Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial.
Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial.
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DOI：
10.7326/0003-4819-151-4-200908180-00005
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发表时间：
2009-08-18
影响因子：
39.2
通讯作者：
Lipsky PE
中科院分区：
文献类型：
--
作者：
Goldbach-Mansky R;Wilson M;Fleischmann R;Olsen N;Silverfield J;Kempf P;Kivitz A;Sherrer Y;Pucino F;Csako G;Costello R;Pham TH;Snyder C;van der Heijde D;Tao X;Wesley R;Lipsky PE
药用植物雷公藤的提取物在中国已经使用了几个世纪，用于治疗一系列炎症性疾病。比较雷公藤提取物与柳氮磺胺吡啶治疗活动性类风湿关节炎的疗效和副作用。随机对照试验。使用具有随机排列区组的计算机生成代码分配治疗。2个美国学术中心（位于马里兰州贝塞斯达的国立卫生研究院和位于德克萨斯州达拉斯的德克萨斯大学）和9个风湿病学专科诊所（位于德克萨斯州达拉斯和奥斯汀、佛罗里达州坦帕和劳德代尔堡、弗吉尼亚州阿灵顿、宾夕法尼亚州邓肯维尔、马里兰州惠顿和绿地以及密歇根州兰辛）。121例活动性类风湿关节炎和6个或更多关节疼痛和肿胀的患者。TwHF提取物，60 mg，每日3次，或柳氮磺胺吡啶，1 g，每日2次。患者可以继续使用稳定剂量的口服泼尼松或非甾体抗炎药，但必须在随机化前至少28天停止服用病情缓解抗风湿药。主要结局是24周时美国流变学学会标准（ACR 20）改善20%的实现率。次要终点是安全性;关节损伤的放射学评分;白细胞介素-6、胆固醇、皮质醇和促肾上腺皮质激素的血清水平。在24周时，仅62例患者的结局数据可用。在一项插补脱落患者数据的混合模型分析中，TwHF组65.0%（95% CI，51.6%-76.9%）和柳氮磺胺吡啶组32.8%（CI，21.3%-46.0%）符合ACR 20缓解标准（P = 0.001）。在混合模型分析中，接受TwHF的患者的ACR 50和ACR 70应答率也显著较高。仅完成者的分析显示治疗组之间存在相似的显著性差异。ACR反应的所有个体组成部分都有显著改善，包括健康评估问卷残疾评分。白细胞介素-6水平迅速和显着下降的TwHF组。虽然没有统计学意义，但TwHF组的放射学进展较低。两组不良事件的发生率相似。在24周的研究中，分别只有62%和41%的患者继续接受TwHF提取物和柳氮磺胺吡啶。未收集停止治疗的参与者的长期结局数据。在持续治疗24周并且还可以使用稳定的口服泼尼松和非甾体抗炎药的患者中，TwHF提取物达到ACR 20反应标准的程度显著高于柳氮磺胺吡啶。国家关节炎、肌肉骨骼和皮肤病研究所。
Extracts of the medicinal plant Tripterygium wilfordii Hook F (TwHF) have been used in China for centuries to treat a spectrum of inflammatory diseases. To compare the benefits and side effects of TwHF extract with those of sulfasalazine for the treatment of active rheumatoid arthritis. Randomized, controlled trial. A computer-generated code with random, permuted blocks was used to assign treatment. 2 U.S. academic centers (National Institutes of Health, Bethesda, Maryland, and University of Texas, Dallas, Texas) and 9 rheumatology subspecialty clinics (in Dallas and Austin, Texas; Tampa and Fort Lauderdale, Florida; Arlington, Virginia; Duncanville, Pennsylvania; Wheaton and Greenbelt, Maryland; and Lansing, Michigan). 121 patients with active rheumatoid arthritis and 6 or more painful and swollen joints. TwHF extract, 60 mg 3 times daily, or sulfasalazine, 1 g twice daily. Patients could continue stable doses of oral prednisone or nonsteroidal anti-inflammatory drugs but had to stop taking disease-modifying antirheumatic drugs at least 28 days before randomization. The primary outcome was the rate of achievement of 20% improvement in the American College of Rheumatology criteria (ACR 20) at 24 weeks. Secondary end points were safety; radiographic scores of joint damage; and serum levels of interleukin-6, cholesterol, cortisol, and adrenocorticotropic hormone. Outcome data were available for only 62 patients at 24 weeks. In a mixed-model analysis that imputed data for patients who dropped out, 65.0% (95% CI, 51.6% to 76.9%) of the TwHF group and 32.8% (CI, 21.3% to 46.0%) of the sulfasalazine group met the ACR 20 response criteria (P = 0.001). Patients receiving TwHF also had significantly higher response rates for ACR 50 and ACR 70 in mixed-model analyses. Analyses of only completers showed similar significant differences between the treatment groups. Significant improvement was demonstrated in all individual components of the ACR response, including the Health Assessment Questionnaire disability score. Interleukin-6 levels rapidly and significantly decreased in the TwHF group. Although not statistically significant, radiographic progression was lower in the TwHF group. The frequency of adverse events was similar in both groups. Only 62% and 41% of patients continued receiving TwHF extract and sulfasalazine, respectively, during the 24 weeks of the study. Long-term outcome data were not collected on participants who discontinued treatment. In patients who continued treatment for 24 weeks and could also use stable oral prednisone and nonsteroidal anti-inflammatory drugs, attainment of the ACR 20 response criteria was significantly greater with TwHF extract than with sulfasalazine. National Institute of Arthritis and Musculoskeletal and Skin Diseases.
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DOI：
10.1196/annals.1351.039
发表时间：
2006-01-01
期刊：
BASIC AND CLINICAL ASPECTS OF NEUROENDOCRINE IMMUNOLOGY IN RHEUMATIC DISEASES
影响因子：
--
作者：
Seriolo, Bruno;Paolino, Sabrina;Cutolo, Maurizio
通讯作者：
Cutolo, Maurizio
影响因子：
--
作者：
Cohen, Stanley B.;Emery, Paul;Totoritis, Mark C.
通讯作者：
Totoritis, Mark C.
影响因子：
--
作者：
REDELMEIER, DA;LORIG, K
通讯作者：
LORIG, K
影响因子：
4.8
作者：
Lee, KY;Chang, WT;Rosen, GD
通讯作者：
Rosen, GD
DOI：
10.1073/pnas.0700499104
发表时间：
2007-03-13
影响因子：
11.1
作者：
Leuenroth, Stephanie J.;Okuhara, Dayne;Crews, Craig M.
通讯作者：
Crews, Craig M.