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他达拉非在保留神经的机器人辅助根治性前列腺切除术之前开始的阴茎康复中的疗效:一项双盲试点研究。

Efficacy of Tadalafil in Penile Rehabilitation Started Before Nerve-Sparing Robot-Assisted Radical Prostatectomy: A Double-Blind Pilot Study.

作者信息

Noh Tae Il, Shim Ji Sung, Kang Sung Gu, Cheon Jun, Lee Jeong Gu, Kang Seok Ho

机构信息

Department of Urology, Korea University College of Medicine, Seoul, Korea.

Department of Urology, Korea University College of Medicine, Seoul, Korea.

出版信息

Sex Med. 2022 Jun;10(3):100508. doi: 10.1016/j.esxm.2022.100508. Epub 2022 Apr 6.

DOI:10.1016/j.esxm.2022.100508
PMID:35395569
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9177888/
Abstract

BACKGROUND

Despite the widespread practice of nerve-sparing robot-assisted radical prostatectomy (nsRARP) for the treatment of localized prostate cancer (PCa), erectile dysfunction remains a significant sequela of radical prostatectomy.

AIM

This study aimed to compare the efficacy of tadalafil 5 mg once daily for erectile function recovery in patients who underwent nsRARP according to the timing of rehabilitation initiation.

METHODS

In this double-blind, prospective pilot study, a total of 41 patients who underwent nsRARP were randomly assigned into 2 groups according to the timing of rehabilitation initiation. In the preRARP group (n = 20), tadalafil was started 2 weeks before nsRARP, and in the postRARP group (n = 21), it was started 4 weeks after nsRARP. Erectile function recovery after nsRARP was defined as an International Index of Erectile Function (IIEF-5) score of ≥17.

OUTCOMES

The measures of EF recovery were the changes in IIEF-5 score.

RESULTS

The rate of erectile function recovery at 12-month follow-up was 80.0% and 71.4% in the preRARP and postRARP groups, respectively. The mean differences between baseline and postoperative IIEF-5 scores at 1-, 3-, 6-, and 12-month follow-up were -11.7 ± 3.2, -7.4 ± 3.2, -5.6 ± 1.5, and -4.1 ± 1.1 in the preRARP group and -14.7 ± 4.7, -12.0 ± 5.0, -9.7 ± 3.9, and -6.0 ± 3.1 in the postRARP group, respectively (1-month, P = .259; 3-months, P = .077; 6-months, P = .014; 12-months, P = .007).

CLINICAL IMPLICATIONS

Preoperative tadalafil 5 mg once a day could be used effectively and safely as a strategy for penile rehabilitation after nsRARP.

STRENGTHS AND LIMITATIONS

This study is the first prospective trial of penile rehabilitation with tadalafil 5 mg once a day prior to nsRARP. This is a pilot study with the limitations of a small sample; further and large-scale studies with multiple cohorts, such as an untreated control group and an early immediate rehabilitation group for EF recovery, are needed.

CONCLUSION

This study suggests that preoperative penile rehabilitation using tadalafil may lead to better erectile function recovery than postoperative penile rehabilitation using tadalafil. Noh T, Shim JS, Kang SG, et al. Efficacy of Tadalafil in Penile Rehabilitation Started Before Nerve-Sparing Robot-Assisted Radical Prostatectomy: A Double-Blind Pilot Study. Sex Med 2022;10:100508.

摘要

背景

尽管保留神经的机器人辅助根治性前列腺切除术(nsRARP)广泛应用于局限性前列腺癌(PCa)的治疗,但勃起功能障碍仍是根治性前列腺切除术后的一个重要后遗症。

目的

本研究旨在比较每天一次服用5毫克他达拉非,根据康复开始时间对接受nsRARP的患者勃起功能恢复的疗效。

方法

在这项双盲、前瞻性试点研究中,共有41例接受nsRARP的患者根据康复开始时间随机分为2组。在RARP前组(n = 20),在nsRARP前2周开始服用他达拉非,在RARP后组(n = 21),在nsRARP后4周开始服用。nsRARP后勃起功能恢复定义为国际勃起功能指数(IIEF-5)评分≥17。

结果

在12个月的随访中,RARP前组和RARP后组的勃起功能恢复率分别为80.0%和71.4%。在1个月、3个月、6个月和12个月的随访中,RARP前组基线与术后IIEF-5评分的平均差异分别为-11.7±3.2、-7.4±3.2、-5.6±1.5和-4.1±1.1,RARP后组分别为-14.7±4.7、-12.0±5.0、-9.7±3.9和-6.0±3.1(1个月,P = 0.259;3个月,P = 0.077;6个月,P = 0.014;12个月,P = 0.007)。

临床意义

术前每天一次服用5毫克他达拉非可有效且安全地用作nsRARP后阴茎康复的策略。

优点和局限性

本研究是首次对nsRARP前每天一次服用5毫克他达拉非进行阴茎康复的前瞻性试验。这是一项试点研究,存在样本量小的局限性;需要进一步进行大规模的多队列研究,如设立未治疗的对照组和用于勃起功能恢复的早期即刻康复组。

结论

本研究表明,与术后使用他达拉非进行阴茎康复相比,术前使用他达拉非进行阴茎康复可能导致更好的勃起功能恢复。Noh T、Shim JS、Kang SG等人。保留神经的机器人辅助根治性前列腺切除术之前开始使用他达拉非进行阴茎康复的疗效:一项双盲试点研究。性医学2022;10:100508。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23f6/9177888/df3377bba35e/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23f6/9177888/a79ec89472f2/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23f6/9177888/d5befa856521/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23f6/9177888/573a3c565c05/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23f6/9177888/df3377bba35e/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23f6/9177888/a79ec89472f2/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23f6/9177888/d5befa856521/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23f6/9177888/573a3c565c05/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23f6/9177888/df3377bba35e/gr4.jpg

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