Rabe T, Runnebaum B, Kohlmeyer M, Weicker H
Department of Gynecologic Endocrinology, University Women's Hospital, Heidelberg, FRG.
Int J Fertil. 1986;31 SU [UPDATE]:46-52.
A clinical trial was conducted to determine the effects of a norethindrone-containing triphasic oral contraceptive, Ortho-Novum 7/7/7, on lipid, carbohydrate, and androgen metabolism in 22 women during 12 cycles of use. Examinations were made in two consecutive cycles before treatment and after 3, 6, 9, and 12 cycles of treatment. Treatment consisted of ethinyl estradiol, 35 micrograms/d for 21 days, together with norethindrone in stepwise-increasing doses of 0.5, 0.75, and 1.0 mg/d, with each dose given for seven days. Only a minimal impact on lipid metabolism was observed during treatment. There were no unfavorable changes in any HDL-related measurement. HDL-cholesterol and alpha levels were not altered in any cycle. The HDL:LDL ratio was not significantly altered during treatment. LDL cholesterol levels were also unaltered during treatment, but there were slight elevations in other LDL-related measurements in some cycles. Total cholesterol, phospholipid, and triglyceride levels were elevated in cycle 9, and triglyceride levels also increased in cycle 3, but no significant changes were observed in these levels at any other sampling times. Carbohydrate metabolism did not change significantly as indicated by mean fasting levels of glucose, insulin, and HbA1c or by levels of these parameters after a glucose load. Changes observed in androgenic parameters indicate the lack of androgenicity. The results of this study demonstrate that Ortho-Novum 7/7/7 use results in a minimal impact on lipid metabolism, no change in carbohydrate metabolism, and no potential for androgenic side effects.
进行了一项临床试验,以确定含炔诺酮的三相口服避孕药 Ortho-Novum 7/7/7 对 22 名女性在 12 个使用周期内脂质、碳水化合物和雄激素代谢的影响。在治疗前的两个连续周期以及治疗 3、6、9 和 12 个周期后进行检查。治疗方案为炔雌醇,每日 35 微克,共 21 天,同时炔诺酮剂量逐步增加,分别为每日 0.5、0.75 和 1.0 毫克,每个剂量服用 7 天。治疗期间仅观察到对脂质代谢有极小影响。任何与高密度脂蛋白(HDL)相关的测量指标均未出现不利变化。HDL 胆固醇和α水平在任何周期均未改变。治疗期间 HDL 与低密度脂蛋白(LDL)的比率未显著改变。治疗期间 LDL 胆固醇水平也未改变,但在某些周期中其他与 LDL 相关的测量指标略有升高。总胆固醇、磷脂和甘油三酯水平在第 9 周期升高,甘油三酯水平在第 3 周期也有所增加,但在任何其他采样时间这些水平均未观察到显著变化。碳水化合物代谢未出现显著变化,这通过空腹血糖、胰岛素和糖化血红蛋白(HbA1c)的平均水平或葡萄糖负荷后这些参数的水平得以体现。雄激素参数的变化表明该药缺乏雄激素活性。本研究结果表明,使用 Ortho-Novum 7/7/7 对脂质代谢影响极小,碳水化合物代谢无变化,且无雄激素副作用的可能性。