中文摘要：

目的评价普瑞巴林联合依帕司他和甲钴胺治疗痛性糖尿病周围神经病变（PDPN）的疗效和安全性。方法将80例PDPN患者根据随机数字表法分为普瑞巴林组（A组）和普瑞巴林联合依帕司他和甲钴胺组（B组）,每组各40例。两组患者均予以控制血糖、改善循环等治疗4周。治疗前、治疗后4周用视觉模拟评分（VAS）评估患者的疼痛强度变化,用生活质量量表（WHO QOL-100）评定生活质量的改变,测定神经传导速度（NCV）,以及记录药物不良反应。结果与治疗前比较,治疗4周后,两组患者VAS评分均明显降低,生活质量有所改善,差异均有统计学意义（P〈0.05）;且B组患者的疼痛缓解和生活质量改善均优于A组（P〈0.05）。治疗后,A组患者NCV与治疗前比较无明显改善（P〉0.05）,但B组患者NCV较治疗前明显增加（P〈0.05）,且B组患者NCV较A组也显著增加（P〈0.05）。两组不良反应发生率差异无统计学意义（P〉0.05）。结论普瑞巴林联合依帕司他和甲钴胺较单独使用普瑞巴林治疗PDPN的疗效更佳,而且没有增加药物不良反应。

英文摘要：

Objective To evaluate the efficacy and safety of pregabalin combined with epalrestat and methylcobalamin in the treatment of painful diabetic peripheral neuropathy （PDPN）. Methods Eighty patients with PDPN were randomly divided into the pregabalin group （A, n=40）and pregabalin combined with epalrestat and methylcobalamin （B, n=40）.The two groups were given the therapy of controlling blood sugar level and improving circulation for 4 weeks. The pain intensity change before treatment and in 4 weeks after treatment was assessed with the Visual Analogue Scale （VAS）. The quality of life was evaluated by the short form of World Health Organization Quality of Life （WHOQOL- 100）, too. Moreover, the nerve conduction velocity （NCV） was detected and the adverse drug reactions were recorded. Results The VAS scores after 4-week treatment in the two groups were significantly decreased compared with before treatment and the quality of life was significantly improved, the differences were sta- tistically significant （P〈0.05）,moreover the pain alleviation and living quality improvement in the group B were superior to the group A （P〈0.05）. After treatment, NCV in the group A had no obvious improvement compared with before treatment （P〉0.05）. However, NCV in the group B was obviously increased compared with before treatment, moreover NCV in the group B was significantly increased compared with the group A（P〈0.05）. The occurrence rate of adverse reactions had no statistical difference between the two groups （P〉0.05）. Conclusion Pregabalin combined with epalrestat and methylcobalamin has better effect than single pregabahn for treating PDPN, moreover without increasing the risk of increasing adverse drug reactions.