From the Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville, Jacksonville, Florida; Department of Obstetrics and Gynecology, Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Québec, Canada; Human Reproduction Unit, Department of Obstetrics and Gynecology, School of Medicine, University of Campinas (UNICAMP), Campinas, São Paulo, Brazil; Bayer Schering Pharma Oy, Espoo, Finland; Bayer Schering Pharma AG, Berlin, Germany; Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, Oregon.
Obstet Gynecol. 2010 Sep;116(3):625-632. doi: 10.1097/AOG.0b013e3181ec622b.
To compare the efficacy and safety of the levonorgestrel-releasing intrauterine system and oral medroxyprogesterone acetate in the treatment of idiopathic heavy menstrual bleeding.
In this multicenter, randomized, controlled study, women aged 18 years or older with heavy menstrual bleeding (menstrual blood loss 80 mL or more per cycle) were randomly assigned to six cycles of treatment with either levonorgestrel-releasing intrauterine system or oral medroxyprogesterone acetate (10 mg daily for 10 days beginning on day 16 of each cycle). The primary efficacy variables were the absolute change in menstrual blood loss from baseline to end of study and the proportion of women with successful treatment (defined as menstrual blood loss less than 80 mL and a 50% or greater reduction in menstrual blood loss from baseline).
Of 807 women screened, 165 were randomly assigned to treatment (levonorgestrel-releasing intrauterine system n=82, oral medroxyprogesterone acetate n=83). At the end of the study, the absolute reduction in median menstrual blood loss was significantly greater in the levonorgestrel-releasing intrauterine system group (-128.8 mL, range -393.6 to +1242.2 mL) than in the medroxyprogesterone acetate arm (-17.8 mL, range -271.5 to +78.6 mL, P < .001), and the proportion of women with successful treatment was significantly higher for the levonorgestrel-releasing intrauterine system (84.8%) than for medroxyprogesterone acetate (22.2%, P < .001).
In women with idiopathic heavy menstrual bleeding, the levonorgestrel-releasing intrauterine system reduces menstrual blood loss more effectively and has a higher likelihood of treatment success than oral medroxyprogesterone acetate.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00360490.
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比较左炔诺孕酮宫内缓释系统与醋酸甲羟孕酮口服治疗特发性月经过多的疗效和安全性。
这是一项多中心、随机、对照研究，纳入年龄在 18 岁及以上、月经过多（每周期失血量 80ml 或以上）的女性患者，按 6 个周期随机分组，分别接受左炔诺孕酮宫内缓释系统或醋酸甲羟孕酮治疗（每日 10mg，于每个周期第 16 天开始，连用 10 天）。主要疗效变量为从基线到研究结束时的月经失血量绝对变化值和治疗成功的女性比例（定义为月经失血量<80ml，且与基线相比减少 50%或以上）。
在 807 名筛查的女性中，165 名女性被随机分配到治疗组（左炔诺孕酮宫内缓释系统组 82 例，醋酸甲羟孕酮组 83 例）。研究结束时，左炔诺孕酮宫内缓释系统组的中位月经失血量绝对减少量显著大于醋酸甲羟孕酮组（-128.8ml，范围-393.6 至+1242.2ml；P<.001），且左炔诺孕酮宫内缓释系统组的治疗成功比例也显著高于醋酸甲羟孕酮组（84.8%比 22.2%，P<.001）。
在特发性月经过多的女性中，左炔诺孕酮宫内缓释系统比醋酸甲羟孕酮更有效地减少月经失血量，且更有可能取得治疗成功。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00360490。
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