2013, Número 1
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Rev Cubana Farm 2013; 47 (1)
Enemas de factor de crecimiento epidérmico para inducir la remisión de la colitis ulcerosa izquierda
Nodarse-Cuní H, Más-Paez JA, Gutierrez-Pérez Y, Valenzuela-Silva CM, Lazo-Diago OC, Carlos Gutierrez-Alvarez, Zambrano-Pérez G, Barbón-García A, Bermúdez-Badell CH, Melo-Suárez G, Periles-Gordillo U, Palomino-Besada A, Páez-Meireles R, Berlanga-Acosta J, López-Saura P
Idioma: Español
Referencias bibliográficas: 20
Paginas:
Archivo PDF: 215.02 Kb.
RESUMEN
Introduction: Ulcerative colitis is a little known chronic inflammatory disease in colonic mucosa. The positive effect of epidermal growth factor was shown in a previous report, with enema use for treatment of mild to moderate left-sided manifestation of the disease. This evidence provided the basis for evaluating the efficacy and safety profile of a viscous solution of this product.
Methods: Thirty-one patients were randomized to three groups for daily medications during 14 days. Twelve received one 10 mg enema of epidermal growth factor dissolved in 100 mL of viscous solution whereas nine were treated with placebo enema; both groups also received 1.2 g of oral mesalamine per day. The other group included ten patients with 3 g / 100 mL of mesalamine enema. Primary end point was clinical responses after two weeks of treatment, defined as a decreased of, at least three points from baseline, the Disease Activity Index and endoscopic or histological evidences of improvement.
Results: Remission of disease was observed in all patients in the epidermal growth factor group, and six in both, mesalamine enema and placebo group. All the comparisons between groups showed statistically significant superiority for epidermal growth factor, the only product with significant reduction in disease activity index as well as the presence and intensity of digestive symptoms in patients after treatment. None adverse event was reported.
Conclusions: The results agree with previous molecular and clinical evidences, indicating that the epidermal growth factor is effective to reduce disease activity and to induce remission. A new study involving more patients should be conducted to confirm the efficacy of the epidermal growth factor enemas.
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