Gauthier A, Upmalis D, Dain M P
Service de Gynecologie Sociale, Centre Hospitalier, Lille, France.
Acta Obstet Gynecol Scand Suppl. 1992;156:27-32. doi: 10.3109/00016349209156512.
The safety and efficacy of the triphasic oral contraceptive agent containing norgestimate and ethinyl estradiol were evaluated in a 12-month study of 661 women. Excellent contraceptive efficacy was achieved, with two pregnancies ascribed to product failure in a total of 6,511 treatment cycles. The life-table predicted pregnancy rate was 0.57 per 100 woman-years of use. The overall and theoretical Pearl indexes were 0.55 and 0.37, respectively. Good cycle control was maintained in patterns similar to those noted in previous studies. The incidence of dysmenorrhea and premenstrual syndrome was sharply reduced. Side effects reported were typical of those associated with use of low-dose oral contraceptive agents. Acceptability was high compared with agents used previously by the subjects. Total cholesterol did not change but high-density lipoprotein cholesterol was significantly elevated at 3 and 12 months. There were no clinically significant changes in the parameters of hematology or blood chemistry tested.
在一项针对661名女性的为期12个月的研究中，对含有诺孕酯和炔雌醇的三相口服避孕药的安全性和有效性进行了评估。避孕效果极佳，在总共6511个治疗周期中，仅有两例妊娠归因于产品失效。生命表预测的妊娠率为每100名女性使用年0.57例。总体Pearl指数和理论Pearl指数分别为0.55和0.37。月经周期控制良好，与先前研究中观察到的模式相似。痛经和经前综合征的发生率大幅降低。报告的副作用是使用低剂量口服避孕药常见的副作用。与受试者先前使用的药物相比，该药物的可接受性较高。总胆固醇没有变化，但高密度脂蛋白胆固醇在3个月和12个月时显著升高。所检测的血液学或血液化学参数没有临床显著变化。
