对儿科用布洛芬的安全性进行评估. 一个基于实践者的随机临床试验
1Slone Epidemiology Unit, School of Public Health, Boston University School of Medicine, Brookline, MA 02146.
JAMA
|March 22, 1995
概括
在儿童中短期使用布洛芬并没有增加因胃肠道出血,功能衰竭或过敏反应而住院的病例. 这项研究侧重于特定的严重结果,而不是较轻的严重事件或长期使用.
科学领域:
- 儿科药理学 儿科药理学
- 临床研究是临床研究.
- 药物安全 药物安全
背景情况:
- 发烧在儿童中很常见,通常用抗发烧药物治疗,如布洛芬和乙氨基.
- 对于儿科患者群体中与布洛芬相关的潜在严重不良事件存在担忧.
- 了解常见抗热药的比较安全性概况对于临床实践至关重要.
研究的目的:
- 评估易布洛芬是否会增加患有发烧的儿童因特定严重不良事件而入院的风险.
- 在一个大型儿科队列中,比较布洛芬与乙氨基的安全性.
- 为了调查胃肠道出血,功能衰竭和过敏反应的住院病例.
主要方法:
- 一个随机的,双盲的,乙氨基受控的试验是在门诊儿科和家庭医学机构进行的.
- 84,192名发烧儿童被随机分配给接受乙氨基或两剂伊布罗芬之一.
- 主要结局包括住院治疗急性胃肠道出血,急性功能衰竭和过敏反应.
主要成果:
- 布洛芬和乙氨基组之间的住院率没有差异.
- 发生了四起非重大胃肠道出血病例,在布洛芬和乙氨基之间的风险没有显著差异.
- 没有观察到急性功能衰竭或过敏反应的住院病例; 治疗ibuprofen的儿童的风险估计很低.
结论:
- 儿童短期使用布洛芬并没有增加因胃肠道出血,功能衰竭或过敏反应而入院的风险.
- 该研究提供了关于这些特定严重结果的布洛芬安全性的证据.
- 数据没有扩展到与长期使用布洛芬相关的不那么严重的结果或风险.
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