Effects of continuous versus cyclical oral contraception:: A randomized controlled trial
Effects of continuous versus cyclical oral contraception:: A randomized controlled trial
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DOI：
10.1210/jc.2007-2287
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发表时间：
2008-02-01
影响因子：
5.8
通讯作者：
Dodson, William C.
中科院分区：
文献类型：
--
作者：
Legro, Richard S.;Pauli, Jaimey G.;Dodson, William C.
背景：连续口服避孕药可以更好地抑制卵巢和子宫内膜，有助于治疗其他疾病。目的：我们的目的是确定连续口服避孕药与周期性口服避孕药的效果。设计：这是一项随机双盲试验。背景：该试验在宾夕法尼亚州的一个学术医疗中心进行。患者：总共 62 名月经规律的健康女性被纳入研究。干预：周期性口服避孕药（21 天）对连续六个 28 天周期的主动/7 天安慰剂治疗与使用单相药丸（20 μg 炔雌醇和 1 mg 醋酸炔诺酮）的连续治疗（168 天主动药丸）进行了检查。主要结果指标：主要结果是阴道出血，次要结果包括激素、盆腔超声、生活质量和安全措施。结果：数量上没有统计学上的显着差异。组间总出血天数的差异，但周期性治疗方案的中度/重度出血明显增多[平均 11.0 天 (SD8.5) 对比连续 5.2 天 (SD 6.8)； P= 0.005]，两组加时赛都减少了。连续组在六个周期内测得的内源性血清和尿液雌激素显着低于周期组（分别为 P = 0.02 和 0.04）。通过连续超声检查，在试验过程中，连续组中的女性卵巢体积和卵泡尺寸也较小。 Moos 月经困扰问卷显示，接受持续治疗的女性经前疼痛较少（P = 0.01），行为也有良好改善（P = 0.04）。结论：在 168 天的观察期内，持续口服避孕药不会导致出血天数减少，但会更大程度地抑制卵巢和子宫内膜。这些作用与患者症状的改善有关。
Context: Continuous oral contraception may better suppress the ovary and endometrium, lending itself to the treatment of other medical conditions.Objective: Our objective was to determine the effects of continuous vs. cyclical oral contraception.Design: This was a randomized double-blind trial.Setting: This trial was performed at an academic medical center in Pennsylvania.Patients: A total of 62 healthy women with regular menses were included in the study.Intervention: Cyclical oral contraception (21-d active/7-d placebo given for six consecutive 28-d cycles) vs. continuous (168-d active pill)therapy using a monophasic pill (20 mu g ethinyl estradiol and 1 mg norethindrone acetate) was examined.Main Outcome Measures: The primary outcome was vaginal bleeding, and secondary outcomes included hormonal, pelvic ultrasound, quality of life, and safety measures.Results: There was no statistically significant difference in the number of total bleeding days between groups, but moderate/heavy bleeding was significantly greater with the cyclical regimen [mean 11.0 d (SD8.5) vs. continuous 5.2 d (SD 6.8); P= 0.005], with both groups decreasing overtime. Endogenous serum and urinary estrogens measured over six cycles were significantly lower (P = 0.02 and 0.04, respectively) in the continuous group than the cyclical group. Women in the continuous group also had a smaller ovarian volume and lead follicle size over the course of the trial by serial ultrasound examinations. The Moos Menstrual Distress Questionnaire showed that women on continuous therapy had less associated menstrual pain (P = 0.01) and favorable improvements in behavior (P = 0.04) during the premenstrual period.Conclusions: Continuous oral contraception does not result in a reduction of bleeding days over a 168-d period of observation but provides greater suppression of the ovary and endometrium. These effects are associated with improved patient symptomatology.