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醋酸甲地孕酮治疗癌症厌食和恶病质的对照试验。

Controlled trial of megestrol acetate for the treatment of cancer anorexia and cachexia.

作者信息

Loprinzi C L, Ellison N M, Schaid D J, Krook J E, Athmann L M, Dose A M, Mailliard J A, Johnson P S, Ebbert L P, Geeraerts L H

机构信息

National Cancer Institute, National Institutes of Health, Department of Health Service.

出版信息

J Natl Cancer Inst. 1990 Jul 4;82(13):1127-32. doi: 10.1093/jnci/82.13.1127.

DOI:10.1093/jnci/82.13.1127
PMID:2193166
Abstract

Preliminary information has suggested that megestrol acetate leads to appetite stimulation and nonfluid weight gain in patients with breast cancer, other cancers, and AIDS. Pursuant to this, we developed a randomized, double-blind, placebo-controlled trial of megestrol acetate in patients with cancer-associated anorexia and cachexia. We randomly assigned 133 eligible patients to receive 800 mg of megestrol acetate per day or a placebo. Patients assigned to megestrol acetate more frequently reported improved appetite (P = .003) and food intake (P = .009) when compared with patients receiving the placebo. A weight gain of 15 lb or more over baseline was seen in 11 of 67 (16%) patients receiving megestrol acetate compared with one of 66 (2%) given the placebo (P = .003). Patients receiving megestrol acetate reported significantly less nausea (13% vs. 38%; P = .001) and emesis (8% vs. 25%, P = .009). No clinically or statistically significant toxic reactions were ascribed to megestrol acetate, with the exception of mild edema. This study convincingly demonstrated that megestrol acetate can stimulate appetite and food intake in patients with anorexia and cachexia associated with cancer, leading to significant weight gain in a proportion of such patients.

摘要

初步信息表明,醋酸甲地孕酮可刺激乳腺癌、其他癌症及艾滋病患者的食欲并导致非体液性体重增加。据此,我们开展了一项针对癌症相关性厌食和恶病质患者的醋酸甲地孕酮随机、双盲、安慰剂对照试验。我们将133名符合条件的患者随机分组,分别给予每日800毫克醋酸甲地孕酮或安慰剂。与接受安慰剂的患者相比,服用醋酸甲地孕酮的患者更频繁地报告食欲改善(P = 0.003)和食物摄入量增加(P = 0.009)。在接受醋酸甲地孕酮治疗的67名患者中,有11名(16%)体重较基线增加了15磅或更多,而接受安慰剂治疗的66名患者中仅有1名(2%)体重增加(P = 0.003)。服用醋酸甲地孕酮的患者报告的恶心(13% 对 38%;P = 0.001)和呕吐(8% 对 25%,P = 0.009)明显较少。除轻度水肿外,未发现醋酸甲地孕酮有临床或统计学上显著的毒性反应。这项研究令人信服地证明,醋酸甲地孕酮可刺激癌症相关性厌食和恶病质患者的食欲和食物摄入量,使部分此类患者体重显著增加。

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J Natl Cancer Inst. 1990 Jul 4;82(13):1127-32. doi: 10.1093/jnci/82.13.1127.
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