Stracke H, Meyer U E, Schumacher H E, Federlin K
Med. Klinik III und Poliklinik, Justus-Liebig Universitaet Giessen, Germany.
Diabetes Care. 1992 Nov;15(11):1550-5. doi: 10.2337/diacare.15.11.1550.
To prove the efficacy of mexiletine in painful diabetic neuropathy.
Treatment was provided in three dosages. For pain measurements, a VAS and McGill's verbal rating scale were chosen. Ninety-five patients were included in the study.
A global assessment of the VAS among patients showed no differences between mexiletine treatment and placebo. The total evaluation (PRIT) of the McGill scale fell just below the level of significance. More specific exploratory evaluations of subclasses of the McGill scale, representing different degrees of pain, gave remarkable differences between mexiletine and placebo in sensory and miscellaneous items. In special subgroups, which were formed according to types and courses of complaints compiled at the beginning of this evaluation, the substantial advantages of the mexiletine treatment were shown with both the VAS and the McGill scale.
Evidence strongly indicates that, in particular, those patients with stabbing or burning pain, heat sensations, or formication will benefit most by mexiletine therapy. Concerning the dosage, a medium regimen of 450 mg/day seems to be appropriate. With an increase in the antiarryhthmic dosage level, the efficacy does not rise proportionally. Mexiletine proved to be a safe therapy with negligible side effects at the medium dose range, even less than placebo; and remarkably, no cardiovascular side effects were noted. Further studies should avoid global assessments and pay more attention to the variety of complaints and quality of life.
证明美西律对糖尿病性疼痛性神经病变的疗效。
采用三种剂量进行治疗。疼痛测量选用视觉模拟评分法（VAS）和麦吉尔疼痛问卷（McGill）言语评定量表。95例患者纳入本研究。
患者VAS总体评估显示美西律治疗与安慰剂之间无差异。麦吉尔量表的总体评估（PRIT）略低于显著性水平。对麦吉尔量表代表不同疼痛程度的亚类进行更具体的探索性评估，显示美西律与安慰剂在感觉和其他项目上有显著差异。在根据本次评估开始时收集的症状类型和病程形成的特殊亚组中，VAS和麦吉尔量表均显示美西律治疗具有显著优势。
有力证据表明，尤其是那些有刺痛或灼痛、热感或蚁走感的患者，将从美西律治疗中获益最多。关于剂量，450毫克/天的中等剂量方案似乎合适。随着抗心律失常剂量水平的增加，疗效并非成比例提高。美西律在中等剂量范围内被证明是一种安全的治疗方法，副作用可忽略不计，甚至低于安慰剂；而且，未观察到心血管副作用。进一步的研究应避免总体评估，更多关注症状的多样性和生活质量。
