Kohli Sadhna, Fisher Susan G, Tra Yolande, Adams M Jacob, Mapstone Mark E, Wesnes Keith A, Roscoe Joseph A, Morrow Gary R
Department of Medicine and Radiation Oncology, James P. Wilmot Cancer Center, University of Rochester, Rochester School of Medicine and Dentistry, Rochester, New York, USA.
Cancer. 2009 Jun 15;115(12):2605-16. doi: 10.1002/cncr.24287.
The authors conducted a randomized clinical trial examining the effects of modafinil in reducing persistent fatigue in patients after treatment for cancer and performed secondary analyses to assess the effect of modafinil on cognitive function.
Breast cancer patients who reported a score of >or=2 on the Brief Fatigue Inventory were enrolled in the study. In phase 1 (P1), patients received 200 mg modafinil open-label once daily for 4 weeks. In phase 2 (P2), patients with a positive response after P1 were randomized either to an additional 4 weeks of modafinil or to placebo. Tests of memory and attention selected from the Cognitive Drug Research (CDR) computerized cognitive assessment were performed at baseline (before modafinil) and after completing phases 1 and 2. The paired differences for each test score were subjected to a Wilcoxon signed rank test.
Of the 82 women who were enrolled, 76 completed P1, and 68 completed all assessments in the study. Modafinil had a significant effect on the Speed of Memory (P = .0073) and Quality of Episodic Memory (P < .0001) during P1 of the study. After randomization at Week 8, those patients who continued modafinil demonstrated significantly greater improvement in Speed of Memory (P = .029), Quality of Episodic Memory (P = .0151), and mean Continuity of Attention (P = .0101) relative to the group that was switched to placebo.
The authors found that modafinil improved cognitive performance in breast cancer survivors by enhancing some memory and attention skills. Although confirmation is needed, these findings suggest that modafinil may enhance quality of life in this patient population.
作者进行了一项随机临床试验，研究莫达非尼对癌症治疗后患者持续性疲劳的影响，并进行了二次分析以评估莫达非尼对认知功能的影响。
入选研究的为在简明疲劳量表上得分≥2分的乳腺癌患者。在第1阶段（P1），患者接受200毫克莫达非尼开放标签治疗，每日一次，共4周。在第2阶段（P2），P1期有阳性反应的患者被随机分为继续服用莫达非尼4周或服用安慰剂。在基线（服用莫达非尼前）以及完成第1阶段和第2阶段后，进行从认知药物研究（CDR）计算机化认知评估中选取的记忆和注意力测试。对每个测试分数的配对差异进行Wilcoxon符号秩检验。
82名入选女性中，76名完成了P1阶段，68名完成了研究中的所有评估。在研究的P1阶段，莫达非尼对记忆速度（P = 0.0073）和情景记忆质量（P < 0.0001）有显著影响。在第8周随机分组后，相对于改用安慰剂的组，继续服用莫达非尼的患者在记忆速度（P = 0.029）、情景记忆质量（P = 0.0151）和平均注意力连续性（P = 0.0101）方面有显著更大的改善。
作者发现莫达非尼通过增强一些记忆和注意力技能改善了乳腺癌幸存者的认知表现。尽管需要进一步证实，但这些发现表明莫达非尼可能提高该患者群体的生活质量。
