A 12-month comparative study of raloxifene, estrogen, and placebo on the postmenopausal endometrium
A 12-month comparative study of raloxifene, estrogen, and placebo on the postmenopausal endometrium
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DOI：
10.1016/s0029-7844(99)00502-5
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发表时间：
2000-01-01
影响因子：
7.2
通讯作者：
Parsons, AK
中科院分区：
文献类型：
--
作者：
Goldstein, SR;Scheele, WH;Parsons, AK
目的：探讨选择性雌激素受体调节剂雷洛昔芬对绝经后子宫内膜的影响。方法：健康绝经后妇女4 15例，随机分为4组：60 mg/d或15 0 mg/d盐酸雷洛昔芬、0.625 mg/d马结合雌激素或安慰剂，治疗1年。在基线和超声检查后每6个月进行一次盲法子宫内膜活检。在基线和每隔3个月进行一次阴道超声检查，并测量子宫大小。在基线和每6个月进行一次超声宫腔造影。结果：两组的基线特征差异无统计学意义。在安慰剂组和雷洛昔芬组，经阴道超声测量的平均子宫内膜厚度从基线到终点没有变化，而在雌激素组，子宫内膜厚度显著增加5.5 mm(P<；.001)。根据经阴道超声测量得出的平均子宫体积仅在雌激素组中较高(22厘米(3)，P<；.001)。在358名接受配对活检的妇女中，安慰剂组、雷洛昔芬组和雌激素组的子宫内膜增生症分别占终点活检的2.1%、0%和26.1%(P<；.001)。在安慰剂组、联合雷洛昔芬组和雌激素组，增殖期子宫内膜的比例分别为2.1%、1.7%和39.8%(P<；.001)。结论：每天服用60或150 mg雷洛昔芬1年，对绝经后子宫内膜无刺激作用。雷洛昔芬组的终点子宫内膜厚度、形态和子宫体积与基线和安慰剂组相似。《妇科杂志》2000；95：95-103。(C)2000年由美国妇产科医师学会颁发。
Objective: To determine the effects of a selective estrogen receptor modulator, raloxifene, on postmenopausal endometrium.Methods: Healthy postmenopausal women (n = 415) were randomly assigned to one of the following four groups: 60 or 150 mg/day raloxifene hydrochloride, 0.625 mg/day conjugated equine estrogens, or placebo, and treated for 1 year. Endometrial biopsies were obtained in a blinded fashion at baseline and every 6 months after the ultrasound studies. Transvaginal ultrasound, with uterine size measurements, was done at baseline and at 3-month intervals. Saline-infusion sonohysterography was done at baseline and every 6 months.Results: There were no statistically significant differences in baseline characteristics. Mean endometrial thickness, measured by transvaginal ultrasound, was unchanged from baseline to end point in the placebo and raloxifene groups, whereas in the estrogen group it was significantly thicker by 5.5 mm (P < .001). Mean uterine volume, calculated from transvaginal ultrasound measurements, was higher in the estrogen group only (22 cm(3), P < .001). Of the 358 women with paired biopsies, endometrial hyperplasia was present in 2.1%, 0%, and 26.1% of the end-point biopsies in the placebo, raloxifene, and estrogen groups, respectively (P < .001). Proliferative endometrium was present in 2.1% of the end-point biopsies in the placebo group, 1.7% in the combined raloxifene groups, and 39.8% in the estrogen group (P < .001).Conclusion: Raloxifene, at 60 or 150 mg/day for 1 year, did not stimulate the postmenopausal endometrium. End-point endometrial thickness, morphology, and uterine volume in the raloxifene groups were similar to those observed at baseline and in the placebo group. (Obstet Gynecol 2000;95: 95-103. (C) 2000 by The American College of Obstetricians and Gynecologists.).