PDF(Pubmed)
Abstract：
We conducted a national in-depth analysis including pharmacovigilance reports and clinical study to assess the reporting rate (RR) and to determine the clinical profile of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) in COVID-19-vaccinated individuals. First, based on the French pharmacovigilance database, we estimated the RR of PMR and GCA cases in individuals aged over 50 who developed their initial symptoms within one month of receiving the BNT162b2 mRNA, mRNA-1273, ChAdOx1 nCoV-19, and Ad26.COV2.S vaccines. We then conducted a nationwide survey to gather clinical profiles, therapeutic management, and follow-up data from individuals registered in the pharmacovigilance study. A total of 70 854 684 COVID-19 vaccine doses were administered to 25 260 485 adults, among which, 179 cases of PMR (RR 7. 1 cases/1 000 000 persons) and 54 cases of GCA (RR 2. 1 cases/1 000 000 persons) have been reported. The nationwide survey allowed the characterization of 60 PMR and 35 GCA cases. Median time to the onset of first symptoms was 10 (range 2-30) and 7 (range 2-25) days for PMR and GCA, respectively. Phenotype, GCA-related ischemic complications and -large vessel vasculitis as well as therapeutic management and follow-up seemed similar according to the number of vaccine shots received and when compared to the literature data of unvaccinated population. Although rare, the short time between immunization and the onset of first symptoms of PMR and GCA suggests a temporal association. Physician should be aware of this potential vaccine-related phenomenon.
摘要：
我们进行了一项全国性的深入分析，包括药物警戒报告和临床研究，以评估报告率（RR），并确定接种COVID-19的个体中风湿性多肌痛（PMR）和巨细胞动脉炎（GCA）的临床特征。首先,基于法国药物警戒数据库，我们估计在接受BNT162b2mRNA后一个月内出现初始症状的50岁以上个体的PMR和GCA病例的RR，mRNA-1273、ChAdOx1nCoV-19和Ad26。COV2.S疫苗。然后我们在全国范围内进行了调查以收集临床资料，治疗管理，以及药物警戒研究中登记的个体的随访数据。总共向25260485名成年人施用了70854684剂COVID-19疫苗，其中,179例PMR(RR7。1例/1000000人）和54例GCA（RR2。1例/1000000人)已报告。全国范围的调查允许对60例PMR和35例GCA病例进行定性。PMR和GCA出现首发症状的中位时间为10天（范围2-30天）和7天（范围2-25天），分别。表型,与GCA相关的缺血性并发症和大血管血管炎以及治疗管理和随访根据接种疫苗的数量以及与未接种疫苗人群的文献数据相比似乎相似。虽然罕见，从免疫接种到PMR和GCA出现首发症状的时间较短,提示存在时间相关性.医生应该意识到这种潜在的疫苗相关现象。
