摘要
目的 :评估万艾可 (Viagra○R)治疗男性勃起功能障碍 (ED)的有效性和安全性。 方法 :本试验为双盲、随机(安慰剂 :西地那非 ,1:3)、安慰剂对照、剂量可调整 (2 5、5 0和 10 0mg)、持续 12周的临床研究。共有 84名受试者参与本研究。 结果 :对主要疗效指标 (IIEF问题 3、4)的分析结果显示 ,万艾可对ED病人达到和维持勃起能力的改善作用显著优于安慰剂 (P <0 .0 0 0 1) ,万艾可的临床总有效率为 86 % ,显著高于安慰剂 (37% ) ;对心理性、器质性和混合性ED的有效率分别为 83%、79%和 81% (安慰剂组分别为 5 0 %、33%和 30 % )。同时 ,对次要疗效指标评估 (IIEF其余 13个问题、记事表和总评题 )亦显示 ,万艾可改善性生活的作用明显优于安慰剂 ;万艾可组性交成功率平均为71.8% ,显著高于安慰剂组 (17.0 % ) ;有 87.3%的万艾可组受试者认为研究药物改善了其勃起功能 ,显著高于安慰剂组 (36 .8% )。无 1名受试者因不良事件而中断研究 ,万艾可组的不良事件发生率 (33.3% )较安慰剂组高(19.0 % ) ,但绝大多数为轻度、一过性的。 结论 :口服万艾可是一种可治疗各种病因导致的勃起功能障碍安全有效的药物 ,按需服用时能很好耐受。
s: Objectives: To evaluate the efficacy and safety of Viagra on men with ED of various etiologies. Methods: This study was a double blind, randomized (placebo:Viagra,1:3), placebo controlled, flexible dose study of Viagra oral tablets(25, 50 and 100mg) taken over 8 weeks. A total of 84 subjects were screened and randomized. Results: The primary efficacy variables (Questions 3 and 4 from IIEF) revealed a statistically significant( P <0.0001) improvement over placebo with an effective rate of 86% on Viagra vs 37% on placebo. The secondary efficacy variables supported the conclusion of the primary efficacy variables and included the remaining 13 IIEF questions,event log data(assessing the proportion of successful attempts at sexual intercourse, 71.8% on Viagra vs 17.0% on placebo), and the global assessment question(treatment had improved their erections,87.3% on Viagra vs 36.8% on placebo) .Viagra was well tolerated.The incidence of adverse events was higher for Viagra(33.3%) than for placebo(19.0%). Conclusions: Oral Viagra is an effective, well tolerated treatment for various erectile dysfunction.
出处
《中华男科学杂志》
CAS
CSCD
2000年第3期150-153,共4页
National Journal of Andrology
