Global burden of vaccine-associated Raynaud's phenomenon, 1968-2024: A comprehensive analysis of the pharmacovigilance database.

IF 2.7 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-08-01 Epub Date: 2025-06-06 DOI:10.1007/s00228-025-03854-2

Jinyoung Jeong, Hyunjee Kim, Hyesu Jo, Jaeyu Park, Jaehyeong Cho, Hayeon Lee, Hanseul Cho, Masoud Rahmati, Ho Geol Woo, Dong Keon Yon

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引用次数: 0

Abstract

Purpose: Reports of Raynaud's phenomenon following vaccination have been steadily increasing; however, research on vaccine-associated Raynaud's phenomenon remains limited. This study aims to provide a comprehensive analysis of the association between Raynaud's phenomenon and various vaccines.

Method: This study used data from international pharmacovigilance, which contains over 35 million adverse event cases from more than 140 countries. Two established pharmacovigilance indicators, the information component (IC) and reporting odds ratio (ROR), were employed in the analysis with 95% confidence interval (CI). The IC was derived using a Bayesian methodology to compare the reporting and non-reporting groups, while the ROR, a frequentist measure of association, was calculated using contingency tables based on the number of adverse events.

Results: The signal with Raynaud's phenomenon was highest for papillomavirus vaccines (ROR: 11.49 [95% CI, 9.66-13.67]; IC: 3.45 [IC_0.25, 3.16]), followed in order by typhoid (5.86 [2.93-11.72]), hepatitis B (5.63 [4.25-7.45]; 2.42 [1.95]), COVID-19 mRNA (5.00 [4.70-5.31]; 2.00 [1.91]), and hepatitis A vaccines (4.35 [2.87-6.62]; 2.02 [1.30]). The signal was higher in females (ROR: 3.74 [95% CI, 3.54-3.95]; IC: 1.67 [IC_0.25, 1.59]) compared to males (3.44 [3.12-3.78]; 1.57 [1.43]), and it increased monotonically with age (0-11 years: IC [IC_0.25] 0.03 [-0.56]; 12-17 years: 1.54 [1.25]; 18-44 years: 1.64 [1.52]; 45-64 years: 2.00 [1.87]; ≥ 65 years: 2.12 [1.91]).

Conclusion: This study suggests the potential signal association between various vaccines and Raynaud's phenomenon. Although our study does not imply causality, we propose the need to strengthen post-vaccination monitoring and establish support policies to address such adverse events.

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1968-2024年疫苗相关雷诺现象的全球负担：药物警戒数据库的综合分析

目的：关于接种后雷诺现象的报道一直在稳步增加；然而，对疫苗相关雷诺现象的研究仍然有限。本研究旨在全面分析雷诺氏现象与各种疫苗之间的关系。方法：本研究使用了来自国际药物警戒的数据，其中包含来自140多个国家的3500多万例不良事件病例。采用信息成分（IC）和报告优势比（ROR）两项已建立的药物警戒指标进行分析，可信区间为95%。IC是使用贝叶斯方法来比较报告组和未报告组，而ROR是一种关联的频率测量，使用基于不良事件数量的列联表来计算。结果：乳头瘤病毒疫苗的雷诺现象信号最高(ROR: 11.49 [95% CI, 9.66 ~ 13.67]；IC: 3.45 [IC0.25, 3.16])，其次为伤寒（5.86[2.93-11.72]）、乙型肝炎（5.63 [4.25-7.45]）；2.42 [1.95]), COVID-19 mRNA (5.00 [4.70-5.31]；2.00[1.91])，甲型肝炎疫苗(4.35 [2.87-6.62]；2.02[1.30])。女性的信号更高(ROR: 3.74 [95% CI, 3.54-3.95]；IC: 1.67 [IC0.25, 1.59])，男性为3.44 [3.12-3.78]；1.57[1.43])，随年龄单调增加(0 ~ 11岁：IC [IC0.25] 0.03 [-0.56]；12-17岁：1.54 [1.25]；18-44岁：1.64 [1.52]；45 - 64年:2.00(1.87);≥65年:2.12[1.91])。结论：本研究提示各种疫苗与雷诺氏现象之间存在潜在的信号关联。虽然我们的研究并不意味着因果关系，但我们提出有必要加强疫苗接种后监测并制定支持政策来解决此类不良事件。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.