Berthier Marcelo L, Green Cristina, Lara J Pablo, Higueras Carolina, Barbancho Miguel A, Dávila Guadalupe, Pulvermüller Friedemann
Unidades de Neurología Cognitiva y Afasia y Neurofisiología Humana, Facultad de Psicología, Universidad de Málaga, Málaga, Spain.
Ann Neurol. 2009 May;65(5):577-85. doi: 10.1002/ana.21597.
We conducted a randomized, double-blind, placebo-controlled, parallel-group study of both memantine and constraint-induced aphasia therapy (CIAT) on chronic poststroke aphasia followed by an open-label extension phase.
Patients were randomized to memantine (20 mg/day) or placebo alone during 16 weeks, followed by combined drug treatment with CIAT (weeks 16-18), drug treatment alone (weeks 18-20), and washout (weeks 20-24), and finally, an open-label extension phase of memantine (weeks 24-48). After baseline evaluations, clinical assessments were done at two end points (weeks 16 and 18), and at weeks 20, 24, and 48. Outcome measures were changes in the Western Aphasia Battery-Aphasia Quotient and the Communicative Activity Log.
Twenty-eight patients were included, and 27 completed both treatment phases. The memantine group showed significantly better improvement on Western Aphasia Battery-Aphasia Quotient compared with the placebo group while the drug was taken (week 16, p = 0.002; week 18, p = 0.0001; week 20, p = 0.005) and at the washout assessment (p = 0.041). A significant increase in Communicative Activity Log was found in favor of memantine-CIAT relative to placebo-CIAT (week 18, p = 0.040). CIAT treatment led to significant improvement in both groups (p = 0.001), which was even greater under additional memantine treatment (p = 0.038). Beneficial effects of memantine were maintained in the long-term follow-up evaluation, and patients who switched to memantine from placebo experienced a benefit (p = 0.02).
Both memantine and CIAT alone improved aphasia severity, but best outcomes were achieved combining memantine with CIAT. Beneficial effects of memantine and CIAT persisted on long-term follow-up.
我们开展了一项随机、双盲、安慰剂对照、平行组研究，评估美金刚和强制性诱导失语症疗法（CIAT）对慢性脑卒中后失语症的疗效，并进行了开放标签的延长期研究。
患者在16周内被随机分配接受美金刚（20毫克/天）或安慰剂单药治疗，随后进行美金刚与CIAT联合药物治疗（第16 - 18周）、单药治疗（第18 - 20周）和洗脱期（第20 - 24周），最后是美金刚的开放标签延长期（第24 - 48周）。在基线评估后，在两个终点（第16周和第18周）以及第20、24和48周进行临床评估。疗效指标为西方失语症成套测验 - 失语商数和交流活动日志的变化。
纳入28例患者，27例完成了两个治疗阶段。在服用药物期间（第16周，p = 0.002；第18周，p = 0.0001；第20周，p = 0.005）以及洗脱期评估时（p = 0.041），美金刚组在西方失语症成套测验 - 失语商数方面的改善显著优于安慰剂组。相对于安慰剂 - CIAT，美金刚 - CIAT在交流活动日志方面有显著增加（第18周，p = 0.040）。CIAT治疗在两组中均导致显著改善（p = 0.001），在额外的美金刚治疗下改善更大（p = 0.038）。美金刚的有益效果在长期随访评估中得以维持，从安慰剂转换为美金刚的患者也有获益（p = 0.02）。
美金刚和CIAT单药治疗均改善了失语严重程度，但美金刚与CIAT联合使用时效果最佳。美金刚和CIAT的有益效果在长期随访中持续存在。
