一项关于缓释哌醋甲酯治疗癌症患者疲劳的随机、双盲、两阶段、安慰剂对照交叉试验。
A randomized, double-blind, 2-period, placebo-controlled crossover trial of a sustained-release methylphenidate in the treatment of fatigue in cancer patients.
作者信息
Escalante Carmen P, Meyers Christina, Reuben James M, Wang Xuemei, Qiao Wei, Manzullo Ellen, Alvarez Ricardo H, Morrow Phuong Khanh, Gonzalez-Angulo Ana M, Wang Xin Shelley, Mendoza Tito, Liu Wenli, Holmes Holly, Hwang Jessica, Pisters Katherine, Overman Michael, Cleeland Charles
机构信息
From the *The University of Texas MD Anderson Cancer Center, Houston, TX; and †Hematology/Oncology Therapeutic Area, Amgen, Thousand Oaks, CA.
出版信息
Cancer J. 2014 Jan-Feb;20(1):8-14. doi: 10.1097/PPO.0000000000000018.
PURPOSE
This study assessed the efficacy of methylphenidate versus placebo for cancer-related fatigue reduction. Other objectives were to analyze cytokine levels and to determine the effects of methylphenidate on other symptoms, cognitive function, work yield, and patients' perceptions and preferences.
METHODS
Patients were randomly assigned (1:1) to receive methylphenidate-placebo or placebo-methylphenidate for 4 weeks. Patients crossed over after 2 weeks. Wilcoxon signed rank tests and McNemar tests were used to assess continuous and categorical variables. The primary efficacy endpoint was change in the level of worst fatigue on the Brief Fatigue Inventory (BFI) at the end of each 2-week period.
RESULTS
The mean baseline BFI score was moderate (5.7). Methylphenidate treatment did not affect patients' worst level of fatigue or other symptoms. Results from the Wechsler Adult Intelligence Scale Digit Symbol Test and the Hopkins Verbal Learning Test with BFI interference questions and BFI activity questions showed significant improvement in the methylphenidate-treated patients' verbal learning, memory, visual perception, analysis, and scanning speed. Patients treated with methylphenidate missed significantly fewer work hours owing to health reasons and worked significantly more hours. After 4 weeks, 64% of patients reported that methylphenidate improved their cancer-related fatigue, and 58% wanted to continue treatment. Significant difference in interleukin 6R (positive), interleukin 10 (negative), and tumor necrosis factor α (positive) was noted between the methylphenidate and the placebo group.
CONCLUSIONS
Low-dose methylphenidate did not improve cancer-related fatigue. Patients taking methylphenidate had better cognition and were able to work more hours. Patients tolerated methylphenidate well, and the majority felt better and wanted to continue treatment.
目的
本研究评估了哌甲酯与安慰剂在减轻癌症相关疲劳方面的疗效。其他目的包括分析细胞因子水平，以及确定哌甲酯对其他症状、认知功能、工作产出、患者认知和偏好的影响。
方法
患者被随机分配（1:1）接受哌甲酯-安慰剂或安慰剂-哌甲酯治疗4周。2周后患者进行交叉治疗。采用Wilcoxon符号秩检验和McNemar检验评估连续变量和分类变量。主要疗效终点是每2周结束时简明疲劳量表（BFI）上最严重疲劳水平的变化。
结果
平均基线BFI评分为中度（5.7）。哌甲酯治疗未影响患者最严重的疲劳水平或其他症状。韦氏成人智力量表数字符号测验以及带有BFI干扰问题和BFI活动问题的霍普金斯言语学习测验结果显示，接受哌甲酯治疗的患者在言语学习、记忆、视觉感知、分析和扫描速度方面有显著改善。因健康原因，接受哌甲酯治疗的患者缺勤时间显著减少，工作时间显著增加。4周后，64%的患者报告哌甲酯改善了他们的癌症相关疲劳，58%的患者希望继续治疗。哌甲酯组和安慰剂组在白细胞介素6R（阳性）、白细胞介素10（阴性）和肿瘤坏死因子α（阳性）方面存在显著差异。
结论
低剂量哌甲酯未改善癌症相关疲劳。服用哌甲酯的患者认知功能更好，能够工作更长时间。患者对哌甲酯耐受性良好，大多数患者感觉更好并希望继续治疗。
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