Wiegratz Inka, Elliesen Jörg, Paoletti Anna Maria, Walzer Anja, Kirsch Bodo
Kinderwunschpraxis am Goetheplatz, Frankfurt, Germany ; MVZ Kinderwunschzentrum Wiesbaden GmbH, Wiesbaden, Germany.
Bayer HealthCare Pharmaceuticals, Berlin, Germany.
Int J Womens Health. 2015 Jan 5;7:19-29. doi: 10.2147/IJWH.S71906. eCollection 2015.
To evaluate the effect of a digital dispenser's acoustic alarm function on adherence to ethinylestradiol (EE) 20 μg/drospirenone 3 mg in a flexible extended regimen (EE/drospirenoneFlex) among women in five European countries (France, Germany, Italy, Spain, UK) seeking oral contraception.
Randomized, parallel-group open-label study.
Women aged 18-35 years received EE/drospirenoneFlex administered in a regimen with cycle lengths of their choice with the aid of a digital pill dispenser over 1 year. In group A (N=250), the dispenser's acoustic alarm was activated (ie, acoustic alarm + visual reminder). In group B (N=249), the acoustic alarm was deactivated (ie, visual reminder only). In addition, the women recorded pill intake daily in diary cards. The primary efficacy variable was the mean delay of daily pill release after the dispenser reminded the woman to take a pill (reference time). Secondary efficacy variables included number of missed pills, contraceptive efficacy, bleeding pattern, tolerability, and user satisfaction.
Dispenser data showed a mean (standard deviation [SD]) daily delay in pill release of 88 (126) minutes in group A vs 178 (140) minutes in group B (P<0.0001). Median (lower quartile, Q1; upper quartile, Q3) number of missed pills was 0 (0; 1) in group A vs 4 (1; 9) in group B (P<0.0001). Diary card results revealed similar trends; however, underreporting of missed pills was evident in both groups. No pregnancies were reported during 424 women-years of exposure. Across the two groups, the mean (SD) EE/drospirenoneFlex cycle length was 51.0 (31.8) days with strong regional differences, and the mean (SD) number of bleeding/spotting days was 50.4 (33.0) days. EE/drospirenoneFlex was well tolerated, and 80% of women were satisfied with treatment.
The dispenser's activated acoustic alarm improved adherence with daily tablet intake of EE/drospirenoneFlex, reducing missed pills. EE/drospirenoneFlex provided effective contraception and a good tolerability profile.
评估数字式药剂分配器的声音警报功能对五个欧洲国家（法国、德国、意大利、西班牙、英国）寻求口服避孕药的女性在灵活延长疗程（乙炔雌二醇/屈螺酮Flex）中服用20μg乙炔雌二醇/3mg屈螺酮的依从性的影响。
随机、平行组开放标签研究。
18至35岁的女性在数字式药丸分配器的帮助下，按照她们选择的周期长度服用乙炔雌二醇/屈螺酮Flex，为期1年。A组（N = 250）中，分配器的声音警报被激活（即声音警报+视觉提醒）。B组（N = 249）中，声音警报被停用（即仅视觉提醒）。此外，女性每天在日记卡上记录服药情况。主要疗效变量是分配器提醒女性服药（参考时间）后每日药丸释放的平均延迟时间。次要疗效变量包括漏服药丸数量、避孕效果、出血模式、耐受性和用户满意度。
分配器数据显示，A组药丸释放的每日平均（标准差[SD]）延迟时间为88（126）分钟，B组为178（140）分钟（P<0.0001）。A组漏服药丸的中位数（下四分位数，Q1；上四分位数，Q3）为0（0；1）颗，B组为4（1；9）颗（P<0.0001）。日记卡结果显示了类似趋势；然而，两组中漏服药丸的报告不足现象都很明显。在424名女性年的暴露期间未报告怀孕情况。在两组中，乙炔雌二醇/屈螺酮Flex的平均（SD）周期长度为51.0（31.8）天，存在显著的地区差异，出血/点滴出血天数的平均（SD）为50.4（33.0）天。乙炔雌二醇/屈螺酮Flex耐受性良好，80%的女性对治疗满意。
分配器激活的声音警报提高了乙炔雌二醇/屈螺酮Flex每日片剂服用的依从性，减少了漏服药丸的情况。乙炔雌二醇/屈螺酮Flex提供了有效的避孕效果和良好的耐受性。
