%0 Journal Article
%T Efectos adversos asociados al tratamiento con factor de transferencia: Ciudad de La Habana, 2004 Adverse drug effects associated to the treatment of patients with transfer factor: City of Havana , 2004
%A Mar赤a Aida Cruz Barrios
%A Blanca Nieves Rodr赤guez Montiel
%A Juan Antonio Furones Mourelle
%A Liuba Alonso Carbonell
%J Revista Cubana de Farmacia
%D 2006
%I ECIMED
%X El factor de transferencia (Hebertrans) constituye un inmunoestimulante que se emplea en una amplia gama de enfermedades. Su seguridad ha sido evaluada en los ensayos cl赤nicos pre-registro, pero no as赤 en investigaciones poscomercializaci車n, por tal motivo se realiz車 un estudio observacional y multic谷ntrico de vigilancia activa, en pacientes tratados con factor de transferencia en 11 hospitales de la Ciudad de La Habana , para identificar los eventos presentados durante el tratamiento, as赤 como clasificarlos seg迆n su causalidad y gravedad. La informaci車n fue recogida por el m谷dico inmun車logo de cada hospital y supervisada por el farmacoepidemi車logo hospitalario. Durante el tratamiento se obtuvo informaci車n de 387 pacientes y se reportaron 133 eventos en 86 casos (22,2 %). Los m芍s frecuentes fueron fiebre, dolor y eritema en el sitio de la inyecci車n, cefalea y diarrea; el 92,5 % de los eventos observados fueron leves. El 27,8 % se clasific車 como definitivamente provocados por el f芍rmaco, estos 迆ltimos relacionados con la v赤a de administraci車n. El factor de transferencia result車 un medicamento seguro en los pacientes observados Transfer factor called Hebertrans is an immunostimulant used in a wide range of diseases. The safety of this drug has been assessed in several clinical assays prior to registration, but not in aftermarket research studies. Therefore, a multicenter observational study of active surveillance was carried out in patients treated with transfer factor in 11 hospitals located in the City of Havana to detect adverse events in the course of treatment, and then to classify them by cause and severity. Data was collected by the immunologist in each hospital and supervised by the pharmacological epidemiologist. During the treatment, information was gathered from 387 patients where 133 events were reported in 86 cases (22,2%). The most frequent were fever, pain, erythema at the site of injection, headache and diarrhea; 92,5% of events were slight. 27,8% of adverse events were definitively caused by the drug and mainly related to the route of administration. Transfer factor was a safe drug for the patients under observation
%K Factor de transferencia
%K Hebertrans
%K reacciones adversas
%K eventos adversos
%K Farmacovigilancia
%K Farmacoepidemiolog赤a
%K Transfer factor
%K Hebertrans
%K adverse reactions
%K adverse events
%K Drug Surveillance
%K Pharmacological Epidemiology
%U http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152006000100004