日本首例 SARS-CoV-2 mRNA-1273 疫苗接种后迟发性局部大反应评估。
Assessment of Delayed Large Local Reactions After the First Dose of the SARS-CoV-2 mRNA-1273 Vaccine in Japan.
机构信息
Department of Dermatology, Self-Defense Forces Central Hospital, Setagaya, Tokyo, Japan.
Department of Dermatology, National Defense Medical College, Tokorozawa, Saitama, Japan.
出版信息
JAMA Dermatol. 2022 Aug 1;158(8):923-927. doi: 10.1001/jamadermatol.2022.2088.
IMPORTANCE
A delayed large local reaction (DLLR) is a delayed-onset adverse skin reaction that may occur after injection of the mRNA-1273 vaccine against SARS-CoV-2.
OBJECTIVE
To examine the associations between sex and age and susceptibility of DLLRs after mRNA-1273 vaccination.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective cross-sectional study was conducted at the Self-Defense Forces large-scale vaccination center in Tokyo, Japan, from May 24 to November 30, 2021. Participants were recipients of the second dose of the mRNA-1273 vaccine who had received the first dose 4 to 6 weeks earlier. Five experienced dermatologists interviewed participants to assess whether they had experienced symptoms of DLLR after administration of the first dose of the vaccine.
EXPOSURE
Receipt of the first dose of the mRNA-1273 vaccine.
MAIN OUTCOMES AND MEASURES
The primary outcome was the incidence rate of DLLR stratified by sex and age group. Odds ratios (ORs) were calculated to evaluate the differences between groups. Outcomes were tested for significance using the Pearson χ2 test with 95% CIs.
RESULTS
Of 5893 participants in the study, 3318 (56.3%) were male (median age, 55 years [IQR, 38-68 years]) and 2575 (43.7%) were female (median age, 50 years [IQR, 34-67 years]). A total of 747 participants (12.7%) experienced DLLR symptoms after the first dose of the mRNA-1273 vaccine. Symptoms were mild and not considered as contraindications to the vaccine. The incidence rate was significantly higher among females (22.4% [577 participants]; OR, 5.30; 95% CI, 4.42-6.34) than among males (5.1% [170 participants]; reference). Moreover, the incidence rate was significantly higher among participants aged 30 to 39 years (14.3% [129 participants]; OR, 1.68; 95% CI, 1.25-2.26), 40 to 49 years (15.8% [136 participants]; OR, 1.89; 95% CI, 1.41-2.53), 50 to 59 years (14.9% [104 participants]; OR, 1.76; 95% CI, 1.29-2.40), and 60 to 69 years (12.6% [182 participants]; OR, 1.45; 95% CI, 1.10-1.91) than among participants aged 18 to 29 years (9.0% [81 participants]; reference).
CONCLUSIONS AND RELEVANCE
In this cross-sectional study, the first dose of the SARS-CoV-2 mRNA-1273 vaccine was associated with a higher incidence of DLLR among females and among individuals aged 30 to 69 years. The findings suggest that DLLR may be a type IV allergic skin reaction.
重要性
延迟性大局部反应（DLLR）是一种迟发性不良反应，可能在接种 SARS-CoV-2 的 mRNA-1273 疫苗后发生。
目的
研究性别和年龄与 mRNA-1273 疫苗接种后 DLLR 易感性的关系。
设计、设置和参与者：这是一项回顾性的横断面研究，在日本东京自卫队大规模疫苗接种中心进行，时间为 2021 年 5 月 24 日至 11 月 30 日。参与者为接受第二剂 mRNA-1273 疫苗的人，他们在 4 至 6 周前接受了第一剂疫苗。五名经验丰富的皮肤科医生对参与者进行采访，以评估他们在接种第一剂疫苗后是否出现 DLLR 症状。
暴露
接受第一剂 mRNA-1273 疫苗。
主要结果和测量指标
主要结局是按性别和年龄组分层的 DLLR 发生率。计算了优势比（OR）以评估组间差异。使用 95%CI 的 Pearson χ2 检验来检验结果的显著性。
结果
在这项研究的 5893 名参与者中，3318 名（56.3%）为男性（中位数年龄，55 岁[IQR，38-68 岁]），2575 名（43.7%）为女性（中位数年龄，50 岁[IQR，34-67 岁]）。共有 747 名（12.7%）参与者在接种第一剂 mRNA-1273 疫苗后出现 DLLR 症状。这些症状轻微，不被认为是疫苗接种的禁忌症。女性（22.4%[577 名参与者]；OR，5.30；95%CI，4.42-6.34）的发生率明显高于男性（5.1%[170 名参与者]；参考）。此外，30 至 39 岁（14.3%[129 名参与者]；OR，1.68；95%CI，1.25-2.26）、40 至 49 岁（15.8%[136 名参与者]；OR，1.89；95%CI，1.41-2.53）、50 至 59 岁（14.9%[104 名参与者]；OR，1.76；95%CI，1.29-2.40）和 60 至 69 岁（12.6%[182 名参与者]；OR，1.45；95%CI，1.10-1.91）的发生率明显高于 18 至 29 岁（9.0%[81 名参与者]；参考）。
结论和相关性
在这项横断面研究中，SARS-CoV-2 的 mRNA-1273 疫苗的第一剂与女性和 30 至 69 岁人群 DLLR 发生率较高有关。研究结果表明，DLLR 可能是一种 IV 型过敏皮肤反应。
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