Oskarsson P, Ljunggren J G, Lins P E
Department of Internal Medicine, Danderyd Hospital, Sweden.
Diabetes Care. 1997 Oct;20(10):1594-7. doi: 10.2337/diacare.20.10.1594.
To investigate the efficacy and safety of mexiletine in the treatment of painful diabetic neuropathy.
A total of 216 insulin-treated diabetes patients with painful diabetic neuropathy were randomly allocated to three dosages of mexiletine or placebo. The Visual Analog Scale (VAS) for pain/discomfort was scored each day during daytime and nighttime, and sleeping disturbances were also recorded by the patients. Plasma levels of mexiletine and 24-h electrocardiogram (ECG) mapping were assessed before and during the 3-week study period.
A significant reduction in sleep disturbances and pain during nighttime was observed in the group of patients taking the highest dosages (675 mg/day) of mexiletine compared with the other groups. No significant correlation was found between plasma concentration of mexiletine and the therapeutic effect or adverse events. No serious adverse events were seen. The 24-h ECG mapping did not disclose onset of significant arrhythmias in any patient.
Mexiletine in a dosage of 675 mg daily can reduce pain caused by diabetic neuropathy, and the effect of this drug appears to have a rapid onset.
研究美西律治疗痛性糖尿病神经病变的疗效及安全性。
总共216例接受胰岛素治疗的痛性糖尿病神经病变患者被随机分配至三种剂量的美西律组或安慰剂组。在白天和夜间每天对疼痛/不适进行视觉模拟评分（VAS），患者还需记录睡眠障碍情况。在为期3周的研究期之前及期间评估美西律的血浆水平和24小时心电图（ECG）描记。
与其他组相比，服用最高剂量（675毫克/天）美西律的患者组夜间睡眠障碍和疼痛显著减轻。美西律的血浆浓度与治疗效果或不良事件之间未发现显著相关性。未观察到严重不良事件。24小时心电图描记未显示任何患者出现明显心律失常。
每日675毫克剂量的美西律可减轻糖尿病神经病变引起的疼痛，且该药似乎起效迅速。
