一个系统的审查和注射部位反应在生物注射随机对照试验的元分析
Patrick J Kim1, Rafael Paolo Lansang1, Ron Vender1
1Faculty of Medicine, McMaster University, Hamilton, Canada.
Journal of cutaneous medicine and surgery
|August 3, 2023
概括
注射部位反应 (ISR) 是生物药物中常见的,其患病率差异很大. 虽然大多数ISR是温和的,但了解哪些生物药物具有更高或更低的反应率对于患者护理至关重要.
科学领域:
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 生物药物越来越多地用于免疫媒介疾病.
- 在皮下生物注射后注射部位反应 (ISR) 需要进一步描述.
研究的目的:
- 系统地审查和元分析生物药物的第三阶段试验中的ISR数据.
- 为了确定个人生物疗法的ISRs的流行率.
主要方法:
- 在 MEDLINE,Embase 和 CENTRAL 数据库的系统文献搜索.
- 进行比例元分析,以计算每个生物病原体的ISR流行率.
- 包括158篇文章和80项研究用于对16种生物进行元分析.
主要成果:
- 常见的ISR包括红血 (42.8%),未指定的反应 (23.3%),疼痛 (12.4%),和 (5.7%).
- 抗胰岛素反应的患病率在0.8% (瑞桑基祖马布) 到15.5% (卡纳基努马布) 之间.
- 卡纳基努马布,杜皮卢马布,埃坦塞普特和伊克西祖马布的ISR患病率最高; 里桑基祖马布,布罗德卢马布,古塞尔库马布和塞库金努马布的ISR患病率最低.
结论:
- 在不同的生物药物中,ISR发生的流行率范围广泛 (0.08%15.5%).
- 在生物制品中,ISR率存在显著的变化,特定的药物表现出更高或更低的频率.
- 建议改善不良事件报告,以提高对ISR流行病学的理解.
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