小柯机器人

美国哈佛医学院Scott D. Solomon联合明尼苏达大学Orly Vardeny团队，比较了高剂量三价流感疫苗与标准剂量四价流感疫苗对高危心血管疾病患者死亡率或心肺住院率的影响。2020年12月4日，该研究发表在《美国医学会杂志》上。

流感与心肺疾病的发病率和死亡率与季节有关，这些心血管疾病患者对疫苗接种的免疫反应可能较弱。流感疫苗剂量越大，患流感的风险就越低。

为了评估高剂量三价流感疫苗与标准剂量四价流感疫苗相比，是否可减少心血管疾病高危患者的全因死亡或心肺住院率，2016年9月21日至2019年1月31日，研究组在美国和加拿大的157个地点进行了一项实用性、多中心、双盲、主动比较研究者的随机临床试验，共招募了5260名近期有急性心肌梗塞或心力衰竭住院且至少有1个其他危险因素的患者。将其随机分组，其中2630例接种大剂量三价灭活流感疫苗，2630例接种标准剂量四价灭活流感疫苗，最多可以接种3个流感季。主要结局为每个流感季全因死亡或心肺住院发生率。

在3个流感季节中，5260名随机参与者的平均年龄为65.5岁，72%为男性，其中63％患有心力衰竭，共接种了7154针疫苗，有5226例（99.4％）参与者完成了试验。在3577个参与者-季节中，大剂量三价疫苗组中有884例参与者发生975起主要结局事件，其中883起心血管或肺部原因住院，92起全因死亡，事件发生率为每100患者-年45次；而标准剂量四价疫苗组中有837例参与者发生924起主要结局事件，其中846起心血管或肺部原因住院，78起全因死亡，事件发生率为每100患者-年42起，风险比为1.06，差异不显著。高剂量组与标准剂量组中与疫苗相关的不良反应发生率分别为40.5％和34.4％，严重不良反应发生率分别为2.1％和1.7％。

研究结果表明，对于高危心血管疾病患者，采用高剂量三价灭活流感疫苗与标准剂量四价灭活流感疫苗相比，并未显著降低全因死亡率或心肺住院率。

附：英文原文

Title: Effect of High-Dose Trivalent vs Standard-Dose Quadrivalent Influenza Vaccine on Mortality or Cardiopulmonary Hospitalization in Patients With High-risk Cardiovascular Disease: A Randomized Clinical Trial

Author: Orly Vardeny, KyungMann Kim, Jacob A. Udell, Jacob Joseph, Akshay S. Desai, Michael E. Farkouh, Sheila M. Hegde, Adrian F. Hernandez, Allison McGeer, H. Keipp Talbot, Inder Anand, Deepak L. Bhatt, Christopher P. Cannon, David DeMets, J. Michael Gaziano, Shaun G. Goodman, Kristin Nichol, Matthew C. Tattersall, Jonathan L. Temte, Janet Wittes, Clyde Yancy, Brian Claggett, Yi Chen, Lu Mao, Thomas C. Havighurst, Lawton S. Cooper, Scott D. Solomon, INVESTED Committees and Investigators

Issue&Volume: 2020-12-04

Abstract:

Importance  Influenza is temporally associated with cardiopulmonary morbidity and mortality among those with cardiovascular disease who may mount a less vigorous immune response to vaccination. Higher influenza vaccine dose has been associated with reduced risk of influenza illness.

Objective  To evaluate whether high-dose trivalent influenza vaccine compared with standard-dose quadrivalent influenza vaccine would reduce all-cause death or cardiopulmonary hospitalization in high-risk patients with cardiovascular disease.

Design, Setting, and Participants  Pragmatic multicenter, double-blind, active comparator randomized clinical trial conducted in 5260 participants vaccinated for up to 3 influenza seasons in 157 sites in the US and Canada between September 21, 2016, and January 31, 2019. Patients with a recent acute myocardial infarction or heart failure hospitalization and at least 1 additional risk factor were eligible.

Interventions  Participants were randomly assigned to receive high-dose trivalent (n=2630) or standard-dose quadrivalent (n=2630) inactivated influenza vaccine and could be revaccinated for up to 3 seasons.

Main Outcomes and Measures  The primary outcome was the time to the composite of all-cause death or cardiopulmonary hospitalization during each enrolling season. The final date of follow-up was July 31, 2019. Vaccine-related adverse events were also assessed.

Results  Among 5260 randomized participants (mean [SD] age, 65.5 [12.6] years; 3787 [72%] men; 3289 [63%] with heart failure) over 3 influenza seasons, there were 7154 total vaccinations administered and 5226 (99.4%) participants completed the trial. In the high-dose trivalent vaccine group, there were 975 primary outcome events (883 hospitalizations for cardiovascular or pulmonary causes and 92 deaths from any cause) among 884 participants during 3577 participant-seasons (event rate, 45 per 100 patient-years), whereas in the standard-dose quadrivalent vaccine group, there were 924 primary outcome events (846 hospitalizations for cardiovascular or pulmonary causes and 78 deaths from any cause) among 837 participants during 3577 participant-seasons (event rate, 42 per 100 patient-years) (hazard ratio, 1.06 [95% CI, 0.97-1.17]; P=.21). In the high-dose vs standard-dose groups, vaccine-related adverse reactions occurred in 1449 (40.5%) vs 1229 (34.4%) participants and severe adverse reactions occurred in 55 (2.1%) vs 44 (1.7%) participants.

Conclusions and Relevance  In patients with high-risk cardiovascular disease, high-dose trivalent inactivated influenza vaccine, compared with standard-dose quadrivalent inactivated influenza vaccine, did not significantly reduce all-cause mortality or cardiopulmonary hospitalizations. Influenza vaccination remains strongly recommended in this population.

DOI: 10.1001/jama.2020.23649

Source: https://jamanetwork.com/journals/jama/fullarticle/2773989

JAMA-Journal of The American Medical Association：《美国医学会杂志》，创刊于1883年。隶属于美国医学协会，最新IF：157.335
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