探讨甲氨蝶呤 (MTX) 加羟氯喹 (HCQ) 联合治疗与 MTX 单药治疗类风湿性关节炎 (RA) 患者的疗效和安全性。将 60 名既往未接受过 RA 治疗的患者按 1:1 的比例随机分为两组：一个接受 MTX 加 HCQ，另一个接受 MTX 单药治疗。我们在12周试验前后进行了比较分析，评估了视觉模拟评分（VAS）、28个关节的疾病活动评分（DAS）、血清炎症因子（包括血清C反应蛋白（CRP）、红细胞沉降）率（ESR）、白细胞介素6（IL-6）、肿瘤坏死因子-α（TNF-α），以及世界卫生组织生活质量简明版问卷（WHOQOL-BREF）的结果和治疗紧急情况研究中所有参与者的不良事件（TEAE）。在试验第 12 周，可以注意到受试者的疼痛评分（VAS）、疾病活动评分（DAS）和血清炎症因子水平有更显着的下降。 MTX  HCQ 组的生活质量评分也高于 MTX 单药治疗组，MTX  HCQ 组和 MTX 单药治疗组的不良反应发生率分别为 10.00% 和 6.67%。然而，没有观察到统计学显着性（p > .05）。在我们的研究中，MTX  HCQ 联合疗法和 MTX 单药疗法均显示 RA 患者的症状、病情和生活质量有所改善。值得注意的是，与 MTX 单药治疗相比，联合治疗在所有指标上都能取得更好的结果，凸显了其作为 RA 最佳一线治疗的潜力。 © 2024 亚太风湿病协会联盟和 John Wiley

To explore the efficacy and safety of combination therapy with methotrexate (MTX) plus hydroxychloroquine (HCQ) vs. MTX monotherapy in patients with rheumatoid arthritis (RA).Sixty patients without prior RA treatments were randomly allocated in a 1:1 ratio to two groups: one receiving MTX plus HCQ, and the other receiving MTX monotherapy. We conducted a comparative analysis before and after the 12-week trial, evaluating the visual analogue scale (VAS), the disease activity score in 28 joints (DAS), serum inflammatory factor (including serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), as well as the outcome of the World Health Organization Quality of Life Brief Version questionnaire (WHOQOL-BREF) and the treatment-emergent adverse events (TEAEs) for all the participants in the study.At the 12th week of the trial, a more remarkable decrease in pain score (VAS), disease activity score (DAS), and serum inflammatory factor levels could be noticed in individuals on the combination therapy. The quality of life score was as well found to be higher in the MTX + HCQ group than the MTX monotherapy group. The incidence of adverse reactions in the MTX + HCQ and the MTX monotherapy groups were 10.00% and 6.67%, respectively. However, no statistical significance could be observed (p > .05).In our study, both the MTX + HCQ combination therapy and MTX monotherapy demonstrated improvements in symptoms, conditions and quality of life for patients with RA. Notably, the combination therapy could achieve better outcomes across all indices compared to MTX monotherapy, highlighting its potential as the optimal first-line treatment for RA. © 2024 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.© 2024 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.