[延长释放西尔代纳菲尔与标准西尔代纳菲尔在随机对照的安慰剂研究中的比较]
R Bogatova S1,2,3, O Morozov A1,2,3, Ch Ysypbaev A1,2,3
1Institute of the Clinical Medicine named after N.V. Sklifosovsky of FGAOU VO I.M. Sechenov First Moscow State Medical University, Moscow, Russia.
Urologiia (Moscow, Russia : 1999)
|May 16, 2025
概括
维尔德格拉为勃起功能障碍提供了与伟哥相似的治疗方法,副作用较少,作用更长. 这种西尔代纳菲尔配方可能会改善患者的治疗结果和患者的治疗坚持.
科学领域:
- 药理学 药理学是指药理学的学科.
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 临床医学 临床医学
背景情况:
- 西尔德纳菲尔酸盐 (Viagra) 有效地治疗勃起功能障碍 (ED),但经常出现不良事件.
- 维尔德格拉是一种缓释西尔代纳菲尔配方,具有较长的作用 (13小时与4小时相比),可能减少副作用.
研究的目的:
- 为了比较Vildegra 50 mg与Viagra 50 mg在治疗ED方面的疗效,耐受性和安全性.
- 评估Vildegra在治疗有效性方面与Viagra的非劣势.
主要方法:
- 进行了一项三臂,交叉,开放标签,安慰剂控制的随机临床试验.
- 患有ED的19-60岁的男性接受了Vildegra,安慰剂和Viagra的交叉设计.
- 国际勃起功能指数 (IIEF-5) 评分和不良事件频率是主要结果指标.
主要成果:
- 与Viagra相比,Vildegra显示性活动增加了1.6倍,与安慰剂相比增加了2.4倍.
- 在Vildegra和Viagra (p=0.678) 之间没有观察到IIEF-5评分的显著差异.
- 维尔德格拉的不良事件频率比伟哥低1.6倍,对临床参数没有负面影响.
结论:
- 维尔德格拉在治疗勃起功能障碍方面不低于伟哥.
- 与伟哥相比,维尔德格拉表现出更好的耐受性和安全性,导致按需使用的增加.
- 维尔德格拉的缓释配方可能为ED管理提供更好的治疗选择.
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