三种低剂量、复方口服避孕药的临床比较性研究

本文应用随机化双盲法,对三种低剂量含雌、孕甾体激素避孕药(含18-甲基炔诺酮及炔雌醇的复方三相制剂,含18-甲基炔诺酮150μg及炔雌醇30μg的固定剂量制剂,含炔诺酮600μg及炔雌醇35μg的Ⅰ号避孕药)进行比较性研究。共收集合格健康育龄妇女279例;其中复方三相制剂96例,固定剂量制剂93例,Ⅰ号避孕药90例。按生命表法统计,其6个月的每百妇女累积续用率:复方三相制剂82.3,左旋18-甲基炔诺酮/炔雌醇固定剂量制剂81.6,Ⅰ号避孕药80.9,三组间在统计学上无显著差别。副反应的发生率,三组间亦甚相似。有关出血类型:在复方三相制刺中月经周期较为规则,滴血最为少见,行经期长度亦较少受影响。研究证实复方三相制剂是一种有效的低剂量口服避孕药,值得进一步研究。

A COMPARATIVE CLINICAL STUDY OF THE EFFECTS OF THREE TYPES OF LOW DOSE ESTROGEN/PROGESTOGEN ORAL CONTRACEPTIVES

A double-blind randomized clinical study to compare the use-effectiveness and bleeding patterns among women using the triphasic preparations levonorgestrel (LNG) 50-125 mcg/ethinyl estradiol (EE) 30-40 mcg; microgynon 30 (LNG 150 mcg/EE 35 mcg), and pill No. 1 NNET 600 mcg/EE 35 mcg) during February and July 1983. The recruited volunteers totalled 279 women, 96 in the 1st group, 93 in the 2nd, and 90 in the last. Using life table calculations, the cumulative continuation rates/100 women at the end of 24 weeks were 82.3, 81.6, and 80.9. There were no statistical differences between them. The incidence of side effects was also similar. As to the bleeding patterns, the triphasic preparation had less impact on the menstrual cycle; there was less spotting and less effect on the length of the menstrual flow. Results showed that the triphasic preparation which contained much smaller doses of progestogen is an effective low-dose contraceptive. (author's modified)