背景:在日本人群中,严重急性呼吸综合征冠状病毒2(SARS-CoV-2)mRNA疫苗与心肌炎/心包炎之间的关系尚未得到系统研究。本研究旨在通过使用日本不良药物事件报告数据库,阐明SARS-CoV-2mRNA疫苗(BNT162b2和mRNA-1273)与心肌炎/心包炎之间的关系及其影响因素。
方法:使用数据库中的数据(2004年4月至2023年12月)计算疫苗与心肌炎/心包炎之间关联的报告比值比(ROR)和95%置信区间(95%CI)。年龄,性别,发病时间,并对有症状患者的结局进行评估.
结果:报告总数为880,999(心肌炎:1,846;心包炎:761)。与疫苗相关的不良事件包括心肌炎(919例)和心包炎(321例)。两者的ROR[95%CIs]均显著(心肌炎:30.51[27.82-33.45],心包炎:21.99[19.03-25.40])。此外,BNT162b2和mRNA-1273的ROR[95%CIs]分别为15.64[14.15-17.28]和54.23[48.13-61.10],分别,心肌炎,和15.78[13.52-18.42]和27.03[21.58-33.87],分别,心包炎.此外,大多数病例为≤30岁或男性。从疫苗接种到发病的时间≤8天,对应于早期故障类型,采用威布尔分布进行分析。结果是大多数病例的恢复或缓解;然而,在某些情况下,他们是严重的或导致死亡。
结论:在日本人口中,SARS-CoV-2mRNA疫苗接种与心肌炎/心包炎的发作显着相关。影响因素包括年龄≤30岁和男性。此外,尽管大多数不良事件发生在疫苗接种后早期,总体结果良好。
BACKGROUND: The association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines and myocarditis/
pericarditis in the Japanese population has not been systematically investigated. This study was aimed at clarifying the association between SARS-CoV-2 mRNA vaccines (BNT162b2 and mRNA-1273) and myocarditis/
pericarditis as well as influencing factors by using the Japanese Adverse Drug Event Report database.
METHODS: Reporting odds ratios (RORs) and 95 % confidence intervals (95 % CIs) for the association between the vaccines and myocarditis/pericarditis were calculated using data from the database (April 2004-December 2023). Age, sex, onset time, and outcomes in symptomatic patients were evaluated.
RESULTS: The total number of reports was 880,999 (myocarditis: 1846;
pericarditis: 761). The adverse events associated with the vaccines included myocarditis (919 cases) and
pericarditis (321 cases), with the ROR [95 % CIs] being significant for both (myocarditis: 30.51 [27.82-33.45],
pericarditis: 21.99 [19.03-25.40]). Furthermore, the ROR [95 % CIs] of BNT162b2 and mRNA-1273 were 15.64 [14.15-17.28] and 54.23 [48.13-61.10], respectively, for myocarditis, and 15.78 [13.52-18.42] and 27.03 [21.58-33.87], respectively, for pericarditis. Furthermore, most cases were ≤30 years or male. The period from vaccination to onset was ≤8 days, corresponding to early failure type based on analysis using the Weibull distribution. Outcomes were recovery or remission for most cases; however, they were severe or caused death in some cases.
CONCLUSIONS: In the Japanese population, SARS-CoV-2 mRNA vaccination was significantly associated with the onset of myocarditis/pericarditis. The influencing factors included age of ≤30 years and male. Furthermore, although most adverse events occurred early after vaccination, overall outcomes were good.