Department of Cardiology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
Department of Echocardiography, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.
Chin Med J (Engl). 2024 Mar 20;137(6):669-675. doi: 10.1097/CM9.0000000000002767. Epub 2023 Jul 13.
Coronavirus disease 2019 (COVID-19) has potential risks for both clinically worsening pulmonary hypertension (PH) and increasing mortality. However, the data regarding the protective role of vaccination in this population are still lacking. This study aimed to assess the safety of approved vaccination for patients with PH.
In this national prospective cohort study, patients diagnosed with PH (World Health Organization [WHO] groups 1 and 4) were enrolled from October 2021 to April 2022. The primary outcome was the composite of PH-related major adverse events. We used an inverse probability weighting (IPW) approach to control for possible confounding factors in the baseline characteristics of patients.
In total, 706 patients with PH participated in this study (mean age, 40.3 years; mean duration after diagnosis of PH, 8.2 years). All patients received standardized treatment for PH in accordance with guidelines for the diagnosis and treatment of PH in China. Among them, 278 patients did not receive vaccination, whereas 428 patients completed the vaccination series. None of the participants were infected with COVID-19 during our study period. Overall, 398 patients received inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine, whereas 30 received recombinant protein subunit vaccine. After adjusting for baseline covariates using the IPW approach, the odds of any adverse events due to PH in the vaccinated group did not statistically significantly increase (27/428 [6.3%] vs. 24/278 [8.6%], odds ratio = 0.72, P = 0.302). Approximately half of the vaccinated patients reported at least one post-vaccination side effects, most of which were mild, including pain at the injection site (159/428, 37.1%), fever (11/428, 2.6%), and fatigue (26/428, 6.1%).
COVID-19 vaccination did not significantly augment the PH-related major adverse events for patients with WHO groups 1 and 4 PH, although there were some tolerable side effects. A large-scale randomized controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.
2019 年冠状病毒病（COVID-19）对临床恶化的肺动脉高压（PH）和死亡率增加都有潜在风险。然而，关于该人群疫苗接种的保护作用的数据仍然缺乏。本研究旨在评估 PH 患者接种已批准疫苗的安全性。
在这项全国前瞻性队列研究中，2021 年 10 月至 2022 年 4 月期间从确诊为 PH（世界卫生组织[WHO]第 1 组和第 4 组）的患者中招募了患者。主要结局是 PH 相关主要不良事件的复合事件。我们使用逆概率加权（IPW）方法来控制患者基线特征中可能存在的混杂因素。
共有 706 例 PH 患者参与了本研究（平均年龄 40.3 岁；PH 确诊后平均时间为 8.2 年）。所有患者均按照中国 PH 诊断和治疗指南接受 PH 的标准化治疗。其中，278 例患者未接种疫苗，而 428 例患者完成了疫苗系列接种。在我们的研究期间，没有参与者感染 COVID-19。总体而言，398 例患者接种了灭活严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）疫苗，30 例患者接种了重组蛋白亚单位疫苗。使用 IPW 方法调整基线协变量后，接种组因 PH 发生任何不良事件的几率没有统计学意义上的增加（27/428 [6.3%] 比 24/278 [8.6%]，比值比=0.72，P=0.302）。约一半的接种疫苗患者报告了至少一种接种后副作用，大多数为轻度，包括注射部位疼痛（159/428，37.1%）、发热（11/428，2.6%）和疲劳（26/428，6.1%）。
COVID-19 疫苗接种并未显著增加 WHO 第 1 组和第 4 组 PH 患者的 PH 相关主要不良事件，尽管存在一些可耐受的副作用。需要进行大规模随机对照试验来证实这一发现。作为一项公共卫生策略，为 PH 患者批准 COVID-19 疫苗接种是有希望的。
