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首页> 外文期刊>International journal of fertility and women's medicine >Effect of a unique constant-estrogen, pulsed-progestin hormone replacement therapy containing 17beta-estradiol and norgestimate on endometrial histology.
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Effect of a unique constant-estrogen, pulsed-progestin hormone replacement therapy containing 17beta-estradiol and norgestimate on endometrial histology.

机译：含有17β-雌二醇和norgestimate的独特的恒定雌激素，脉冲孕激素激素替代疗法对子宫内膜组织学的影响。

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OBJECTIVE: To evaluate the effect of a 17beta-estradiol(E2)orgestimate (NGM) HRT regimen, which provides constant estrogen in combination with pulsed progestin administration, on endometrial histology in healthy postmenopausal women 40 to 65 years of age who had experienced natural menopause at least 12 months before the start of the study. METHODS: A total of 1,253 postmenopausal women were randomized to receive either continuous 1 mg E2, or constant estrogen, pulsed progestin regimens of 1 mg E2/30 microg NGM, 1 mg E2/90 microg NGM, or 1 mg E2/180 microg NGM (3 days on, 3 days off) in a 12-month, multicenter, double-blind study. Endometrial biopsies were obtained pre- and post-treatment, and were evaluated by at least 2 (if required, by 3) pathologists who were blinded with respect to treatment and to each other's diagnosis. RESULTS: At the end of the study, no cases of endometrial hyperplasia were diagnosed in subjects who received E2 1 mg/NGM 90 microg or E21 mg/NGM 180 microg, whereas 74 (28%) and 16 (6%) cases of endometrial hyperplasia were diagnosed in subjects who received continuous E2 1 mg and E2 1 mg/NGM 30 microg, respectively. A dose-related endometrial response to NGM was apparent (P < .001). The percentage of patients with inactive/atrophic endometrium increased with NGM dose. CONCLUSION: The results of this study support the safety and efficacy of this unique HRT regimen and suggest that the minimal NGM dose required to protect the endometrium from hyperplasia in a pulsed progestin regimen consisting of continuous E2 1 mg is 90 microg.
机译：目的：评估17β-雌二醇（E2）/孕激素（NGM）HRT方案对健康的40至65岁绝经后妇女的自然子宫内膜组织学的影响，该方案可提供恒定的雌激素与脉冲黄体酮联合给药更年期至少在研究开始前12个月。方法：总共1,253名绝经后妇女被随机分配接受连续1 mg E2或恒定雌激素的脉冲孕激素方案，分别为1 mg E2 / 30微克NGM，1 mg E2 / 90微克NGM或1 mg E2 / 180微克NGM （为期3天，请假3天）进行为期12个月的多中心，双盲研究。子宫内膜活检是在治疗前和治疗后获得的，并由至少2位（如果需要，由3位）病理学家进行评估，他们对治疗和彼此的诊断视而不见。结果：在研究结束时，接受E2 1 mg / NGM 90 microg或E21 mg / NGM 180 microg的受试者中没有诊断出子宫内膜增生的病例，而子宫内膜的74例（28％）和16例（6％）在分别连续接受E2 1 mg和E2 1 mg / NGM 30 microg的受试者中诊断出增生。对NGM的剂量相关的子宫内膜反应是明显的（P <.001）。随着NGM剂量的增加，子宫内膜失活/萎缩的患者百分比增加。结论：这项研究的结果支持这种独特的HRT方案的安全性和有效性，并建议在连续1 mg E2孕激素方案中，保护子宫内膜免于增生所需的最小NGM剂量为90 microg。

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