Zhu Xuan-Wen, Li Fang-Yin, Fang Jia-Jie
Department of Urology, First Affiliated Hospital to Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, China.
Zhonghua Nan Ke Xue. 2006 May;12(5):421-3, 427.
To observe the safety and efficacy of tadalafil in the treatment of erectile dysfunction in clinical research.
Eighty patients with ED, before and after 20 mg tadalafil administered orally, received respectively the rigiscan examination with aural and visual sexual stimulation at the same time, and then Bphallic circumference variation, stiffness index, duration were compared before and after the treatment.
Phallic stiffness index, duration revealed a statistically (P < 0.05) obvious improvement before and after the treatment for all patients. A significant difference (P < 0.01) on the phallic stiffness index, duration were found between the patients with psychogenic ED and others with organic or mixed ED after the treatment. Overall satisfaction with tadalafil was 82.5%. There was an obvious difference on the curative rates between the patients with psychogenic ED (92.3%) and others with organic ED (68.7%) or mixed ED (58.3%). All adverse events (11 cases of headache and dizziness, 8 cases of digestive canal unwell, 5 cases of flushing, 2 cases of back muscle pain) associated with tadalafil were mild and recovered without any treatment.
Tadalafil improves erectile function significantly in most patients. Adverse reactions are generally transient and mild to moderate in nature.
观察他达拉非在临床研究中治疗勃起功能障碍的安全性和有效性。
80例勃起功能障碍患者，口服20mg他达拉非前后，同时接受听觉和视觉性刺激下的阴茎硬度测试检查，然后比较治疗前后阴茎周长变化、硬度指数、持续时间。
所有患者治疗前后阴茎硬度指数、持续时间有统计学意义（P<0.05）的明显改善。治疗后，心因性勃起功能障碍患者与器质性或混合性勃起功能障碍患者在阴茎硬度指数、持续时间上有显著差异（P<0.01）。他达拉非总体满意度为82.5%。心因性勃起功能障碍患者（92.3%）与器质性勃起功能障碍患者（68.7%）或混合性勃起功能障碍患者（58.3%）的治愈率有明显差异。与他达拉非相关的所有不良事件（11例头痛头晕、8例消化道不适、5例面部潮红、2例背部肌肉疼痛）均较轻微，未经任何治疗即恢复。
他达拉非能显著改善大多数患者的勃起功能。不良反应一般为短暂性，性质为轻至中度。
