Palliative Medicine, University of Navarra Clinic, Pamplona, Spain.
Culture and Society Institute, ATLANTES Project, University of Navarra, Pamplona, Spain.
BMJ Support Palliat Care. 2022 Jun;12(2):226-234. doi: 10.1136/bmjspcare-2020-002454. Epub 2020 Nov 9.
Methylphenidate is a psychostimulant drug used to treat fatigue in patients with advanced cancer, for which there is no gold standard of treatment.
To explore the efficacy of methylphenidate in the relief of fatigue in patients with advanced cancer.
A randomised double-blind placebo-controlled multicentre clinical trial, stratified according to the intensity of fatigue. The treatment was considered effective if the improvement in mean fatigue intensity between baseline values and day 6 was significantly higher in the methylphenidate group than in the placebo group. The responses were measured using the Edmonton Symptoms Assessment System (ESAS) and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scales.
35 patients received placebo and 42 patients received methylphenidate. The populations of both groups were homogeneous. Patients receiving methylphenidate did not exhibit statistically significant improvement of fatigue in comparison to patients receiving placebo (p=0.52). The mean improvement of fatigue (ESAS) on day 6 was -1.9 (±2.5) in the placebo group, and -2.3 (±2.6) in the methylphenidate group (p=0.52). The results obtained with the FACT-F were congruent with those obtained by the ESAS. The responses in patients with severe fatigue were -2.4 (±2.9) in the placebo group and -3.4 (±2.5) in the methylphenidate group; the difference was not statistically significant (p=0.3).
Methylphenidate was not more efficient than placebo to treat cancer-related fatigue. Fatigue improved significantly after 3 days of treatment and was stabilised on day 6, both with placebo and methylphenidate. The side effects of methylphenidate were mild and infrequent.
EudraCT Registry (2008-002171-27).
哌醋甲酯是一种精神兴奋剂药物，用于治疗晚期癌症患者的疲劳，目前对此尚无金标准治疗方法。
探索哌醋甲酯治疗晚期癌症患者疲劳的疗效。
一项随机、双盲、安慰剂对照、多中心临床试验，按疲劳强度分层。如果哌醋甲酯组与基线值相比，在第 6 天的平均疲劳强度改善显著高于安慰剂组，则认为治疗有效。使用 Edmonton 症状评估系统（ESAS）和癌症治疗功能评估-疲劳（FACT-F）量表来衡量反应。
35 名患者接受安慰剂，42 名患者接受哌醋甲酯。两组的人群均具有同质性。与接受安慰剂的患者相比，接受哌醋甲酯的患者的疲劳状况并未表现出统计学上的显著改善（p=0.52）。在安慰剂组中，第 6 天的疲劳（ESAS）平均改善为-1.9（±2.5），在哌醋甲酯组中为-2.3（±2.6）（p=0.52）。FACT-F 量表的结果与 ESAS 的结果一致。严重疲劳患者的反应在安慰剂组中为-2.4（±2.9），在哌醋甲酯组中为-3.4（±2.5），差异无统计学意义（p=0.3）。
哌醋甲酯在治疗癌症相关疲劳方面并不比安慰剂更有效。在接受安慰剂和哌醋甲酯治疗后，第 3 天疲劳明显改善，第 6 天稳定。哌醋甲酯的副作用轻微且不频繁。
EudraCT 注册（2008-002171-27）。
