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ASSESS - 3:一项关于口服西地那非治疗台湾勃起功能障碍男性疗效与安全性的随机、双盲、灵活剂量临床试验。

ASSESS-3: a randomised, double-blind, flexible-dose clinical trial of the efficacy and safety of oral sildenafil in the treatment of men with erectile dysfunction in Taiwan.

作者信息

Chen K K, Hsieh J T, Huang S T, Jiaan D B, Lin J S, Wang C J

机构信息

Taipei Veterans General Hospital, Taipei, Taiwan.

出版信息

Int J Impot Res. 2001 Aug;13(4):221-9. doi: 10.1038/sj.ijir.3900685.

Abstract

The efficacy and safety of sildenafil were evaluated in a randomised, double-blind, placebo-controlled, flexible-dose study in Taiwanese men aged 26 to 80 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months' duration. A total of 236 patients were randomised at six medical centres in Taiwan to receive either sildenafil (50 mg initially increased if necessary to 100 mg or decreased to 25 mg depending on efficacy and toleration) (n=119) or matching placebo (n=117) taken on an 'as needed' basis 1 h prior to anticipated sexual activity for a period of 12 weeks. At the end of 12 weeks, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the IIEF (International Index of Erectile Function) scale, (2) the percentage of successful intercourse attempts; and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P<0.0001). Treatment-related adverse events occurred in 43.7% of patients receiving sildenafil and 18.8% receiving placebo. The most common adverse events with sildenafil were flushing, dizziness and headache (25.2, 6.7 and 5.9% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in the population of Taiwanese men appears similar to that reported in other studies in western populations.

摘要

在一项针对年龄在26至80岁、患有广谱病因且病程超过6个月的台湾勃起功能障碍(ED)男性的随机、双盲、安慰剂对照、灵活剂量研究中,评估了西地那非的疗效和安全性。共有236名患者在台湾的六个医疗中心被随机分组,分别接受西地那非(初始剂量50毫克,必要时根据疗效和耐受性增加至100毫克或减少至25毫克)(n = 119)或匹配的安慰剂(n = 117),在预期性活动前1小时按需服用,为期12周。在12周结束时,与实现和维持足以进行性交的勃起相关的主要疗效变量,以及次要疗效变量,包括:(1)国际勃起功能指数(IIEF)量表性功能的五个独立领域,(2)性交尝试成功率;以及(3)对勃起的总体评估,与安慰剂相比,西地那非均有统计学显著改善(P < 0.0001)。接受西地那非治疗的患者中有43.7%发生了与治疗相关的不良事件,接受安慰剂治疗者为18.8%。西地那非最常见的不良事件是潮红、头晕和头痛(分别占患者的25.2%、6.7%和5.9%),且大多数性质轻微。西地那非在台湾男性人群中的疗效和安全性似乎与其他西方人群研究报告的相似。

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