德诺苏马布诱导的儿童高血症:病例报告和对FDA不良事件报告系统数据库的分析
Yiyu Chen1, Chuxuan Fang1, Zhiyong Yang2
1Department of Pharmacy, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Expert opinion on drug safety
|July 15, 2024
概括
停用德诺苏马布在儿科患者,特别是男性和年幼儿童中存在显著的高血症风险. 早期识别风险因素对于在未成年人中安全地给药denosumab至关重要.
科学领域:
- 儿科药理学 儿科药理学
- 药物监督 药物监督 药物监督
- 内分泌学 在内分泌学.
背景情况:
- 对于儿科患者的登苏马布安全性存在担忧.
- 这项研究重点关注denozumab对未成年人的不良影响,特别是高血症.
研究的目的:
- 分析denosumab对儿科患者的不良影响.
- 为了调查在未成年人中断denosumab治疗后出现高血症的风险.
主要方法:
- 利用OpenVigil 2.1从FAERS数据库中提取儿科患者的denosumab不良事件数据.
- 在停止服用德诺苏马布后,对儿童出现高血症的已发表病例进行了审查.
主要成果:
- 在18岁以下的个体中,denosumab诱导的高血症的发生率更高.
- 超血症的风险在男性中较高,在青少年中最高,通常在停药4个月后出现.
- 男性的峰值含量较高,年幼的儿童 (0-11岁) 的平均峰值血清含量高于年长的儿童 (12-17岁).
结论:
- 在未成年人中停止使用登苏马布,存在显著的高血症风险.
- 年轻的年龄和男性性别被确定为在儿科患者中发生德诺苏马布诱导的高血症的潜在危险因素.
- 调查结果提供了安全警告和预防策略,用于在儿童中使用denosumab.
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