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Inicio Clínica e Investigación en Ginecología y Obstetricia Administración transdérmica combinada continua de estradiol-acetato de noretin...
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Vol. 29. Núm. 4.
Páginas 133-142 (Enero 2002)
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Vol. 29. Núm. 4.
Páginas 133-142 (Enero 2002)
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Administración transdérmica combinada continua de estradiol-acetato de noretindrona frente a estradiol solo en mujeres menopáusicas
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L.C. Tejerizo-Lópezc, A. Tejerizo-Garcíac, R.M. García-Roblesc, A. Leivac, E. Moránc, F. Correderac, R. Moralesa, J.M. Jorge-Mendozaa, M.M. Sánchez-Sáncheza, A.T. Teijelob
a Servicio de Obstetricia y Ginecología. Hospital General de Lanzarote. Arrecife de Lanzarote. Las Palmas.
b Servicio de Obstetricia y Ginecología. Hospital General de Vinaroz. Vinaroz. Castellón de la Plana. España.
c Servicio de Obstetricia y Ginecología. Hospital Virgen de la Vega. Salamanca.
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Resumen

Se estudia si un sistema administración continuo deestradiol/acetato de noretindrona transdérmico reducela incidencia de hiperplasia endometrial en mujerespostmenopáusicas en mayor medida que el estradiol (E2) transdérmico solo.

Doscientas mujeres posmenopáusicas fueron asignadas aleatoriamente a uno de cuatro tratamientos,50μg/día de E2transdérmico, o E2-acetato de noretindrona transdérmico, con 50 μg/día de E2y 140, 250, o400 μg/día de acetato de noretindrona. Las visitas deseguimiento para recoger información sobre seguridad y eficacia fueron efectuadas a los 3, 6, 9 y 12 meses tras el inicio de la terapia. Las biopsias endometriales para la evaluación histológica fueron hechascon valores basales y tras la salida del estudio (acabado o supresión). La histología endometrial fue evaluada por dos anatomopatólogos independientes.

Se encontró hiperplasia en el 13,33% (6 de 45) enel grupo de E2solo frente al 1,81 (1 de 55), 0, y2,56% (uno de 39) en los grupos E2-acetato de noretindrona 50-140, 50-250, y 50-400 μg/día, respectivamente (p < 0,001). La hemorragia uterina fue menosfrecuente en el grupo E2-acetato de noretindrona 50-140 μg/día que con los otros tratamientos. El númerode sofocos por día decreció a menos de uno en el final de cada tratamiento. Los parches de E2-acetato denoretindrona mostraron una tolerancia dérmica comparable a los de E2únicamente.

La administración continua transdérmica de E2combinado con acetato de noretindrona previene deforma eficaz la hiperplasia endometrial en mujeresposmenopáusicas sanas. Los sistemas de administración transdérmica combinada continua proporcionanuna mayor flexibilidad en la dosificación y podríanmejorar la conveniencia y confianza en la terapia hormonal sustitutiva.

Summary

A study was made to determine whether continuous transdermal oestradiol-norethindrone acetate reduces the incidence of endometrial hyperplasia in post-menopausal women more than transdermal oestradiol (E2) only. Two hundred post-menopausal women were randomly assigned to one of 4 treatments, 50 μg/day of transdermal E2 or transdermal E2-norethindrone acetate or 50 μg/day of E2 also 140, 250, or 400 μg/day of norethindrone acetate. Follow-up visits to collect information on safety and efficacy were made at 3, 6, 9, and 12 months after initial treatment. Endometrial biopsies were taken as a baseline, and following exit from the study (completion or withdrawal). Endome-trial histology was evaluated by two independent pathologists.

Hyperplasia was found in 13.3% (6 of 45) in the oestradiol only group versus 1.8% (1 of 55), 0% and 2.56% (1 of 39) in the oestradiol-norethindrone acetate 50-140, 50-250 and 50-400 groups respectively (P < 0.01). Uterine bleeding was less frequent in the oes-tradiol-norethindrone acetate 50-140 group than with the other treatments. The mean number of hot flushes per day decreased by at least one at the end of each treatment. The oestradiol-norethindrone acetate combination patches had a skin tolerance comparable to that of oestradiol only.

Continuous transdermal delivery of oestradiol combined with norethindrone acetate effectively prevented endometrial hyperplasia in healthy post-menopausal women, providing a greater flexibility of dose, and could improve the convenience and compliance with hormone replacement therapy.

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Copyright © 2002. Elsevier España, S.L.. Todos los derechos reservados
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