A prospective study of the incidence of myocarditis/pericarditis and new onset cardiac symptoms following smallpox and influenza vaccination.
A prospective study of the incidence of myocarditis/pericarditis and new onset cardiac symptoms following smallpox and influenza vaccination.
复制标题
DOI：
10.1371/journal.pone.0118283
复制
发表时间：
2015
期刊：
影响因子：
3.7
通讯作者：
Davis RL
中科院分区：
文献类型：
--
作者：
Engler RJ;Nelson MR;Collins LC Jr;Spooner C;Hemann BA;Gibbs BT;Atwood JE;Howard RS;Chang AS;Cruser DL;Gates DG;Vernalis MN;Lengkeek MS;McClenathan BM;Jaffe AS;Cooper LT;Black S;Carlson C;Wilson C;Davis RL
虽然心肌炎/心包炎(MP)已被确定为天花疫苗(SPX)后的不良事件，但这种反应的预期发生率和新出现的心脏症状，包括可能的亚临床损伤，尚未有前瞻性的定义。这项研究的主要目的是确定与免疫相关的新发心脏症状、临床和可能的亚临床MP的预期发生率。在一项对接受天花疫苗或三价流感疫苗(TIV)的健康受试者进行的多中心前瞻性主动监测队列研究中，测量了SPX后新出现的心脏症状、临床MP和心脏特异性肌钙蛋白T(CTnT)升高(高于个体基线值)。接种SPX疫苗的10.6%和接种TIV疫苗的2.6%的人在免疫后30天内出现新的胸痛、呼吸困难和/或心悸(相对危险度(RR)4.0，95%可信区间：1.7-9.3)。在1081名获得完全随访的SPX疫苗接种者中，4名高加索男性被诊断为疑似心肌炎，1名女性被诊断为疑似心包炎。这表明SPX后的发病率是SPX前心肌炎/心包炎背景人群监测率的200多倍(RR 214，95%CI 65-558)。此外，31名没有特定心脏症状的SPX疫苗接种者被发现，在临床心肌炎/心包炎的风险窗口期间，cTnT(>；99%百分位数)比基线(SPX前)增加了2倍以上，并符合可能的亚临床心肌炎的拟议病例定义。这一比例是临床病例发病率的60倍。在TIV疫苗接种组中没有发现临床或可能的亚临床心肌炎病例。被动监测大大低估了天花免疫后心肌炎/心包炎的真实发病率。疫苗免疫后亚临床一过性心肌损伤的证据需要进一步研究，以包括长期结果监测。需要积极的安全监测，以确定未被很好地理解或先前认识到的不良事件。
Although myocarditis/pericarditis (MP) has been identified as an adverse event following smallpox vaccine (SPX), the prospective incidence of this reaction and new onset cardiac symptoms, including possible subclinical injury, has not been prospectively defined. The study’s primary objective was to determine the prospective incidence of new onset cardiac symptoms, clinical and possible subclinical MP in temporal association with immunization. New onset cardiac symptoms, clinical MP and cardiac specific troponin T (cTnT) elevations following SPX (above individual baseline values) were measured in a multi-center prospective, active surveillance cohort study of healthy subjects receiving either smallpox vaccine or trivalent influenza vaccine (TIV). New onset chest pain, dyspnea, and/or palpitations occurred in 10.6% of SPX-vaccinees and 2.6% of TIV-vaccinees within 30 days of immunization (relative risk (RR) 4.0, 95% CI: 1.7-9.3). Among the 1081 SPX-vaccinees with complete follow-up, 4 Caucasian males were diagnosed with probable myocarditis and 1 female with suspected pericarditis. This indicates a post-SPX incidence rate more than 200-times higher than the pre-SPX background population surveillance rate of myocarditis/pericarditis (RR 214, 95% CI 65-558). Additionally, 31 SPX-vaccinees without specific cardiac symptoms were found to have over 2-fold increases in cTnT (>99th percentile) from baseline (pre-SPX) during the window of risk for clinical myocarditis/pericarditis and meeting a proposed case definition for possible subclinical myocarditis. This rate is 60-times higher than the incidence rate of overt clinical cases. No clinical or possible subclinical myocarditis cases were identified in the TIV-vaccinated group. Passive surveillance significantly underestimates the true incidence of myocarditis/pericarditis after smallpox immunization. Evidence of subclinical transient cardiac muscle injury post-vaccinia immunization is a finding that requires further study to include long-term outcomes surveillance. Active safety surveillance is needed to identify adverse events that are not well understood or previously recognized.
登录
查看更多内容
影响因子：
1.2
作者：
Haim, M;Gdalevich, M;Shemer, J
通讯作者：
Shemer, J
影响因子：
120.7
作者：
de Lemos, James A.
通讯作者：
de Lemos, James A.
影响因子：
1.9
作者：
Kao, CD;Chen, JT;Liao, KK
通讯作者：
Liao, KK
影响因子：
9.3
作者：
Apple, FS;Quist, HE;Murakami, MM
通讯作者：
Murakami, MM
影响因子：
5
作者：
Arness, MK;Eckart, RE;Tornberg, DN
通讯作者：
Tornberg, DN