Kuhnz W, Back D, Power J, Schütt B, Louton T
Schering Research Laboratories, Berlin/Bergkamen, FRG.
Horm Res. 1991;36(1-2):63-9. doi: 10.1159/000182110.
Two low-dose oral contraceptives, both containing the same dose of ethinyl estradiol (EE2) but different progestins (gestodene and desogestrel, respectively), were compared with respect to the relative bioavailability of EE2. The study was conducted with 31 women as an open intraindividual comparison with the ingestion of both preparations for 3 months, respectively. On days 1, 10 and 21 of the 1st, 3rd and 6th cycle, blood was sampled at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 h following administration. The concentrations of EE2 were determined in the serum samples of each individual and the area under the serum concentration versus time curves, AUC (0-4 h) and AUC (0-24 h), were calculated. Corresponding parameters obtained on days 1, 10 and 21 of the 3rd and 6th month of treatment were compared on a statistical basis, and no differences were found. This result was in concordance with a previously performed study, where both formulations were administered to 18 women in a single-dose cross-over design. However, the results of the previous and the present study are at variance with the result of one other study, reporting higher EE2 levels in the serum of women taking the gestodene-containing formulation as compared to those taking the desogestrel-containing formulation.
对两种低剂量口服避孕药进行了比较,二者均含有相同剂量的炔雌醇(EE2),但孕激素不同(分别为孕二烯酮和去氧孕烯),比较内容为EE2的相对生物利用度。该研究以31名女性为对象,采用开放个体内对照设计,分别服用两种制剂3个月。在第1、3和6个周期的第1、10和21天,给药后0、0.5、1、1.5、2、3、4、6、8、10和24小时采集血样。测定每个个体血清样本中EE2的浓度,并计算血清浓度-时间曲线下面积,即AUC(0 - 4小时)和AUC(0 - 24小时)。对治疗第3和6个月第1、10和21天获得的相应参数进行统计学比较,未发现差异。该结果与之前一项研究一致,在之前的研究中,两种制剂以单剂量交叉设计给予18名女性。然而,之前和本研究的结果与另一项研究的结果不同,另一项研究报告称,服用含孕二烯酮制剂的女性血清中EE2水平高于服用含去氧孕烯制剂的女性。