三种口服避孕药的随机试验：按避孕药类型和甾体激素水平比较出血模式

A randomized trial of three oral contraceptives: comparison of bleeding patterns by contraceptive types and steroid levels.

作者信息

Saleh W A, Burkman R T, Zacur H A, Kimball A W, Kwiterovich P, Bell W K

机构信息

Department of Gynecology and Obstetrics, Henry Ford Hospital, Detroit, MI 48202.

出版信息

Am J Obstet Gynecol. 1993 Jun;168(6 Pt 1):1740-5; discussion 1745-7. doi: 10.1016/0002-9378(93)90685-c.

DOI:10.1016/0002-9378(93)90685-c

PMID:8317516

Abstract

OBJECTIVE

Our purpose was to determine the relationship between bioavailability of contraceptive steroids and bleeding patterns.

STUDY DESIGN

A randomized clinical trial evaluated 192 women on 50 micrograms of ethinyl estradiol and 1.0 mg of norethindrone (OC1), 35 micrograms ethinyl estradiol and 1.0 mg of norethindrone (OC2), and 35 micrograms ethinyl estradiol and 0.5 mg norethindrone (OC3) over nine cycles.

RESULTS

Intermenstrual bleeding rates were higher for OC3 when compared with OC1 (p = 0.01). The number of intermenstrual bleeding days was highest for OC3 (p = 0.001) and higher for OC2 when compared with OC1 (p < 0.006). The onset of withdrawal bleeding occurred faster in OC3 patients (p < 0.02). Bioavailability of both contraceptive steroids as measured by baseline values and 1-hour slopes did not correlate with bleeding patterns at 3, 6, and 9 months of use.

CONCLUSION

These data suggest that differences in biologic responses associated with pill use cannot be explained solely on the basis of these particular hormone measurements.

摘要

目的

我们的目的是确定避孕甾体激素的生物利用度与出血模式之间的关系。

研究设计

一项随机临床试验对192名女性进行了为期九个周期的评估，她们分别服用含50微克炔雌醇和1.0毫克炔诺酮的避孕药（OC1）、含35微克炔雌醇和1.0毫克炔诺酮的避孕药（OC2）以及含35微克炔雌醇和0.5毫克炔诺酮的避孕药（OC3）。

结果

与OC1相比，OC3的经间期出血率更高（p = 0.01）。OC3的经间期出血天数最多（p = 0.001），与OC1相比，OC2的经间期出血天数也更多（p < 0.006）。OC3组患者撤退性出血的发生更快（p < 0.02）。通过基线值和1小时斜率测量的两种避孕甾体激素的生物利用度与使用3个月、6个月和9个月时的出血模式均无相关性。