A 13-month multicenter clinical experience of a low-dose monophasic oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene in Latin American women

This prospective, multicenter study was conducted to evaluate the contraceptive reliability, cycle control and tolerability of a 21-day oral contraceptive regimen containing 20 μg ethinylestradiol and 75 μg gestodene in four Latin American countries (Mexico, Argentina, Brazil and Colombia). Participants took trial medication daily for 21 days. Contraceptive efficacy, cycle control and tolerability were evaluated over a period of 13 cycles. Efficacy data gathered from 5,109 treatment cycles were obtained from 393 participants. The trial medication proved to be an effective contraceptive and provided good cycle control. One pregnancy because of poor compliance was recorded. This resulted in a study Pearl index of 0.25. Forty-six percent of Latin American women reported one intracyclic spotting bleeding episode and 37.6% reported one intracyclic breakthrough bleeding (medium/excessive bleeding) episode during cycles 2-4 (primary target). Overall, intracyclic bleeding was reported in 41%. Overall, there was a trend towards a lower incidence of spotting in all the countries and this difference had statistical significance between Argentina and the others three countries (p < 0.05) during cycles 2-4. This trend was also apparent with respect to breakthrough bleeding, but again the difference did not achieve statistical significance. The discontinuation rate because of adverse events was low (3%); no serious adverse events were reported. More than 78% of the women in the four countries maintained constant body weight or lost weight (2 kg) during the study. The treatment effect on blood pressure was negligible. There were no appreciable changes in mean laboratory values over the course of the study.     

Fertility and reproductive history of sterilized and non-sterilized women in Campinas, São Paulo, Brazil

This article compares sterilized and non-sterilized women in relation to socio-demographic characteristics, reproductive history, and cohabitation status. Women from 30 to 49 years of age and residing in Campinas, S?o Paulo State, Brazil, were interviewed with a pre-tested and structured questionnaire: 236 women sterilized at least five years before the interview and 236 non-sterilized women. The sterilized women were significantly more likely to be married or cohabiting, to be younger when they began cohabiting, and to have been in the union longer than the non-sterilized women. They also began childbearing at an earlier age and had a history of more pregnancies and more live births than non-sterilized women. Factors associated with a history of 3 or more live births at the time of the interview were surgical sterilization, younger age at first childbirth, older age at the interview, recognition of fewer contraceptive methods, and lower per capita income. The article concludes that sterilization generally appears to be the consequence of higher fertility in a group of women who initiate childbearing early in life, although its role in preventing these women from having even larger families may also have a demographic impact.     

Prognosis of varicocelectomy in the treatment of infertility, based on pre-surgery characteristics

The semen characteristics, before and after varicocelectomy, were studied in 220 husbands from infertile couples, whose wives had no significant abnormalities. All couples were followed for one year or until the wife became pregnant. Sperm density, vitality, motility and percent with normal morphology were analysed before surgery. Based on these results, subjects were divided into 2 groups according to whether their semen had normal or abnormal characteristics. The group with semen parameters within normal limits showed significantly less improvement after surgery, and the posttreatment pregnancy rate was independent of the effect of surgery on the characteristics of sperm. Between 71 and 84% of the subjects with abnormal semen characteristics showed improvement after surgery, and between 56 and 72% of those who improved, impregnated their wives. Subjects whose abnormal semen characteristics did not improve after surgery, had a very low pregnancy rate.     

Lumbar epidural anaesthesia and sensory profiles in term pregnant patients

Sensory profiles of lumbar epidural anaesthesia were studied in 57 patients during active labour. The local anaesthetics used were chloroprocaine three per cent with and without epinephrine, chloroprocaine two per cent, bupivacaine 0.25 per cent and a mixture of chloroprocaine three per cent and bupivacaine 0.5 per cent. A common pattern of spread was found for all local anaesthetic solutions with the onset of the block affecting the dermatomes innervated by the thinnest nerve roots (T₁₂L₁). There was a percentage of failure to block the thickest nerve root (S₁). Inguinal and suprapubic discomfort (“missing segment”) occurred when S₁ was not blocked. Under the conditions of this experiment, the addition of bupivacaine to chloroprocaine did not increase the duration of the blockade significantly.     

Cardiovascular responsiveness of the pig fetus to autonomic blockade

We studied the development of responsiveness to pharmacological blockade of parasympathetic, -adrenergic and -adrenergic control of the circulation of the pig fetus during the last 30 days of gestation (term is 114 days). Heart rate increased following administration of atropine, the increase in fetuses aged 85–90 days gestation being significantly smaller then at term. Infusion of phentolamine decreased fetal blood pressure, the fall in pressure seen in younger fetuses being less than that observed in fetuses near term. However, when expressed in relation to control pressures, the percentage change was the same at all ages. Propranolol slowed the heart rate of all fetuses with no significant differences between stages of gestation. We conclude that vagal control over the circulation continues to ncrease during the last month of gestation and that the substantial sympathetic activity seen at the earlier ages studied appeared to show no further development prior to term.Supported by USPHS program project grant HL06285 from the National Heart, Lung and Blood Institute     

Vaginal safety after use of a bioadhesive, acid-buffering, microbicidal contraceptive gel (ACIDFORM) and a 2% nonoxynol-9 product

BACKGROUND: ACIDFORM is a microbicidal and contraceptive candidate with strong buffering capacity. METHODS: This was a Phase I blinded, randomized and crossover clinical study on two products, ACIDFORM and a commercial nonoxynol-9 (N-9) product (2%), evaluating their vaginal safety in 20 couples aged between 19 and 45 years. The women had regular menses, underwent previous tubal ligation, were not breast-feeding, had no vaginal sign and symptom and were in a stable partnership; both partners had no previous STI. Colposcopy, vaginal microbiology, inflammation markers and subject complaints were studied after coitus. Women were randomly assigned sequentially to receive ACIDFORM 0-30 min (0-30 min before intercourse), ACIDFORM 8-10 h (8-10 h before intercourse) or N-9 0-30 min after a control cycle. RESULTS: Mild/moderate vulvar irritation was observed in five postcoital test colposcopies, burning and pruritus were reported in six treated cycles and non-irritation-related symptoms were found in five cycles with different treatments. No difference in vaginal pH, Nugent scores, H2O2-producing lactobacillus or leukocytes and interleukin 6 in the cervicovaginal lavage was found between the treatment and control cycles. CONCLUSIONS: ACIDFORM appears to be safe for clinical use once a day. There is a potential spermicidal-microbicidal role for ACIDFORM as a vaginal flora helper or as a vehicle for products, except N-9.     

Autologous stem cell transplantation for patients with chronic myeloid leukemia. The Argentine Group of Bone Marrow Transplantation (GATMO) experience

BACKGROUND: The objective of this analysis was to evaluate the role of autologous stem cell transplantation (ASCT) in prolonging disease free survival (DFS) and overall survival (OS) in patients with chronic myeloid leukemia (CML) who received autografts of Philadelphia chromosome (Ph) positive or Ph negative cell harvests. METHODS: Over a 4-year period (1994-1999), 53 patients who underwent ASCT for CML were reported to the Argentine Group of Bone Marrow Transplantation (GATMO) Registry. RESULTS: Ph negative cell products were harvested in only 18 patients (34%). Comparison of disease status at the time of autograft, duration of neutropenia, thrombocytopenia, days of antibiotics, and transfusional requirements of red blood cells and platelets did not reveal statistical significant differences between the Ph positive group and the Ph negative group. Only days of hospitalization were increased significantly in patients who received Ph positive autografts. Although DFS at 36 months was significantly longer after infusion of Ph negative cell products (54% vs. 14%; P 相似文献   

Pharmacokinetic study of different dosing regimens of levonorgestrel for emergency contraception in healthy women

BACKGROUND: Levonorgestrel (LNG) is a commonly used progestin for emergency contraception; however, little is known about its pharmacokinetics and optimal dose for use. METHODS: Serum levels of LNG and sex hormone-binding globulin (SHBG) were measured in five women who received three different regimens: A: 0.75 mg LNG twice with a 12 h interval; B: 0.75 mg twice with a 24 h interval; and C: 1.50 mg in a single dose, with a washout period of 28 days between each treatment. Blood samples were taken before pill intake and at 1, 2, 4, 8 and 12 h after each dose, every 12 h up to day 4 and every 24 h until day 10. LNG and SHBG were measured in all samples. RESULTS: Maximum LNG concentrations were of approximately 27 nmol/l for treatments A and B, and close to 40 nmol/l for treatment C. The area under the curve was significantly higher for treatment C during the first 12 h, and significantly lower for treatment B during the first 24 h. After 48 h and up to 9 days from onset of treatment, serum LNG levels were similar in all three regimens. SHBG levels remained stable for 24 h, decreasing to 60% of the initial value from day 5 until day 10, with no difference between regimens. CONCLUSIONS: The similarity of LNG serum levels obtained with one single dose of 1.5 mg or two doses of 0.75 mg with a 12 h interval justify a clinical comparison of these two regimes.