Gironell Alexandre, Kulisevsky Jaime, Pascual-Sedano Berta, Flamarich David
Movement Disorders Unit, Department of Neurology, Sant Pau Hospital, Autonomous University of Barcelona, Catalonia, Spain.
Mov Disord. 2006 Apr;21(4):441-5. doi: 10.1002/mds.20676.
There is a need for new medication for essential tremor (ET). Preliminary evidence suggests that amantadine may be effective in the treatment of ET. We studied the effects of amantadine in a double-blind, cross-over, placebo-controlled trial in ET patients. Sixteen patients with ET received amantadine 100 mg b.i.d. and placebo for 15 days, with a 1-week wash-out period between treatments. Major evaluation outcomes consisted of a tremor clinical rating scale, accelerometric recordings, and a self-reported disability scale obtained before drug intake and on study days 1 and 15 of each treatment period. A two-way repeated measures analysis of variance (treatment, time) was applied. Any P value < 0.05 was considered significant. On day 15, amantadine did not demonstrate any significant efficacy in reducing tremor with respect to baseline in any tremor measures. An increase in postural tremor as an adverse effect of amantadine was referred by 37.5% of patients. Results from the present trial indicate amantadine at 100 mg b.i.d. is not effective as a treatment for ET.
原发性震颤(ET)需要新的药物治疗。初步证据表明金刚烷胺可能对ET治疗有效。我们在一项针对ET患者的双盲、交叉、安慰剂对照试验中研究了金刚烷胺的效果。16例ET患者接受100mg bid的金刚烷胺和安慰剂治疗15天,治疗期间有1周的洗脱期。主要评估指标包括震颤临床评定量表、加速度记录以及在服药前和每个治疗期的第1天和第15天获得的自我报告残疾量表。应用双向重复测量方差分析(治疗、时间)。任何P值<0.05被认为具有统计学意义。在第15天,金刚烷胺在任何震颤测量指标上相对于基线均未显示出在减轻震颤方面的显著疗效。37.5%的患者报告金刚烷胺的不良反应为姿势性震颤增加。本试验结果表明,100mg bid的金刚烷胺作为ET的治疗方法无效。