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关于轮状病毒疫苗安全性的自控风险间隔研究:发现和影响

Jacob Puliyel¹, Brian S Hooker^2,3

¹International Institute of Health Management Research, New Delhi, India.

The International journal of risk & safety in medicine

|June 14, 2024

概括

传统的自我控制病例系列 (SCCS) 方法可能会错过轮状病毒疫苗对内的风险. 替代分析显示,内接风险增加,特别是在第三剂疫苗接种后,突出显示需要精确的安全监测.

科学领域:

流行病学流行病学
疫苗安全研究疫苗安全研究
儿科胃肠病学儿科胃肠病学

背景情况:

自控病例系列 (SCCS) 方法是疫苗安全监测的标准.
在轮状病毒疫苗接种后评估肠胎风险是具有挑战性的,因为依赖于年龄的基线率.
时间变化的基线风险调整和自控风险间隔 (SCRI) 方法用于解决这些复杂性.

研究的目的:

用替代统计方法重新分析印度轮状病毒疫苗的现有SCCS数据.
通过比较接种疫苗的婴儿与未接种疫苗的婴儿的肠接率来检查疫苗的安全性.
为了调查年龄对轮状病毒疫苗接种后肠胎风险的影响.

主要方法:

对监测数据进行了自我控制的风险间隔 (SCRI) 分析,将观察时间限制在180天.
分析了自上次接种疫苗以来的输肠异常时间.
进行了SCCS分析,排除未接种疫苗的病例,以评估轮状病毒疫苗的安全性.

主要成果:

接种疫苗的 (205天) 与未接种疫苗 (223天) 的婴儿 (p=0.0026) 中,输血接的平均年龄显著较低 (p=0.0026).
SCRI分析显示事件风险比率 (IRR) 为1.62 (95%CI为1.07-2.44).
在SCCS分析中排除未接种疫苗的婴儿显示,第三剂后1-21天的风险显著增加 (IRR2.47,95%CI1.70-3.59),传统SCCS中错过的风险.

结论:

传统的SCCS风险调整可能不适合在罗塔病毒疫苗接种后进行输肠胎风险评估.
这项研究强调,轮状病毒疫苗接种可以降低腹腔内分泌的平均年龄.
精细的分析方法是必要的,以准确地检测疫苗相关的风险,如内.

关键词:

旋转动作旋转动作输入输入输入输入微生物学的微生物.药学流行病学药学流行病学药物监督和药物监督自主控制的案例系列.时间到输入的异常疫苗的不良影响疫苗的不良影响疫苗,疫苗的使用情况.

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