Components of variance for vibratory and thermal threshold testing in normal and diabetic subjects
Components of variance for vibratory and thermal threshold testing in normal and diabetic subjects
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DOI：
10.1016/1056-8727(94)00042-m
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发表时间：
1995-07-01
影响因子：
3
通讯作者：
Bril, V
中科院分区：
文献类型：
--
作者：
Gelber, DA;Pfeifer, MA;Bril, V
定量感觉测试(QST)常用于糖尿病神经病变的评估。然而，关于触觉和热测试设备的可靠性的数据很少。中心间QST测量的重复性此前未见报道。这项研究旨在验证QST测试程序，并确定这些设备是否适合大规模多中心临床试验。用OTT触觉测试仪(OTT)和热敏测试仪(TST)对10名正常人进行了手指和脚趾振动(V-f，V-t)和温度(T-f，T-t)阈值的测定。阈值测量在技术人员之间是可重复的，并且具有V-f 20%、V-t 23%、T-f 41%和T-t 95%的逐日变异系数。对6个中心的140名正常人进行了阈值测定。各中心之间的平均阈值无显著差异。中心-中心变异系数(CV)分别为V-f 44%，V-t 45%，T-f 47%，T-t 87%。在性别、侧方研究、是否有骨痂或皮肤温度方面，阈值测量没有显著差异。V-f阈值与年龄显著相关(p<；0.01)。正常人的振动阈值和温度阈值与神经传导速度(NCV)无相关性。对98例糖尿病患者进行了热阈值和振动阈值的测定。无神经病变临床证据的糖尿病患者与正常人无显著差异，但有神经病变的糖尿病患者的阈值高于正常人(p<；0.05)。我们的结论是，OTT和TST的温度和振动阈值测试在正常人中产生了可重复性的测量，并提供了一种非常适合于多中心试验的临床糖尿病神经病变的客观测量方法。
Quantitative sensory testing (QST) is commonly used in the assessment of diabetic neuropathy. However, little data are available on the reliability of tactile and thermal testing devices. Reproducibility of QST measures between centers has not been previously reported. This study was designed to validate QST testing procedures and determine if these devices are suitable for large scale multicenter clinical trials. Finger and toe vibratory (V-f, V-t) and thermal (T-f, T-t) thresholds were determined for ten normal individuals by a two-alternative forced-choice procedure using the Optacon Tactile Tester (OTT) and Thermal Sensitivity Tester (TST). Threshold measurements were reproducible between technologists and had a day-to-day coefficient of variation of V-f 20%, V-t 23%, T-f 41%, and T-t 95%. Thresholds were determined for 140 normal individuals at six centers. Mean threshold values between centers were not significantly different. Center-to-center coefficents of variation (CV) were V-f 44%, V-t 45%, T-f 47%, and T-t 87%. There was no significant difference in threshold measures with regard to sex, side studied, presence of calluses, or skin temperature. V-f thresholds significantly correlated with age (p < 0.01). There was no correlation between either vibratory or thermal thresholds in normal individuals, and nerve conduction velocities (NCV). Thermal and vibratory thresholds were determined for 98 diabetic patients. Diabetic subjects without clinical evidence of neuropathy were not significantly different from normal individuals, but diabetic patients with neuropathy had increased thresholds compared to normals (p < 0.05). We conclude that thermal and vibratory threshold testing with the OTT and TST yields reproducible measurements in normal individuals and provides an objective measure of clinical diabetic neuropathy that is well suited for multicenter trials.