ed的药物治疗专题知识.ppt

在一项多中心、随机、双盲研究中，艾力达和对照组不固定剂量给药，结果显示： 在第4周和第8周调整剂量，疗程为12周，艾力达组的男性平均EF评分为22.9，对照组为14.9，二者有显著性差异。 艾力达治疗组中的男性平均插入成功率为79％，相对于安慰剂组中53％有明显的统计学差异，说明服药组的勃起功能得到了明显的改善。（p0.0001） * Global Assessment Question Has the treatment you have been taking over the past 4 weeks improved your erections? 83% of men reported an improvement in their erections following treatment with vardenafil compared to 30% with placebo (p0.0001). * HAM-D17 Total Score Based on the HAM-D17 total score, a decrease in depressive symptoms was observed in both the placebo and vardenafil-treated groups compared to their respective baselines. At endpoint, treatment with vardenafil significantly improved depressive symptoms by 2.2 points compared to placebo (p=0.0001). * Rosenberg Self-Esteem Scale Based on the Rosenberg Self-Esteem Scale, an increase in total score was noted in both the placebo and vardenafil treated-groups compared to their respective baselines. Of significance, treatment with vardenafil improved quality of life by 1.2 points over placebo (p=0.023) at endpoint. * Treatment-emergent AEs ?2% The most common treatment-emergent adverse events (AEs) were headache (11% vs 1%), flushing(7% vs 1%), nasal congestion (3% vs 0%) and insomnia (0% vs 3%). These AEs were mild-to-moderate and transient in nature. There were three serious adverse events (SEAs). One patient in the vardenafil group experienced thrombosis in his leg and two patients in the placebo group experienced polyarthritis and hepatitis C (separate cases). These SAEs were considered by the investigator to be unrelated to the study medication. There were no reports of death in this study. * Summary Vardenafil was well-tolerated and highly effective in men with ED and untreated mild MDD. Significant improvements in EF, depression and self-esteem were observed in patients treated with vardenafil compared to placebo. These results may have important implications for the management in men with ED and depression. * 这张图反映出艾力达治