Bruera E, Ernst S, Hagen N, Spachynski K, Belzile M, Hanson J, Summers N, Brown B, Dulude H, Gallant G
Cross Cancer Institute, University of Alberta, Edmonton.
Cancer Prev Control. 1998 Apr;2(2):74-8.
To evaluate the effect of megestrol acetate at a lower dose than previously investigated on the symptoms of cachexia in patients with advanced cancer.
A total of 84 patients with advanced, solid tumours not responsive to hormone therapy were enrolled in this double-blind, crossover study. During phase 1, patients were randomly assigned to receive megestrol acetate (160 mg 3 times daily) for 10 days or placebo. During phase 2, after a 2-day washout period, patients received the alternate treatment for 10 days. Patients underwent daily assessments of activity, nausea, appetite and well-being by means of a visual analogue scale (VAS). In addition, nutritional status (weight, tricep skinfold measure, arm muscle circumference), energy intake, fatigue (Piper Fatigue Scale) and quality of life (Functional Living Index-Cancer [FLIC]) were assessed.
Among the 53 evaluable patients megestrol acetate resulted in a significant improvement in appetite (p = 0.005), activity (p = 0.007) and well-being (p = 0.03). There was no significant change in the intensity of nausea, nutritional parameters, energy intake or FLIC scores. There was a significant improvement in 2 of the 3 factors measured by the Piper Fatigue Scale and in the overall fatigue score. Upon completion of the study, while still blind to the treatment condition, 30 patients indicated that they felt better overall after megestrol, 15 said they felt better after placebo, and 10 indicated no preference (p = 0.001).
Treatment with megestrol acetate results in rapid and significant improvement of symptoms in terminally ill patients at lower doses than previously reported. The effects are not secondary to nutritional changes. The FLIC quality-of-life questionnaire was unable to detect these changes.
评估醋酸甲地孕酮以低于先前研究剂量对晚期癌症患者恶病质症状的影响。
本双盲交叉研究共纳入84例对激素治疗无反应的晚期实体瘤患者。在第1阶段，患者被随机分配接受醋酸甲地孕酮（每日3次，每次160 mg）治疗10天或安慰剂治疗。在第2阶段，经过2天的洗脱期后，患者接受替代治疗10天。患者通过视觉模拟量表（VAS）对活动、恶心、食欲和健康状况进行每日评估。此外，还评估了营养状况（体重、三头肌皮褶厚度、上臂肌肉周长）、能量摄入、疲劳程度（派珀疲劳量表）和生活质量（癌症功能生活指数[FLIC]）。
在53例可评估患者中，醋酸甲地孕酮使食欲（p = 0.005）、活动能力（p = 0.007）和健康状况（p = 0.03）有显著改善。恶心强度、营养参数、能量摄入或FLIC评分无显著变化。派珀疲劳量表测量的3个因素中有2个及总体疲劳评分有显著改善。研究结束时，在对治疗情况仍不知情的情况下，30例患者表示服用醋酸甲地孕酮后总体感觉更好，15例表示服用安慰剂后感觉更好，10例表示无偏好（p = 0.001）。
与先前报道相比，较低剂量的醋酸甲地孕酮治疗可使晚期患者症状迅速且显著改善。这些效果并非继发于营养变化。FLIC生活质量问卷无法检测到这些变化。
