Efficacy and safety of methotrexate plus hydroxychloroquine combination therapy vs. methotrexate monotherapy in the treatment of rheumatoid arthritis: A randomized controlled clinical trial

IF 2 4区医学 Q2 RHEUMATOLOGY International Journal of Rheumatic Diseases Pub Date : 2024-09-02 DOI:10.1111/1756-185X.15319

Jiasheng Ma, Miaoyu Zeng, Chi-Jen Hsu, Dandan Li, Mei Na Fok, Yan Jiang, Qiaoqiao Li, Jie Ma, Jiaze Zhou, Brian Shiian Chen, Fengju Li

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Abstract

Objective

To explore the efficacy and safety of combination therapy with methotrexate (MTX) plus hydroxychloroquine (HCQ) vs. MTX monotherapy in patients with rheumatoid arthritis (RA).

Methods

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.

Results

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).

Conclusion

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.

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甲氨蝶呤加羟氯喹联合疗法与甲氨蝶呤单药治疗类风湿性关节炎的疗效和安全性对比：随机对照临床试验。

目的探讨类风湿性关节炎（RA）患者接受甲氨蝶呤（MTX）加羟氯喹（HCQ）联合疗法与MTX单药疗法的疗效和安全性：将 60 名未接受过 RA 治疗的患者按 1:1 的比例随机分配到两组：一组接受 MTX 加 HCQ 治疗，另一组接受 MTX 单药治疗。我们在为期 12 周的试验前后进行了对比分析，评估了视觉模拟量表（VAS）、28 个关节的疾病活动度评分（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）、血清 C 反应蛋白（CRP）、红细胞沉降率（ESR）和白细胞介素 6（IL-6））、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易版问卷调查（WHOQOL-BREF）的结果和所有参与者的治疗突发不良事件（TEAEs）。研究结果试验进行到第12周时，联合疗法患者的疼痛评分（VAS）、疾病活动评分（DAS）和血清炎症因子水平均有明显下降。MTX+HCQ组的生活质量评分也高于MTX单药治疗组。MTX+HCQ组和MTX单药组的不良反应发生率分别为10.00%和6.67%。结论：在我们的研究中，MTX+HCQ组和MTX单药组的不良反应发生率分别为10.00%和6.67%：在我们的研究中，MTX + HCQ 联合疗法和 MTX 单药疗法都能改善 RA 患者的症状、病情和生活质量。值得注意的是，与MTX单药治疗相比，联合疗法在所有指标上都能取得更好的疗效，这凸显了其作为RA最佳一线治疗方法的潜力。© 2024 亚太风湿病学协会联盟和澳大利亚约翰威利父子有限公司版权所有。

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来源期刊

International Journal of Rheumatic Diseases RHEUMATOLOGY-

CiteScore

3.70

自引率

4.00%

发文量

362

审稿时长

1 months

期刊介绍： The International Journal of Rheumatic Diseases (formerly APLAR Journal of Rheumatology) is the official journal of the Asia Pacific League of Associations for Rheumatology. The Journal accepts original articles on clinical or experimental research pertinent to the rheumatic diseases, work on connective tissue diseases and other immune and allergic disorders. The acceptance criteria for all papers are the quality and originality of the research and its significance to our readership. Except where otherwise stated, manuscripts are peer reviewed by two anonymous reviewers and the Editor.