· 糖尿病神经病变·

　　[摘要] 目的 评价普瑞巴林治疗糖尿病周围神经病疼痛的疗效和安全性。方法 入选T2DM患者60例，随机分为普瑞巴林组和阿米替林组，每组各30例。共观察4周。治疗开始和4周时测定血生化及周围神经传导速度，每日行疼痛强度数字分级法(NRS)评估，并记录药物不良反应。计算两组治疗4周时疼痛缓解≥50%的发生率。结果 治疗后两组FPG、LDL-C下降(P<0.05)，但两组间差异无统计学意义。治疗前后主要终点指标NRS评分，普瑞巴林组为(5.2±1.4) vs (1.3±1.2);阿米替林组为(4.9±0.9) vs (2.2±1.3)(P均<0.01)。4周时普瑞巴林组NRS低于阿米替林组(P<0.05)。普瑞巴林组和阿米替林组疼痛缓解≥50%的发生率为75.9% vs 50.0%(P<0.05)。普瑞巴林组头痛1例，心悸1例;阿米替林组头晕1例，嗜睡5例，便秘1例，水肿1例。结论 普瑞巴林和阿米替林均可缓解糖尿病周围神经病疼痛。且普瑞巴林更有效、起效更快。

　　[关键词] 糖尿病周围神经病;神经病理性疼痛;普瑞巴林;阿米替林

　　[Abstract] Objective To evaluate the efficacy and safety of pregabalin on diabetic peripheral neuropathy pain. Methods A total of 60 type 2 diabetes patients were enrolled, and randomized into pregabalin group (n= 30,treated with pregabalin 75mg twice daily) and amitriptyline group (n= 30, amitriptyline 25mg twice daily). The trial period lasted four weeks. At the beginning and the 4th week, the biochemical parameters and nerve conduction velocity (NCV) were detected. The numeric rating scales (NRS) of pain intensity was recorded each day. And the side effects were recorded at the end of trial. At the same time， the ratio of patients whose pain remission was more than 50% was calculated in two groups. Results There was no significant difference in clinical and biochemical parameters between two groups at the beginning of trial. Results There were no significant differences in clinical and biochemical parameters between two groups at the beginning of trial. At the end of trial， the fasting plasma glucose and low density lipoprotein cholesterol levels decreased significantly, however the other clinical and biochemical parameters did not change significantly.From the beginning to the end of trial，.the NRS reduced from (5.2 ± 1.4) to (1.3 ± 1.2) (P = 0.000) in pregabalin group and from (4.9 ± 0.9) to (2.2 ± 1.3)(P = 0.000) in amitriptyline group. At the 4th week, the NRS was significantly lower in pregabalin group than in amitriptyline group (P = 0.012). The ratio of patients， whose rate of pain remission was more than 50%, was much more in pregabalin group than that in amitriptyline group at the 4th week (75.9% vs 50%，P=0.043). One case with headache and one case with palpitation were found in pregabalin group. In amitriptyline group, one case with dizzy, five cases with drowsiness , one case with constipation, and one case with edema presented. Conclusions Both pregabalin and amitriptyline can alleviate pain in diabetic neuropathy effectively. Pregabalin is more effective and works faster than amitriptyline.

　　[Keywords] Diabetic peripheral neuropathy; Neuropathy pain; Pregabalin; Amitriptyline