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性功能的改善与生活质量的提高相关,无论排尿功能是否改善:来自IDIProst® Gold研究的结果。

An improvement in sexual function is related to better quality of life, regardless of urinary function improvement: results from the IDIProst® Gold Study.

作者信息

Cai Tommaso, Morgia Giuseppe, Carrieri Giuseppe, Terrone Carlo, Imbimbo Ciro, Verze Paolo, Mirone Vincenzo

机构信息

Department of Urology, Santa Chiara Regional Hospital, Trento.

出版信息

Arch Ital Urol Androl. 2013 Dec 31;85(4):184-9. doi: 10.4081/aiua.2013.4.184.

Abstract

OBJECTIVE

The relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) has recently received increased attention. The aim of this study was to evaluate the efficacy of the Alfa-5® association of Serenoa repens, Pinus massoniana Bark Extract (PMBE) and Crocus sativus (IDIProst® Gold) in improvement of patient's quality of life, when compared with Serenoa repens alone.

MATERIALS AND METHODS

All patients with clinical and instrumental diagnosis of LUTS due to Benign Prostatic Hyperplasia (BPH) and ED, attending 5 Italians Urological Institutions from May to December 2012 were enrolled in this prospective, multicentre, phase 3 study. Participants were assigned to receive oral capsules of IDIProst® Gold (one capsule q24 h) or Serenoa repens 320 mg (one capsule q24h) for 3 months. Clinical and instrumental analyses were carried out at the enrollment and at the end of therapy. IPSS, IIEF-5 and SF-36 questionnaires have been used. The main outcome measure was the improvement of quality of life at the end of the whole study period.

RESULTS

129 (mean age 45-71 ± 4.36) men were randomly allocated to IDIProst® Gold (n = 83) or Serenoa repens (n = 46). The baseline questionnaire mean scores were 17.1 ± 6.4, 14.9 ± 3.7, 96.3 ± 1.2 for IPSS, IIEF-5 and SF-36, respectively. At the follow-up examination, statistically significant differences have been reported in terms of IPSS (11.9 vs 13.8; p < 0.001), IIEF-5 and SF-36 mean scores (19.3 vs 16.1; 99.7 vs 96.3; p < 0.003; p < 0.001). Moreover, statistically significant differences were then reported between the two visits, in terms of IPSS, IIEF-5 and SF-36 scores (p < 0.003; p < 0.001; p < 0.001), only in the IDIProst® Gold group.

CONCLUSIONS

In conclusions, we found that IDIProst® Gold significantly improve the quality of life of patients affected by LUTS due to BPH and ED, specifically in terms of sexual function, highlighting that a better sexual quality of life is correlated with an higher overall quality of life regardless of the urinary function.

摘要

目的

下尿路症状(LUTS)与勃起功能障碍(ED)之间的关系近来受到更多关注。本研究旨在评估锯叶棕果实提取物、马尾松树皮提取物(PMBE)和藏红花(IDIProst® Gold)联合用药(Alfa-5®)与单独使用锯叶棕果实提取物相比,对改善患者生活质量的疗效。

材料与方法

2012年5月至12月,在5家意大利泌尿机构就诊的所有因良性前列腺增生(BPH)和ED导致LUTS且经临床和仪器诊断的患者被纳入这项前瞻性、多中心、3期研究。参与者被分配接受IDIProst® Gold口服胶囊(每24小时1粒)或320毫克锯叶棕果实提取物(每24小时1粒),为期3个月。在入组时和治疗结束时进行临床和仪器分析。使用了国际前列腺症状评分(IPSS)、勃起功能国际问卷-5(IIEF-5)和健康调查简表(SF-36)问卷。主要观察指标是整个研究期结束时生活质量的改善情况。

结果

129名(平均年龄45 - 71±4.36岁)男性被随机分配至IDIProst® Gold组(n = 83)或锯叶棕果实提取物组(n = 46)。IPSS、IIEF-5和SF-36问卷的基线平均得分分别为17.1±6.4、14.9±3.7、96.3±1.2。在随访检查中,IPSS(11.9对13.8;p < 0.001)、IIEF-5和SF-36平均得分(19.3对16.1;99.7对96.3;p < 0.003;p < 0.001)方面报告有统计学显著差异。此外,仅在IDIProst® Gold组中,两次就诊之间在IPSS、IIEF-5和SF-36得分方面报告有统计学显著差异(p < 0.003;p < 0.001;p < 0.001)。

结论

总之,我们发现IDIProst® Gold显著改善了因BPH和ED导致LUTS患者的生活质量,特别是在性功能方面,突出表明无论排尿功能如何,更好的性生活质量与更高的总体生活质量相关。

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