Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.
Sportology Center, Juntendo University Graduate School of Medicine.
J Atheroscler Thromb. 2021 Aug 1;28(8):826-834. doi: 10.5551/jat.58297. Epub 2020 Oct 15.
Pneumococcal and influenza infections can cause serious morbidity and mortality in patients with cardiovascular diseases. The purpose of this study was to investigate the safety and efficacy of simultaneous inoculations of 23-valent pneumococcal polysaccharide vaccine (PPSV23) and trivalent influenza vaccine (TIV) in patients with coronary artery disease (CAD).
This was a prospective, randomized, single-blind, placebo-controlled study. A total of 40 patients with CAD were randomly assigned to the TIV+PPSV23 (simultaneous inoculations of TIV and PPSV23) and TIV+Placebo (inoculations of TIV and placebo) groups. Primary outcomes were the safety of simultaneous vaccinations and the changing of circulating cardiovascular biomarkers before, at 4-, and at 12-weeks after vaccinations.
The baseline characteristics between the two groups were identical. The prevalence of injection-site pain, swelling, and reddening were 47%, 37%, and 37% in the TIV+PPSV23 group, and 10%, 5%, and 0% in the TIV+Placebo group, respectively. All reactions were self-limited. Body temperature >37.0℃ or serious injection-related reaction was not observed. The levels of white blood cells, high-sensitivity C-reactive protein, N-terminal pro-B-type natriuretic peptide, pentraxin-3, and malondialdehide-modified low-density lipoprotein (LDL), were not significantly different between the two groups before and after vaccinations. The levels of anti-oxidized LDL were significantly and step-wisely decreased from baseline, to 4-, and 12-weeks vaccinations in the both groups. No significant changes of other markers were observed in both groups at each time point.
Simultaneous inoculations of TIV and PPSV23 were safety in patients with CAD, suggesting that dual vaccinations can be considered even in patients with CAD.
肺炎球菌和流感感染可导致心血管疾病患者发生严重的发病率和死亡率。本研究旨在研究 23 价肺炎球菌多糖疫苗(PPSV23)和三价流感疫苗(TIV)同时接种在冠状动脉疾病(CAD)患者中的安全性和有效性。
这是一项前瞻性、随机、单盲、安慰剂对照研究。将 40 例 CAD 患者随机分为 TIV+PPSV23(TIV 和 PPSV23 同时接种)和 TIV+安慰剂(TIV 和安慰剂接种)组。主要结局为同时接种的安全性和接种前后 4 周和 12 周循环心血管生物标志物的变化。
两组的基线特征相同。TIV+PPSV23 组注射部位疼痛、肿胀和发红的发生率分别为 47%、37%和 37%,TIV+安慰剂组分别为 10%、5%和 0%。所有反应均为自限性的。未观察到体温>37.0℃或严重与注射相关的反应。接种前后两组白细胞、高敏 C 反应蛋白、N 末端 B 型利钠肽前体、五聚素 3 和丙二醛修饰的低密度脂蛋白(LDL)水平无显著差异。两组的抗氧化低密度脂蛋白水平均从基线显著且逐步降低,在接种后 4 周和 12 周时均降低。两组在每个时间点的其他标志物均无明显变化。
TIV 和 PPSV23 同时接种在 CAD 患者中是安全的,这表明即使在 CAD 患者中也可以考虑双重接种。