The comparative effect on bone density, endometrium, and lipids of continuous hormones as replacement therapy (CHART study) - A randomized controlled trial
The comparative effect on bone density, endometrium, and lipids of continuous hormones as replacement therapy (CHART study) - A randomized controlled trial
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DOI：
10.1001/jama.276.17.1397
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发表时间：
1996-11-06
影响因子：
120.7
通讯作者：
Wilborn, W
中科院分区：
文献类型：
--
作者：
Speroff, L;Rowan, J;Wilborn, W
客观。-比较连续醋酸炔诺酮（NA）-炔雌醇（EE（2））组合与匹配的非对抗性EE（2）或安慰剂的效果。一项为期2年的双盲、安慰剂对照、平行组临床试验。65个中心的门诊病人。无症状或轻度症状的妇女年龄40岁或以上谁经历了自发绝经期的发作在过去5年内，谁有一个完整的子宫。患者随机分为安慰剂组或8个治疗组：0.2 mg NA和1 μ g EE（2）; 0.5 mg NA和2.5 μ g EE（2）; 1 mg NA和5 μ g EE（2）; 1 mg NA和10 μ g EE（2）; 1 μ g EE（2）; 2.5 μ g EE（2）; 5 μ g EE（2）;或10 μ g EE（2）。主要结局指标。通过定量计算机断层扫描测量骨密度（BMD）、血脂和子宫内膜影响，通过增生率和增殖状态评估。1265例患者入组研究，骨密度较基线显著增加（P
Objective.-To compare the effect of continuous norethindrone acetate (NA)-ethinyl estradiol (EE(2)) combinations with matching unopposed EE(2) or placebo.Design.-A 2-year, double-blind, placebo-controlled, parallel-group clinical trial.Setting.-Outpatients at 65 centers.Patients.-Asymptomatic or mildly symptomatic women aged 40 years or older who had undergone the onset of spontaneous menopause within the last 5 years and who had an intact uterus.Interventions.-Patients were equally randomized to placebo or 1 of 8 treatment groups: 0.2 mg of NA and 1 mu g of EE(2); 0.5 mg of NA and 2.5 mu g of EE(2); 1 mg of NA and 5 mu g of EE(2); 1 mg of NA and 10 mu g of EE(2); 1 mu g of EE(2); 2.5 mu g of EE(2); 5 mu g of EE(2); or 10 mu g of EE(2).Primary Outcome Measures.-Bone mineral density (BMD) measured by quantitative computed tomography, serum lipids, and endometrial effects as assessed by rate of hyperplasia and proliferative status.Results.-Twelve hundred sixty-five patients entered the study, Bone mineral density increased significantly from baseline (P