Asma y nifedipina: estudio comparativo del efecto profilactico de la nifedipina frente al ketotifeno y placebo en asma alergica infantil / Asthma and nifedipine: comparative study of the profilactic effect of nifedipine against ketotifen and placebo in child's allergic asthma

RESUMEN

Se presentan los resultados de un estudio doble ciego, al azar, que compara los efectos de la nifedipina, una dihidropiridina antagonista del calcio, de amplia utilizacion cardiovascular, con los del Ketotifeno y los de un placebo; cada uno de ellos fue administrado por via oral cada 12 horas, durante 4 meses, a un grupo de 20 ninos mayores de 5 anos con asma alergica de una evolucion minima de 2 anos; el estudio se llevo a cabo en el Servicio de Alergias del Hospital Universitario San Vicente de Paul, de Medellin, Colombia, entre Julio de 1984 y Diciembre de 1986. La nifedipina produjo disminucion de la frecuecnia de las crisis en 17 pacientes (85%) y de su intensidad y duracion en 16 (80%); en esta misma proporcion (80%) se disminuyo el consumo de broncodilatadores; 18 pacientes (90%) informaron efectos beneficos de la nifedipina y la mejoria, evaluada por el medico, se hallo en 14 (70%). No hubo con la nifedipina modificaciones del pulso ni de la presion arterial ni, tampoco de 14 pruebas de funcion pulmonar; los efectos secundarios fueron minimos y autolimitados. Los resultados obtenidos con la nifedipina fueron estadisticamente semejantes a los de ketotifeno y los de ambos significativamente superiores a los logrados con el placebo(p<0.05)En conclusion: la nifedipina podria ser una alternativa en le manejo del asma alergica infantil leve o moderada, dado su comportamiento similar al del ketotifeno que es de eficacia reconocida en este campo; en un futuro los antagonistas del calcio pueden llegar a ser el tratamiento de elección del paciente asmatico si..

ABSTRACT

Between July 1984 and December 1986 a double blind randomized study was conducted at the Allergy Clinic of the Hospital Universitario San Vicente de Paúl, Medellín, Colombia, in order to compare the effects of Nifedipine, Ketotifen and placebo on allergic asthma in children; each drug and the placebo were administered orally every 12 hours for a period of 4 months to a group of 20 children. The objective was to evaluate the usefulness of Nifedipine In the prophylactic management of allergic asthma in this population and to compare it with Ketotifen, a provenly efficacious drug, and placebo. AII patients were older than 5 years and had suffered the disease for more than 2 years. Nifedipine treated patients showed a reduction in the frequency of their asthmatic crisis (17 patients; 85%) and in their intensity and duration (16 patients; 80%); a similar reduction was observed In the need for bronchodilators; 18 patients (90%) reported beneficial effects with this drug and medical evaluation confirmed Improvement In 14 (70%). These results resembled those obtained with Ketotifen and both were statistically superior to placebo (p<0.05). Pulmonary function tests, pulse rate and blood pressure did not show any significant changes. Secondary effects were minimal and self-Limited. It is concluded that Nifedipine can be an alternative drug for the treatment of mild to moderate allergic asthma in children. If calcium antagonists with higher affinity for the respiratory tract and better blocking effects are synthesized they might become the elective therapeutic choice for these patients