Khoo S K, Coglan M J, Wright G R, DeVoss K N, Battistutta D
University of Queensland Department of Obstetrics and Gynaecology, Royal Women's Hospital, Brisbane.
Med J Aust. 1998 Mar 2;168(5):216-20.
To determine whether hormone treatment of women during the menopause transition induces changes in body weight, blood pressure, lipoprotein levels, antithrombin III activity, and the endometrium.
Prospective, randomised, placebo-controlled, double-blind, 12-month study, with crossover at 6 months.
Outpatient clinic of a city hospital.
105 apparently healthy women in the menopause transition (40-52 years), with menstrual function, who were experiencing minor menopausal symptoms, were selected from the general population by advertising.
Active arm--oral conjugated oestrogens (0.625 mg daily) and cyclic medroxyprogesterone acetate (10 mg daily) on Day 14-27 of each menstrual cycle; placebo arm--placebos of both medications.
Excess change from baseline associated with active compared with placebo treatment for all variables; effect of order of treatment.
Baseline biochemical values were similar for both treatment-order groups, but baseline blood pressures and body weights were higher in the group receiving placebo first. With treatment, there were no differences in overall values for body weight and blood pressure (P > 0.4), and order of treatment had no significant influence (P > 0.3). There were no differences in total and low density lipoprotein cholesterol levels, overall or with order of treatment. Active treatment increased high density lipoprotein (HDL) cholesterol levels (overall and when placebo was given first; P = 0.001), and triglyceride levels (when active treatment was given first; P = 0.03). There was no overall treatment effect, but a significant order-of-treatment effect, on antithrombin III activity (mean levels were decreased by active treatment to a greater extent when it was given first; P = 0.02). The endometrium showed only physiological changes regardless of treatment.
The lack of significant excess change in anthropometry, lipoprotein levels, antithrombin III activity, and endometrial histology in women given hormone treatment compared with placebo is reassuring. The increase in HDL cholesterol level is an extra benefit. Our study provides conclusive evidence that hormone treatment does not produce weight gain in women during the menopause transition.
确定在绝经过渡期对女性进行激素治疗是否会引起体重、血压、脂蛋白水平、抗凝血酶III活性及子宫内膜的变化。
前瞻性、随机、安慰剂对照、双盲、为期12个月的研究，在6个月时进行交叉试验。
城市医院门诊。
通过广告从普通人群中选取105名处于绝经过渡期（40 - 52岁）、月经功能正常且有轻微绝经症状的明显健康女性。
活性组——在每个月经周期的第14 - 27天口服结合雌激素（每日0.625毫克）和周期性醋酸甲羟孕酮（每日10毫克）；安慰剂组——两种药物的安慰剂。
与安慰剂治疗相比，活性治疗在所有变量上与基线相比的额外变化；治疗顺序的影响。
两个治疗顺序组的基线生化值相似，但先接受安慰剂治疗组的基线血压和体重较高。治疗后，体重和血压的总体值无差异（P > 0.4），治疗顺序也无显著影响（P > 0.3）。总胆固醇和低密度脂蛋白胆固醇水平在总体上或治疗顺序方面均无差异。活性治疗可提高高密度脂蛋白（HDL）胆固醇水平（总体及先给予安慰剂时；P = 0.001），以及甘油三酯水平（先给予活性治疗时；P = 0.03）。在抗凝血酶III活性方面，无总体治疗效果，但有显著的治疗顺序效应（首次给予活性治疗时，其平均水平降低幅度更大；P = 0.02）。无论治疗如何，子宫内膜仅显示生理性变化。
与安慰剂相比，接受激素治疗的女性在人体测量学、脂蛋白水平、抗凝血酶III活性及子宫内膜组织学方面缺乏显著的额外变化，这令人安心。高密度脂蛋白胆固醇水平的升高是一项额外益处。我们的研究提供了确凿证据，表明在绝经过渡期激素治疗不会导致女性体重增加。
