Leonard F, Gaspard U, Theunissen L
Department of Gynaecology, University of Liège, CHU Sart Tilman, Belgium.
Curr Med Res Opin. 1993;13(2):78-86. doi: 10.1185/03007999309111536.
The clinical effects and the contraceptive effectiveness of a monophasic preparation containing 30 micrograms ethinyloestradiol and 75 micrograms gestodene per tablet were assessed in a study of 115 healthy adolescents (mean age 18.5 +/- 2 years) covering a total of 712 menstrual cycles (mean of 8 cycles per patient). There was a number of cases of discontinuation of the study (70/115), mainly due to poor discipline in tablet intake in this particular age group. Only 20 cases discontinued the study for medical reasons. No pregnancies occurred, in spite of the fact that tablets were frequently forgotten (11% of cycles). Eighty-eight percent of cycles presented a normal bleeding pattern from the second month of treatment on. Spotting was sporadic (less than 8% from the 2nd cycle) and was mainly associated with tablet omission. Intermenstrual bleeding (breakthrough bleeding) occurred in 19% of the first menstrual cycles but only in 5% of the second and following cycles. Tenderness of the breast was the most frequent subjective complaint (3.4% of cycles), followed by urogenital problems, headaches and digestive disorders. However, all complaints remained sporadic (13.4% of cycles). The systolic blood pressure showed little variation, with only a slight increase from 123 to 125 mmHg after 6 months of treatment. Though not clinically important, an increase in diastolic blood pressure was observed (from 76 to 82 mmHg after 6 months). The patients showed a tendency to increase weight (from 54.4 to 56.7 kg after 6 months.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项针对115名健康青少年（平均年龄18.5±2岁）的研究中，评估了一种每片含30微克乙炔雌二醇和75微克孕二烯酮的单相制剂的临床效果和避孕效果，该研究涵盖了总共712个月经周期（每位患者平均8个周期）。有许多例研究中断情况（70/115），主要是由于这个特定年龄组服药纪律差。只有20例因医学原因中断研究。尽管经常忘记服药（11%的周期），但未发生妊娠。从治疗第二个月起，88%的周期呈现正常出血模式。点滴出血是偶发的（从第2个周期起少于8%），主要与漏服药物有关。月经间期出血（突破性出血）在第一个月经周期中发生率为19%，但在第二个及后续周期中仅为5%。乳房压痛是最常见的主观症状（3.4%的周期），其次是泌尿生殖系统问题、头痛和消化系统紊乱。然而，所有症状仍为偶发（13.4%的周期）。收缩压变化不大，治疗6个月后仅从123 mmHg略有升至125 mmHg。虽然在临床上不重要，但观察到舒张压有所升高（6个月后从76 mmHg升至82 mmHg）。患者有体重增加的趋势（6个月后从54.4 kg增至56.7 kg）。（摘要截选至250词）
