An open, comparative, multicentre clinical study of combined oral therapy with sildenafil and doxazosin GITS for treating Chinese patients with erectile dysfunction, and lower urinary tract symptoms secondary to benign prostatic hyperplasia

This study sought to investigate the clinical efficacy and safety of combined oral therapy with sildenafil and doxazosin GITS compared to sildenafil monotherapy in treating Chinese patients with erectile dysfunction （ED） and lower urinary tract symptoms secondary to benign prostatic hyperplasia （BPH/LUTS）. The trial was conducted in hospitals in Beijing, Shanghai, Changsha, Wuhan and Guangzhou, five major cities in China. A total of 250 patients diagnosed with ED and BPH/LUTS aged 50-75 years, and who had International Index of Erection Function-5 （IIEF-5） scores ≤ 21 and International Prostate Symptom Score （IPSS） ≥ 10 points, were enrolled and randomly divided into Group A （168 cases; doxazosin GITS 4 mg once daily plus sildenafi125-100 mg on demand） and Group B （82 cases; sildenafi125-100 mg on demand）. Efficacies were evaluated by IIEF-5 and IPSS scores and a quality of life （QoL） questionnaire, and adverse effects were evaluated during the treatment period. There were no statistically significant differences in mean age, and IIEF-5, IPSS and QoL scores pre-treatment between the two groups. After treatment, IIEF-5, IPSS and QoL scores were significantly improved in Group A, while only IIEF-5 scores were significantly improved in Group B compared with pre-treatment. There were no significant differences in side effects between the two groups. The results indicated that combined therapy with sildenafil and doxazosin GITS for the treatment of ED and BPH/LUTS is safe and effective compared to sildenafil monotherapy.

内皮功能水平与勃起功能障碍关联性评估

目的:为评估勃起功能障碍(ED)与内皮功能水平关系,检测了外周循环血管内皮祖细胞(EPCs)、内皮细胞微粒(EMPs)等指标,比较长期小剂量西地那非治疗前后内皮功能的变化。方法:纳入健康男性30例,泌尿外科就诊的ED患者60例。ED患者予25 mg口服西地那非3个月,进行国际勃起功能指数(IIEF-5)和勃起硬度等级(EHGS)评估,并做EPCs、EMPs采用流式细胞术检测等,评估两组内皮功能水平,比较西地那非持续小剂量治疗前后ED患者的内皮功能变化。结果:治疗后ED组IIEF-5明显低于对照组(10.5±4.9 vs 23.7±1.0)、EHGS明显低于对照组(2.3±0.8 vs 3.9±0.5)(P<0.05);外周循环EPCs数量和EMPS显著高于对照组。持续小剂量西地那非治疗后,IIEF-5评分较治疗前明显提高(17.8±6.1 vs 10.5±4.9)、EHGS较治疗前提高明显(3.2±0.5 vs 2.3±0.8)(P<0.05),外周循环EPCs数量和EMPS明显低于治疗前。结论:持续小剂量口服西地那非能有效改善勃起功能,同时对内皮功能的改善也有一定的作用。