Eventos adversos observados años después del tratamiento con factor de transferencia / Adverse events occurred some years after the application of a transfer factor treatment

RESUMEN

Introducción: el factor de transferencia es un inmunoestimulante que se emplea en varias enfermedades, su seguridad en las condiciones de la práctica médica no se ha establecido. Objetivos: identificar eventos adversos presentados años después de finalizado el tratamiento con factor de transferencia y determinar la relación entre su utilización y los eventos observados. Métodos: estudio observacional, retrospectivo, de fármacovigilancia activa. El universo estuvo constituido por 413 pacientes tratados con este fármaco entre los años 2001 y 2004 en 11 hospitales de La Habana. El periodo de observación abarcó los 6 a 8 años posteriores al tratamiento. Los pacientes fueron entrevistados acerca de la presencia de infecciones, cáncer y otros eventos, en su hogar. Si un evento era la muerte, se entrevistaba al familiar para registrar causa y fecha. Resultados: se entrevistaron 356 pacientes, 66 (18,53 por ciento) presentaron al menos un evento adverso, 21(31,8 por ciento) en mayores de 60 años. Se registraron 87 eventos adversos, 8 (9,2 por ciento) fueron infecciones como hepatitis B, hepatitis C, foliculosis, mononucleosis y verrugas vulgares, 1 (1,1 por ciento) cáncer y 78 (89,7 por ciento) otros eventos. Su relación con la administración del fármaco resultó condicional en 64 (73,6 por ciento) pacientes e improbable en 21 (24,1 por ciento), en esta última categoría se incluyeron las infecciones y la mayoría de los eventos mortales. Conclusiones: los eventos adversos que se registraron en los pacientes, años después de haber recibido tratamiento con factor de transferencia, no se consideran relacionados con su administración, aunque necesitan ser vigilados pues la información obtenida en este estudio debe ser contrastada con un mayor número de observaciones y estudios observacionales controlados

ABSTRACT

Introduction: the transfer factor is an immunostimulant that is used to treat several diseases but its safety in the medical practice has not been assured yet. Objectives: to identify the adverse events occurred some years after the end of a transfer factor treatment and to determine the association of the use and the observed events. Methods: observational active drug surveillance study. The universe of study was 413 patients who were treated with the transfer factor from 2001 to 2004 in eleven hospitals located in La Habana province. The observation period ranged 6 to 8 years after the treatment. The patients were interviewed at home on the occurrence of infections, cancer or any other events. If some death occurred, then a family member was interviewed to record the cause and the date of the decease. Results: three hundred fifty six patients were interviewed; 66(18.53 percent) stated at least one adverse event and 21(31.80 percent) events occurred in over 60 years-old patients. Eighty seven adverse effects were recorded; 8 (9.20 percent) comprised infections such as hepatitis B, hepatitis C, foliculosis, mononucleosis and warts, one (1.10 percent) event corresponded to cancer and 78 (89.70 percent) to other type of events. Their relationship with the administration of the drug was considered as conditional in 64 events (73.60 percent) and as unlikely in 21 (24.10 percent) events comprising infections and most of the fatal events. Conclusions: the adverse events observed in the patients, some years after the end of the treatment with the transfer factor, were not considered to be related to the administration of this drug; however, they must be under surveillance since the information obtained from this study should be compared with the information collected by a higher number of observations and of controlled observational studies