Levens Eric D, Potlog-Nahari Clariss, Armstrong Alicia Y, Wesley Robert, Premkumar Ahalya, Blithe Diana L, Blocker Wendy, Nieman Lynnette K
Reproductive Biology and Medicine Branch, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland 20892, USA.
Obstet Gynecol. 2008 May;111(5):1129-36. doi: 10.1097/AOG.0b013e3181705d0e.
To evaluate whether 3-month administration of CDB-2914, a selective progesterone receptor modulator, reduces leiomyoma size and symptoms.
Premenopausal women with symptomatic uterine leiomyomata were randomly assigned to CDB-2914 at 10 mg (T1) or 20 mg (T2) daily or to placebo (PLC) for 3 cycles or 90-102 days if no menses occurred. The primary outcome was leiomyoma volume change determined by magnetic resonance imaging at study entry and within 2 weeks of hysterectomy. Secondary outcomes included the proportion of amenorrhea, change in hemoglobin and hematocrit, ovulation inhibition, and quality-of-life assessment.
Twenty-two patients were allocated, and 18 completed the trial. Age and body mass index were similar among groups. Leiomyoma volume was significantly reduced with CDB-2914 administration (PLC 6%; CDB-2914 -29%; P=.01), decreasing 36% and 21% in the T1 and T2 groups, respectively. During treatment, hemoglobin was unchanged, and the median estradiol was greater than 50 pg/mL in all groups. CDB-2914 eliminated menstrual bleeding and inhibited ovulation (% ovulatory cycles: CDB-2914, 20%; PLC, 83%; P=.001). CDB-2914 improved the concern scores of the uterine leiomyoma symptom quality-of-life subscale (P=.04). One CDB-2914 woman developed endometrial cystic hyperplasia without evidence of atypia. No serious adverse events were reported.
Compared with PLC, CDB-2914 significantly reduced leiomyoma volume after three cycles, or 90-102 days. CDB-2914 treatment resulted in improvements in the concern subscale of the Uterine Fibroid Symptom Quality of Life assessment. In this small study, CDB-2914 was well-tolerated without serious adverse events. Thus, there may be a role for CDB-2914 in the treatment of leiomyomata.
ClinicalTrials.gov,www.clinicaltrials.gov, NCT00290251
I.
评估选择性孕激素受体调节剂CDB - 2914服用3个月是否能缩小子宫肌瘤大小并缓解症状。
有症状的绝经前子宫肌瘤女性被随机分配至每日服用10 mg（T1组）或20 mg（T2组）的CDB - 2914组，或安慰剂（PLC组），为期3个周期或90 - 102天（若未出现月经）。主要结局是通过研究开始时及子宫切除术前2周的磁共振成像确定的子宫肌瘤体积变化。次要结局包括闭经比例、血红蛋白和血细胞比容变化、排卵抑制及生活质量评估。
共纳入22例患者，18例完成试验。各组间年龄和体重指数相似。服用CDB - 2914后子宫肌瘤体积显著缩小（PLC组6%；CDB - 2914组 - 29%；P = 0.01），T1组和T2组分别缩小36%和21%。治疗期间，血红蛋白无变化，所有组的雌二醇中位数均大于50 pg/mL。CDB - 2914消除了月经出血并抑制了排卵（排卵周期百分比：CDB - 2914组20%；PLC组83%；P = 0.001）。CDB - 2914改善了子宫肌瘤症状生活质量子量表的关注评分（P = 0.04）。1例服用CDB - 2914的女性发生子宫内膜囊性增生，无非典型性证据。未报告严重不良事件。
与PLC组相比，CDB - 2914在3个周期或90 - 102天后显著缩小了子宫肌瘤体积。CDB - 2914治疗改善了子宫肌瘤症状生活质量评估的关注子量表。在这项小型研究中，CDB - 2914耐受性良好，无严重不良事件。因此，CDB - 2914在子宫肌瘤治疗中可能有一定作用。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00290251
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