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Erectile dysfunction in a primary care setting: results of an observational, no-control-group, prospective study with sildenafil under routine conditions of use.
International Journal of Impotence Research ( IF 2.6 ) Pub Date : 2002-03-29 , DOI: 10.1038/sj.ijir.3900782
A Gil 1 , E Martínez , I Oyagüez , G Palacios , J Rejas
Affiliation  

In order to assess the effectiveness of sildenafil under routine conditions of use in primary care settings and to evaluate its impact on patient's life satisfaction and partner's satisfaction with treatment for erectile dysfunction (ED), an open, multicentre, observational, prospective study was designed in which 2816 patients were treated with sildenafil for at least 10 weeks. Effectiveness was assessed using the International Index of Erectile Dysfunction (IIEF), life satisfaction was measured with 'Life-satisfaction Check List' (LISAT 8), and EDITS was optionally used to assess the partner's satisfaction with ED therapy. Sildenafil was effective in 86.6% of patients. All dimensions of IIEF significantly increased with sildenafil, particularly erectile domain which overall sample mean score improved was 13.2 points (P < 0.001). The greatest increases in satisfaction with all aspects of life were seen in sex life and relationship with partner dimensions. The patients' partners, answered by a minority of partners, were highly satisfied with the treatment and its rapid action, therefore they were in favour of continuing with same. The adverse events occurring were similar to those seen in clinical research on sildenafil in the premarketing phase. No control group was included in this study.

中文翻译:

初级保健机构中的勃起功能障碍:在常规使用条件下,西地那非观察性,无对照组,前瞻性研究的结果。

为了评估西地那非在基层医疗常规使用条件下的有效性,并评估其对患者的生活满意度和伴侣对勃起功能障碍(ED)治疗的满意度的影响,我们设计了一项开放,多中心,观察性和前瞻性研究。其中2816例患者接受西地那非治疗至少10周。使用国际勃起功能障碍指数(IIEF)评估疗效,通过“生活满意度检查表”(LISAT 8)评估生活满意度,并可以选择使用EDITS评估伴侣对ED治疗的满意度。西地那非对86.6%的患者有效。西地那非使IIEF的所有维度均显着增加,尤其是勃起区域,总体样本平均评分提高了13.2分(P <0。001)。在性生活中以及与伴侣之间的关系中,人们对生活各个方面的满意度有了最大的提高。少数伴侣的回答使患者的伴侣对治疗及其迅速的作用高度满意,因此,他们赞成继续治疗。发生的不良事件与上市前阶段西地那非的临床研究相似。该研究未包括对照组。发生的不良事件与上市前阶段西地那非的临床研究相似。本研究未包括对照组。发生的不良事件与上市前阶段西地那非的临床研究相似。该研究未包括对照组。
更新日期:2019-11-01
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