Topiramate and physiologic measures of nerve function in polyneuropathy
Topiramate and physiologic measures of nerve function in polyneuropathy
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DOI：
10.1111/j.1600-0404.2006.00789.x
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发表时间：
2007-04-01
影响因子：
3.5
通讯作者：
Thienel, U.
中科院分区：
文献类型：
--
作者：
Freeman, R.;McIntosh, K. A.;Thienel, U.
目的：采用电生理学方法和非劣效性临床试验设计评价托吡酯治疗神经功能的疗效。方法：采用双盲、多中心、安慰剂对照试验对67例疼痛性糖尿病多发神经病变患者进行研究。腓运动神经传导速度（NCV）的变化是主要观察指标。其次测量腓肠感觉神经和尺神经的NCVs，以及振幅和潜伏期的变化。周围神经功能也在报告治疗后出现感觉异常的患者亚组中进行了评估。结果-最小二乘平均NCV下降安慰剂组（-0.2 m/s）大于托吡酯组（-0.1 m/s） （95% CI: -1.30, 1.42）。二次测量显示托吡酯治疗患者的神经功能没有下降。有和没有感觉异常的患者的神经生理指标相似。托吡酯最常见的不良事件是感觉异常、厌食症、体重减轻和味觉变态。结论：本神经传导研究未发现托吡酯与神经功能恶化相关的证据。
Objective- To evaluate topiramate treatment on nerve function using electrophysiologic methods and a non-inferiority clinical trial design. Methods-A double-blind, multicenter, placebo-controlled trial was conducted in patients with painful diabetic polyneuropathy (n = 67). Change in peroneal motor nerve conduction velocity (NCV) was the primary outcome. NCVs of sural sensory and ulnar nerves, and amplitude and latency changes were measured secondarily. Peripheral nerve function was also evaluated in a patient subgroup reporting treatment-emergent paresthesias. Results- Least squares mean decrease in NCV was greater for placebo (-0.2 m/s) than for topiramate treatment (-0.1 m/s) (95% CI: -1.30, 1.42). Secondary measures showed no decrease in nerve function for topiramate-treated patients. Neurophysiologic measures were similar in patients with and without paresthesias. The most common adverse events with topiramate were paresthesias, anorexia, weight decrease, and taste perversion. Conclusion-This nerve conduction study found no evidence that topiramate is associated with deterioration of nerve function.