Pericarditis

心包炎
  • 文章类型: Journal Article
    背景:根据不同年龄段,关于急性心包炎的数据有限。这项研究的目的是探讨年龄相关特征在临床特征中的作用。管理,和急性心包炎的结果,重点是老年人。
    方法:2014年1月至2022年6月连续纳入首次急性心包炎发作的患者,并根据年龄分为四组(G1:18-35岁;G2:35-55岁;G3:55-75岁;G4:>75岁)。基线时记录临床特征和药物治疗,在后续行动中。
    结果:共有471名患者(中位年龄56.3(IQR33-73)岁,32.3%的妇女)被包括在内。年龄较小(G1-G2-G3)与较高的胸痛频率相关,心包摩擦(p<0001),心电图改变(p=0.002),更常用秋水仙碱治疗(p<0.001),和非甾体抗炎药(p=0.006)。老年患者(G4)描述更常见的呼吸困难,心包/胸腔积液(p=0.007),更常使用皮质类固醇治疗(p=0.037)。在128/471(27.2%)患者中发现了心包炎的次要原因。年龄较大的患者更常见的住院治疗,并有一个复杂的过程,新发房颤(p<0.001)和心脏压塞(p=0.005),与年轻患者相比,谁出现了更多的复发(分别为G1:43.0%,G2:34.7%,G3:28.2%和G4:16.2%;p<0.001)。经过多变量分析,年轻年龄仍然是复发的最强独立预测因子(HR3.23,95%CI1.81~5.58,p<0.001).
    结论:年龄越大,心包炎复发越少,但更严重的并发症需要住院治疗。
    BACKGROUND: There are limited data on acute pericarditis according to different age groups. The aim of this study is to investigate the role of age-related features in clinical characteristics, management, and outcomes of acute pericarditis, with a focus on the geriatric population.
    METHODS: Patients with a first episode of acute pericarditis were consecutively enrolled between January 2014 and June 2022, and divided into four groups according to age (G1: 18-35 years; G2: 35-55 years; G3: 55-75 years; G4: >75 years). Clinical characteristics and medical therapy were recorded at baseline, and during follow-up.
    RESULTS: A total of 471 patients (median age 56.3 (IQR 33-73) years, 32.3% women) were included. Younger age (G1-G2-G3) was associated with a higher frequency of chest pain, pericardial rubs (p<0001), ECG changes (p=0.002) and were more commonly treated with colchicine (p<0.001), and non-steroidal anti-inflammatory drugs (p=0.006). Older patients (G4) depicted more commonly dyspnoea, pericardial/pleural effusion (p=0.007) and were more often treated with corticosteroids (p=0.037). A secondary cause of pericarditis was detected in 128/471 (27.2%) patients. Older patients were more commonly hospitalised and had a complicated course with new-onset atrial fibrillation (p<0.001) and cardiac tamponade (p=0.005), compared with younger patients, who presented more recurrences (respectively G1: 43.0%, G2: 34.7%, G3: 28.2% and G4: 16.2%; p<0.001). After multivariable analysis, younger age remained the strongest independent predictor for recurrences (HR 3.23, 95% CI 1.81 to 5.58, p<0.001).
    CONCLUSIONS: Older age is associated with less recurrences of pericarditis, but more severe complications with need for hospitalisation.
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  • 文章类型: Journal Article
    背景:癌症患者患心血管疾病的风险增加,并且易患2019年冠状病毒病(COVID-19)感染。我们旨在评估韩国癌症患者接种COVID-19疫苗的心血管安全性。
    方法:我们使用K-COV-N队列(2018-2021年)进行了自我对照病例系列研究。确定了12岁或以上的癌症患者,他们经历了心血管疾病的结局。心血管结局定义为心肌梗死,中风,静脉血栓栓塞症(VTE),心肌炎,或者心包炎,危险期为接受每剂COVID-19疫苗后0-28天。使用条件泊松回归模型以95%置信区间(CI)计算发病率比率(IRR)。
    结果:在318,105名癌症患者中,纳入了4,754例心血管结局患者。总体心血管风险没有增加(调整后的IRR,0.99[95%CI,0.90-1.08])在整个风险期内。在mRNA疫苗亚组中,根据疫苗类型在整个风险期内调整的总心血管结局的IRRs为1.07(95%CI,0.95-1.21),ChAdOx1nCoV-19疫苗亚组的0.99(95%CI,0.83-1.19),和0.86(95%CI,0.68-1.10)在混合匹配的疫苗接种亚组。然而,在对个体结果的分析中,在整个危险期,心肌炎的校正IRR增加至11.71(95%CI,5.88~23.35).相比之下,未观察到其他结局的风险增加,比如心肌梗塞,中风,VTE,和心包炎.
    结论:对于癌症患者,COVID-19疫苗接种在心血管结局方面表现出总体安全的特征。然而,需要谨慎,因为在这项研究中观察到接种COVID-19疫苗后心肌炎的风险增加。
    BACKGROUND: Cancer patients have an increased risk of cardiovascular outcomes and are susceptible to coronavirus disease 2019 (COVID-19) infection. We aimed to assess the cardiovascular safety of COVID-19 vaccination for cancer patients in South Korea.
    METHODS: We conducted a self-controlled case series study using the K-COV-N cohort (2018-2021). Patients with cancer aged 12 years or older who experienced cardiovascular outcomes were identified. Cardiovascular outcomes were defined as myocardial infarction, stroke, venous thromboembolism (VTE), myocarditis, or pericarditis, and the risk period was 0-28 days after receiving each dose of COVID-19 vaccines. A conditional Poisson regression model was used to calculate the incidence rate ratio (IRR) with 95% confidence interval (CI).
    RESULTS: Among 318,105 patients with cancer, 4,754 patients with cardiovascular outcomes were included. The overall cardiovascular risk was not increased (adjusted IRR, 0.99 [95% CI, 0.90-1.08]) during the whole risk period. The adjusted IRRs of total cardiovascular outcomes during the whole risk period according to the vaccine type were 1.07 (95% CI, 0.95-1.21) in the mRNA vaccine subgroup, 0.99 (95% CI, 0.83-1.19) in the ChAdOx1 nCoV-19 vaccine subgroup, and 0.86 (95% CI, 0.68-1.10) in the mix-matched vaccination subgroup. However, in the analysis of individual outcome, the adjusted IRR of myocarditis was increased to 11.71 (95% CI, 5.88-23.35) during the whole risk period. In contrast, no increased risk was observed for other outcomes, such as myocardial infarction, stroke, VTE, and pericarditis.
    CONCLUSIONS: For cancer patients, COVID-19 vaccination demonstrated an overall safe profile in terms of cardiovascular outcomes. However, caution is required as an increased risk of myocarditis following COVID-19 vaccination was observed in this study.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    发表了许多关于长型Covid患病率的数据,关于COVID-19康复患者新的心脏改变(NCA)的发现很少。ARCA-post-COVID是一项观察性研究,旨在调查从Covid-19康复的患者中NCA的患病率。方法:从2020年6月至2022年12月,我们招募了502例SARS-CoV2鼻咽拭子阳性和随后阴性的患者。我们做了回忆,实验室测试,和常规心脏检查(心电图,Holter,TTE)。
    中位年龄为56岁(IQR44-67);女性为52.19%;在急性期,有24.1%的患者在医疗部门接受治疗,在ICU和其他人在家里的7.2%。参观时,389例患者(77.49%)主诉广泛的症状。我们根据病程和症状的持续性报告了患者的特征。138例患者中发现NCA(27.49%):其中心包积液60例(11.95%)。NCA患者年龄较大(中位数60岁,IQR:47-72,相对于中位数56y,IQR42-65),吸烟者的患病率较高(27%vs17%;p0.014),CAD(11%vs6%;p0.048)和卒中/TIA(3.6%vs0.3%;p0.002),高胆固醇血症患病率较低(18%vs30%;p0.007)。NCA的流行率似乎在病毒的不同亚型下是恒定的。
    自大流行开始以来,从COVID-19康复的患者中NCA的患病率很高且恒定;根据住院和长期症状(9.64%-42.52%),这是可以预测的。具有这些特征之一的患者应进行心脏筛查。
    UNASSIGNED: Many data were published about Long-Covid prevalence, very few about the findings of new cardiac alterations (NCA) in COVID-19-recovered people. ARCA-post-COVID is an observational study designed to investigate the prevalence of NCA in patients recovered from Covid-19.Methods: from June 2020 to December 2022, we enrolled 502 patients with a positive nasopharyngeal swab for SARS-CoV2 and a subsequent negative one. We performed anamnesis, lab-test, and routine cardiological tests (ECG, Holter, TTE).
    UNASSIGNED: The median age was 56 years (IQR 44-67); women were 52.19%; in the acute phase 24.1% of patients were treated in a medical department, 7.2% in the ICU and the others at home. At the visit, 389 patients (77.49%) complained of a broad range of symptoms. We reported patients\' characteristics according to the course of the disease and the persistence of symptoms. NCA were found in 138 patients (27.49%): among them 60 cases (11.95%) of pericardial effusion. Patients with NCA were older (median 60y, IQR: 47-72, vs median 56y, IQR 42-65), had a higher prevalence of smokers (27% vs 17%; p0.014), CAD (11% vs 6%; p0.048) and stroke/TIA (3.6% vs 0.3%; p0.002) and a lower prevalence of hypercholesterolemia (18% vs 30%; p0.007). The prevalence of NCA seems constant with different subtypes of the virus.
    UNASSIGNED: the prevalence of NCA in patients who recovered from COVID-19 is high and constant since the beginning of the pandemic; it is predictable based on hospitalization and long-lasting symptoms (9.64%-42.52%). Patients with one of these characteristics should undergo cardiological screening.
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  • 文章类型: Journal Article
    目的:二价COVID-19mRNA疫苗,包含两种不同的成分,被授权对SARS-CoV-2的原始毒株和Omicron变体提供保护,作为应对COVID-19大流行的措施。由于观察到的优异的中和抗体应答,已经引起了对与二价疫苗接种相关的心肌炎/心包炎风险的关注。这项研究旨在调查与单价疫苗接种相比,二价COVID-19mRNA疫苗接种后心肌炎/心包炎的风险。
    方法:在2020年12月13日至2023年3月8日之间对CDCCOVID数据跟踪器和疫苗不良事件报告系统(VAERS)进行了分析。通过将心肌炎/心包炎病例数除以施用的疫苗剂量总数来确定报告率。使用报告优势比(ROR)评估了各种COVID-19mRNA疫苗接种的心肌炎/心包炎的不成比例模式。
    结果:初始单价COVID-19mRNA疫苗接种后心肌炎/心包炎的报告率为每百万剂6.91(95%置信区间[95CI]6.71-7.12),而二价疫苗接种的报告率显著较低(1.24,95CI0.96-1.58).不相称性分析显示,在最初的ROR为2.21(95CI2.00-2.43)的疫苗接种后,心肌炎/心包炎的报告较高,而二价COVID-19mRNA疫苗接种与心肌炎/心包炎的报告较少相关(ROR0.57,95CI0.45-0.72)。基于症状的子分析,性别,年龄和制造商进一步支持这些发现.
    结论:这项基于人群的研究提供了证据,表明二价COVID-19mRNA疫苗接种与心肌炎/心包炎的风险无关。这些发现为二价COVID-19mRNA疫苗的安全性提供了重要见解,并支持其继续用作更新的助推器。
    OBJECTIVE: Bivalent COVID-19 mRNA vaccines, which contain two different components, were authorized to provide protection against both the original strain of SARS-CoV-2 and the Omicron variant as a measure to address the COVID-19 pandemic. Concerns regarding the risk of myocarditis/pericarditis associated with bivalent vaccination have been raised due to the observed superior neutralizing antibody responses. This study aimed to investigate the risk of myocarditis/pericarditis following bivalent COVID-19 mRNA vaccination compared to monovalent vaccination.
    METHODS: The CDC COVID Data Tracker and the Vaccines Adverse Event Reporting System (VAERS) were analyzed between December 13, 2020 to March 8, 2023. Reporting rates were determined by dividing the number of myocarditis/pericarditis cases by the total number of vaccine doses administered. Disproportionality patterns regarding myocarditis/pericarditis were evaluated for various COVID-19 mRNA vaccinations using reporting odds ratios (RORs).
    RESULTS: The reporting rate for myocarditis/pericarditis following original monovalent COVID-19 mRNA vaccination was 6.91 (95 % confidence interval [95 %CI] 6.71-7.12) per million doses, while the reporting rate for bivalent vaccination was significantly lower (1.24, 95%CI 0.96-1.58). Disproportionality analysis revealed a higher reporting of myocarditis/pericarditis following original vaccination with a ROR of 2.21 (95 %CI 2.00-2.43), while bivalent COVID-19 mRNA vaccination was associated with fewer reports of myocarditis/pericarditis (ROR 0.57, 95 %CI 0.45-0.72). Sub-analyses based on symptoms, sex, age and manufacturer further supported these findings.
    CONCLUSIONS: This population-based study provides evidence that bivalent COVID-19 mRNA vaccination is not associated with risk of myocarditis/pericarditis. These findings provide important insights into the safety profile of bivalent COVID-19 mRNA vaccines and support their continued use as updated boosters.
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  • 文章类型: Journal Article
    目的:我们的研究旨在通过心血管磁共振(CMR)探讨急性心包炎患者左心房(LA)和左心室(LV)心肌应变的影响,并探讨其在不良预后中的可能意义。
    方法:这项回顾性研究连续对36例急性心包炎患者进行了CMR扫描(24例男性,52岁[23-52])。主要终点是复发性心包炎的组合,缩窄性心包炎,心包疾病的手术定义为心包事件。对常规猪SSFP序列进行心房和心室应变功能。
    结果:中位随访时间为16个月(四分位距[13-24])后,12例急性心包炎患者达到主要终点。在多变量Cox回归分析中,LA储层和LA导管应变参数都是不良心包疾病的独立决定因素。相反,LV心肌应变参数并不是预后的独立预测因子。用接收工作特性曲线分析,对于12个月的结果预测,LA导管和储层应变显示出出色的预测性能(曲线下面积分别为0.914和0.895)。
    结论:LA对CMR的储集和导管机制与心包不良事件的较高风险独立相关。在急性心包炎的治疗中包括心房应变参数可以改善风险分层。
    结论:心房应变可能是预测急性心包炎患者心包不良并发症的一个合适的无创和非对比心血管磁共振参数。
    结论:•心肌应变是心血管疾病风险分层的一个经过充分验证的CMR参数。•LA储层和导管功能与不良心包事件显著相关。•心房应变可作为对急性心包炎患者进行分层的额外非对比CMR参数。
    OBJECTIVE: Our study aimed to explore with cardiovascular magnetic resonance (CMR) the impact of left atrial (LA) and left ventricular (LV) myocardial strain in patients with acute pericarditis and to investigate their possible prognostic significance in adverse outcomes.
    METHODS: This retrospective study performed CMR scans in 36 consecutive patients with acute pericarditis (24 males, age 52 [23-52]). The primary endpoint was the combination of recurrent pericarditis, constrictive pericarditis, and surgery for pericardial diseases defined as pericardial events. Atrial and ventricular strain function were performed on conventional cine SSFP sequences.
    RESULTS: After a median follow-up time of 16 months (interquartile range [13-24]), 12 patients with acute pericarditis reached the primary endpoint. In multivariable Cox regression analysis, LA reservoir and LA conduit strain parameters were all independent determinants of adverse pericardial diseases. Conversely, LV myocardial strain parameters did not remain an independent predictor of outcome. With receiving operating characteristics curve analysis, LA conduit and reservoir strain showed excellent predictive performance (area under the curve of 0.914 and 0.895, respectively) for outcome prediction at 12 months.
    CONCLUSIONS: LA reservoir and conduit mechanisms on CMR are independently associated with a higher risk of adverse pericardial events. Including atrial strain parameters in the management of acute pericarditis may improve risk stratification.
    CONCLUSIONS: Atrial strain could be a suitable non-invasive and non-contrast cardiovascular magnetic resonance parameter for predicting adverse pericardial complications in patients with acute pericarditis.
    CONCLUSIONS: • Myocardial strain is a well-validated CMR parameter for risk stratification in cardiovascular diseases. • LA reservoir and conduit functions are significantly associated with adverse pericardial events. • Atrial strain may serve as an additional non-contrast CMR parameter for stratifying patients with acute pericarditis.
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  • 文章类型: Journal Article
    背景:在2019年冠状病毒病(COVID-19)大流行期间,几种COVID-19疫苗获得了快速程序的许可。尽管这些疫苗已经证明了高免疫原性,青少年人群对COVID-19疫苗接种后的严重不良事件(AE)存在担忧.我们的目的是分析青少年接种COVID-19疫苗的安全性。
    方法:在这项药物警戒研究中,我们使用Vigibase进行了不相称性分析,世界卫生组织的全球个案安全报告(ICSR)数据库。比较COVID-19疫苗后报告的严重不良事件与12-17岁青少年接种的所有其他疫苗,包括对12-17岁青少年接种任何疫苗后的ICSR,将病例定义为具有感兴趣的AE的报告,将所有其他AE视为非病例。感兴趣的AE是心肌炎/心包炎,多系统炎症综合征/川崎病(MIS/KD),过敏反应,格林-巴利综合征(GBS)和免疫性血小板减少症(ITP)。我们进行了不成比例分析,以估计每个感兴趣的AE的报告优势比(ROR)和95%置信区间(CI)。使用逻辑回归校正性别。
    结果:在青少年接种疫苗后的99,735例不良事件报告中,80,018份报告来自接种COVID-19疫苗的青少年(52.9%为女性;56.3%为美国)。感兴趣的AE主要报告为mRNA疫苗(99.4%)的严重AE(76.1%)。一般来说,青少年接种COVID-19疫苗后,发现AE的报告几率更高;心肌炎/心包炎(2,829例COVID-19疫苗报告与35所有其他疫苗,调整后的ROR[aROR],19.61;95%CI,14.05-27.39),和MIS/KD(104vs.6,aROR,4.33;95%CI,1.89-9.88)。过敏反应的报告几率(515vs.165,AROR,0.86;95%CI,0.72-1.02),GBS(94vs.40,AROR,0.64;95%CI,0.44-0.92)和ITP(52与12,aROR,1.12;95%CI,0.59-2.09)在接种COVID-19疫苗后没有明显升高。
    结论:在这项研究中,COVID-19疫苗接种后,免疫相关不良事件的报告不成比例。在等待明确证据的同时,有必要密切监测青少年接种COVID-19疫苗后免疫相关不良事件的任何迹象.
    BACKGROUND: During coronavirus disease 2019 (COVID-19) pandemic, several COVID-19 vaccines were licensed with fast-track procedures. Although these vaccines have demonstrated high immunogenicity, there has been concerns on the serious adverse events (AEs) following COVID-19 vaccination among adolescents. We aimed to analyze comparative safety of COVID-19 vaccination in adolescents.
    METHODS: In this pharmacovigilance study, we performed a disproportionality analysis using VigiBase, the World Health Organization\'s global individual case safety report (ICSR) database. To compare serious AEs reported following COVID-19 vaccines vs. all other vaccines in adolescents aged 12-17 years, ICSRs following any vaccines on adolescents aged 12-17 years were included, defining cases as reports with the AEs of interest, with all other AEs as non-cases. The AEs of interest were myocarditis/pericarditis, multisystem inflammatory syndrome/Kawasaki disease (MIS/KD), anaphylaxis, Guillain-Barré syndrome (GBS), and immune thrombocytopenia (ITP). We conducted a disproportionality analysis to estimate reporting odds ratio (ROR) with 95% confidence interval (CI) for each AE of interest, adjusted for sex by using logistic regression.
    RESULTS: Of 99,735 AE reports after vaccination in adolescents, 80,018 reports were from COVID-19 vaccinated adolescents (52.9% females; 56.3% America). The AEs of interest were predominantly reported as serious AE (76.1%) with mRNA vaccines (99.4%). Generally, higher reporting odds for the AEs were identified following COVID-19 vaccination in adolescents; myocarditis/pericarditis (2,829 reports for the COVID-19 vaccine vs. 35 for all other vaccines, adjusted ROR [aROR], 19.61; 95% CI, 14.05-27.39), and MIS/KD (104 vs. 6, aROR, 4.33; 95% CI, 1.89-9.88). The reporting odds for anaphylaxis (515 vs. 165, aROR, 0.86; 95% CI, 0.72-1.02), GBS (94 vs. 40, aROR, 0.64; 95% CI, 0.44-0.92) and ITP (52 vs. 12, aROR, 1.12; 95% CI, 0.59-2.09) were not significantly higher following COVID-19 vaccination.
    CONCLUSIONS: In this study, there were disproportionate reporting of immune-related AEs following COVID-19 vaccination. While awaiting definitive evidence, there is a need to closely monitor for any signs of immune-related AEs following COVID-19 vaccination among adolescents.
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  • 文章类型: Journal Article
    背景:要正确评估疫苗与特定不良事件之间的关联,需要对观察到的发生率和背景发生率进行比较;然而,目前在韩国的研究有限。因此,在这项研究中,我们估计了过敏反应的背景发生率,心肌炎,心包炎,格林-巴利综合征(GBS)以及韩国的死亡率。
    方法:使用国家样本队列(NSC)数据进行回顾性队列研究。使用NSC,背景发病率是通过将2009-2019年期间的发作次数除以按年份划分的总人口,然后乘以100,000来估算的.使用韩国统计数据,背景死亡率是通过除以死亡人数来估计的,在2009-2019年期间,按当年的标准人口计算,然后乘以100,000。使用背景死亡率,我们使用自回归综合移动平均模型预测了2021年的死亡率。Further,将预期死亡率与观察到的死亡率进行了比较.
    结果:根据年龄调整的过敏反应发生率(AIR)从每100,000人4.28例增加到22.90例(p=0.003);心肌炎没有显着增加,从每100,000人口0.56例增加到1.26例(p=0.276);心包炎从每100,000人口0.94例增加到1.88例(p=0.005);GBS从每100,000人口0.78例增加到1.21例(p=0.013).年龄调整后的死亡率从每100,000人645.24降至475.70人(p<0.001)。2021年总体观察/预期死亡率(比率:1.08,95%置信区间[CI]:1.07-1.08),男性(比率:1.07,95%CI:1.07-1.08),和女性(比率:1.08,95%CI:1.07-1.09),都明显更高。当按年龄组分层时,年龄≥80岁(比率:1.16,95%CI:1.15-1.17),60-69(比率:1.11,95%CI:1.10-1.13),而20-29岁(比值:1.07,95%CI:1.02-1.13)也明显增高。
    结论:通过评估与过敏反应相关的背景发生率,心肌炎,心包炎,GBS,和死亡率,我们建立了一个参考点,用于评估COVID-19疫苗接种后不良事件的潜在过度发生率.这一参考点是支持COVID-19疫苗安全性的实质性证据。
    BACKGROUND: To properly assess an association between vaccines and specific adverse events requires a comparison between the observed and background rates; however, studies in South Korea are currently limited. Therefore, in this study, we estimated the background incidence of anaphylaxis, myocarditis, pericarditis, Guillain-Barré syndrome (GBS), and mortality in South Korea.
    METHODS: A retrospective cohort study was conducted using the National Sample Cohort (NSC) data. Using NSC, the background incidence rate was estimated by dividing the number of episodes during 2009-2019 by the total population by year and then multiplying by 100,000. Using Statistics Korea data, the background mortality rate was estimated by dividing the number of deaths, during 2009-2019 by the standard population for that year and then multiplying by 100,000. Using background mortality rates, we predicted mortality rates for 2021 using autoregressive integrated moving average models. Further, the expected mortality rates were compared with observed mortality rates.
    RESULTS: The age-adjusted incidence rate (AIR) of anaphylaxis increased from 4.28 to 22.90 cases per 100,000 population (p = 0.003); myocarditis showed no significant increase, changing from 0.56 to 1.26 cases per 100,000 population (p = 0.276); pericarditis increased from 0.94 to 1.88 cases per 100,000 population (p = 0.005); and GBS increased from 0.78 to 1.21 cases per 100,000 population (p = 0.013). The age-adjusted mortality rate decreased from 645.24 to 475.70 deaths per 100,000 population (p <0.001). The 2021 observed/expected mortality rates for overall (ratio: 1.08, 95% confidence interval [CI]: 1.07-1.08), men (ratio: 1.07, 95% CI: 1.07-1.08), and women (ratio: 1.08, 95% CI: 1.07-1.09), were all significantly higher. When stratified by age group, those aged ≥80 (ratio: 1.16, 95% CI: 1.15-1.17), 60-69 (ratio: 1.11, 95% CI: 1.10-1.13), and 20-29 years old (ratio: 1.07, 95% CI: 1.02-1.13) were also significantly higher.
    CONCLUSIONS: Through the estimation of background rates related to anaphylaxis, myocarditis, pericarditis, GBS, and mortality, we established a reference point for evaluating the potential excess occurrence of adverse events following COVID-19 vaccination. This reference point serves as substantive evidence supporting the safety profile of COVID-19 vaccines.
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  • 文章类型: Observational Study
    背景:2021年,美国疾病控制和预防中心报告了在美国使用mRNACOVID-19疫苗后,心肌炎和心包炎的病例增加。我们的研究旨在评估阿普里亚(意大利南部)心肌炎的发病率以及COVID-19mRNA疫苗与心肌炎风险之间的因果关系。
    方法:使用Apulian地区出院表格档案来定义Apulia的心肌炎病例,考虑2017年至2022年的数据。通过从区域免疫数据库收集的数据评估患者的总体疫苗接种状态。SARS-CoV-2感染的病史是从意大利卫生研究所平台提取的。
    结果:自2017年以来,Apulian受试者中记录了5,687例心肌炎;总体发病率呈下降趋势,在0-40岁的受试者中略有增加。从2021年到2022年,施用了2,930,276剂COVID-19mRNA疫苗;据报道,894名(0.03%)的普利亚居民在第二剂mRNA疫苗后诊断为心肌炎,发病率为17.9×1,000,000人-月。多变量分析,根据年龄调整,性别,潜在的医疗状况,和COVID-19的诊断表明,即使在年轻受试者中,mRNA疫苗也是心肌炎的保护因素(aOR=0.4;95CI=0.3-0.5)。
    结论:暴露与结果之间的时间关联并不等同于因果关系。我们的研究强调了如何在该主题的研究中优先考虑考虑心肌炎(主要是COVID-19)的其他潜在原因和因果关系评估的方法。
    OBJECTIVE: In 2021, the US Centers for Disease Control and Prevention reported increased cases of myocarditis and pericarditis in the United States after mRNA COVID-19 vaccines. Our study aims to estimate the incidence of myocarditis in Apulia (Southern Italy) and the cause-effect relationship between COVID-19 mRNA vaccines and the risk of myocarditis.
    METHODS: The Apulian regional archive of hospital discharge forms was used to define the cases of myocarditis in Apulia, considering data from 2017 to 2022. The overall vaccination status of patients was assessed via data collected from the Regional Immunization Database. The history of SARS-CoV-2 infection was extracted from the Italian Institute of Health platform.
    RESULTS: Since 2017, 5687 cases of myocarditis have been recorded in Apulian subjects; the overall incidence described a decreasing trend, with a slight increase in 0-40 years-old subjects. From 2021 to 2022, 2,930,276 doses of COVID-19 mRNA vaccines were administered; a diagnosis of myocarditis after the second dose of the mRNA vaccine was reported for 894 (0.03%) of Apulian inhabitants, with an incidence rate of 17.9 × 1,000,000 persons-month. The multivariate analysis, adjusted for age, sex, underlying medical conditions, and diagnosis of COVID-19, showed that mRNA vaccination is a protective factor for myocarditis even in younger subjects (aOR = 0.4; 95% CI = 0.3-0.5).
    CONCLUSIONS: A temporal association between an exposure and an outcome is not equivalent to a causal association. Our study underlines how an approach that considers the other potential causes of myocarditis (primarily COVID-19) and a causality assessment must be prioritized in the study of the topic.
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  • 文章类型: Observational Study
    背景:全球COVID疫苗安全(GCoVS)项目,2021年在跨国公司全球疫苗数据网络™(GVDN®)下成立,有利于全面评估疫苗的安全性。这项研究旨在评估来自8个国家10个地点的COVID-19疫苗接种后特殊关注不良事件(AESI)的风险。
    方法:使用通用协议,这项观察性队列研究与13个选定的AESI在神经系统中的预期发生率进行了比较,血液学,和心脏结果。参与地点使用按年龄和性别分层的COVID-19疫苗接种前医疗保健数据获得了预期率。自COVID-19疫苗接种计划推出以来,观察到的发生率来自相同的医疗保健数据集。在用mRNA(BNT162b2和mRNA-1273)和腺病毒载体(ChAdOx1)疫苗接种后至多42天发生的AESI被包括在初步分析中。使用具有95%置信区间的观察与预期(OE)比率评估风险。优先考虑的潜在安全信号是95%置信区间(LBCI)下限大于1.5的信号。
    结果:参与者包括99,068,901接种疫苗的个体。总的来说,在研究期间,跨参与位点施用183,559,462剂量的BNT162b2、36,178,442剂量的mRNA-1273和23,093,399剂量的ChAdOx1。同源疫苗接种时间表后的风险期贡献了23,168,335人年的随访。第一剂ChAdOx1疫苗后,观察到格林-巴利综合征(2.49,95%CI:2.15,2.87)和脑静脉窦血栓形成(3.23,95%CI:2.51,4.09)的OE比率>1.5。在第一剂mRNA-1273疫苗后,急性播散性脑脊髓炎的OE比率为3.78(95%CI:1.52,7.78)。随着LBCI>1.5,BNT162b2,mRNA-1273和ChAdOx1后心肌炎和心包炎的OE比率显着增加。
    结论:这项多国分析证实了心肌炎的预先建立的安全性信号,心包炎,格林-巴利综合征,脑静脉窦血栓形成.确定了其他需要进一步调查的潜在安全信号。
    BACKGROUND: The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries.
    METHODS: Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5.
    RESULTS: Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5.
    CONCLUSIONS: This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified.
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