Hanna Amy, Sledge George, Mayer Mary Lou, Hanna Nasser, Einhorn Lawrence, Monahan Patrick, Daggy Joanne, Bhatia Sumeet
Division of Hematology/Oncology, Department of Medicine, School of Medicine, Indiana University, Indianapolis, IN 46202, USA.
Support Care Cancer. 2006 Mar;14(3):210-5. doi: 10.1007/s00520-005-0857-9. Epub 2005 Aug 12.
Cancer-related fatigue (CRF) is one of the most distressing symptoms patients experience and is seen well after the completion of treatment. Methylphenidate (Ritalin) use includes the treatment of opiate-induced somnolence, depression, and reduced cognition. This phase II study was performed to evaluate the effects of methylphenidate on CRF.
The criteria for the eligibility of patients included the following: a history of breast cancer, absence of disease for greater than 6 months but less than 5 years, a hemoglobin level of >12 g%, less than moderate depression on the Brief Zung Self-administered Depression Scale, and a score of > or =4 on the Brief Fatigue Inventory (BFI). Patients received methylphenidate, 5 mg, orally, twice daily, for 6 weeks, with a dose escalation on week 2 if the BFI score remained > or =4 and no significant toxicities were reported. A response was defined as a decrease in the BFI score of at least two points on weeks 4 and 6 as compared to baseline.
Between May 2001 and May 2003, 37 patients were entered and treated. On weeks 4 and 6, 20 of 37 (54%) responded with a decreased BFI score greater than two points, averaging a decrease of 3.5. Although six patients (19%) withdrew due to adverse events, these were reported as grade 1.
This study suggests that women with breast cancer who are suffering from moderate to severe fatigue may benefit from methylphenidate.
癌症相关疲劳（CRF）是患者经历的最令人痛苦的症状之一，在治疗结束后仍很常见。哌甲酯（利他林）的用途包括治疗阿片类药物引起的嗜睡、抑郁和认知减退。进行这项II期研究以评估哌甲酯对CRF的影响。
患者入选标准如下：乳腺癌病史，疾病缓解超过6个月但少于5年，血红蛋白水平>12 g%，在简明zung自评抑郁量表上抑郁程度为轻度以下，且在简明疲劳量表（BFI）上得分>或 =4。患者口服5 mg哌甲酯，每日两次，共6周，若BFI评分在第2周仍>或 =4且未报告明显毒性反应，则在第2周增加剂量。缓解定义为与基线相比，在第4周和第6周BFI评分至少降低2分。
在2001年5月至2003年5月期间，37例患者入组并接受治疗。在第4周和第6周，37例中有20例（54%）缓解，BFI评分降低超过2分，平均降低3.5分。虽然有6例患者（19%）因不良事件退出，但报告为1级。
本研究表明，患有中度至重度疲劳的乳腺癌女性可能从哌甲酯中获益。
