Guang'anmen Hospital China Academy of Chinese Medical Sciences, Beijing, China.
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong, China.
Phytomedicine. 2022 Sep;104:154236. doi: 10.1016/j.phymed.2022.154236. Epub 2022 Jun 14.
Chinese medicine (CM) has become a popular interventional treatment for rheumatoid arthritis (RA). However, limited knowledge about general characteristics and long-term clinical outcomes hampers the development of CM for RA.
The main objectives of the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) were to describe the population of RA patients receiving CM treatment in multiple centers in China using different variables and compare these findings with internationally reported data.
The CERTAIN is a prospective, multicenter, observational disease registry.
Adult RA patients who fulfilled the 2010 American College of Rheumatology/ European League Against Rheumatism classification criteria for RA and received CM treatment were recruited into the CERTAIN by rheumatologists from 145 hospitals across 30 provinces in China. Data on demographics, disease characteristics, comorbidities, treatments, and adverse events, with a 2-year follow-up, were collected and documented using a predefined protocol.
In the 2 years since the study began in September 2019, 11,764 patients have been enrolled (enrolment is ongoing), and 13.10% of participants have completed the 6-month follow-up. We present the baseline characteristics of the first 11,764 enrollees.
The CERTAIN is the first nationwide registry to document comprehensive data on CM treatment in patients with RA. The development of the CERTAIN resource is a significant step forward for Chinese RA patients, herbal medicine users, and research communities and will deepen our understanding of CM for RA.
The study was registered at ClinicalTrials.gov (NCT05219214).
中医药已成为治疗类风湿关节炎（RA）的一种流行的介入治疗方法。然而，由于对一般特征和长期临床结果的了解有限，阻碍了中医药治疗 RA 的发展。
中国类风湿关节炎患者的中医药注册研究（CERTAIN）的主要目的是使用不同的变量描述在中国多个中心接受中医药治疗的 RA 患者人群，并将这些发现与国际报告的数据进行比较。
CERTAIN 是一项前瞻性、多中心、观察性疾病登记研究。
符合 2010 年美国风湿病学会/欧洲抗风湿病联盟 RA 分类标准的成年 RA 患者，并接受中医药治疗，由中国 30 个省 145 家医院的风湿病学家招募到 CERTAIN 中。使用预定义的方案收集并记录人口统计学、疾病特征、合并症、治疗和不良事件的数据，并进行为期 2 年的随访。
自 2019 年 9 月研究开始以来的 2 年中，已经招募了 11764 名患者（招募仍在进行中），有 13.10%的参与者完成了 6 个月的随访。我们介绍了前 11764 名入组患者的基线特征。
CERTAIN 是第一个记录 RA 患者中医药治疗综合数据的全国性登记处。CERTAIN 资源的开发是中国 RA 患者、草药使用者和研究社区的重要一步，将加深我们对 RA 中医药的理解。
该研究在 ClinicalTrials.gov 上注册（NCT05219214）。
