接种新型冠状病毒疫苗后的血栓栓塞和出血风险：随机对照试验的系统评价和荟萃分析
Thromboembolic and hemorrhagic risks after vaccination against SARS-CoV-2: a systematic review and meta-analysis of randomized controlled trials.
作者信息
Uaprasert Noppacharn, Panrong Krissana, Rojnuckarin Ponlapat, Chiasakul Thita
机构信息
Division of Hematology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.
Research Unit in Translational Hematology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.
出版信息
Thromb J. 2021 Nov 13;19(1):86. doi: 10.1186/s12959-021-00340-4.
BACKGROUND
Thromboembolic and bleeding events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are major public concerns leading to vaccine hesitancy. Due to low incidence, an individual randomized controlled trial (RCT) is underpowered to determine whether SARS-CoV-2 vaccines increase the risks of thromboembolism and hemorrhage.
METHODS
We performed a literature search using PubMed, EMBASE, Cochrane, medRxiv databases, and reference lists of relevant articles to identify RCTs that reported thromboembolic, hemorrhagic events, and thromboembolism/hemorrhage-related death after SARS-CoV-2 vaccination. The primary aim of this systematic review and meta-analysis was to estimate the pooled thromboembolic risk related to SARS-CoV-2 vaccines compared to placebo. The secondary outcomes included estimating the risks of arterial thromboembolism (ATE), venous thromboembolisms (VTE), hemorrhage, thrombocytopenia, and thromboembolism/hemorrhage-related death.
RESULTS
Eight RCTs of 4 vaccine platforms comprised of 195,196 participants were retrieved. SARS-CoV-2 vaccines were not associated with an increased risk of overall thromboembolism (risk ratio [RR], 1.14; 95% CI [confidence interval], 0.61-2.14; I = 35%), ATE (RR, 0.97; 95% CI, 0.46-2.06; I = 21%), VTE (RR, 1.47; 95% CI, 0.72-2.99; I = 0%), hemorrhage (RR, 0.97; 95% CI, 0.35-2.68; I = 0), and thromboembolism/hemorrhage-related death (RR, 0.53; 95% CI, 0.16-1.79; I = 0). Compared to the baseline estimated risk of these outcomes in participants administered placebos, the risk differences with vaccines were very small and not statistically significant. These findings were consistent in the subgroup analysis across 4 vaccine platforms.
CONCLUSION
Vaccines against SARS-CoV-2 are not associated with an increased risk of thromboembolism, hemorrhage, and thromboembolism/hemorrhage-related death.
背景
接种严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗后的血栓栓塞和出血事件是导致疫苗犹豫的主要公众担忧因素。由于发病率较低，一项个体随机对照试验（RCT）在确定SARS-CoV-2疫苗是否会增加血栓栓塞和出血风险方面的效力不足。
方法
我们使用PubMed、EMBASE、Cochrane、medRxiv数据库以及相关文章的参考文献列表进行文献检索，以识别报告SARS-CoV-2疫苗接种后血栓栓塞、出血事件以及血栓栓塞/出血相关死亡的随机对照试验。本系统评价和荟萃分析的主要目的是估计与安慰剂相比，SARS-CoV-2疫苗相关的合并血栓栓塞风险。次要结局包括估计动脉血栓栓塞（ATE）、静脉血栓栓塞（VTE）、出血、血小板减少症以及血栓栓塞/出血相关死亡的风险。
结果
检索到了由4种疫苗平台组成的8项随机对照试验，共195,196名参与者。SARS-CoV-2疫苗与总体血栓栓塞风险增加无关（风险比[RR]，1.14；95%置信区间[CI]，0.61 - 2.14；I² = 35%），与动脉血栓栓塞（RR，0.97；95% CI，0.46 - 2.06；I² = 21%）、静脉血栓栓塞（RR，1.47；95% CI，0.72 - 2.99；I² = 0%）、出血（RR，0.97；95% CI，0.35 - 2.68；I² = 0）以及血栓栓塞/出血相关死亡（RR，0.53；95% CI，0.16 - 1.79；I² = 0）均无关。与接受安慰剂的参与者中这些结局的基线估计风险相比，疫苗的风险差异非常小且无统计学意义。这些发现在4种疫苗平台的亚组分析中是一致的。
结论
SARS-CoV-2疫苗与血栓栓塞、出血以及血栓栓塞/出血相关死亡风险增加无关。
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