目的观察α-硫辛酸联合依帕司他治疗糖尿病痛性神经病变(PDN)的临床效果。方法294例PDN患者随机分为α-硫辛酸组、依帕司他组和α-硫辛酸-依帕司他联合组,每组各98例。比较各组足部压力觉异常点数、密西根神经病变量表(MNSI)症状问卷和足部检查评分、运动神经传导速度(MCV)和感觉神经传导速度(SCV)评分、健康调查简表(SF-36)生存质量评分及治疗总有效率。结果治疗后,α-硫辛酸-依帕司他联合组、α-硫辛酸组和依帕司他组足部压力觉异常点数[(5.61±0.75)vs(8.01±1.24)vs(8.13±1.23)个]、MNSI症状问卷[(5.66±0.55)vs(7.01±0.71)vs(6.84±0.68)分]、MNSI足部检查[(2.35±0.66)vs(4.13±0.77)vs(4.07±0.78)分]、正中神经MCV[(51.37±1.92)vs(44.98±1.93)vs(45.13±1.93)m/s]和SCV[(48.89±2.01)vs(44.63±1.91)vs(44.99±1.93)m/s]、腓总神经MCV[(49.57±1.88)vs(44.73±1.90)vs(45.01±1.89)m/s]、SCV[(51.42±2.13)vs(48.02±2.03)vs(48.21±2.01)m/s]、生理功能评分[(65.33±5.51)vs(53.47±5.41)vs(54.01±5.47)分]、躯体疼痛评分[(82.01±5.01)vs(69.54±4.97)vs(70.74±4.93)分]及治疗总有效率(91.84%vs 77.55%vs 79.59%)比较,差异均有统计学意义(P<0.01)。结论与α-硫辛酸和依帕司他单药相比,α-硫辛酸-依帕司他联合用药治疗PDN的效果更为显著。 Objective To observe the clinical efficacy of α-lipoic acid combined with epalrestat in the treatment of diabetic pain neuropathy (PDN). Methods 294 patients with PDN were randomly divided into α-lipoic acid group, epalrestat group and α-lipoic acid-epalrestat combination group, 98 cases in each group. The abnormalities of foot pressure sensation points, MNSI symptom questionnaire and foot examination score, motor nerve conduction velocity (MCV) and sensory nerve conduction velocity (SCV) score were compared among groups. SF- 36) The quality of life score and the total effective rate of treatment. Results After treatment, the number of anomalous pressure ulnar feet ([(5.61 ± 0.75) vs (8.01 ± 1.24) vs (8.13 ± 1.23 ), MNSI symptom questionnaire [(5.66 ± 0.55) vs (7.01 ± 0.71) vs (6.84 ± 0.68), MNSI foot examination (2.35 ± 0.66 vs 4.13 ± 0.77 vs 4.07 ± 0.78, (51.37 ± 1.92) vs (44.98 ± 1.93) vs (45.13 ± 1.93) m / s and SCV [(48.89 ± 2.01) vs (44.63 ± 1.91) vs (44.99 ± 1.93) m / (51.42 ± 2.13) vs (48.02 ± 2.03) vs (48.21 ± 2.01) m, respectively, and MCV in the common peroneal nerve (49.57 ± 1.88 vs 44.01 ± 1.89 vs 45.01 ± 1.89 m / s, / s], physical function score [(65.33 ± 5.51) vs (53.47 ± 5.41) vs (54.01 ± 5.47)], body pain score [(82.01 ± 5.01) vs (69.54 ± 4.97) vs (70.74 ± 4.93) ] And total effective rate (91.84% vs 77.55% vs 79.59%), the differences were statistically significant (P <0.01). Conclusions The combination of α-lipoic acid and epalrestat with PDN is more effective than α-lipoic acid and epalrestat.