Beller E, Tattersall M, Lumley T, Levi J, Dalley D, Olver I, Page J, Abdi E, Wynne C, Friedlander M, Boadle D, Wheeler H, Margrie S, Simes R J
NHMRC Clinical Trials Centre, University of Sydney, Australia.
Ann Oncol. 1997 Mar;8(3):277-83. doi: 10.1023/a:1008291825695.
To investigate the effect of two doses of megestrol acetate (MA) compared with placebo on quality of life (QoL) and nutritional status (NS) in patients with advanced endocrine-insensitive cancer.
Two hundred forty patients were randomised to double-blind MA 480 mg/day, MA 160 mg/day, or matching placebo for 12 weeks. Nutritional status (including weight, skinfold thickness and midarm circumference) and QoL (using 6 linear analogue self-assessment (LASA) scales) were assessed at randomisation and after four, eight and 12 weeks. A QoL ranking incorporating QoL and death was also used ranging from 1 = dead to 5 = much better QoL.
One hundred seventy-four patients were assessable at week four, 136 at week eight and 103 patients at week 12. Patients receiving MA reported substantially better appetite (P = 0.001), mood (P = 0.001) and overall quality of life (P < 0.001), and possibly less nausea and vomiting (P = 0.08) than patients receiving placebo, based on a test for trend. A larger benefit was seen with the higher dose which (unlike the lower dose) was significantly better in pairwise comparisons with placebo for appetite, mood and overall QoL (each P < or = 0.001). Despite some missing data on QoL scores, QoL ranking was available on 227 (95%) of patients with significantly higher QoL ranking associated with MA (P = 0.002). Improvements in QoL occurred early within four weeks and were sustained. No statistically significant differences were observed in NS measurements, including weight (P = 0.29). Side effects of therapy were minor and did not differ significantly across treatments.
Megestrol acetate given at 480 mg/day is useful palliation in patients with endocrine-insensitive advanced cancer. It improves appetite, mood and overall quality of life in these patients, although not through a direct effect on nutritional status.
研究两剂醋酸甲地孕酮（MA）与安慰剂相比，对晚期内分泌不敏感癌症患者生活质量（QoL）和营养状况（NS）的影响。
240例患者被随机分为双盲组，分别接受480毫克/天的MA、160毫克/天的MA或匹配的安慰剂，为期12周。在随机分组时以及4周、8周和12周后评估营养状况（包括体重、皮褶厚度和上臂中部周长）和生活质量（使用6个线性模拟自评（LASA）量表）。还使用了一个结合生活质量和死亡情况的生活质量排名，范围从1 = 死亡到5 = 生活质量好得多。
在第4周时可评估174例患者，第8周时可评估136例患者，第12周时可评估103例患者。根据趋势检验，接受MA的患者与接受安慰剂的患者相比，食欲（P = 0.001）、情绪（P = 0.001）和总体生活质量（P < 0.001）显著更好，恶心和呕吐可能也更少（P = 0.08）。高剂量组的获益更大，与安慰剂进行两两比较时，高剂量组在食欲、情绪和总体生活质量方面（均P ≤ 0.001）显著优于低剂量组（与低剂量组不同）。尽管生活质量评分存在一些缺失数据，但227例（95%）患者有生活质量排名，MA组的生活质量排名显著更高（P = 0.002）。生活质量的改善在4周内早期出现并持续存在。在包括体重在内的营养状况测量中未观察到统计学上的显著差异（P = 0.29）。治疗的副作用较小，各治疗组之间无显著差异。
每天给予480毫克醋酸甲地孕酮对内分泌不敏感的晚期癌症患者是有效的姑息治疗方法。它可改善这些患者的食欲、情绪和总体生活质量，尽管并非通过直接影响营养状况来实现。
