Department of Neurology and Psychiatry, Faculty of Medicine and Surgery, The University of Santo Tomas Hospital, Manila, Philippines.
Angiology. 2011 Nov;62(8):625-35. doi: 10.1177/0003319711410594. Epub 2011 Jul 6.
Diabetic polyneuropathy may have vascular and metabolic components in its pathophysiologic mechanism. Cilostazol, aside from its antiplatelet and vasodilatory properties, may increase nerve blood flow and potentially improve neuropathy.
To assess the efficacy and safety of cilostazol in diabetic polyneuropathy.
Forty-seven diabetic patients were randomized into placebo, low-dose (100 mg/d), and high-dose (200 mg/d) cilostazol groups. Primary efficacy parameter was a change in neuropathy symptom scores and secondary efficacy parameter was a change in walking speed from baseline to week 12. Safety parameters were changes in nerve conduction studies as well as reporting of adverse events.
RESULTS/CONCLUSION: Despite significant improvement in the neuropathy symptom scores in the overall motor and sensory categories of the 3 arms of the study from baseline to week 12, no significant differences were found among the groups, indicating nonsuperiority of cilostazol in regard to improvement of neuropathy symptoms over the short study span. However, cilostazol, at low dose, was effective in improving walking speed from baseline to week 12, implying an improved blood flow. No significant worsening nor improvement in motor and sensory nerve conduction parameters were observed, comparing the 3 study arms from baseline to weeks 4, 12, and 16, supporting cilostazol's safety. Overall, the adverse events of the 3 study arms did not significantly differ, and neither were there serious adverse events reported, also signifying safety and tolerability in our Filipino cohort of patients with neuropathy in diabetes mellitus treated with cilostazol.
糖尿病多发性神经病的病理生理机制可能包括血管和代谢因素。西洛他唑除了具有抗血小板和血管扩张作用外，还可能增加神经血流，从而有可能改善神经病。
评估西洛他唑治疗糖尿病多发性神经病的疗效和安全性。
47 例糖尿病患者随机分为安慰剂组、低剂量（100mg/d）组和高剂量（200mg/d）组。主要疗效参数为神经病症状评分的变化，次要疗效参数为从基线到第 12 周的步行速度变化。安全性参数为神经传导研究的变化以及不良事件的报告。
结果/结论：尽管研究中 3 组的神经病症状评分在整体运动和感觉类别中均从基线显著改善，但组间无显著差异，表明西洛他唑在改善神经病症状方面并不优于短期研究期间。然而，西洛他唑低剂量可有效改善从基线到第 12 周的步行速度，表明血流得到改善。与基线相比，在第 4、12 和 16 周时，3 个研究组的运动和感觉神经传导参数均未观察到显著恶化或改善，支持西洛他唑的安全性。总体而言，3 个研究组的不良事件无显著差异，也未报告严重不良事件，这也表明西洛他唑在治疗糖尿病多发性神经病的菲律宾患者中具有安全性和耐受性。
