俄罗斯联邦现实临床实践中对非放射性轴性脊柱关节炎患者管理的非干预性多中心研究(NiSpAR)结果

T. Dubinina, A. Lila, E. V. Kvasova, E. Agafonova, I. Andrianova, L. V. Ivanova, D. V. Yurk, N.  A. Garaeva, E. Akulinushkina, A. N. Vedekhina, I. Bashkova, S. A. Lapshina, Y. Y. Grabovetskaya, N. F. Semenova, M. I. Valkova, D. Krechikova, O. S. Mazhaeva, I. B. Vinogradova, O. V. Bugrova, S. M. Voloshenko, G. R. Enikeeva, E. S. Immis, L. F. Timasheva, E. E. Biserova, L. Z. Shaimukhametova, I. Patrikeeva, A. A. Barakat, P. Shesternya, N. M. Nikitina, M. I. Yupatova, O. Anoshenkova, M. A. Korolev, Y. Ubshaeva, E. Vasilenko, E. Zonova, O. Nesmeyanova, E. Bogdanova, V. I. Mazurov, R. Samigullina, I. M. Marusenko
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In half of the patients the disease duration was more than 2 years, in more than one third – less than 2 years. The median CRP and ESR values were 5.0 [2.0; 12.0] mg/l and 11.0 [5.0; 18.0] mm/h, respectively. The BASDAI averaged 3.5±2.0 and was >4 in more than half of the cases (64.2%). The mean ASDAS-CRP value reached 2.6±1.1. Only 1 in 5 participants (20.8%) had low axSpA activity, while in 61.1% it was high (44.7%) or very high (16.4%). An inactive state was found in a small number of patients (9.4%). Twenty two (13.8%) patients had treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) in anamnesis, and 21 (13.2%) patients were still taking them.Conclusion. The results of the retrospective phase of the study show that in real-life clinical practice in the Russian Federation there is a continued positive trend towards improving the diagnosis of nr-axSpA. The median duration of the disease at the time of enrolment in the study was 3 years. 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引用次数: 0

摘要

NiSpAR是一项非介入性多中心研究,旨在描述俄罗斯联邦非放射学轴性脊柱关节炎(nr-axSpA)患者群及其诊断方法。研究涉及俄罗斯联邦不同地区的 20 个研究中心。研究包括两个阶段:研究入选前12个月的回顾性数据收集,以及对确诊为nr-axSpA的患者进行前瞻性观察(104周)。研究包括272名符合纳入和排除标准的患者(全分析集,FAS)。FAS人群的平均年龄为(38.7±11.0)岁。272 名患者中有 159 人(58.5%)确诊为 nr-axSpA。其余113人(41.5%)中,57人(50.4%)没有确诊所需的信息,34人(30.1%)没有骨盆X光片,22人(19.5%)不符合ASAS nr-axSpA标准。nr-axSpA 患者的平均年龄为(37.6±10.4)岁,其中一半以上(52.8%)为女性。中位病程为 36 [12; 80] 个月。半数患者的病程超过 2 年,超过三分之一的患者少于 2 年。CRP 和 ESR 的中位值分别为 5.0 [2.0; 12.0] mg/l 和 11.0 [5.0; 18.0] mm/h。BASDAI 平均值为 3.5±2.0,半数以上病例(64.2%)的 BASDAI 值大于 4。ASDAS-CRP 平均值为 2.6±1.1。每 5 名参与者中只有 1 人(20.8%)的 axSpA 活性较低,而 61.1% 的参与者的 axSpA 活性较高(44.7%)或非常高(16.4%)。少数患者(9.4%)处于非活动状态。22例(13.8%)患者在病史中接受过生物改良抗风湿药(bDMARDs)治疗,21例(13.2%)患者仍在服用这些药物。回顾性阶段的研究结果表明,在俄罗斯联邦的实际临床实践中,改善 nr-axSpA 诊断的积极趋势仍在继续。参加研究时的中位病程为 3 年。磁共振成像的使用频率增加了1.8倍以上。与此同时,医生在确定 nr-axSpA 的诊断方面仍然存在困难,而且用于治疗这些患者的 bDMARDs 药物短缺。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Results of a non-interventional multicenter study of management of patients with non-radiological axial spondyloarthritis in real-life clinical practice in the Russian Federation (NiSpAR)
NiSpAR is a non-interventional, multicenter study whose aim was to describe a cohort of patients with non-radiological axial spondyloarthritis (nr-axSpA) and approaches to its diagnosis in the Russian Federation.Material and methods. The study involved 20 research centers in different regions of the Russian Federation. The work consisted of two phases: retrospective data collection 12 months before enrolment in the study and prospective observation of patients in whom the diagnosis of nr-axSpA was confirmed (104 weeks).The study included 272 patients who met the inclusion and exclusion criteria (Full Analysis Set, FAS). The mean age of the FAS-population was 38.7±11.0 years. The diagnosis of nr-axSpA was confirmed in 159 (58.5 %) of the 272 patients. Of the remaining 113 (41.5%) participants, 57 (50.4%) did not have the information required to confirm the diagnosis, 34 (30.1%) did not have pelvic radiographs, and 22 (19.5%) did not fulfil the ASAS criteria for nr-axSpA.Results and discussion. The mean age of patients with nr-axSpA was 37.6±10.4 years, more than half of them (52.8%) were women. The median disease duration was 36 [12; 80] months. In half of the patients the disease duration was more than 2 years, in more than one third – less than 2 years. The median CRP and ESR values were 5.0 [2.0; 12.0] mg/l and 11.0 [5.0; 18.0] mm/h, respectively. The BASDAI averaged 3.5±2.0 and was >4 in more than half of the cases (64.2%). The mean ASDAS-CRP value reached 2.6±1.1. Only 1 in 5 participants (20.8%) had low axSpA activity, while in 61.1% it was high (44.7%) or very high (16.4%). An inactive state was found in a small number of patients (9.4%). Twenty two (13.8%) patients had treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) in anamnesis, and 21 (13.2%) patients were still taking them.Conclusion. The results of the retrospective phase of the study show that in real-life clinical practice in the Russian Federation there is a continued positive trend towards improving the diagnosis of nr-axSpA. The median duration of the disease at the time of enrolment in the study was 3 years. The frequency of use of magnetic resonance imaging has increased by more than 1.8 times. At the same time, practitioners still have difficulties in establishing the diagnosis of nr-axSpA and a shortage of bDMARDs for treatment of these patients.
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