替扎尼定在神经病理性疼痛中的作用.doc

替扎尼定在神经病理性疼痛中的作用： 一个开放性试验 Effectiveness of Tizanidine in Neuropathic Pain: An Open-Label Study Marilyn R. Semenchuk and Scott Sherman 摘要： 这个研究的目的是为了评估替扎尼定在神经病理性疼痛（Neuropathic Pain）中的作用和耐受性。在开放性试验中，患者患有神经病理性疼痛，给予1－4mg替扎尼定（每天1次）治疗7天，然后在8周内，每周增加剂量2－8mg直到他/她的最大耐受量或者36mg最大剂量。用整体患者镇痛评价、神经病理性疼痛量表（the Neuropathic Pain Scale）和威斯康星简要疼痛目录（Wisconsin Brief Pain Inventory）的平均每周疼痛评分和每半月评分来评估治疗效果。也检查了不良反应频率和严重性。23例患者参加了试验。基线水平平均每周疼痛评分为6.9，8周后减少1.7为5.2（p≤0.01）。15例患者（68％）报告使用替扎尼定治疗后疼痛得到改善或明显改善，2例患者疼痛完全缓解。以下神经病理性疼痛指标在8周时都较基线水平有明显减轻：疼痛的强度、刺痛、灼痛、钝痛、冷痛、敏感度、不适感和深部疼痛。从基线到治疗8周后，疼痛的各项指标和疼痛对生活质量的影响均有明显减轻。平均有效或最大耐受剂量为23mg/天（范围：6－36mg/天）。副作用主要为头昏（dizziness/lightheadedness）（52％）、嗜睡（48％）、乏力（fatigue/weakness）（43％）、口干（39％）、胃肠不适（30％）和睡眠障碍（22％）。一例患者在第4周时肝脏功能检查（liver function tests，LFTs）明显升高并伴有症状。停止替扎尼定治疗后3周内，LFTs恢复正常。替扎尼定可能是一种神经病理性疼痛的有效治疗方法，为其它治疗方法效果差的患者提供了一种可供选择的方案。建议进行更大的随机、安慰剂对照试验。另外，与其它药物的比较试验也应开展。 关键词：替扎尼定，zanaflex，神经病理性疼痛 Abstract: The purpose of this research trial is to assess the effectiveness and tolerability of tizanidine in neuropathic pain. In an open-label study, patients with neuropathic pain received 1 to 4 mg of tizanidine once daily for 7 days, followed by weekly dose escalation of 2 to 8 mg to his/her effective or maximum tolerated dose or a maximum of 36 mg over an 8-week period. Treatment effects were assessed, using average weekly pain scores as well as biweekly scores for patient global assessment of pain relief, the Neuropathic Pain Scale, and Wisconsin Brief Pain Inventory. Frequency and severity of adverse events were examined also. Twenty-three patients were enrolled. The mean average weekly pain score at baseline was 6.9, which decreased by 1.7 points at the end of week 8 to 5.2 (P≤.01). A total of 15 patients (68%) reported that their pain relief was improved or much improved with tizanidine therapy, and 2 of these patients became completely pain-free. The following neuropathic pain qualities were significantly lower at week 8 compared with baseline: intense, sharp, hot,