两剂与三剂乙型肝炎疫苗与急性心肌梗塞之间的关联
Katia Bruxvoort1,2, Jeff Slezak2, Lei Qian2
1Department of Epidemiology, School of Public Health, University of Alabama at Birmingham.
JAMA
|March 25, 2022
概括
与含有辅助剂的3剂乙肝疫苗相比,使用CpG辅助剂的2剂乙肝疫苗 (HepB- CpG) 没有增加急性心肌梗塞 (MI) 的风险. 这一发现支持HepB- CpG疫苗的安全性.
科学领域:
- 免疫学
- 疫苗学
- 心血管医学
背景情况:
- 与含有氧化辅助剂 (HepB-alum) 的3剂量B型肝炎疫苗相比,二剂量B型肝炎疫苗具有更高的血清保护作用.
- 之前的一项试验表明,HepB- CpG疫苗可能增加急性心肌梗塞 (MI) 的风险,因此需要进一步调查.
研究的目的:
- 在接受HepB-CpG疫苗和接受HepB-alum疫苗的成年人中比较1型急性心肌梗塞 (MI) 的发病率.
- 在急性心脏病发作风险方面评估HepB- CpG疫苗的非劣势性.
主要方法:
- 在南加利福尼亚州凯泽永久医院进行了一项前性队列非劣势性研究,包括接受HepB- CpG或HepB- alum疫苗的69, 625名成年人.
- 参与者在接种疫苗后进行了13个月的急性心脏病发作跟踪,通过诊断代码确定并由心脏病学家判断.
- 使用逆治疗概率 (IPTW) 来调整人口和临床特征,估计急性心脏病的调整危险比率 (HR).
主要成果:
- 该研究包括31,183名HepB- CpG受体和38,442名HepB- 受体,在IPTW调整后的特征是平衡的.
- 在HepB-CpG组中发生了52例1型急性心脏病发作 (1.67/1000人年),在HepB-组中发生了71例 (1.86/1000人年).
- 急性心脏病的调整HR为0. 92 (单边97. 5% CI,∞至1. 32),低于非劣势差值2,符合非劣势的统计标准 (P<. 001).
结论:
- 与HepB-alum疫苗相比,接受HepB-CpG疫苗并没有显示出急性心肌梗塞的统计风险增加.
- 这些发现支持2剂量HepB- CpG疫苗对心血管事件的安全性.
- 这项研究为临床医生和公共卫生官员提供了关于乙型肝炎疫苗安全性的关键证据.
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