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【drug-news】美国《内科学年鉴》2009年8月18日版发
ARTICLE
Comparison of Tripterygium wilfordii Hook F Versus Sulfasalazine in the Treatment of Rheumatoid Arthritis
A Randomized Trial
right arrow Raphaela Goldbach-Mansky, MD, MHS; Mildred Wilson, RN; Roy Fleischmann, MD; Nancy Olsen, MD; Joel Silverfield, MD; Phillip Kempf, MD; Alan Kivitz, MD; Yvonne Sherrer, MD; Frank Pucino, PharmD; Gyorgy Csako, MD; Rene Costello, BS; Tuyet Hang Pham, MT; Christopher Snyder, BS; Désirée van der Heijde, MD; Xuelian Tao, MD; Robert Wesley, PhD; and Peter E. Lipsky, MD
18 August 2009 | Volume 151 Issue 4 | Pages 229-240
[b]Background:[/b]
Extracts of the medicinal plant Tripterygium wilfordii Hook F (TwHF) have been used in China for centuries to treat a spectrum of inflammatory diseases.
Objective: To compare the benefits and side effects of TwHF extract with those of sulfasalazine for the treatment of active rheumatoid arthritis.
[b]Design:[/b]
Randomized, controlled trial. A computer-generated code with random, permuted blocks was used to assign treatment.
[b]Setting:[/b]
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).
[b]Patients: [/b]
121 patients with active rheumatoid arthritis and 6 or more painful and swollen joints.
[b]Intervention: [/b]
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.
[b]Measurements: [/b]
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.
[b]Results:[/b]
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.
[b]Limitations: [/b]
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.
[b]Conclusion:[/b]
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.
Primary Funding Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases. Editors' Notes
Context
* In Chinese medicine, extracts of Tripterygium wilfordii Hook F (TwHF, known as "lei gong teng" or "thunder god vine") are used to treat autoimmune and inflammatory conditions. Small clinical trials suggest that TwHF may benefit patients with rheumatoid arthritis.
Contribution
* This trial compared TwHF extract with sulfasalazine in 121 patients with active rheumatoid arthritis who could continue oral prednisone and nonsteroidal anti-inflammatory drugs but not disease-modifying antirheumatic drugs. Among patients who continued treatment for 24 weeks, achievement of 20% improvement in American College of Rheumatology criteria was greater with TwHF than with sulfasalazine. Adverse event rates were similar.
Caution
* Only 62% and 41% of patients continued TwHF and sulfasalazine treatment, respectively, and provided 24 weeks of data.
—The Editors
Author and Article Information
From the National Institute of Arthritis and Musculoskeletal and Skin Diseases and Clinical Center, National Institutes of Health, U.S. Department of Health and Human Services, Bethesda, Maryland; Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas; Tampa Medical Group, Tampa, and Arthritis Center, Fort Lauderdale, Florida; Arthritis Clinic of Northern Virginia, Arlington, Virginia, Altoona Center for Clinical Research, Duncanville, Pennsylvania; and Leiden University Medical Center, Leiden, the Netherlands.
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作者:admin@医学,生命科学 2010-10-31 05:11
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