RESUMEN
OBJECTIVE: To assess the contraceptive reliability, cycle control and tolerability of a new monophasic oral contraceptive containing 30 g ethinylestradiol plus 3 mg drospirenone (Yasmin, Schering AG, Berlin, Germany), it was compared with an established oral contraceptive containing 30 g ethinylestradiol plus 150 g desogestrel (Marvelon, NV Organon, Oss, The Netherlands). METHODS: A randomized, open-label, 13-cycle study was performed at 80 European centers. Contraceptive reliability, cycle control, blood pressure, body weight, the incidence of adverse events and skin condition were assessed during 13 cycles of oral contraceptive use, and at follow-up. Subjects recorded body weight on three consecutive days pretreatment and weekly thereafter. RESULTS: Of 2069 women who started the study and received the trial preparations in a ratio of 4:1 (ethinylestradiol/drospirenone, n = 1657; ethinylestradiol/desogestrel, n = 412), 1615 completed the 13 cycles plus follow-up, providing data for over 23,000 evaluable cycles. Eleven pregnancies occurred during treatment, only one of which (in the ethinylestradiol/drospirenone group) could not be ascribed to user failure or interaction with other factors. Both preparations provided effective contraception and cycle control. Pre-existing acne and seborrhea were improved and blood pressure was essentially unchanged. The two treatments differed in their effect on body weight, the difference being statistically significant. In the ethinylestradiol/drospirenone group, there was a distinct decrease over the whole treatment phase, while a subtle and less distinct decrease was documented in the ethinylestradiol/desogestrel group. CONCLUSIONS: The combination of 30 g ethinylestradiol/3 mg drospirenone provides effective oral contraception, excellent cycle control, good tolerability and a level of weight loss that may have a significant beneficial effect on compliance in women with a tendency to weight gain due to water retention.
Asunto(s)
Androstenos/farmacología , Anticonceptivos Orales Combinados/farmacología , Congéneres del Estradiol/farmacología , Etinilestradiol/farmacología , Ciclo Menstrual/efectos de los fármacos , Antagonistas de Receptores de Mineralocorticoides/farmacología , Congéneres de la Progesterona/farmacología , Adolescente , Adulto , Androstenos/efectos adversos , Anticonceptivos Orales Combinados/efectos adversos , Congéneres del Estradiol/efectos adversos , Etinilestradiol/efectos adversos , Europa (Continente) , Femenino , Humanos , Antagonistas de Receptores de Mineralocorticoides/efectos adversos , Congéneres de la Progesterona/efectos adversos , Piel/efectos de los fármacos , Aumento de Peso/efectos de los fármacosRESUMEN
The objective of this study was to evaluate the prognostic significance of DNA ploidy and S-phase fraction (SPF) in epithelial ovarian carcinomas analyzed by image cytometry. Frozen tissue of 103 epithelial ovarian carcinomas was analyzed for DNA ploidy and SPF with a Cell Analysis System Image Analyser (CAS 200, Becton-Dickinson) and correlations with clinical and histomorphologic factors and time to progression and overall survival were evaluated by univariate and multivariable analysis. Fifty-four percent of the ovarian carcinomas were found to be diploid, 38% aneuploid, and 8% tetraploid. The S-phase fraction was low (<5%) in 27%, intermediate (5-14.5%) in 47%, and high (>/=14.5%) in 26% of the patients. By univariate analysis overall survival and time to progression were significantly correlated with the S-phase fraction (P = 0.003 and P = 0.003), but not with DNA ploidy (P = 0. 31 and P = 0.51). A DNA index > 1.4 was correlated with poor outcome but the result did not achieve formal statistical significance (P = 0.08 and P = 0.12). A high SPF was a strong predictor of early recurrence, while a low SPF identified patients with a favorable long-term outcome. Other significant predictors of survival were FIGO stage, grade of differentiation, presence of distant metastasis, residual tumor, lymph node metastasis, and patient age. In multivariable statistical analysis only FIGO stage, histologic grade, and residual tumor after surgery were independent predictors of overall survival and time to progression.