Simon James A, Liu James H, Speroff Leon, Shumel Brad S, Symons James P
Women's Health Research Center, Laurel, MD 20707, USA.
Am J Obstet Gynecol. 2003 Jan;188(1):92-9. doi: 10.1067/mob.2003.104.
The purpose of this study was to compare the effects on vaginal bleeding patterns of continuous combined hormone replacement therapy with norethindrone acetate and ethinyl estradiol versus conjugated equine estrogens and medroxyprogesterone acetate.
Three hundred fifty-seven postmenopausal women were selected randomly (in a blinded manner) to 12 months of treatment with 1 mg norethindrone acetate/5 microg ethinyl estradiol, placebo, or open-label 0.625 mg conjugated equine estrogens/2.5 mg medroxyprogesterone acetate (conjugated equine estrogens/medroxyprogesterone acetate [CEE/MPA]; Prempro). The incidence and duration of vaginal bleeding were assessed throughout the study. Statistical analyses used Cochran-Mantel-Haenszel methodology and analysis of variance.
At 3 months, 1 mg norethindrone acetate/5 microg ethinyl estradiol therapy reduced the incidence of bleeding (12% vs 23%; P <.029) and bleeding and/or spotting (22% vs 44%; P <.001), compared with conjugated equine estrogens/medroxyprogesterone acetate therapy. The mean duration of bleeding and bleeding and/or spotting were also reduced with 1 mg norethindrone acetate/5 microg ethinyl estradiol therapy versus conjugated equine estrogens/medroxyprogesterone acetate (P =.004 and P <.001, respectively). The incidence of cumulative amenorrhea at every monthly interval was significantly better with 1 mg norethindrone acetate/5 microg ethinyl estradiol therapy versus conjugated equine estrogens/medroxyprogesterone acetate therapy (P <.05). Associated adverse event (ie, headache, breast pain) incidence rates were similar in the 2 active treatment groups.
The 1 mg norethindrone acetate/5 microg ethinyl estradiol therapy provides significantly better control of vaginal bleeding than conjugated equine estrogens/medroxyprogesterone acetate therapy at all time points investigated in this 12-month study.
本研究旨在比较醋酸炔诺酮与炔雌醇连续联合激素替代疗法和结合马雌激素与醋酸甲羟孕酮对阴道出血模式的影响。
357名绝经后女性被随机（采用盲法）选取，接受1毫克醋酸炔诺酮/5微克炔雌醇、安慰剂或开放标签的0.625毫克结合马雌激素/2.5毫克醋酸甲羟孕酮（结合马雌激素/醋酸甲羟孕酮[CEE/MPA]；倍美安）治疗12个月。在整个研究过程中评估阴道出血的发生率和持续时间。统计分析采用 Cochr an-Mantel-Haenszel方法和方差分析。
在3个月时，与结合马雌激素/醋酸甲羟孕酮治疗相比，1毫克醋酸炔诺酮/5微克炔雌醇治疗降低了出血发生率（12%对23%；P<.029）以及出血和/或点滴出血发生率（22%对44%；P<.001）。与结合马雌激素/醋酸甲羟孕酮相比，1毫克醋酸炔诺酮/5微克炔雌醇治疗还缩短了出血以及出血和/或点滴出血的平均持续时间（分别为P=.004和P<.001）。与结合马雌激素/醋酸甲羟孕酮治疗相比，1毫克醋酸炔诺酮/5微克炔雌醇治疗在每个月间隔时的累积闭经发生率显著更高（P<.05）。两个活性治疗组的相关不良事件（即头痛、乳房疼痛）发生率相似。
在这项为期12个月的研究中所调查的所有时间点，1毫克醋酸炔诺酮/5微克炔雌醇治疗对阴道出血的控制明显优于结合马雌激素/醋酸甲羟孕酮治疗。
