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[兔脊柱关节炎:一种用于轴性脊柱关节炎和银屑病关节炎的新疾病登记系统]

[RABBIT-SpA: a new disease register for axial spondyloarthritis and psoriatic arthritis].

作者信息

Regierer A C, Weiß A, Baraliakos X, Zink A, Listing J, Strangfeld A

机构信息

Programmbereich Epidemiologie, Deutsches Rheuma-Forschungszentrum Berlin, Charitéplatz 1, 10117, Berlin, Deutschland.

Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Bochum, Deutschland.

出版信息

Z Rheumatol. 2020 Mar;79(2):135-142. doi: 10.1007/s00393-019-0613-z.

Abstract

BACKGROUND

The treatment of axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) has changed enormously in recent years due to market authorization of a number of new biologicals with different modes of action and the increasing use of biosimilars. Real-world data on long-term safety and efficacy under routine daily conditions is not yet sufficient. Therefore, the German Rheumatism Research Center has initiated a new cohort study covering axSpA and PsA.

OBJECTIVE

Presentation of initial results from the new register RABBIT-SpA, which was started in May 2017.

MATERIAL AND METHODS

This is a prospective longitudinal cohort study with a similar study design to the German biologics register RABBIT. Patients can be included at the start of a new treatment either in the so-called index drug group or in the comparison group (conventional systemic treatment, including non-steroidal anti-inflammatory drugs, NSAID). Follow-up per patient should be at least 5 years and preferably 10 years. The RABBIT-SpA uses a web-based documentation system.

RESULTS

Up to mid-December 2018 a total of 514 axSpA patients had been documented in RABBIT-SpA, 410 with an index drug and 104 with conventional treatment. There are differences between these treatment groups, e. g. in the duration of the disease and in parameters of disease activity. It is also noticeable that in axSpA patients, approximately 5 years lie between the onset of the symptoms and confirmation of the diagnosis. Of the 355 PsA patients, 265 were included with an index drug and 90 with conventional treatment. Of the PsA patients 86% have a dominant peripheral manifestation. The average number of pressure tender joints is 8 and the average number of swollen joints is 4.

CONCLUSION

The online register RABBIT-SpA is well-received by the participating rheumatological institutions. The electronic recording of patient data can be carried out in a reasonable time. Participation in the RABBIT-SpA is open to new rheumatological institutions at any time.

摘要

背景

近年来,由于多种具有不同作用方式的新型生物制剂获得上市许可以及生物类似药的使用日益增加,中轴型脊柱关节炎(axSpA)和银屑病关节炎(PsA)的治疗发生了巨大变化。关于日常常规条件下长期安全性和有效性的真实世界数据尚不充分。因此,德国风湿病研究中心启动了一项涵盖axSpA和PsA的新队列研究。

目的

介绍2017年5月启动的新登记册RABBIT-SpA的初步结果。

材料与方法

这是一项前瞻性纵向队列研究,研究设计与德国生物制剂登记册RABBIT相似。患者可在新治疗开始时纳入所谓的索引药物组或对照组(传统全身治疗,包括非甾体抗炎药,NSAID)。每位患者的随访时间应至少为5年,最好为10年。RABBIT-SpA使用基于网络的文档系统。

结果

截至2018年12月中旬,RABBIT-SpA共记录了514例axSpA患者,其中410例使用索引药物治疗,104例接受传统治疗。这些治疗组之间存在差异,例如疾病持续时间和疾病活动参数方面。同样值得注意的是,axSpA患者从症状出现到确诊大约间隔5年。在355例PsA患者中,265例使用索引药物治疗,90例接受传统治疗。PsA患者中86%有主要的外周表现。压痛关节的平均数量为8个,肿胀关节的平均数量为4个。

结论

在线登记册RABBIT-SpA受到参与的风湿病机构的好评。患者数据的电子记录可在合理时间内完成。新的风湿病机构可随时参与RABBIT-SpA。

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