Efeito vascular da tibolona nasartérias oftálmica e central da retina: Ensaio clínico randomizado, triplo-cego placebo controlado com estudo dopplervelocimétrico

Abstract

Objective: to evaluate the vascular effect of tibolone in the ophthalmic artery and central retinal artery. Methods: a controlled clinical trail, prospective, longitudinal, randomized, triple blind placebo controlled study, with 100 women in the menopause. 50 had been placed to use tibolone and 50 had been placed to use placebo formed group control. In the A group of the 50 patients who had initiated the study, 44 had returned 84 days latter, for the accomplishment from the examination; and 47 in B group returned. We had studied the ophthalmic and central retiniana arteries, determining the resistance index (RI), pulsatility index (PI) and relation sistole/diastole (S/D). The examination had been made before the medication and 84 days latter. Analysis of the data: we used test t of student for independent samples in the comparison of the averages between the groups and for dependent samples in the comparison inside the same group to evaluated the averages. Results: the comparison of the characteristics of the women in the two groups showed that they had been similar in relation to age, time of menopause, index of corporal mass, blood pressure, parity and cardiac frequency. The group that used the tibolone presented no rise of all Doppler flow indexes: RI, PI and S/D in the ophthalmic and central retinal arteries.In the placebo group there was no increase of the Doppler flow index evaluated 84 days latter. Conclusion: the tibolone has no vascular effect on ophthalmic and central retinal arteries