莫达非尼对原发性脑肿瘤患者疲劳、认知功能和情绪的影响：一项多中心随机对照试验。
The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial.
机构信息
Corresponding Author: Florien W. Boele, MSc, Department of Medical Psychology, D-345, VU University Medical Center, Van der Boechorststraat 7, 1081 BT Amsterdam, the Netherlands.
出版信息
Neuro Oncol. 2013 Oct;15(10):1420-8. doi: 10.1093/neuonc/not102. Epub 2013 Aug 7.
BACKGROUND
Fatigue, cognitive deficits, and depression are frequently reported but often undertreated symptoms that can profoundly affect daily life in patients with primary brain tumors (PBTs). To evaluate the effects of the psychostimulant modafinil on fatigue, depression, health-related quality of life (HRQOL), and cognitive functioning in PBT patients, we performed a multicenter, double-blind placebo-controlled crossover trial.
METHODS
Patients randomly received either 6 weeks of treatment with modafinil (up to 400 mg/day) or 6 weeks with placebo. After a 1-week washout period, the opposite treatment was provided. Assessments took place at baseline and immediately after the first and second condition. Patients completed self-report questionnaires on fatigue (Checklist Individual Strength [CIS]), depression (Center for Epidemiologic Studies Depression Scale [CES-D]), HRQOL (Short-Form Health Survey [SF-36]), and self-perceived cognitive functioning (Medical Outcomes Study [MOS]). They also underwent comprehensive neurocognitive testing.
RESULTS
In total, 37 patients participated. Relative to baseline, patients reported lower fatigue severity (CIS) and better motivation (CIS) in both the modafinil (P = .010 and P = .021, respectively) and the placebo condition (P < .001 and P = .027, respectively). The same held for physical health (SF-36 Physical Component Summary score; P = .001 and P = .008, respectively), working memory (P = .040 and P = .043), and information processing capacity (P = .036 and P = .040). No improvement in depressive symptoms was found in either condition.
CONCLUSIONS
Modafinil did not exceed the effects of placebo with respect to symptom management. Patient accrual was slow, and relatively many patients dropped out during the trial, due mostly to side effects. Other, preferably nonpharmacologic intervention studies should be considered to improve symptom management of PBT patients.
背景
疲劳、认知缺陷和抑郁是原发性脑肿瘤（PBT）患者经常报告但往往治疗不足的症状，这些症状会极大地影响他们的日常生活。为了评估精神兴奋剂莫达非尼对 PBT 患者疲劳、抑郁、健康相关生活质量（HRQOL）和认知功能的影响，我们进行了一项多中心、双盲安慰剂对照交叉试验。
方法
患者随机接受 6 周的莫达非尼（最高 400mg/天）或安慰剂治疗。在 1 周洗脱期后，给予相反的治疗。在基线和第一次和第二次条件后立即进行评估。患者完成了疲劳（个体力量检查表[CIS]）、抑郁（流行病学研究中心抑郁量表[CES-D]）、HRQOL（健康调查简表[SF-36]）和自我感知认知功能（医疗结果研究[MOS]）的自我报告问卷。他们还接受了全面的神经认知测试。
结果
共有 37 名患者参与。与基线相比，患者在莫达非尼（CIS，P=0.010 和 P=0.021）和安慰剂（P<0.001 和 P=0.027）条件下报告的疲劳严重程度（CIS）更低，动力更强。同样的情况也出现在生理健康（SF-36 生理成分综合评分；P=0.001 和 P=0.008）、工作记忆（P=0.040 和 P=0.043）和信息处理能力（P=0.036 和 P=0.040）方面。在任何条件下，抑郁症状都没有改善。
结论
莫达非尼在症状管理方面并未超过安慰剂的效果。由于副作用，患者入组缓慢，试验期间相对较多的患者脱落。应考虑其他、最好是非药物干预研究，以改善 PBT 患者的症状管理。
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