Coffee Andrea L, Sulak Patricia J, Kuehl Thomas J
Department of Obstetrics and Gynecology, Scott & White Memorial Hospital, Texas A&M University System Health Science Center College of Medicine, TX 76508, USA.
Contraception. 2007 Jun;75(6):444-9. doi: 10.1016/j.contraception.2007.01.014. Epub 2007 Mar 23.
The study was conducted to assess hormone withdrawal symptoms, patient acceptance and occurrence and management of bleeding with an extended oral contraceptive (OC) regimen.
Subjects were placed on an OC containing 3 mg drosperinone (DRSP) and 30 microg ethinyl estradiol (EE), in the standard 21/7 fashion for two cycles, before converting to an extended pattern of OC for women who indicated they had menstrually related symptoms such as headaches, cramping and mood swings (52 weeks with phone-call follow-up 6 months later). Daily assessments of bleeding, headache, pelvic pain, mood and number of pain pills were recorded. Results are reported as means with S.E., and values were compared using analysis of variance with Dunnett's post hoc test for comparison with 21/7 cycle, Duncan's post hoc test for comparison of changes during the course of the extended regimen and Pearson's chi-square for comparison of proportions.
Of the 111 women who began the extended OC regimen, 80 completed 1 year of use. Mood scores, headache scores and pelvic pain were all improved in the extended OC intervals, compared to the 21/7 cycle (p<.001 for all comparisons). Improvement in symptoms persisted throughout the 1 year extended regimen. The findings indicated that 53.7% of subjects had no breakthrough bleeding or breakthrough spotting (BTB/BTS) during any given 28-day interval of the extended regimen. BTB/BTS decreased in the second half compared to the first half of the extended regimen. To manage BTB/BTS, instituting a 3-day hormone-free interval (HFI) was significantly more effective than continuing OCs (p<.001). At the 6-month follow-up, most subjects had continued the extended regimen on their own with a high level of satisfaction.
An extended OC regimen containing DRSP/EE significantly improved mood, headaches and pelvic pain scores throughout the 1 year of use, compared to a 21/7 cycle. Sustained BTB/BTS episodes occurred in 45 subjects (56%), decreasing in the second half of the study and effectively managed with a 3-day HFI.
本研究旨在评估延长口服避孕药（OC）方案下的激素撤药症状、患者接受度以及出血情况的发生与处理。
受试者先按照标准的21/7模式服用含3毫克屈螺酮（DRSP）和30微克炔雌醇（EE）的OC，为期两个周期，之后对于表示有月经相关症状（如头痛、痛经和情绪波动）的女性转换为延长模式的OC（52周，6个月后进行电话随访）。记录每日的出血、头痛、盆腔疼痛、情绪及止痛片服用数量情况。结果以均值及标准误表示，采用方差分析及Dunnett事后检验与21/7周期进行比较，采用Duncan事后检验比较延长方案过程中的变化，采用Pearson卡方检验比较比例。
在开始延长OC方案的111名女性中，80名完成了1年的使用。与21/7周期相比，延长OC期间的情绪评分、头痛评分和盆腔疼痛均有所改善（所有比较p<0.001）。症状改善在整个1年的延长方案中持续存在。结果表明，在延长方案的任何给定28天间隔内，53.7%的受试者无突破性出血或突破性点滴出血（BTB/BTS）。与延长方案的前半段相比，后半段的BTB/BTS有所减少。为处理BTB/BTS，设定3天无激素间隔（HFI）比继续服用OC显著更有效（p<0.001）。在6个月随访时，大多数受试者自行继续延长方案，满意度较高。
与21/7周期相比，含DRSP/EE的延长OC方案在1年使用期间显著改善了情绪、头痛和盆腔疼痛评分。45名受试者（56%）出现持续性BTB/BTS发作，在研究后半段减少，并通过3天HFI有效处理。
