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mRNA和病毒载体COVID-19疫苗对葡萄糖代谢事件的欧洲安全性分析。

European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events.

作者信息

di Mauro Gabriella, Mascolo Annamaria, Longo Miriam, Maiorino Maria Ida, Scappaticcio Lorenzo, Bellastella Giuseppe, Esposito Katherine, Capuano Annalisa

机构信息

Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.

Department of Experimental Medicine, Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.

出版信息

Pharmaceuticals (Basel). 2022 May 27;15(6):677. doi: 10.3390/ph15060677.

Abstract

Few data have been published on the effects of impaired glucose metabolism induced by COVID-19 vaccines. We decided to perform a study to describe Individual Case Safety Reports (ICSRs) of impaired glucose metabolism events reported in the European database (Eudravigilance, EV). ICSRs were retrieved from the online website of Eudravigilance. The reporting odds ratios (ROR) were computed to assess the reporting frequency for COVID-19 mRNA vaccines compared to COVID-19 viral vector-based vaccines. A total of 3917 ICSRs with a COVID-19 vaccine suspected were retrieved, with a total of 4275 impaired glucose metabolism events. Overall, the most reported events were related to "high glucose levels" (2012; 47.06%). The mRNA vaccines were associated with an increased reporting frequency of "type 1 diabetes mellitus" (ROR 1.86; 95% CI 1.33-2.60), "type 2 diabetes mellitus" (ROR 1.58; 95% CI 1.03-2.42), "high glucose levels" (ROR 1.16; 95% CI 1.06-1.27), "diabetes mellitus inadequate control" (ROR 1.63; 95% CI 1.25-2.11), and "hypoglycemia" (ROR 1.62; 95% CI 1.41-1.86) compared to viral vector-based vaccines. mRNA COVID-19 vaccines were associated with an increased reporting frequency of alterations of glucose homeostasis compared to viral-vector COVID-19 vaccines. Clinicians should be aware of these events to better manage glycemic perturbations. Larger nationwide studies are warranted to verify these findings.

摘要

关于新冠疫苗诱发的糖代谢受损影响的已发表数据很少。我们决定开展一项研究,以描述欧洲数据库(药物警戒数据库,EV)中报告的糖代谢受损事件的个体病例安全报告(ICSR)。ICSR从药物警戒数据库的在线网站检索。计算报告比值比(ROR),以评估与基于新冠病毒载体疫苗相比,新冠mRNA疫苗的报告频率。共检索到3917份怀疑接种新冠疫苗的ICSR,共有4275起糖代谢受损事件。总体而言,报告最多的事件与“血糖水平升高”有关(2012起;47.06%)。与基于病毒载体的疫苗相比,mRNA疫苗与“1型糖尿病”(ROR 1.86;95%CI 1.33 - 2.60)、“2型糖尿病”(ROR 1.58;95%CI 1.03 - 2.42)、“血糖水平升高”(ROR 1.16;95%CI 1.06 - 1.27)、“糖尿病控制不佳”(ROR 1.63;95%CI 1.25 - 2.11)和“低血糖”(ROR 1.62;95%CI 1.41 - 1.86)的报告频率增加有关。与基于病毒载体的新冠疫苗相比,新冠mRNA疫苗与糖代谢稳态改变的报告频率增加有关。临床医生应了解这些事件,以便更好地管理血糖紊乱。有必要开展更大规模的全国性研究来验证这些发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/74eb/9229409/84b100ac9bea/pharmaceuticals-15-00677-g001.jpg

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