Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study.
Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study.
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DOI：
10.1016/j.fertnstert.2010.09.059
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发表时间：
2011-02
影响因子：
6.7
通讯作者：
Armstrong, Alicia
中科院分区：
文献类型：
--
作者：
Nieman, Lynnette K.;Blocker, Wendy;Nansel, Tonja;Mahoney, Sheila;Reynolds, James;Blithe, Diana;Wesley, Robert;Armstrong, Alicia
评价P受体调节剂CDB-2914（Ulipristal，CDB）的疗效和耐受性。随机、安慰剂对照双盲临床试验。临床研究中心。有症状的子宫肌瘤绝经前妇女。每日一次口服CDB（10或20 mg）或安慰剂（PLC），持续12周（治疗1）。提供了第二个3个月的CDB治疗（治疗2）。使用计算机生成的区组随机化。磁共振成像（MRI）确定的总肌瘤体积（TFV）变化是主要终点;闭经和生活质量（QOL）是次要终点。治疗1的TFV在PLC组中增加了7%，但在CDB 10和CDB 20组中降低了17%和24%。治疗2中的TFV进一步降低（-11%）。26例服用CDB的妇女中有20例发生闭经，而服用PLC的妇女中无一例发生闭经。CDB后恢复排卵。仅CDB组血红蛋白改善（11.9 ± 1.5至12.9 ± 1.0 g/dL），肌瘤QOL问卷症状严重程度、精力/情绪和关注分项评分以及总体QOL评分也改善。CDB耐受性良好，无严重不良事件。治疗期间不良事件未发生变化。给予CDB-2914 3-6个月控制出血，减小纤维瘤大小，并改善QOL。
To evaluate the efficacy and tolerability of the P receptor modulator CDB-2914 (Ulipristal, CDB). Randomized, placebo-controlled double-blind clinical trial. Clinical research center. Premenopausal women with symptomatic uterine fibroids. Once-daily oral CDB (10 or 20 mg) or placebo (PLC) for 12 weeks (treatment 1). A second 3-month treatment with CDB (treatment 2) was offered. A computer-generated blocked randomization was used. Magnetic resonance imaging (MRI)-determined total fibroid volume (TFV) change was the primary outcome; amenorrhea and quality of life (QOL) were secondary end points. Treatment 1 TFV increased 7% in the PLC group, but decreased 17% and 24% in the CDB10 and CDB20 groups. The TFV decreased further in treatment 2 (-11%). Amenorrhea occurred in 20/26 women taking CDB and none on PLC. Ovulation resumed after CDB. Hemoglobin improved only with CDB (11.9 ± 1.5 to 12.9 ± 1.0 g/dL) as did the Fibroid QOL Questionnaire symptom severity, energy/mood, and concern subscores, and overall QOL scores. The CDB was well tolerated, with no serious adverse events. Adverse events were unchanged during treatments. Administration of CDB-2914 for 3–6 months controls bleeding, reduces fibroid size, and improves QOL.
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影响因子：
7.2
作者：
Fiscella, Kevin;Eisinger, Steven H.;Guzick, David S.
通讯作者：
Guzick, David S.
DOI：
10.1097/jom.0b013e3181895e10
发表时间：
2008-10-01
影响因子：
3.2
作者：
Lerner, Debra;Mirza, Fadi;Chelmow, David
通讯作者：
Chelmow, David
影响因子：
4.1
作者：
Eisinger, SH;Bonfiglio, T;Guzick, DS
通讯作者：
Guzick, DS
影响因子：
7.2
作者：
Ware, JE;Gandek, B
通讯作者：
Gandek, B
影响因子：
3.5
作者：
Mauskopf, J;Flynn, M;Duchane, J
通讯作者：
Duchane, J