%0 Journal Article
%T Epidermal growth factor enemas for induction of remission in left-sided ulcerative colitis Enemas de factor de crecimiento epid谷rmico para inducir la remisi車n de la colitis ulcerosa izquierda
%A Hugo Nodarse-Cun赤
%A Antonio M芍s-Paez
%A Yoan Gutierrez-P谷rez
%A Carmen Mar赤a Valenzuela-Silva
%J Revista Cubana de Farmacia
%D 2013
%I ECIMED
%X 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. Introducci車n: la colitis ulcerosa es una enfermedad inflamatoria cr車nica de etiolog赤a poco conocida, que afecta la mucosa del colon. El efecto positivo del factor de crecimiento epid谷rmico fue reportado en estudio previo con uso de enema para tratamiento de la manifestaci車n izquierda leve o moderada de la enfermedad. Este antecedente sirvi車 de base para evaluar la eficacia y perfil de seguridad de una soluci車n viscosa del producto. M谷todos: fueron aleatorizados 31 pacientes hacia tres grupos de tratamiento diario durante 14 d赤as. Doce recibieron enemas de 10 mg de factor de crecimiento epid谷rmico en 100 mL de soluci車n viscosa, mientras nueve fueron tratados con enemas placebo conteniendo solamente soluci車n viscosa. Ambos grupos recibieron adem芍s 1,2 g diarios de mesalacina oral. El tercer grupo incluy車 10 pacientes con mesalacina en enemas de
%K colitis ulcerosa
%K Factor de crecimiento epid谷rmico
%K Mesalacina
%K Ensayo cl赤nico
%K Ulcerative colitis
%K Epidermal Growth Factor
%K Mesalamine
%K Clinical trial
%U http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152013000100008