Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

1. Study Overview Rheumatoid arthritis (RA) is an autoimmune disease primarily characterized by erosive arthritis. Under the guidance of Traditional Chinese Medicine (TCM) syndrome differentiation theory, integrated treatment with TCM and Western medicine has demonstrated significant clinical benefits in managing difficult-to-treat RA (D2T RA) and RA-associated interstitial lung disease (RA-ILD). However, the biological association between RA phenotypes and TCM syndromes remains unclear, and the modern medical material basis of the "disease-syndrome-symptom" framework requires further elucidation. Therefore, employing a "disease-syndrome combination" approach to identify key biomarkers and core syndromes in RA pathogenesis, and to clarify the advantages of integrated treatment strategies, will provide a theoretical foundation for systematic research on RA diagnosis and treatment laws in integrated medicine.

Building upon previous research, this study will enroll at least 10,000 patients in a multicenter cohort receiving integrated TCM and Western medicine treatment for RA, including no less than 1,000 patients with D2T RA and no less than 1,000 patients with RA-ILD. Data to be collected include TCM syndrome characteristics, clinical profiles, treatment regimens, adverse drug reactions, biological samples, complications, and follow-up information. Through systematic data collection and analysis, the study aims to establish a multicenter research cohort biobank and clinical database for integrated RA treatment. By summarizing clinical diagnosis and treatment patterns and integrating multi-omics research data, the study will further explore the modern scientific material basis of D2T RA and RA-ILD within the "disease-syndrome-symptom" framework. The research will focus on elucidating the advantages and patterns of TCM syndrome-based treatment in RA and establishing a scientific, standardized efficacy evaluation system. This study is expected to provide scientific evidence for integrated TCM and Western medicine treatment of RA, validate the unique efficacy of TCM in RA management, offer practical references for clinical practice, provide important theoretical support and practical basis for improving the overall level of RA prevention and treatment in China, and promote the standardization and normalization of integrated RA treatment. 2. Study Objectives and Content 2.1 Study Objectives Currently, the biological association between RA phenotypes and TCM syndromes remains unclear, and the modern medical material basis of the "disease-syndrome-symptom" framework requires further elucidation. Therefore, this study aims to observe the effectiveness and safety of integrated TCM and Western medicine in the clinical treatment of RA, establish an RA clinical information database and biobank, employ a "disease-syndrome combination" approach to explore key biomarkers and core syndromes in RA pathogenesis, identify optimal integrated treatment strategies, and subsequently develop a scientific and standardized efficacy evaluation system.

2.2 Study Content

This study will collect data from a multicenter cohort of 10,000 patients receiving integrated TCM and Western medicine treatment for RA, including at least 1,000 patients with D2T RA and at least 1,000 patients with RA-ILD. The main research components include the following:

Collection of patient clinical data: Including TCM syndrome characteristics, treatment regimens, adverse drug reactions, complications, and follow-up status.