全球精选文摘 - 一项使用两种剂量的醋酸甲地孕酮治疗乳腺癌妇女的更年期综合征的III期随机、安慰剂对照试验：西南肿瘤组研究9626

Phase III Randomized Placebo-Controlled Trial of Two Doses of Megestrol Acetate as Treatment for Menopausal Symptoms in Women with Breast Cancer: Southwest Oncology Group Study 9626

Goodwin JW, Green SJ, Moinpour CM 2009/8/3 17:44:54

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J Clin Oncol, 2008,

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Purpose:
Prior progestin studies treating hot flashes in women have been short duration and single dose. This study tests the progestin megesterol acetate (MA) at two doses versus placebo over 6 months.

Patients and Methods:
Patients with T1-3, N0-1, M0 breast cancer were eligible after completion of surgery and chemotherapy and at least 4 months of tamoxifen (if prescribed). Women were required to have at least 10 hot flashes of any severity or at least five severe episodes per week. Patients were randomly assigned to placebo, MA 20mg, or MA 40mg for 3 months. Success at 3 months was defined as completion of treatment with a≥75% reduction in hot flashes from baseline. If success was achieved, drug treatment for another 3 months was given on the same blinded arm; if not, open-label MA 20mg was added to blinded study drug and continued for 3 months. Other menopausal symptoms were also assessed.

Results:
Two hundred eighty eight eligible women were randomly assigned (286 eligible), of whom 85% were on tamoxifen, 40% had over 63 hot flashes/week, and 75% had vasomotor symptoms for ≥ 6 months. Success at 3 months was 14% on placebo, 65% on 20mg, and 48% on 40mg (both MA doses superior to placebo; P<.0001). Most successes at 3 months were maintained at 6 months (77% on 20mg and 81% on 40mg).

Conclusion:
MA significantly reduced vasomotor symptoms with durable benefit over 6 months. MA 20mg/d is the preferred dose. There was no significant impact on other menopausal symptoms.

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疾病资源中心

高血压	慢性阻塞性肺病
脂肪性肝病	糖尿病
卒中	肺癌
冠心病	子宫内膜异位症
结直肠癌	乳腺癌
心力衰竭	心律失常

病例分析 [栏目介绍]

甲状腺功能亢进合并黄疸

王燕燕王曙

上海交通大学附属瑞金医院内分泌科

患者，女，69岁。2009年1月无明显诱因下出现乏力，当时程度较轻，未予以重视。2009年3月患者乏力症状加重，尿色逐渐加深，大便习惯改变，颜色变淡。4月18日入我院感染科治疗，诉轻度头晕、心慌，体重减轻10kg。无肝区疼痛，无发热，无腹痛、腹泻、腹胀、里急后重，无恶性、呕吐等。入院半月前于外院就诊，查肝功能：ALT 601IU/L，AST 785IU/L，TBIL 97.7umol/L，白蛋白 41g/L，甲状腺功能：游离T3 30.6pmol/L，游离T4 51.9pmol/L，心电图示快速房颤。

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