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KOBIO,首个基于网络的韩国生物制品注册库,在不同疾病实体间通过统一平台运行。

KOBIO, the First Web-based Korean Biologics Registry Operated With a Unified Platform Among Distinct Disease Entities.

作者信息

Kim Jinhyun, Koh Jung Hee, Choi Sung Jae, Jeon Chan Hong, Kwok Seung-Ki, Kim Seong-Kyu, Choi Chan-Bum, Lee Jaejoon, Lee Changhoon, Nam Eon Jeong, Park Yong-Beom, Lee Shin-Seok, Kim Tae-Hwan, Park Sung-Hwan, Koh Eun-Mi, Yoo Dae-Hyun, Song Yeong Wook, Kim Hyoun-Ah, Shin Kichul

机构信息

Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.

Division of Rheumatology, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

出版信息

J Rheum Dis. 2021 Oct 1;28(4):176-182. doi: 10.4078/jrd.2021.28.4.176.

Abstract

The KOrean College of Rheumatology BIOlogics and targeted therapy (KOBIO) registry is a nationwide observational cohort that captures detailed data on exposure of patients to biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). This registry was launched in December 2012 with an aim to prospectively investigate clinical manifestations and outcomes of patients with rheumatoid arthritis (RA), ankylosing spondylitis, and psoriatic arthritis who initiated a biologic or targeted synthetic DMARD or switched to another. Demographic data, disease activity, current treatment, adverse events, terms based on Medical Dictionary for Regulatory Activities, and so on are registered for patients who are then followed up annually in a web-based unified platform. The KOBIO registry also recruits and collects data of patients with RA on conventional DMARDs for comparison. As of today, more than 5,500 patients were enrolled from 47 academic and community Rheumatology centers across Korea. The KOBIO registry has evolved to become a powerful database for clinical research to improve clinical outcomes and quality of treatment.

摘要

韩国风湿病学会生物制剂与靶向治疗(KOBIO)注册库是一项全国性观察性队列研究,收集了患者使用生物制剂和靶向合成改善病情抗风湿药(DMARDs)的详细数据。该注册库于2012年12月启动,旨在前瞻性研究类风湿关节炎(RA)、强直性脊柱炎和银屑病关节炎患者开始使用生物制剂或靶向合成DMARDs或换药后的临床表现及转归。为在基于网络的统一平台上每年进行随访的患者登记人口统计学数据、疾病活动度、当前治疗、不良事件、基于监管活动医学词典的术语等。KOBIO注册库还招募并收集RA患者使用传统DMARDs的数据以作比较。截至目前,韩国47个学术和社区风湿病中心已招募了5500多名患者。KOBIO注册库已发展成为一个强大的临床研究数据库,以改善临床疗效和治疗质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5ca/10324910/4db27f687528/jrd-28-4-176-f1.jpg

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