Yao Chuan-Hui, Zhang Chi, Song Meng-Ge, Xia Cong-Min, Chang Tian, Ma Xie-Li, Liu Wei-Xiang, Liu Zi-Xia, Liu Jia-Meng, Tang Xiao-Po, Liu Ying, Liu Jian, Peng Jiang-Yun, He Dong-Yi, Huang Qing-Chun, Gao Ming-Li, Yu Jian-Ping, Liu Wei, Zhang Jian-Yong, Zhu Yue-Lan, Hou Xiu-Juan, Wang Hai-Dong, Fang Yong-Fei, Wang Yue, Su Yin, Tian Xin-Ping, Lyu Ai-Ping, Gong Xun, Jiang Quan
Department of Rheumatology and Immunology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Department of Internal Medicine, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100007, China.
Chin J Integr Med. 2025 Jul;31(7):581-589. doi: 10.1007/s11655-025-4212-3. Epub 2025 Jun 24.
To evaluate the dynamic changes of glucocorticoid (GC) dose and the feasibility of GC discontinuation in rheumatoid arthritis (RA) patients under the background of Chinese medicine (CM).
This multicenter retrospective cohort study included 1,196 RA patients enrolled in the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) from September 1, 2019 to December 4, 2023, who initiated GC therapy. Participants were divided into the Western medicine (WM) and integrative medicine (IM, combination of CM and WM) groups based on medication regimen. Follow-up was performed at least every 3 months to assess dynamic changes in GC dose. Changes in GC dose were analyzed by generalized estimator equation, the probability of GC discontinuation was assessed using Kaplan-Meier curve, and predictors of GC discontinuation were analyzed by Cox regression. Patients with <12 months of follow-up were excluded for the sensitivity analysis.
Among 1,196 patients (85.4% female; median age 56.4 years), 880 (73.6%) received IM. Over a median 12-month follow-up, 34.3% (410 cases) discontinued GC, with significantly higher rates in the IM group (40.8% vs. 16.1% in WM; P<0.05). GC dose declined progressively, with IM patients demonstrating faster reductions (median 3.75 mg vs. 5.00 mg in WM at 12 months; P<0.05). Multivariate Cox analysis identified age <60 years [P<0.001, hazard ratios (HR)=2.142, 95% confidence interval (CI): 1.523-3.012], IM therapy (P=0.001, HR=2.175, 95% CI: 1.369-3.456), baseline GC dose ⩽7.5 mg (P=0.003, HR=1.637, 95% CI: 1.177-2.275), and absence of non-steroidal anti-inflammatory drugs use (P=0.001, HR=2.546, 95% CI: 1.432-4.527) as significant predictors of GC discontinuation. Sensitivity analysis (545 cases) confirmed these findings.
RA patients receiving CM face difficulties in following guideline-recommended GC discontinuation protocols. IM can promote GC discontinuation and is a promising strategy to reduce GC dependency in RA management. (Trial registration: ClinicalTrials.gov, No. NCT05219214).
评估在中医药背景下类风湿关节炎（RA）患者糖皮质激素（GC）剂量的动态变化以及停用GC的可行性。
这项多中心回顾性队列研究纳入了2019年9月1日至2023年12月4日在中国类风湿关节炎患者中医药登记系统（CERTAIN）中开始接受GC治疗的1196例RA患者。根据用药方案将参与者分为西药（WM）组和中西医结合（IM，中医与西医结合）组。至少每3个月进行一次随访，以评估GC剂量的动态变化。采用广义估计方程分析GC剂量的变化，使用Kaplan-Meier曲线评估GC停用的概率，并通过Cox回归分析GC停用的预测因素。对随访时间<12个月的患者进行敏感性分析时将其排除。
在1196例患者中（女性占85.4%；中位年龄56.4岁），880例（73.6%）接受了中西医结合治疗。在中位12个月的随访期内，34.3%（410例）停用了GC，中西医结合组的停用率显著更高（40.8% vs. 西药组的16.1%；P<0.05）。GC剂量逐渐下降，中西医结合组患者的下降速度更快（12个月时中位剂量为3.75 mg vs. 西药组的5.00 mg；P<0.05）。多变量Cox分析确定年龄<60岁[P<0.001，风险比（HR）=2.142，95%置信区间（CI）：1.523 - 3.012]、中西医结合治疗（P=0.001，HR=2.175，95% CI：1.369 - 3.456）、基线GC剂量⩽7.5 mg（P=0.003，HR=1.637，95% CI：1.177 - 2.275）以及未使用非甾体抗炎药（P=0.001，HR=2.546，95% CI：1.432 - 4.527）是GC停用的显著预测因素。敏感性分析（545例）证实了这些发现。
接受中医药治疗的RA患者在遵循指南推荐的GC停用方案方面存在困难。中西医结合治疗可促进GC停用，是类风湿关节炎管理中减少GC依赖的一种有前景的策略。（试验注册号：ClinicalTrials.gov，编号NCT05219214）
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