 million children with a total of 29.6 million person-years of observation. Of those, 1.3 million children were exposed to at least one of 45 NSAIDs during observation time. Overall prevalence rates of NSAID use in children differed across countries, ranging from 4.4 (Italy) to 197 (Germany) per 1000 person-years in 2007. For Germany, United Kingdom, and Italian pediatricians, we observed high rates of NSAID use among children aged one to four years. For all four countries, NSAID use increased with older age categories for children older than 11. In this analysis, only for ibuprofen (the most frequently used NSAID), enough exposure was available to detect a weak association (relative risk of 2) between exposure and asthma exacerbation (the most common serious adverse event of interest).
Patterns of NSAID use in children were heterogeneous across four European countries. The SOS project platform captures data on more than 1.3 million children who were exposed to NSAIDs. Even larger data platforms and the use of advanced versions of case-only study designs may be needed to conclusively assess the safety of these drugs in children.
关于非甾体抗炎药（NSAIDs）在儿童中的使用模式和安全性的数据很少。本研究的目的是调查在四个欧洲国家中儿童使用 NSAIDs 的情况，这是 Safety Of non-Steroidal anti-inflammatory drugs（SOS）项目的一部分。
我们使用来自七个数据库（GePaRD、IPCI、OSSIFF、Pedianet、PHARMO、SISR 和 THIN）的纵向患者数据，计算了德国、意大利、荷兰和英国 0-18 岁儿童使用 NSAIDs 的患病率。所有数据库都包含具有代表性的人口样本，并记录了人口统计学、诊断和药物处方。根据年龄、性别和日历时间对 NSAID 使用的患病率进行分层。通过使用处方供应的持续时间计算 NSAID 暴露的人时。我们计算了感兴趣的严重不良事件的发生率。对于这些感兴趣的不良事件，进行了样本量计算（alpha = 0.05；1-beta = 0.8），以确定儿童安全研究所需的 NSAID 暴露时间量。
源人群包括 770 万儿童，总观察人数为 2960 万人年。在这些人中，有 130 万名儿童在观察期间至少接触过 45 种 NSAIDs 中的一种。2007 年，各国儿童 NSAIDs 的总体使用率存在差异，从意大利的 4.4（意大利）到德国的 197（德国）/1000 人年不等。对于德国、英国和意大利的儿科医生，我们观察到 1 至 4 岁儿童 NSAIDs 的使用率较高。对于所有四个国家，11 岁以上的儿童年龄越大，NSAIDs 的使用频率越高。在这项分析中，只有布洛芬（使用最频繁的 NSAID）的暴露量足够大，可以检测到暴露与哮喘恶化（最常见的感兴趣的严重不良事件）之间的弱关联（相对风险为 2）。
四个欧洲国家儿童 NSAIDs 的使用模式存在差异。SOS 项目平台记录了超过 130 万名接触 NSAIDs 的儿童的数据。可能需要更大的数据平台和使用更先进的病例对照研究设计来确定这些药物在儿童中的安全性。
