三剂信使核糖核酸（BNT162b2）或灭活（科兴新冠疫苗）新冠疫苗接种后发生心脏炎的风险：一项自我对照病例系列研究和一项病例对照研究。
Risk of carditis after three doses of vaccination with mRNA (BNT162b2) or inactivated (CoronaVac) covid-19 vaccination: a self-controlled cases series and a case-control study.
作者信息
Fan Min, Lai Francisco Tsz Tsun, Cheng Franco Wing Tak, Tsie Natalie Tsz Ying, Li Xue, Wan Eric Yuk Fai, Wong Carlos King Ho, Chan Esther Wai Yin, Yiu Kai Hang, Wong Ian Chi Kei, Chui Celine Sze Ling
机构信息
Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.
Laboratory of Data Discovery for Health (D4H), Hong Kong Science Park, Hong Kong Science and Technology Park, Hong Kong Special Administrative Region, China.
出版信息
Lancet Reg Health West Pac. 2023 Jun;35:100745. doi: 10.1016/j.lanwpc.2023.100745. Epub 2023 Mar 25.
BACKGROUND
Large-scale comparative research exploring the risk after the third dose and after inactivated covid-19 vaccination is limited. This study aimed to assess the risk of carditis following three doses of BNT162b2 or CoronaVac.
METHODS
We conducted a self-controlled case series (SCCS) and a case-control study using electronic health and vaccination records in Hong Kong. Carditis incidents within 28 days of covid-19 vaccination were included as cases. In the case-control study, up to 10 hospitalized controls were selected with stratified probability sampling by age, sex, and hospital admission (±1 day). The incidence rate ratios (IRRs) were reported from conditional Poisson regressions for SCCS, and adjusted odds ratios (ORs) were reported from multivariable logistic regressions.
FINDINGS
A total of 8,924,614 doses of BNT162b2 and 6,129,852 doses of CoronaVac were administered from February 2021 to March 2022. The SCCS detected increased carditis risks after BNT162b2: 4.48 (95%confidence interval [CI]:2.99-6.70] in 1-14 days and 2.50 (95%CI:1.43-4.38) in 15-28 days after first dose; 10.81 (95%CI:7.63-15.32) in 1-14 days and 2.95 (95%CI:1.82-4.78) in 15-28 days after second dose; 4.72 (95%CI:1.40-15.97) in 1-14 days after third dose. Consistent results were observed from the case-control study. Risks were specifically found in people aged below 30 years and males. No significant risk increase was observed after CoronaVac in all primary analyses.
INTERPRETATIONS
We detected increased carditis risks within 28 days after all three doses of BNT162b2 but the risk after the third doses were not higher than that of the second dose when compared with baseline period. Continuous monitoring of carditis after both mRNA and inactivated covid-19 vaccines is needed.
FUNDING
: This study was funded by Hong Kong Health Bureau (COVID19F01).
背景
探索第三剂新冠疫苗接种后以及灭活新冠疫苗接种后的风险的大规模比较研究有限。本研究旨在评估接种三剂BNT162b2或科兴疫苗后发生心肌炎的风险。
方法
我们利用香港的电子健康和疫苗接种记录开展了一项自我对照病例系列研究（SCCS）和一项病例对照研究。将新冠疫苗接种后28天内发生的心肌炎事件纳入病例组。在病例对照研究中，通过年龄、性别和住院情况（±1天）进行分层概率抽样，选取最多10名住院对照。SCCS的条件泊松回归报告发病率比（IRR），多变量逻辑回归报告调整后的优势比（OR）。
结果
2021年2月至2022年3月期间，共接种了8,924,614剂BNT162b2和6,129,852剂科兴疫苗。SCCS检测到BNT162b2接种后心肌炎风险增加：首剂接种后1-14天为4.48（95%置信区间[CI]：2.99-6.70），15-28天为2.50（95%CI：1.43-4.38）；第二剂接种后1-14天为10.81（95%CI：7.63-15.32），15-28天为2.95（95%CI：1.82-4.78）；第三剂接种后1-14天为4.72（95%CI：1.40-15.97）。病例对照研究观察到了一致的结果。风险在30岁以下人群和男性中尤为明显。在所有主要分析中，科兴疫苗接种后未观察到显著的风险增加。
解读
我们检测到三剂BNT162b2接种后28天内心肌炎风险增加，但与基线期相比，第三剂接种后的风险不高于第二剂。需要持续监测mRNA疫苗和灭活新冠疫苗接种后的心肌炎情况。
资助
本研究由香港卫生署资助（COVID19F01）。
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