Park Jin, Kim Dongyeop, Song Tae-Jin
Department of Neurology, Seoul Hospital, Ewha Womans University College of Medicine, 260 Gonghang-daero, Gangseo-gu, Seoul 07804, Korea.
Vaccines (Basel). 2022 May 25;10(6):835. doi: 10.3390/vaccines10060835.
Systemic capillary leak syndrome (SCLS) is a rare and potentially life-threatening disorder characterized by reversible plasma extravasation and vascular collapse. This study aimed to investigate the association between different types of COVID-19 vaccine and SCLS in a real-world setting. We used individual case safety reports of SCLS after COVID-19 vaccination from the WHO pharmacovigilance database, VigiBase. A disproportionality analysis of ChAdOx1 nCoV-19 and mRNA-based vaccines was performed. The information component (IC) and reporting odds ratio (ROR) were calculated from the entire database and viral vaccines data subset. A positive 95% lower end of the IC (IC025) value (>0) using Bayesian neural network analysis and lower end of the ROR 95% confidence interval (ROR025) ≥1 were defined as the ADR signal detection threshold. A total of 101 (0.004%) events of SCLS were identified. A significant potential signal of disproportionality of SCLS was noted in ChAdOx1 nCoV-19 when applied as the denominator for entire database (IC025 = 0.24, ROR025 = 1.23) and all viral vaccines (IC025 = 0.41, ROR025 = 1.59). No significant potential signal was noted for two mRNA-based vaccines as denominators for the entire database (IC025 = −0.49, ROR025 = 0.71) and all viral vaccines (IC025 = −0.32, ROR025 = 0.77). Contrary to ChAdOx1 nCoV-1, no safety signal for developing SCLS was identified for mRNA-based vaccines.
系统性毛细血管渗漏综合征（SCLS）是一种罕见且可能危及生命的疾病，其特征为可逆性血浆外渗和血管塌陷。本研究旨在调查在现实环境中不同类型的新冠疫苗与SCLS之间的关联。我们使用了世界卫生组织药物警戒数据库VigiBase中新冠疫苗接种后SCLS的个体病例安全报告。对ChAdOx1 nCoV-19疫苗和基于mRNA的疫苗进行了不成比例分析。从整个数据库和病毒疫苗数据子集中计算信息成分（IC）和报告比值比（ROR）。使用贝叶斯神经网络分析，IC的95%下限值（IC025）>0以及ROR的95%置信区间下限值（ROR025）≥1被定义为不良事件信号检测阈值。共识别出101例（0.004%）SCLS事件。当以ChAdOx1 nCoV-19作为整个数据库（IC025 = 0.24，ROR025 = 1.23）和所有病毒疫苗（IC025 = 0.41，ROR025 = 1.59）的分母时，发现SCLS存在显著的不成比例潜在信号。对于两种基于mRNA的疫苗，当作为整个数据库（IC025 = -0.49，ROR025 = 0.71）和所有病毒疫苗（IC025 = -0.32，ROR025 = 0.77）的分母时，未发现显著的潜在信号。与ChAdOx1 nCoV-1相反，未发现基于mRNA的疫苗有引发SCLS的安全信号。
