Bruera E, Macmillan K, Kuehn N, Hanson J, MacDonald R N
Edmonton General Hospital, Cross Cancer Institute, University of Alberta, Canada.
Cancer. 1990 Sep 15;66(6):1279-82. doi: 10.1002/1097-0142(19900915)66:6<1279::aid-cncr2820660630>3.0.co;2-r.
This double-blind, cross-over trial was designed to assess the effects of megestrol acetate (MA) on cancer-induced cachexia. Forty consecutive malnourished patients with advanced non-hormone-responsive tumors receiving no antineoplastic treatment were randomized to receive MA 480 mg/day versus placebo for 7 days. During day 8, a cross-over was made until day 15. Appetite, pain, nausea, depression, energy, and well-being were assessed with a visual analog scale (0 to 100 mm) at 9:00 AM and 4:00 PM during days 6, 7, 13, and 14. Weight (W;kg), tricep skinfold (TS; mm), arm circumference (AC; cm), and calf circumference (CC; cm) were measured at days 1, 8, and 15. Caloric intake (CI; Kcal/day) was determined during days 6, 7, 13, and 14. In 31 evaluable patients, the percentual difference in appetite at 9:00 AM, appetite at 4:00 PM, energy, and well-being after MA was +15.1, +14, +3.2, and +5.2, versus -12 (P = 0.03), -5.1 (P = 0.015), -10 (P = 0.024), and -8.3 (not significant) after placebo. Percentual difference in W, TS, AC, and CC after MA was +0.2, +1, -0.1, and +0.4 versus -0.8 (P = 0.03), -0.8 (P = 0.001), -0.3 (not significant), and -0.5 (P = 0.04) after placebo. CI during MA was 3480 +/- 1574 (48-hour intake), versus 2793 +/- 1542 (P less than 0.001) during placebo. Patients and investigators blindly chose MA in 20 (66%, P = 0.023) and 28 cases (92%, P less than 0.001), placebo in eight and two cases, and made no choice in three and one cases, respectively. Toxicity consisted of mild edema and nausea in three and two cases, respectively. After mean follow-up of 27 +/- 13 days, on an open basis, an average increase in W and AC of 4.8 +/- 1.7 kg and 2.8 +/- 1.7 cm was observed, respectively. The authors conclude that MA is a powerful appetite stimulant with subjective and objective effects on nutritional status.
这项双盲交叉试验旨在评估醋酸甲地孕酮（MA）对癌症所致恶病质的影响。40例连续入选的晚期非激素反应性肿瘤且未接受抗肿瘤治疗的营养不良患者被随机分为两组，分别接受480mg/天的MA或安慰剂，为期7天。在第8天进行交叉，直至第15天。在第6、7、13和14天上午9:00和下午4:00，采用视觉模拟量表（0至100mm）评估食欲、疼痛、恶心、抑郁、精力和健康状况。在第1、8和15天测量体重（W；kg）、肱三头肌皮褶厚度（TS；mm）、上臂围（AC；cm）和小腿围（CC；cm）。在第6、7、13和14天测定热量摄入（CI；Kcal/天）。在31例可评估患者中，MA治疗后上午9:00的食欲、下午4:00的食欲、精力和健康状况的百分比差异分别为+15.1、+14、+3.2和+5.2，而安慰剂组分别为-12（P = 0.03）、-5.1（P = 0.01）、-10（P = 0.024）和-8.3（无统计学意义）。MA治疗后W, TS, AC和CC的百分比差异分别为+0.2、+1、-0.1和+0.4，而安慰剂组分别为-0.8（P = 0.03）、-0.8（P = 0.001）、-0.3（无统计学意义）和-0.5（P = 0.04）。MA治疗期间的CI为3480±1574（48小时摄入量），而安慰剂组为2793±1542（P＜0.001）。患者和研究者分别在20例（66%，P = 0.023）和28例（92%，P＜0.001）中盲目选择了MA，8例和2例选择了安慰剂，3例和1例未作选择。毒性反应分别表现为3例轻度水肿和2例恶心。平均随访27±13天后，在开放治疗的基础上，观察到W和AC平均分别增加4.8±1.7kg和2.8±1.7cm。作者得出结论，MA是一种强效的食欲刺激剂，对营养状况有主观和客观影响。
