RESUMO
A phase III clinical study was carried out among 534 fertile Latin American women to evaluate cycle control, side effects, and contraceptive efficacy of a once-a-month combined injectable, Mesigyna, consisting of 50 mg norethisterone enanthate and 5 mg estradiol valerate. The pregnancy rate at 1 year was 0 per 100 woman-years for a total experience of 4688 woman-months. The overall discontinuation rate at one year was 17.9%. Discontinuation rate for bleeding problems was 5.1%. The Colombian women had a significant increase (p <0.001) in bleeding problems compared to other countries. The discontinuation rate for amenorrhea was 1.1%. There were no significant differences between the groups regarding discontinuation for other medical or non-medical reasons. Mean weight gain after one year of use was 1.02 kg. Mesigyna is an appropiate once-a-month injectable contraceptive for Latin American women since it is highly effective and its perception of normal menstrual bleeding is of importance in the Latin American population.
Assuntos
Anticoncepcionais Femininos , Estradiol/análogos & derivados , Noretindrona/análogos & derivados , Adolescente , Adulto , Amenorreia/induzido quimicamente , Pressão Sanguínea , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Combinação de Medicamentos , Feminino , Humanos , Injeções , América Latina , Gravidez , Hemorragia Uterina/induzido quimicamente , Aumento de PesoRESUMO
Cabergoline (CAB) is a long-acting dopamine agonist. In the first national study with CAB--as part of an international multicentric study--39 adult and adolescent females (16 to 44 years old) with hyperprolactinemic amenorrhea (18 microadenomas and 21 idiopathic hyperprolactinemias) were evaluated. CAB or bromocriptine (BEC) was administered for 24 weeks: over 8 weeks, treatment was given under double-blind conditions, and over the remaining 16 weeks (open period) 18 patients received CAB and 21 received BEC as a result of a random distribution. Maximum dosage: CAB = 1.5 mg in 2 or 3 weekly doses; BEC = up to 10 mg in 2 daily doses. Prolactin was measured at base line and 2, 4, 6, 8, 12, 14, 16, 20 and 24 weeks after the initiation of treatment. When vaginal bleeding was restored, progesterone was measured as an ovulation sign. The 4 adolescents continued with CAB treatment for 1 more year. Prolactin was statistically evaluated according to Man Whitney Test (general population) or Wilcoxon Test (adolescents). There were no significant differences between basal levels of prolactin (ng/ml) in patients treated with BEC or CAB: (173.86 +/- 28.23 and 152.11 +/- 14.06 respectively); at the fourth week of treatment the decrease was smaller (p = 0.005) in patients treated with BEC (36.36 +/- 5.71) than in those treated with CAB (14.06 +/- 3.60) and at 24 weeks differences disappeared: BEC = 19.88 +/- 4.48 and CAB = 9.63 +/- 2.62 (p = NS). The adolescents showed a marked decrease in prolactin with no significant differences between BEC and CAB: basal levels = 168.17 +/- 75.47 and 213 +/- 96.99 (p = NS); 4 weeks = 48.00 +/- 8.72 and 35.00 +/- 12.58 (p = NS); 24 weeks = 34.33 +/- 10.17 and 21.75 +/- 7.23 respectively. At 48 weeks (23.25 +/- 11.23) levels remained the same as those of week 24 (p = NS). Some patients treated with BEC had nausea, vomits and epigastralgia; these symptoms were not observed with CAB. All patients resumed menstrual cycles, except one treated with BEC; 6 patients treated with CAB became pregnant, and the 5 patients who continued under our control gave birth to healthy infants. It is concluded that CAB is a useful therapy. This is specially true for adolescents (an age group difficult to manage) because of its easy administration and the almost complete absence of side effects.
Assuntos
Amenorreia/tratamento farmacológico , Agonistas de Dopamina/uso terapêutico , Ergolinas/uso terapêutico , Hiperprolactinemia/tratamento farmacológico , Adolescente , Adulto , Amenorreia/complicações , Bromocriptina/uso terapêutico , Cabergolina , Método Duplo-Cego , Tolerância a Medicamentos , Feminino , Humanos , Hiperprolactinemia/complicações , Prolactina/sangue , Resultado do TratamentoRESUMO
BACKGROUND: Human papillomavirus (HPVs) types 6 and 11, are frequently found in non-malignant anogenital condylomas and laryngeal papillomas. However, in an ongoing epidemiological study in Argentina in which 163 anogenital and aero-respiratory cancer biopsies were analyzed, several cases infected with low-risk HPVs could be detected. METHODS: Tumor samples were analyzed by Southern blot hybridization, using HPVs 6, 11, 16, 18, 30, 31, 33 and 35 as probes, and polymerase chain reaction (PCR) with type-specific primers and probes. RESULTS: Four invasive carcinomas containing HPV 6 or 11 could be detected (2.4%) by Southern blot technique. HPV 6 DNA was found in a penile carcinoma, a groin carcinoma, and in a tonsillar carcinoma. One cervical carcinoma harbored HPV 11 DNA. Using HPVs 6, 11, 16, 18 and 33 anticontamination primers and probes in PCR, no additional high-risk HPV types could be detected in these four cancers. CONCLUSION: This report shows the presence of low-risk HPVs (HPV 6 and 11) associated to malignant tumors in a frequency higher than usually observed. The data raise questions about which are the circumstances which may favor low-risk HPV related oncogenesis.