Perkins Bruce A, Ngo Mylan, Bril Vera
EN 11-209, Toronto General Hospital, University Health Network, University of Toronto, 200 Elizabeth St., Toronto, Ontario, Canada M5G 2C4.
Muscle Nerve. 2002 Feb;25(2):212-7. doi: 10.1002/mus.10044.
Nerve conduction studies (NCS) in diabetic sensorimotor polyneuropathy (DSP) are sensitive, noninvasive, and associated with small coefficients of variation, and correlate well with underlying peripheral nerve morphological change. For these reasons, the current reference standard for DSP involves multivariate instruments that emphasize NCS results. However, the interside symmetry of NCS findings in different stages of DSP are unknown, although requirement for symmetry has been suggested in clinical trials of DSP. We therefore aimed to determine the degree of symmetry of NCS findings in DSP of differing severity stages. A cohort of diabetic patients, including patients without neuropathy and those with mild to severe DSP, was studied. We also studied a series of nondiabetic, healthy subjects. A variation of stratified sampling by means of a clinical neuropathy score ensured that a broad spectrum of neuropathy was studied. A total of 478 subjects was ascertained; patient accrual was discontinued when the smallest clinical group consisted of 50 subjects. Nerve conduction studies were conducted prospectively and in a blinded fashion using surface recordings, averaging for sensory action potentials, control of limb temperature, and standardized techniques. Median and ulnar motor and sensory, peroneal and tibial motor, and sural NCS were performed. Interside symmetry, independent of neuropathy severity, was observed for all investigated nerves, except for the median sensory nerve action potential amplitude, which was lower on the right side. These results confirm that abnormal NCS findings consistent with DSP are reliably symmetrical with the exception of the amplitude of the median sensory nerve action potential. Thus, unilateral evaluation of NCS in DSP is sufficient as a reference standard in clinical trials. We also conclude that great degrees of asymmetry in NCS results are reason to question inclusion of DSP patients in clinical trials.
糖尿病性感觉运动性多发性神经病变(DSP)的神经传导研究(NCS)具有敏感性、非侵入性,变异系数小,且与潜在的周围神经形态学改变相关性良好。基于这些原因,目前DSP的参考标准涉及强调NCS结果的多变量检测方法。然而,尽管在DSP的临床试验中已有人提出对称性的要求,但不同阶段DSP中NCS结果的双侧对称性尚不清楚。因此,我们旨在确定不同严重程度阶段的DSP中NCS结果的对称程度。我们研究了一组糖尿病患者,包括无神经病变的患者以及患有轻至重度DSP的患者。我们还研究了一系列非糖尿病健康受试者。通过临床神经病变评分进行分层抽样,确保研究了广泛的神经病变谱。共确定了478名受试者;当最小的临床组由50名受试者组成时,停止招募患者。前瞻性地以盲法进行神经传导研究,使用表面记录、感觉动作电位平均、肢体温度控制和标准化技术。进行了正中神经、尺神经运动和感觉、腓总神经和胫神经运动以及腓肠神经的NCS检测。除正中神经感觉神经动作电位幅度右侧较低外,所有研究神经均观察到与神经病变严重程度无关的双侧对称性。这些结果证实,除正中神经感觉神经动作电位幅度外,与DSP一致的异常NCS结果具有可靠的对称性。因此,在DSP中对NCS进行单侧评估足以作为临床试验中的参考标准。我们还得出结论,NCS结果中存在高度不对称性是对将DSP患者纳入临床试验提出质疑的原因。