Objective: To investigate the safety and efficacy of pancreatic kininogenase combined with sildenafil in the treatment of erectile dysfunction(ED) in type 2 diabetes mellitus (DM) patients in the high-altitude area.
Methods: This study included 93 ED patients with type 2 DM, all residents of the Xining area 1500 meters above sea level. We randomly divided them into an experimental group (n = 48) and a control group (n = 45), the former treated with pancreatic kininogenase(120 u, tid) and sildenafil (25 mg, qd at bedtime), while the latter with sildenafil only (25 mg, qd at bedtime).After 4 and 8 weeks of medication, we obtained the penile hemodynamic parameters,IIEF-5 scores, and sexual intercourse satisfaction(SIS) scores and compared them between the two groups of patients.
Results: There were no statistically significant differences in age or DM course between the two groups of patients (P >0.05).Compared with the baseline, both the experimental and control groups showed remarkably improvement inthe IIEF-5 score (8.81 ± 2.06 vs 11.54 ± 7.72 and 8.29 ± 1.91 vs 9.37± 1.65, P <0.05), SIS score (3.35 ± 2.43vs6.83± 2.61and 3.41 ± 2.38 vs 4.92± 2.49, P <0.05), and penile hemodynamic parameters obtained by color duplex Doppler ultrasonography(P <0.05), with significant differences between the two groups in the IIEF-5 score (11.54 ± 7.72 vs 9.37± 1.65, P <0.05) and SIS score (6.83± 2.61 vs 4.92± 2.49, P <0.05) but not in the penile hemodynamic parameters (P >0.05). Even more remarkable improvement was observed at 8 weeks in the experimental and control groups in the IIEF-5 score (19.29± 1.85 and 15.43± 1.74)(P <0.05), SIS score (11.73 ± 2.57 and 6.55± 2.71) (P <0.05), and penile hemodynamic parameters(P <0.05), all with significant differences between the two groups (P <0.05).
Conclusions: Pancreatic kininogenase combined with sildenafil has a better clinical effect than sildenafil alone on ED in type 2 DM patientsin the high-altitude area.
目的： 探讨胰激肽原酶肠溶片联合西地那非治疗高海拔地区2型糖尿病合并勃起功能障碍(ED)患者的安全性及疗效。方法： 选择青海西宁地区糖尿病合并ED患者93例，随机分成两组，试验组(48例)服用胰激肽原酶肠溶片（120 u，3次/d）联合小剂量西地那非规律服用（25 mg，每晚1次），对照组(45例) 小剂量西地那非规律服用（25 mg，每晚1次），两组治疗4、8周后评价两组阴茎彩色多普勒超声（CDDU）检查、国际勃起功能指数(IIEF-5)、性交满意度。结果： 患者年龄及糖尿病病程两组间均无显著差异(P>0.05)。治疗4周：试验组和对照组治疗前后IIEF-5评分［(8.81±2.06)分 vs (11.54±7.72)分和(8.29±1.91)分 vs (9.37±1.65)分］、SIS［(3.35±2.43)分 vs (6.83±2.61)分和(3.41±2.38)分 vs (4.92±2.49)分］、CDDU均有显著差异(P<0.05)，两组间IIEF-5评分［(11.54±7.72)分 vs (9.37±1.65)分］和SIS［(6.83±2.61)分 vs (4.92±2.49)分］有显著差异(P<0.05)，而CDDU参数无差异(P>0.05)。治疗8周：试验组和对照组治疗前后IIEF-5评分［(8.81±2.06)分 vs (19.29±1.85)分和(8.29±1.91)分 vs (15.43±1.74)分］均有显著差异 (P<0.05)，两组间IIEF-5评分［(19.29±1.85)分 vs (15.43±1.74)分］、SIS［(11.73±2.57)分 vs (6.55±2.71)分］、CDDU参数均有显著差异(P<0.05)。结论： 胰激肽原酶肠溶片联合西地那非治疗高海拔地区2型糖尿病合并ED患者具有一定临床疗效，且较单一西地那非治疗更为有效。.
Keywords: erectile dysfunction; pancreatic kininogenase; sildenafil; type 2 diabetes mellitus; high-altitude area.