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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。
Objective: To investigate the safety and efficacy of pancreatic kallikrein enteric-coated tablets combined with sildenafil in the treatment of type 2 diabetes mellitus with erectile dysfunction (ED) in high altitude areas. Methods Ninety-three diabetic patients with ED in Xining, Qinghai Province were randomly divided into two groups. The experimental group (48 cases) took pancreatic kallikrein enteric-coated tablets (120 u, 3 times daily) combined with low-dose sildenafil The patients in the control group (25 mg once a night) and the control group (45 patients) were given low-dose sildenafil (25 mg once a night). After 4 and 8 weeks of treatment, the penile color Doppler (CDDU) examination, International Index of Erectile Function (IIEF-5), sexual satisfaction. Results: There was no significant difference between the two groups in age and duration of diabetes (P> 0.05). After 4 weeks of treatment, the scores of IIEF-5 in the experimental group and the control group before and after treatment [(8.81 ± 2.06) vs (11.54 ± 7.72) vs 8.29 ± 1.91 vs (9.37 ± 1.65), SIS [(3.35 ± (2.43) points vs (6.83 ± 2.61) points and (3.41 ± 2.38) points vs (4.92 ± 2.49) points respectively, there was a significant difference in CDDU between two groups (P <0.05) (9.37 ± 1.65) points and SIS (6.83 ± 2.61) points vs (4.92 ± 2.49) points (P <0.05), while there was no difference in CDDU parameters (P> 0.05). After 8 weeks of treatment, the IIEF-5 scores in the experimental group and the control group before and after treatment [(8.81 ± 2.06) vs (19.29 ± 1.85) vs (8.29 ± 1.91) vs (15.43 ± 1.74)] were significantly different (P <0.05). There was significant difference in the IIEF-5 score between the two groups [(19.29 ± 1.85) vs (15.43 ± 1.74), SIS (11.73 ± 2.57 vs 6.55 ± 2.71, (P <0.05). Conclusion: The combination of pancreatic kallikrein enteric-coated tablets and sildenafil in the treatment of type 2 diabetes mellitus patients with ED at high altitude has some clinical efficacy and is more effective than single sildenafil treatment.