Barbosa I, Coutinho E, Athayde C, Ladipo O, Olsson S E, Ulmsten U
Federal University of Bahia, Maternidade Climerio de Oliveira, Salvador, Brazil.
Contraception. 1995 Aug;52(2):111-4. doi: 10.1016/s0010-7824(95)00144-1.
This study was undertaken to assess possible variations in body weight, blood pressure, fasting glucose, HbA1C, insulin, total cholesterol, HDL-C, LDL-C, triglycerides, SGPT, SGOT, GGT and bilirubin in women bearing a single subdermal Silastic implant containing 55 mg (10%) of nomegestrol acetate during two years. A total of eighteen volunteers of reproductive age who desired to avoid conception were enrolled in this study. Subjects were healthy women with no contraindications to hormonal contraception. All women were investigated before starting treatment and were followed up for one year. At the end of one year the capsules were removed and a new capsule was inserted. Fasting blood samples were drawn at 8:00 to 8:30 am twice prior to implant insertion and then at the first, third, sixth and twelfth months and every six months thereafter. Body weight increased from 54.9 +/- 1.5 kg at admission to 55.3 +/- 2.0 kg at 12 months of use (p < 0.05) and to 56.0 +/- 2.7 kg at 24 months of use. A slight increase in both systolic and diastolic blood pressure was recorded at month 12 (p < 0.01). At month 24, blood pressure was not significantly different from admission values. All levels were within the normal range. Insulin, HbA1C, LDL-C and GGT remained unchanged during twenty-four months of Uniplant use. A significant decrease in total cholesterol (p < 0.05) was observed in the third month while a significant decrease in HDL-C (p < 0.01) was observed only in the sixth month of Uniplant use.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究旨在评估在两年内,植入含55毫克(10%)醋酸诺美孕酮的皮下硅橡胶单棒的女性,其体重、血压、空腹血糖、糖化血红蛋白、胰岛素、总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯、谷丙转氨酶、谷草转氨酶、γ-谷氨酰转肽酶和胆红素可能出现的变化。共有18名有避孕需求的育龄志愿者参与了本研究。受试者均为健康女性,无激素避孕的禁忌证。所有女性在开始治疗前接受了检查,并随访一年。一年后取出胶囊并插入新的胶囊。在植入前,于上午8:00至8:30采集两次空腹血样,然后在植入后的第1、3、6和12个月以及此后每6个月采集一次。体重从入院时的54.9±1.5千克增加到使用12个月时的55.3±2.0千克(p<0.05),使用24个月时增加到56.0±2.7千克。在第12个月时,收缩压和舒张压均略有升高(p<0.01)。在第24个月时,血压与入院时的值无显著差异。所有指标均在正常范围内。在使用单棒的24个月期间,胰岛素、糖化血红蛋白、低密度脂蛋白胆固醇和γ-谷氨酰转肽酶保持不变。在使用单棒的第3个月,总胆固醇显著下降(p<0.05),而高密度脂蛋白胆固醇仅在第6个月显著下降(p<0.01)。(摘要截选至250字)