Bird Shawn J, Brown Mark J, Spino Cathie, Watling Sharon, Foyt Howard L
Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
Muscle Nerve. 2006 Aug;34(2):214-24. doi: 10.1002/mus.20577.
Conduct of a large, multicenter trial of the aldose reductase inhibitor zenarestat provided data on the reproducibility of multiple electrophysiologic (nerve conduction studies, NCS) and quantitative sensory (QST) tests. Baseline and 12-month electrophysiologic data from approximately 1100 patients at multiple centers were available for analysis. Intersite variability contributed minimally to overall test variance. All NCS tests were highly reproducible. Cool thermal and vibration QST thresholds, as measured by CASE IV instrumentation, were also highly reproducible. Intersubject variance accounted for the majority of variance for all parameters measured. Repeating NCS and QST measures decreased sample sizes needed to show statistical significance. Consideration of these observations, particularly with regard to QST, should aid in the design of future clinical trials investigating neuropathy.
一项关于醛糖还原酶抑制剂泽那司他的大型多中心试验提供了多项电生理(神经传导研究,NCS)和定量感觉(QST)测试可重复性的数据。来自多个中心约1100名患者的基线和12个月的电生理数据可供分析。不同地点间的变异性对总体测试方差的贡献极小。所有NCS测试都具有高度可重复性。通过CASE IV仪器测量的冷觉和振动觉QST阈值也具有高度可重复性。受试者间的变异性占所有测量参数方差的大部分。重复进行NCS和QST测量可减少显示统计学显著性所需的样本量。考虑到这些观察结果,特别是关于QST的观察结果,应有助于未来研究神经病变的临床试验的设计。