Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Rheumatology, Affiliated Hospital of Inner Mongolia Medical College, Huhhot, China.
Ann Rheum Dis. 2015 Jun;74(6):1078-86. doi: 10.1136/annrheumdis-2013-204807. Epub 2014 Apr 14.
To compare the efficacy and safety of Tripterygium wilfordii Hook F (TwHF) with methotrexate (MTX) in the treatment of active rheumatoid arthritis (RA).
Design: a multicentre, open-label, randomised controlled trial. All patients were assessed by trained investigators who were unaware of the therapeutic regimen.
207 patients with active RA were randomly allocated (1:1:1) to treatment with MTX 12.5 mg once a week, or TwHF 20 mg three times a day, or the two in combination. At week 12, if reduction of the 28-joint count Disease Activity Score (DAS28) was <30% in the monotherapy groups, the patient was switched to MTX+TwHF. The primary efficacy point was the proportion of patients achieving an American College of Rheumatology (ACR) 50 response at week 24.
174/207 (84.1%) patients completed 24 weeks of the trial. In an intention-to-treat analysis, the proportion of patients reaching the ACR50 response criteria was 46.4% (32/69), 55.1% (38/69) and 76.8% (53/69), respectively, in the MTX, TwHF and MTX+TwHF groups (TwHF vs MTX monotherapy, p=0.014; MTX+TwHF vs MTX monotherapy, p<0.001). Similar statistically significant patterns at week 24 were found for ACR20, ACR70, clinical Disease Activity Index good responses, EULAR good response, remission rate and low disease activity rate. Significant improvement in the Health Assessment Questionnaire and 36-item Short-Form Health Survey questionnaire scores from baseline to week 24 was seen in each treatment arm (p<0.05), though no significant difference was found among the treatment arms (p>0.05). The result of per-protocol analysis agreed with that seen in the intention-to-treat analysis. Seven, three and five women in the TwHF, MTX and combination groups, respectively, developed irregular menstruation (TwHF vs MTX monotherapy, p=0.216).
TwHF monotherapy was not inferior to, and MTX+TwHF was better than, MTX monotherapy in controlling disease activity in patients with active RA.
NCT01613079.
比较雷公藤多苷（TwHF）与甲氨蝶呤（MTX）治疗活动期类风湿关节炎（RA）的疗效和安全性。
设计：多中心、开放标签、随机对照试验。所有患者均由接受过培训的研究人员进行评估，这些研究人员对治疗方案不知情。
207 例活动期 RA 患者随机（1:1:1）分为 MTX 12.5mg 每周 1 次组、TwHF 20mg 每日 3 次组或两药联合组。在第 12 周，如果单药治疗组 28 个关节疾病活动度评分（DAS28）降低<30%，则患者转为 MTX+TwHF 治疗。主要疗效终点为第 24 周达到美国风湿病学会（ACR）50 缓解的患者比例。
207 例患者中有 174 例（84.1%）完成了 24 周的试验。意向性治疗分析显示，MTX、TwHF 和 MTX+TwHF 组分别有 46.4%（32/69）、55.1%（38/69）和 76.8%（53/69）的患者达到 ACR50 缓解标准（TwHF 与 MTX 单药治疗比较，p=0.014；MTX+TwHF 与 MTX 单药治疗比较，p<0.001）。第 24 周时，ACR20、ACR70、临床疾病活动指数良好反应、EULAR 良好反应、缓解率和低疾病活动率也存在类似的统计学显著差异。每个治疗组在基线至第 24 周时健康评估问卷和 36 项简短健康调查问卷评分均有显著改善（p<0.05），但治疗组间无显著差异（p>0.05）。方案分析的结果与意向性治疗分析的结果一致。TwHF、MTX 和联合组分别有 7、3 和 5 名女性出现月经不规则（TwHF 与 MTX 单药治疗比较，p=0.216）。
TwHF 单药治疗在控制活动期 RA 患者的疾病活动方面并不劣于 MTX+TwHF，且 MTX+TwHF 优于 MTX 单药治疗。
NCT01613079。
