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他达拉非每日单次5毫克剂量对终身性早泄的影响:一项单盲安慰剂对照研究。

Effect of a tadalafil 5-mg single daily dose on lifelong premature ejaculation: A single-blinded placebo-controlled study.

作者信息

Abou Faddan Amr Hassan, Gaber Hisham Diab, Oamonov Daniar

机构信息

Department of Urology, Faculty of Medicine, Assiut University, Assiut, Egypt.

Department of Dermatology and Andrology, Faculty of Medicine, Assiut University, Assiut, Egypt.

出版信息

Arab J Urol. 2022 Feb 26;20(2):100-104. doi: 10.1080/2090598X.2021.2007464. eCollection 2022.

DOI:10.1080/2090598X.2021.2007464
PMID:35530567
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9067979/
Abstract

OBJECTIVE

To investigate the effectiveness and safety of a tadalafil 5-mg single daily dose in the treatment of lifelong premature ejaculation (PE).

PATIENTS AND METHODS

A total of 55 men with lifelong PE were enrolled in this study. The intravaginal ejaculatory latency time (IELT) and Premature Ejaculation Diagnostic Tool (PEDT) were used to assess the efficacy of tadalafil. Baseline recording of the IELT (using a stopwatch) and PEDT was done. Patients were randomised to take a single daily dose of tadalafil 5 mg or placebo. Re-assessment was done by IELT and PEDT after 1 and 3 months.

RESULTS

As regard, age, number of children, frequency of intercourse and duration of PE there are no statically significant differences between both groups. In both the tadalafil 5-mg and placebo groups the IELT statically significantly increased after 1 month by a mean (SD) of 4.8 (4.7) and 5 (4.9) s, and after 3 months by a mean (SD) of 6.6 (7) and 4.5 (9) s; and the PEDT scores significantly improved after 1 month by a mean (SD) of 2.1 (1.9) and 2 (1.5), and after 3 months by a mean (SD) of 3.5 (2.5) and 3.3 (2.2). However, there is was no statically significant difference between the tadalafil 5-mg and placebo groups for the IELT and PEDT at baseline or after 1 and 3 months of treatment.

CONCLUSIONS

Despite 5-mg tadalafil once daily being safe and it showed only a slight improvement in IELT and PEDT in the treatment of lifelong PE, failing to show any statistically significant difference from the placebo drug.: ED: erectile dysfunction; 5-HT: 5-hydroxytryptamine (serotonin); IELT: the intravaginal ejaculation latency time; ISSM: International Society of Sexual Medicine; PE: premature ejaculation; PEDT: Premature Ejaculation Diagnostic Tool; PDE5i: phosphodiesterase-5 inhibitor; SSRI: selective serotonin reuptake inhibitor.

摘要

目的

探讨每日单次服用5毫克他达拉非治疗终生性早泄(PE)的有效性和安全性。

患者与方法

本研究共纳入55名终生性早泄男性。采用阴道内射精潜伏期(IELT)和早泄诊断工具(PEDT)评估他达拉非的疗效。使用秒表对IELT进行基线记录,并完成PEDT评估。患者被随机分为每日单次服用5毫克他达拉非或安慰剂组。在1个月和3个月后通过IELT和PEDT进行重新评估。

结果

在年龄、子女数量、性交频率和早泄持续时间方面,两组之间无统计学显著差异。在5毫克他达拉非组和安慰剂组中,IELT在1个月后平均(标准差)分别显著增加4.8(4.7)秒和5(4.9)秒,在3个月后分别为6.6(7)秒和4.5(9)秒;PEDT评分在1个月后平均(标准差)分别显著改善2.1(1.9)和2(1.5),在3个月后分别为3.5(2.5)和3.3(2.2)。然而,在基线时以及治疗1个月和3个月后,5毫克他达拉非组和安慰剂组在IELT和PEDT方面无统计学显著差异。

结论

尽管每日一次服用5毫克他达拉非是安全的,且在治疗终生性早泄时IELT和PEDT仅略有改善,但与安慰剂药物相比未显示出任何统计学显著差异。:ED:勃起功能障碍;5-HT:5-羟色胺(血清素);IELT:阴道内射精潜伏期;ISSM:国际性医学学会;PE:早泄;PEDT:早泄诊断工具;PDE5i:磷酸二酯酶5抑制剂;SSRI:选择性5-羟色胺再摄取抑制剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc92/9067979/7481f8eef858/TAJU_A_2007464_F0001_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc92/9067979/7481f8eef858/TAJU_A_2007464_F0001_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc92/9067979/7481f8eef858/TAJU_A_2007464_F0001_B.jpg

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本文引用的文献

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Are There Differences in Brain Morphology in Patients with Lifelong Premature Ejaculation?终身早泄患者的大脑形态是否存在差异?
J Sex Med. 2019 Jul;16(7):992-998. doi: 10.1016/j.jsxm.2019.04.008. Epub 2019 May 15.
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Efficacy and safety of daily use of tadalafil in treatment of patients with premature ejaculation: A randomised placebo-controlled clinical trial.他达拉非每日用药治疗早泄患者的疗效与安全性:一项随机安慰剂对照临床试验
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Serotonergic polymorphisms in the control of ejaculation.
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Study of the link between dopamine transporter gene polymorphisms and response to paroxetin and escitalopram in patients with lifelong premature ejaculation.终身性早泄患者多巴胺转运体基因多态性与帕罗西汀和艾司西酞普兰反应之间的联系研究。
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Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies.他达拉非 5 毫克每日一次治疗下尿路症状提示良性前列腺增生的疗效和安全性:来自 4 项多中心、随机、安慰剂对照临床研究的汇总数据的亚组分析。
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