质子抑制剂在儿科中的安全性:基于EudraVigilance数据的研究
Greta Santi Laurini1, Victoria Nikitina1, Nicola Montanaro2
1Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
Fundamental & clinical pharmacology
|July 7, 2025
概括
质子抑制剂 (PPI) 在儿童中的使用正在增加,研究表明胃肠道问题是常见的不良药物反应 (ADR). 在儿童患者中也报告了很大一部分严重的副作用和罕见的严重皮肤反应.
科学领域:
- 儿科药理学 儿科药理学
- 药物安全和药物监督是药物安全和药物监督的重要组成部分.
- 胃肠病学 胃肠病学
背景情况:
- 尽管批准有限,但在儿童中增加了质子抑制剂 (PPI) 的使用.
- 越来越多的人担心儿童群体中PPI的安全性,包括过敏风险.
研究的目的:
- 调查与儿童 (0-11岁) PPI使用相关的可疑药物不良反应 (ADR).
- 提供关于儿童临床实践中PPI安全性的证据.
主要方法:
- 来自EudraVigilance (2003-2022) 的0-11岁儿童的PPI对1389个疑似ADR报告的分析.
- 报告的副作用和过敏状况的描述性分析.
- 使用报告几率比率 (ROR) 来识别重大关联的案例与非案例分析.
主要成果:
- 胃肠道疾病是最常见的副作用,吐是常见的.
- 奥梅普拉与窒息和肺炎有关;埃索梅普拉与胃肠道疾病和便秘有关.
- 报告中有很高的百分比 (75.8%) 涉及严重的后果,包括罕见的严重皮肤反应,如史蒂文斯-约翰逊综合征.
结论:
- 儿科PPI使用通常导致胃肠道ADR,与产品标签保持一致.
- 在儿童中观察到相当一部分严重的副作用和一些严重的皮肤不良反应.
- 对于儿童群体的PPI安全性,需要进一步警.
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