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mRNA COVID-19 疫苗接种后在聚合电子健康记录数据中新的视网膜血管闭塞的风险。

Risk of New Retinal Vascular Occlusion After mRNA COVID-19 Vaccination Within Aggregated Electronic Health Record Data.

机构信息

Case Western Reserve University School of Medicine, Cleveland, Ohio.

Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.

出版信息

JAMA Ophthalmol. 2023 May 1;141(5):441-447. doi: 10.1001/jamaophthalmol.2023.0610.

Abstract

IMPORTANCE

New-onset retinal vascular occlusion (RVO) occurring acutely after messenger RNA (mRNA) COVID-19 vaccination has been described in recent literature. Because RVO can cause vision loss or blindness, an epidemiologic investigation evaluating this potential association is of great importance to public health.

OBJECTIVE

To investigate how often patients are diagnosed with new RVO acutely after the mRNA COVID-19 vaccine compared with influenza and tetanus, diphtheria, pertussis (Tdap) vaccines.

DESIGN, SETTING, AND PARTICIPANTS: A retrospective population-based cohort design using the TriNetX Analytics platform, a federated, aggregated electronic health record (EHR) research network containing the deidentified EHR data of more than 103 million patients, was used to examine aggregate EHR data. Data were collected and analyzed on October 20, 2022. Data on patients within the TriNetX Analytics platform were searched for the presence of vaccination Common Procedural Technology codes, and instances of newly diagnosed RVO within 21 days of vaccination were recorded and reported. Propensity score matching based on demographic characteristics (age, sex, race and ethnicity) and comorbidities (diabetes, hypertension, and hyperlipidemia) was performed between vaccination groups for evaluation of relative risks (RRs).

MAIN OUTCOMES AND MEASURES

The appearance of a new-encounter diagnosis of RVO within 21 days of the mRNA COVID-19 vaccination was the primary outcome. Historical comparison cohorts of patients receiving influenza and Tdap vaccinations allowed for evaluation of the RRs for RVO.

RESULTS

Of 3 108 829 patients (mean [SD] age at vaccination, 50.7 [20.4] years; 56.4% women) who received the mRNA COVID-19 vaccine, 104 (0.003%; 95% CI, 0.003%-0.004%) patients had a new diagnosis of RVO within 21 days of vaccination. After propensity score matching, the RR for new RVO diagnosis after the first dose of COVID-19 vaccination was not significantly different from that after influenza (RR, 0.74; 95% CI, 0.54-1.01) or Tdap (RR, 0.78; 95% CI, 0.44-1.38) vaccinations, but was greater when compared with the second dose of the COVID-19 vaccination (RR, 2.25; 95% CI, 1.33-3.81).

CONCLUSIONS AND RELEVANCE

The findings of this study suggest that RVO diagnosed acutely after mRNA COVID-19 vaccination occurs extremely rarely at rates similar to those of 2 different historically used vaccinations, the influenza and Tdap vaccines. No evidence suggesting an association between the mRNA COVID-19 vaccination and newly diagnosed RVO was found.

摘要

重要性

信使 RNA(mRNA)COVID-19 疫苗接种后急性发生的新发性视网膜血管闭塞(RVO)在最近的文献中已有描述。由于 RVO 可导致视力丧失或失明,因此评估这种潜在关联的流行病学调查对公共卫生非常重要。

目的

调查与流感和破伤风、白喉、百日咳(Tdap)疫苗相比,mRNA COVID-19 疫苗接种后患者急性诊断新发 RVO 的频率。

设计、设置和参与者:使用 TriNetX Analytics 平台进行回顾性基于人群的队列设计,该平台是一个联邦的、聚合的电子健康记录(EHR)研究网络,包含超过 1.03 亿患者的去识别 EHR 数据。使用该平台分析聚合的 EHR 数据。数据于 2022 年 10 月 20 日收集和分析。在 TriNetX Analytics 平台内搜索疫苗通用程序技术代码,记录并报告疫苗接种后 21 天内新诊断出的 RVO 实例。根据人口统计学特征(年龄、性别、种族和民族)和合并症(糖尿病、高血压和高血脂)对疫苗接种组进行倾向评分匹配,以评估相对风险(RR)。

主要结局和测量

mRNA COVID-19 疫苗接种后 21 天内新发 RVO 的新出现诊断是主要结局。接受流感和 Tdap 疫苗接种的患者的历史比较队列允许评估 RVO 的 RR。

结果

在 3108829 名(平均[SD]接种疫苗时年龄,50.7[20.4]岁;56.4%为女性)接受 mRNA COVID-19 疫苗的患者中,有 104 名(0.003%;95%CI,0.003%-0.004%)患者在疫苗接种后 21 天内新诊断出 RVO。在进行倾向评分匹配后,COVID-19 疫苗第一剂接种后新发 RVO 诊断的 RR 与流感(RR,0.74;95%CI,0.54-1.01)或 Tdap(RR,0.78;95%CI,0.44-1.38)疫苗接种无显著差异,但与 COVID-19 疫苗第二剂接种相比更大(RR,2.25;95%CI,1.33-3.81)。

结论和相关性

本研究结果表明,mRNA COVID-19 疫苗接种后急性诊断的 RVO 发生率极低,与流感和 Tdap 疫苗(流感和 Tdap)相似。未发现 mRNA COVID-19 疫苗接种与新诊断出的 RVO 之间存在关联的证据。

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