From the Cardiology Department, Rabin Medical Center, Beilinson Hospital, Petah Tikva (G.W., S.H., I.R., M.W., Y.A., T.G., R.K.), the Faculty of Medicine, Tel Aviv University (G.W., S.H., I.R., M.W., Y.A., T.G., R.K.), and the Innovation Division, Clalit Research Institute, Clalit Health Services (N.B., O.A., N.D., R.D.B.), Tel Aviv, and the Department of Software and Information Systems Engineering (N.B., N.D.) and the School of Public Health, Faculty of Health Sciences (R.D.B.), Ben Gurion University, Be'er Sheva - all in Israel; and the Department of Biomedical Informatics, Harvard Medical School (N.B., N.D.), and the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute (N.B., N.D., R.D.B.) - both in Boston.
N Engl J Med. 2021 Dec 2;385(23):2132-2139. doi: 10.1056/NEJMoa2110737. Epub 2021 Oct 6.
BACKGROUND: Reports have suggested an association between the development of myocarditis and the receipt of messenger RNA (mRNA) vaccines against coronavirus disease 2019 (Covid-19), but the frequency and severity of myocarditis after vaccination have not been extensively explored. METHODS: We searched the database of Clalit Health Services, the largest health care organization (HCO) in Israel, for diagnoses of myocarditis in patients who had received at least one dose of the BNT162b2 mRNA vaccine (Pfizer-BioNTech). The diagnosis of myocarditis was adjudicated by cardiologists using the case definition used by the Centers for Disease Control and Prevention. We abstracted the presentation, clinical course, and outcome from the patient's electronic health record. We performed a Kaplan-Meier analysis of the incidence of myocarditis up to 42 days after the first vaccine dose. RESULTS: Among more than 2.5 million vaccinated HCO members who were 16 years of age or older, 54 cases met the criteria for myocarditis. The estimated incidence per 100,000 persons who had received at least one dose of vaccine was 2.13 cases (95% confidence interval [CI], 1.56 to 2.70). The highest incidence of myocarditis (10.69 cases per 100,000 persons; 95% CI, 6.93 to 14.46) was reported in male patients between the ages of 16 and 29 years. A total of 76% of cases of myocarditis were described as mild and 22% as intermediate; 1 case was associated with cardiogenic shock. After a median follow-up of 83 days after the onset of myocarditis, 1 patient had been readmitted to the hospital, and 1 had died of an unknown cause after discharge. Of 14 patients who had left ventricular dysfunction on echocardiography during admission, 10 still had such dysfunction at the time of hospital discharge. Of these patients, 5 underwent subsequent testing that revealed normal heart function. CONCLUSIONS: Among patients in a large Israeli health care system who had received at least one dose of the BNT162b2 mRNA vaccine, the estimated incidence of myocarditis was 2.13 cases per 100,000 persons; the highest incidence was among male patients between the ages of 16 and 29 years. Most cases of myocarditis were mild or moderate in severity. (Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.).
背景:有报道称,心肌炎的发生与接种针对 2019 年冠状病毒病(COVID-19)的信使 RNA(mRNA)疫苗有关,但疫苗接种后心肌炎的频率和严重程度尚未得到广泛探讨。
方法:我们在以色列最大的医疗保健组织(HCO)Clalit 健康服务数据库中搜索了至少接受过一剂 BNT162b2 mRNA 疫苗(辉瑞-生物技术)的患者中心肌炎的诊断。心肌炎的诊断由心脏病专家根据疾病控制与预防中心使用的病例定义进行判定。我们从患者的电子健康记录中提取了临床表现、临床病程和结局。我们对首次接种疫苗后 42 天内心肌炎的发生率进行了 Kaplan-Meier 分析。
结果:在超过 250 万接种 HCO 成员中,年龄在 16 岁及以上的患者中,有 54 例符合心肌炎的标准。每 100000 名接受至少一剂疫苗接种者的估计发病率为 2.13 例(95%置信区间[CI],1.56 至 2.70)。最高的心肌炎发病率(每 100000 人 10.69 例;95%CI,6.93 至 14.46)报告发生在 16 至 29 岁的男性患者中。共有 76%的心肌炎病例为轻度,22%为中度;1 例与心源性休克有关。在心肌炎发病后中位随访 83 天后,1 例患者再次住院,1 例患者出院后死因不明。在入院时接受超声心动图检查显示左心室功能障碍的 14 例患者中,有 10 例在出院时仍存在这种功能障碍。其中 5 例患者随后的检查显示心脏功能正常。
结论:在接受至少一剂 BNT162b2 mRNA 疫苗的大型以色列医疗保健系统的患者中,心肌炎的估计发病率为每 100000 人 2.13 例;发病率最高的是 16 至 29 岁的男性患者。大多数心肌炎病例的严重程度为轻度或中度。(由哈佛医学院 Ivan 和 Francesca Berkowitz 家庭生活实验室合作研究基金和 Clalit 研究所资助)。
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