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在体外测量射精潜伏期 (ELT) 和伐地那非对终身早泄患者 ELT 的影响:安慰剂对照、双盲、交叉实验室设置。

In vitro measurement of ejaculation latency time (ELT) and the effects of vardenafil on ELT on lifelong premature ejaculators: placebo-controlled, double-blind, cross-over laboratory setting.

机构信息

Medical Faculty, Department of Urology, Erciyes University, 38060, Kayseri, Turkey.

出版信息

Int Urol Nephrol. 2010 Dec;42(4):881-7. doi: 10.1007/s11255-010-9710-2. Epub 2010 Feb 20.

DOI:10.1007/s11255-010-9710-2
PMID:20174968
Abstract

OBJECTIVE

The aim of this study is to measure the ejaculation latency time (ELT) and to evaluate the effects of vardenafil on ELT and rigidity parameters of patients with lifelong premature ejaculation (PE) in a laboratory setting.

MATERIALS AND METHODS

Double-blind, placebo-controlled, cross-over laboratory study was performed with 40 males with lifelong PE. As the subject ingested the placebo or vardenafil, real-time penile tumescence and rigidity monitoring began. Audiovisual sexual stimulation (AVSS) was performed 45 min later. The patient began vibratory stimulation to the frenular area at 8th minute of AVSS till ejaculation. A button has been placed under the cover where the patient presses to operate the vibrator. ELT was calculated in seconds with a chronometer. Following ejaculation, AVSS was stopped. The test was repeated with second medication in 7-15 days.

RESULTS

Among 40 patients, the results of 17 could be evaluated. When the patient took placebo and vardenafil, mean ELTs were 62.7 and 189.5 s, respectively. When compared with placebo, vardenafil improved ELT significantly (P = 0.04). After the beginning of AVSS, time to first recorded base or tip rigidities was shorter and time to last recorded tip or base rigidities following ejaculation was longer than placebo; however, these differences were not significant (P > 0.05 for each).

CONCLUSIONS

This laboratory design might be used to evaluate the effects of drugs on patients with ejaculation disorders. In this laboratory setting study, vardenafil exerted a threefold increase in ejaculation delay outside the vagina in patients with lifelong PE.

摘要

目的

本研究旨在测量早泄患者的射精潜伏期(ELT),并评估伐地那非对早泄患者 ELT 和硬度参数的影响。

材料和方法

对 40 名患有终身早泄的男性进行了双盲、安慰剂对照、交叉实验室研究。当患者服用安慰剂或伐地那非时,开始实时阴茎勃起和硬度监测。45 分钟后进行视听性性刺激(AVSS)。患者在 AVSS 的第 8 分钟开始对系带区域进行振动刺激,直到射精。在患者的阴茎下方放置一个按钮,以便操作振动器。使用秒表计算 ELT 持续时间(以秒为单位)。射精后,停止 AVSS。在 7-15 天内,用第二种药物重复测试。

结果

在 40 名患者中,有 17 名患者的结果可进行评估。当患者服用安慰剂和伐地那非时,平均 ELT 分别为 62.7 和 189.5 秒。与安慰剂相比,伐地那非显著改善了 ELT(P=0.04)。在开始 AVSS 后,首次记录到的基底或尖端硬度的时间更短,而射精后最后一次记录到的尖端或基底硬度的时间更长,但这些差异无统计学意义(每个差异均大于 0.05)。

结论

这种实验室设计可用于评估药物对射精障碍患者的影响。在这项实验室研究中,伐地那非使终身早泄患者阴道外射精潜伏期延长了三倍。

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本文引用的文献

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Int J Impot Res. 2009 Jul-Aug;21(4):221-7. doi: 10.1038/ijir.2009.21. Epub 2009 May 28.
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Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study.伐地那非与舍曲林治疗早泄的安全性和有效性:一项随机、前瞻性交叉研究。
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PSD502 improves ejaculatory latency, control and sexual satisfaction when applied topically 5 min before intercourse in men with premature ejaculation: results of a phase III, multicentre, double-blind, placebo-controlled study.
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Asian J Androl. 2016 Sep-Oct;18(5):723-31. doi: 10.4103/1008-682X.167721.
对于早泄男性,在性交前5分钟局部应用PSD502可改善射精潜伏期、控制能力和性满意度:一项III期、多中心、双盲、安慰剂对照研究的结果。
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[A clinical study of sertraline and vardenafil in the treatment of premature ejaculation complicated by erectile dysfunction].舍曲林与伐地那非治疗合并勃起功能障碍的早泄的临床研究
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