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术前阿托伐他汀治疗对根治性前列腺切除术后勃起功能的影响:ESTO1 随机、双盲、安慰剂对照研究亚组的结果。

Effects of Preoperative Atorvastatin Treatment On Erectile Function After Radical Prostatectomy: Results From a Subgroup of ESTO1, a Randomized, Double-Blind, Placebo-Controlled Study.

机构信息

Tampere University, Faculty of Medicine and Life Sciences, Tampere, Finland.

Tampere University Hospital, Department of Urology, Tampere, Finland.

出版信息

J Sex Med. 2019 Oct;16(10):1597-1605. doi: 10.1016/j.jsxm.2019.07.001. Epub 2019 Aug 9.

DOI:10.1016/j.jsxm.2019.07.001
PMID:31405764
Abstract

INTRODUCTION

Erectile dysfunction is common after radical prostatectomy because of damage to the cavernous nerves. Thus, it is important to identify new ways to avoid this problem. For example, statins have shown positive effects on erectile function and may have anti-inflammatory effects that improve recovery after surgery.

AIM

The aim of this exploratory analysis of a subgroup from ESTO1, a randomized, double-blind, placebo-controlled study, was to evaluate the preoperative use of atorvastatin on erectile function after radical prostatectomy.

METHOD

Patients were randomized to either 80 mg atorvastatin or placebo daily before undergoing radical prostatectomy from study inclusion to the day of surgery. Altogether 118 men with prostate cancer and scheduled for radical prostatectomy were asked to fill out the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire before surgery and at 3, 6, 9, and 12 months after surgery.

MAIN OUTCOME MEASUREMENTS

The study was exploratory, with the main outcome being the overall difference between IIEF-5 scores in the 2 groups at 12 months. Several hypotheses generating sub-analyses were conducted.

RESULTS

Overall, 85% filled out the IIEF-5 questionnaire before their operation and 85%, 81%, 78%, and 78% completed it at 3, 6, 9, and 12 months follow-up, respectively. 52% of men had information available at all time points. There were no statistically significant differences between the groups at baseline in either erectile function, comorbidities, or tumor characteristics. The median duration of use of atorvastatin and placebo before surgery was 27 and 25 days, respectively. Preoperative atorvastatin treatment had no statistically significant effect on erectile function after prostatectomy as compared with placebo, although IIEF-5 scores were higher at all time points in the statin arm. Furthermore, atorvastatin treatment compared with placebo improved IIEF-5 scores at 12 months after surgery when the cavernous nerves were at least partially intact bilaterally (P < .04, n = 65); however, after full bilateral or unilateral nerve-sparing, the difference was not statistically significant.

CLINICAL IMPLICATION

Short-term statin treatment did not improve recovery of erectile function after prostatectomy; however, further studies are needed before final conclusions.

STRENGTHS & LIMITATIONS: This was a randomized placebo-controlled study. Original ESTO1 study was designed to detect a difference in prostate cancer biomarkers.

CONCLUSION

Short-term atorvastatin treatment before radical prostatectomy had no statistically significant effect on the recovery of erectile functions in a non-selected cohort of patients undergoing radical prostatectomy. Further studies will be needed to clarify the role of long-term atorvastatin use before and after prostatectomy. Siltari A, Riikonen J, Fode M, et al. Effects of Preoperative Atorvastatin Treatment On Erectile Function After Radical Prostatectomy: Results From a Subgroup of ESTO1, a Randomized, Double-Blind, Placebo-Controlled Study. J Sex Med 2019;16:1597-1605.

摘要

简介

由于海绵体神经受损,根治性前列腺切除术后常发生勃起功能障碍。因此,寻找新的方法来避免这个问题很重要。例如,他汀类药物对勃起功能有积极影响,可能具有抗炎作用,有助于手术后的恢复。

目的

本研究旨在评估他汀类药物在根治性前列腺切除术前应用对术后勃起功能的影响,这是 ESTO1 研究的亚组分析,该研究为一项随机、双盲、安慰剂对照研究。

方法

从研究纳入到手术当天,患者随机每日服用 80mg 阿托伐他汀或安慰剂。共有 118 名患有前列腺癌并计划接受根治性前列腺切除术的男性在术前和术后 3、6、9 和 12 个月填写了 5 项国际勃起功能指数(IIEF-5)问卷。

主要观察指标

本研究为探索性研究,主要观察指标为两组患者在 12 个月时 IIEF-5 评分的总体差异。进行了几个假设生成的亚分析。

结果

总体而言,85%的患者在手术前填写了 IIEF-5 问卷,85%、81%、78%和 78%的患者分别在术后 3、6、9 和 12 个月时完成了问卷。52%的患者在所有时间点都有信息。两组患者在勃起功能、合并症或肿瘤特征方面在基线时均无统计学差异。阿托伐他汀和安慰剂术前使用的中位时间分别为 27 天和 25 天。与安慰剂相比,前列腺切除术前使用阿托伐他汀治疗对勃起功能无统计学意义,但他汀组在所有时间点的 IIEF-5 评分均较高。此外,当双侧海绵体神经至少部分完整时(n=65),与安慰剂相比,阿托伐他汀治疗可改善术后 12 个月的 IIEF-5 评分(P<.04);然而,当双侧或单侧完全保留神经时,差异无统计学意义。

临床意义

短期他汀类药物治疗并不能改善前列腺切除术后勃起功能的恢复;然而,在得出最终结论之前,还需要进一步的研究。

局限性

这是一项随机安慰剂对照研究。最初的 ESTO1 研究旨在检测前列腺癌生物标志物的差异。

结论

在非选择性接受根治性前列腺切除术的患者亚组中,术前阿托伐他汀治疗对勃起功能的恢复无统计学意义。需要进一步的研究来阐明前列腺切除术前和术后长期使用阿托伐他汀的作用。

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