Cyclophosphamide versus Placebo in Scleroderma Lung Disease
| Autor: | Edgar Arriola, Arthur C. Theodore, Robert W. Simms, Charlie Strange, Philip J. Clements, Virginia D. Steen, Naomi F. Rothfield, Kamal K. Mubarak, B. J. Fessler, M. Kari Connolly, Vivien Hsu, Mark L. Metersky, Fredrick M. Wigley, Jonathan G. Goldin, Daniel E. Furst, Ed Parsley, James R. Seibold, Barbara White, John Varga, Robert A. Wise, Richard M. Silver, Michael D. Roth, Charles A. Read, Jeffrey A. Golden, Dean E. Schraufnagel, Robert Elashoff, Maureen D. Mayes, Donald P. Tashkin, Mitchell A. Olman, Marcy B. Bolster, David J. Riley |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
Adult
Male medicine.medical_specialty Vital capacity Cyclophosphamide Vital Capacity Administration Oral Placebo Scleroderma Autoimmune Diseases Pulmonary function testing FEV1/FVC ratio Double-Blind Method Internal medicine medicine Humans Aged Aged 80 and over Scleroderma Systemic business.industry Respiratory disease Interstitial lung disease Leukopenia General Medicine Middle Aged medicine.disease Respiratory Function Tests respiratory tract diseases Surgery Treatment Outcome Regression Analysis Female Lung Diseases Interstitial business Bronchoalveolar Lavage Fluid Immunosuppressive Agents medicine.drug |
| Zdroj: | New England Journal of Medicine. 354:2655-2666 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa055120 |
| Popis: | BACKGROUND We conducted a double-blind, randomized, placebo-controlled trial to determine the effects of oral cyclophosphamide on lung function and health-related symptoms in patients with evidence of active alveolitis and scleroderma-related interstitial lung disease. METHODS At 13 clinical centers throughout the United States, we enrolled 158 patients with scleroderma, restrictive lung physiology, dyspnea, and evidence of inflammatory interstitial lung disease on examination of bronchoalveolar-lavage fluid, thoracic highresolution computed tomography, or both. Patients received oral cyclophosphamide (≤2 mg per kilogram of body weight per day) or matching placebo for one year and were followed for an additional year. Pulmonary function was assessed every three months during the first year, and the primary end point was the forced vital capacity (FVC, expressed as a percentage of the predicted value) at 12 months, after adjustment for the baseline FVC. RESULTS Of 158 patients, 145 completed at least six months of treatment and were included in the analysis. The mean absolute difference in adjusted 12-month FVC percent predicted between the cyclophosphamide and placebo groups was 2.53 percent (95 percent confidence interval, 0.28 to 4.79 percent), favoring cyclophosphamide (P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|