Department of Rheumatology, Puyang Oilfield General Hospital, Puyang, China.
Department of Radiology, Shenzhen Futian Hospital for Rheumatic Diseases, Shenzhen, China.
Int J Rheum Dis. 2024 Sep;27(9):e15319. doi: 10.1111/1756-185X.15319.
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.
探索甲氨蝶呤（MTX）联合羟氯喹（HCQ）与 MTX 单药治疗类风湿关节炎（RA）患者的疗效和安全性。
将 60 例无 RA 既往治疗的患者随机分为两组，每组 30 例，一组给予 MTX 联合 HCQ，另一组给予 MTX 单药治疗。我们在 12 周试验前后进行了比较分析，评估视觉模拟量表（VAS）、28 个关节疾病活动度评分（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表问卷（WHOQOL-BREF）的结果和所有研究参与者的治疗中出现的不良事件（TEAEs）。
在试验的第 12 周，可以观察到联合治疗组疼痛评分（VAS）、疾病活动度评分（DAS）和血清炎症因子水平下降更明显。MTX + HCQ 组的生活质量评分也高于 MTX 单药组。MTX + HCQ 组和 MTX 单药组不良反应发生率分别为 10.00%和 6.67%，但差异无统计学意义（p>0.05）。
在我们的研究中，MTX + HCQ 联合治疗和 MTX 单药治疗均能改善 RA 患者的症状、病情和生活质量。值得注意的是，联合治疗在所有指标上的疗效均优于 MTX 单药治疗，这表明其可能成为 RA 的最佳一线治疗。© 2024 亚太风湿病联盟和约翰威立父子公司。
