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恶拉戈利治疗子宫肌瘤患者的月经过多
Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids


William D. Schlaff ... 妇产科和儿科 • 2020.01.23
相关阅读
• 子宫肌瘤所致月经过多的激素治疗方案 • 药物治疗改善子宫肌瘤患者的生活质量 • 子宫肌瘤的药物治疗既应考虑GnRH激动剂也应考虑GnRH拮抗剂

摘要


背景

子宫肌瘤是一种对激素治疗有应答的肿瘤,与月经过多相关。恶拉戈利是口服促性腺激素释放素拮抗剂,可迅速、可逆地抑制卵巢性激素,有可能减少与子宫肌瘤相关的出血。

 

方法

我们开展了两项相同的双盲、随机、安慰剂对照、6个月3期试验(Elaris子宫肌瘤1和2[Elaris Uterine Fibroids 1 and 2,UF-1和UF-2]),目的是在有子宫肌瘤相关出血的女性中评估每日2次、每次300 mg恶拉戈利联合激素“反加”(add-back)疗法(用于代替减少的内源性激素;本研究采用的是每日1次、每次1 mg雌二醇和0.5 mg醋炔诺酮)的疗效和安全性。本研究还包括了一个恶拉戈利单药治疗组,旨在评估反加疗法对恶拉戈利的低雌激素效应所产生的影响。主要终点是最后一个月治疗期间的月经失血量少于80 mL,以及最后一个月的月经失血量相对于基线减少至少50%;我们利用多重填补法对缺失数据进行了填补。

 

结果

UF-1试验的412名女性和UF-2试验的378名女性被随机分组,接受了恶拉戈利或安慰剂治疗,并被纳入分析。在接受恶拉戈利+反加疗法的女性中,UF-1试验206人中的68.5%和UF-2试验189人中的76.5%达到了主要终点标准;而在接受安慰剂治疗的女性中,UF-1试验102人中的8.7%和UF-2试验94人中的10%达到了主要终点标准(对于两项试验,P<0.001)。在接受恶拉戈利单药治疗的女性中,UF-1试验104人中的84.1%和UF-2试验95人中的77%达到了主要终点。在恶拉戈利+反加疗法组中,潮热(两项试验)和子宫出血(UF-1)的发生率显著高于安慰剂组。反加疗法减轻了恶拉戈利的低雌激素效应,尤其是降低骨密度方面的低雌激素效应。

 

结论

在患子宫肌瘤的女性中,恶拉戈利联合反加疗法可有效减轻月经过多(由艾伯维资助;Elaris UF-1和Elaris UF-2在ClinicalTrials.gov注册号分别为NCT02654054和NCT02691494)。





作者信息

William D. Schlaff, M.D., Ronald T. Ackerman, M.D., Ayman Al-Hendy, M.D., Ph.D., David F. Archer, M.D., Kurt T. Barnhart, M.D., Linda D. Bradley, M.D., Bruce R. Carr, M.D., Eve C. Feinberg, M.D., Sandra M. Hurtado, M.D., JinHee Kim, M.D., Ran Liu, Ph.D., R. Garn Mabey, Jr., M.D., Charlotte D. Owens, M.D., Alfred Poindexter, M.D., Elizabeth E. Puscheck, M.D., M.B.A., Henry Rodriguez-Ginorio, M.D., James A. Simon, M.D., Ahmed M. Soliman, Ph.D., Elizabeth A. Stewart, M.D., Nelson B. Watts, M.D., and Ozgul Muneyyirci-Delale, M.D.
From Thomas Jefferson University (W.D.S.) and the University of Pennsylvania (K.T.B.), Philadelphia; Comprehensive Clinical Trials, West Palm Beach, FL (R.T.A.); University of Illinois at Chicago (A.A.-H.) and Northwestern University (E.C.F.), Chicago, AbbVie, North Chicago (R.L., C.D.O., A.M.S.), and InVia Fertility, Hoffman Estates (E.E.P.) — all in Illinois; Eastern Virginia Medical School, Norfolk (D.F.A.); Cleveland Clinic, Cleveland (L.D.B.); University of Texas Southwestern Medical Center, Dallas (B.R.C.); University of Texas Health Science Center at Houston (S.M.H.) and Advances in Health (A.P.), Houston; Columbia University (J.K.) and SUNY Downstate Health Sciences University (O.M.-D.), New York; private practice, Las Vegas (R.G.M.); Wayne State University, Detroit (E.E.P.); Torre de Auxilio Mutuo, San Juan, Puerto Rico (H.R.-G.); George Washington University, Washington, DC (J.A.S.); Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN (E.A.S.); and Mercy Health, Cincinnati (N.B.W.). Address reprint requests to Dr. Schlaff at Thomas Jefferson University, 833 Chestnut St., Mezzanine, Philadelphia, PA 19107, or at william.schlaff@jefferson.edu.

 

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