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白塞病和家族性地中海热患者接种新型冠状病毒疫苗的安全性:基于信使核糖核酸疫苗和灭活疫苗效果的横断面比较研究

Safety of SARS-CoV-2 vaccination in patients with Behcet's syndrome and familial Mediterranean fever: a cross-sectional comparative study on the effects of M-RNA based and inactivated vaccine.

作者信息

Ozdede Ayse, Guner Sabriye, Ozcifci Guzin, Yurttas Berna, Toker Dincer Zeynep, Atli Zeynep, Uygunoğlu Uğur, Durmaz Eser, Uçar Didar, Uğurlu Serdal, Saip Sabahattin, Tabak Fehmi, Hamuryudan Vedat, Seyahi Emire

机构信息

Division of Rheumatology, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey.

Division of Allergy, Immunology, and Rheumatology, Department of Pediatrics, Columbia University Irving Medical Center, New York, USA.

出版信息

Rheumatol Int. 2022 Jun;42(6):973-987. doi: 10.1007/s00296-022-05119-y. Epub 2022 Apr 4.

DOI:10.1007/s00296-022-05119-y
PMID:35376962
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8977433/
Abstract

Most of the published data relate to classical forms of rheumatic diseases (RD) and information on rare inflammatory disorders such as Behçet's syndrome (BS) and familial Mediterranean fever (FMF) is limited. We studied the frequency of side effects and disease flares after COVID-19 vaccination with either Pfizer/BioNTech or Sinovac/CoronaVac in 256 patients with BS, 247 with FMF, and 601 with RD. Telephone interviews were conducted using a questionnaire survey in a cross-sectional design in patients with BS, FMF, and RD followed by a single university hospital. Study participants were vaccinated either with CoronaVac (BS:109, FMF: 90, and RD: 343,) or BioNTech (BS: 147, FMF: 157 and RD: 258). The majority have received double dose (BS: 94.9%, FMF 92.3% and RD: 86.2%). BioNTech ensured a significantly better efficacy than CoronaVac against COVID-19 in all patient groups (BS: 1.4% vs 10.1%; FMF: 3.2% vs 12.2%, RD:2.7% vs 6.4%). Those with at least one adverse event (AE) were significantly more frequent among those vaccinated with BioNTech than those with CoronaVac (BS: 86.4% vs 45%; FMF: 83.4% vs 53.3%; and RD: 83.3% vs 45.5%). The majority of AEs were mild to moderate and transient and this was true for either vaccine. There were also AEs that required medical attention in all study groups following CoronaVac (BS: 5.5%, FMF: 3.3%, and RD:2.9%) or BioNTech (BS: 5.4%, FMF: 1.9%, and RD: 4.7%). The main causes for medical assistance were disease flare and cardiovascular events. Patients with BS (16.0%) and FMF (17.4%) were found to flare significantly more frequently when compared to those with RD (6.0%) (p < 0.001). This was true for either vaccine. BS patients reported mainly skin-mucosa lesions; there were however, 11 (4.3%) who developed major organ attack such as uveitis, thrombosis or stroke. Flare in FMF patients were associated mainly with acute serositis with or without fever. Arthralgia/arthritis or inflammatory back pain were observed mainly in the RD group. Our study demonstrates that BS and FMF patients vaccinated with either CoronaVac or BioNTech demonstrated similar AE profile and frequency compared to RD patients. AEs that required physician consultation or hospitalization occurred in all study groups after either CoronaVac or BioNTech. Increased frequency of flares in BS and FMF compared to that seen in RD might reflect defects in innate immunity and deserves further investigation. Caution should be required when monitoring these patients after vaccination.

摘要

大多数已发表的数据都与风湿性疾病(RD)的经典形式有关,而关于白塞病(BS)和家族性地中海热(FMF)等罕见炎症性疾病的信息有限。我们研究了256例BS患者、247例FMF患者和601例RD患者接种辉瑞/生物新技术公司或科兴/克尔来福新冠疫苗后的副作用和疾病复发频率。采用问卷调查的方式,对一家大学附属医院随访的BS、FMF和RD患者进行横断面设计的电话访谈。研究参与者接种了克尔来福(BS:109例,FMF:90例,RD:343例)或生物新技术公司的疫苗(BS:147例,FMF:157例,RD:258例)。大多数人接种了两剂(BS:94.9%,FMF:92.3%,RD:86.2%)。在所有患者组中,生物新技术公司的疫苗对新冠病毒的疗效明显优于克尔来福(BS:1.4%对10.1%;FMF:3.2%对12.2%,RD:2.7%对6.4%)。接种生物新技术公司疫苗的患者中至少出现一次不良事件(AE)的频率明显高于接种克尔来福的患者(BS:86.4%对45%;FMF:83.4%对53.3%;RD:83.3%对45.5%)。大多数不良事件为轻至中度且短暂,两种疫苗都是如此。接种克尔来福(BS:5.5%,FMF:3.3%,RD:2.9%)或生物新技术公司疫苗(BS:5.4%,FMF:1.9%,RD:4.7%)后,所有研究组中也都出现了需要医疗关注的不良事件。医疗救助的主要原因是疾病复发和心血管事件。与RD患者(6.0%)相比,BS患者(16.0%)和FMF患者(17.4%)的疾病复发频率明显更高(p<0.001)。两种疫苗都是如此。BS患者主要报告皮肤黏膜病变;然而,有11例(4.3%)出现了葡萄膜炎、血栓形成或中风等主要器官受累情况。FMF患者的疾病复发主要与伴有或不伴有发热的急性浆膜炎有关。关节痛/关节炎或炎性背痛主要出现在RD组。我们的研究表明,接种克尔来福或生物新技术公司疫苗的BS和FMF患者与RD患者相比,不良事件的特征和频率相似。接种克尔来福或生物新技术公司疫苗后,所有研究组中都出现了需要医生咨询或住院治疗的不良事件。与RD患者相比,BS和FMF患者疾病复发频率增加可能反映了先天免疫缺陷,值得进一步研究。接种疫苗后监测这些患者时应谨慎。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c4a/8977433/20d7abc5a48c/296_2022_5119_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c4a/8977433/889f5d040328/296_2022_5119_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c4a/8977433/20d7abc5a48c/296_2022_5119_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c4a/8977433/889f5d040328/296_2022_5119_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c4a/8977433/20d7abc5a48c/296_2022_5119_Fig2_HTML.jpg

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