Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study
Chinese Herbal Formula Huayu-Qiangshen-Tongbi Decoction Compared With Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis: An Open-Label, Randomized, Controlled, Pilot Study
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中药化瘀强肾通痹汤与来氟米特联合甲氨蝶呤治疗活动性类风湿性关节炎的比较：一项开放、随机、对照的初步研究
DOI：
10.3389/fmed.2020.00484
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发表时间：
2020-09-04
影响因子：
3.9
通讯作者：
Huang，Runyue
中科院分区：
文献类型：
--
作者：
Wu，Jiaqi;Chen，Xianghong;Huang，Runyue
背景：中医是现代医学的补充和替代。中国在类风湿性关节炎(RA)的治疗中逐渐广泛采用中药制剂与抗风湿药物的联合治疗。目的：观察化瘀强肾通闭汤联合甲氨蝶呤(MTX)治疗活动期类风湿关节炎(RA)的疗效和安全性，并与MTX联合来氟米特(LEF)治疗进行比较。方法：这项先导性研究是一项单中心、开放标签、随机对照试验，有两个平行的手臂。90例活动期RA患者随机分为两组，HQT每日2次，每次250毫升，LEF每日1次，每次20毫克，MTX每周1次，每次10-15毫克。主要疗效终点是在治疗24周后在美国风湿病学会标准(ACR20)中获得20%改善的患者的比例。结果：84.4%(76/90)的患者完成了24周的观察。在意向处理分析中，符合ACR20标准的百分比值分别为72.1%(31/43)和74.4%(32/43)(p=0.808)。ACR50、ACR70、临床疾病活动性指数良好反应、欧洲风湿病联盟良好反应、缓解率、疾病低活动率等其他指标均无显著差异。按方案分析的结果与意向处理分析的结果一致。两组24周时van der Heijde改良总评分为3·59±4·75和1·34±8·67，两组比较差异无统计学意义(P=0.613)。两组不良事件发生率相似(MTX+HQT组11例，MTX+LEF组17例，p>；0.05)。结论：在活动期RA患者中，HQT和MTX的联合治疗与体征、症状和身体功能的改善有关。HQT或其他中药方剂联合MTX治疗类风湿关节炎具有良好的临床疗效和可接受的耐受性，是较好的治疗方案。试验注册：中国临床试验注册中心，CHICCTR-INR-16009031,2016年8月15日注册，http://www.chictr.org.cn/enindex.aspx.
Background: Traditional Chinese Medicine is complementary and an alternative to modern medicine. The combination therapies of herbal products with disease-modifying anti-rheumatic drugs are gradually and widely adopted in the management of rheumatoid arthritis (RA) in China. Purpose: To evaluate the efficacy and safety of Huayu-Qiangshen-Tongbi (HQT) decoction, a Chinese medicine formula, combined with methotrexate (MTX) in the treatment of patients with active RA, in comparison with the combination therapy of MTX with leflunomide (LEF). Methods: This pilot study was a monocenter, open-label, randomized controlled trial with two parallel arms. Ninety patients with active RA were randomly allocated to receive either HQT at a dose of 250 ml twice daily or LEF at a dose of 20 mg once daily, and all participants received MTX at a dose of 10–15 mg once weekly. The primary efficacy endpoint was the proportion of patients who achieved a 20% improvement in the American College of Rheumatology criteria (ACR20) after a 24-week treatment. Results: 84.4% (76/90) patients completed the 24-week observation. In the intention-to-treat analysis, the percentage values of patients achieving the ACR20 response criteria were 72.1% (31/43) in MTX + HQT group and 74.4% (32/43) in MTX + LEF group (p = 0.808). No significant difference was observed in other parameters, including ACR50, ACR70, clinical disease activity index good responses, European League Against Rheumatism good response, remission rate, and low disease activity rate. The results of the per-protocol analysis showed consistency with those of the intention-to-treat analysis. The mean change from baseline at week 24 for the van der Heijde modified total sharp score had no significant difference between two groups (3.59 ± 4.75 and 1.34 ± 8.67 in the MTX + HQT group and MTX + LEF group, respectively, p = 0.613). The frequency of adverse events was similar in both groups (11 cases in the MTX + HQT and 17 cases in the MTX + LEF, p > 0.05). Conclusions: In patients with active RA, treatment with the combination of HQT and MTX was associated with improvement in signs, symptoms, and physical function. With a beneficial clinical response and acceptable tolerability, HQT or other Chinese medicine formula may be a good therapeutic option in combination with MTX for RA treatment. Trial registration: Chinese Clinical Trails Registry, ChiCTR-INR-16009031, Registered on 15th August 2016, http://www.chictr.org.cn/enindex.aspx.