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Efficacy of intravenous cyclosporin in moderately severe ulcerative colitis refractory to steroids
Authors:Message Laurent  Bourreille Arnaud  Laharie David  Quinton André  Galmiche Jean-Paul  Lamouliatte Hervé  Alamdari Afchine  Zerbib Frank
Affiliation:1. Infectious Diseases and Tropical Medicine Research Center, Resistant Tuberculosis Institute, Zahedan University of Medical Sciences, Zahedan, Iran;2. Department of Parasitology and Mycology, Faculty of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran;3. Management & Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran;4. Department of Parasitology and Mycology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran;5. Cutaneous Leishmaniasis Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran;6. Department of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran;1. Instituto de Química, Universidade Federal de Uberlândia, Av. João Naves de Ávila, 2121, Campus Santa Mônica, Uberlândia, MG 38400-902, Brazil;2. Instituto Ciências Exatas e da Terra, Universidade Federal de Mato Grosso, Pontal do Araguaia, MT, Brazil;3. Faculdade de Ciências Farmacêuticas, Universidade Estadual Paulista, Campus Araraquara, Araraquara, SP, Brazil;4. Departamento de Química, Universidade Federal de Juiz de Fora, Campus Martelos, Juiz de Fora, MG, Brazil;5. Instituto de Biotecnologia, Universidade Federal de Uberlândia, Uberlândia, MG, Brazil
Abstract:OBJECTIVE: The efficacy of intravenous cyclosporin (CSA) in acute severe ulcerative colitis (UC) is well established. The aim of this study was to evaluate its efficacy in moderately severe colitis refractory to steroids. METHODS: Twenty-six patients (17 men, mean age 41 +/- 14 yr) with UC refractory to steroids treated with CSA were included in this study. Severity was defined according to Truelove criteria. A clinical activity score below 10 during 2 consecutive days defined clinical response. RESULTS: According to Truelove criteria, all patients had moderate UC. CSA was administered IV at a mean daily dose of 3.7 +/- 0,5 mg/kg until response and then orally for 3.5 +/- 2.6 months. A clinical response was achieved in 20/26 patients (76,9%) within 5.7 +/- 2.8 days (5/6 failures were treated by proctocolectomy). During a follow-up of 27.8 +/- 20.8 months, relapse rate was 60% (12/20): 7 patients underwent proctocolectomy and 5 had clinical remission with CSA retreatment (N=4) and steroids (N=1). At the end of follow-up, 12 patients (46%) were in clinical remission, 12 (46%) required colectomy, 1 had chronic active UC and 1 was lost of follow-up. The probability to avoid surgery was 52% at 78 months. The only factor associated with avoidance of surgery was concomitant treatment with azathioprine (P=0.007). Ten reversible adverse events occurred in 9 patients. CONCLUSION: This study shows that CSA is safe and effective in moderately severe steroid resistant UC. Concomitant treatment with azathioprine significantly decreases the rate of subsequent surgery. CSA may act as a "bridge" until the therapeutic action of azathioprine is achieved for maintenance treatment. These results should be further confirmed by a prospective controlled study.
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