伐地那非每日一次用于双侧保留神经机器人辅助腹腔镜根治性前列腺切除术后勃起功能障碍患者的疗效与安全性：一项随机、双盲、安慰剂对照研究。

Efficacy and Safety of Udenafil Once Daily in Patients with Erectile Dysfunction after Bilateral Nerve-Sparing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized, Double-Blind, Placebo-Controlled Study.

作者信息

Chung Jae Hoon, Kwon Tae Gyun, Kwak Cheol, Sung Gyung Tak, Kim Soo Dong, Cho Jin Seon, Kim Hyung Jin, Ahn Hanjong, Jeon Seong Soo

机构信息

Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Department of Urology, School of Medicine, Kyungpook National University, Daegu, Korea.

出版信息

World J Mens Health. 2023 Jul;41(3):612-622. doi: 10.5534/wjmh.220057. Epub 2022 Sep 2.

PURPOSE

To evaluate the efficacy and safety of udenafil 75 mg once daily in patients with erectile dysfunction following bilateral nerve-sparing robot-assisted laparoscopic radical prostatectomy (BNS-RALP).

MATERIALS AND METHODS

A multi-center, prospective, randomized, controlled, double-blind study was conducted. Among patients with localized prostate cancer with international index of erectile function-erectile function domain (IIEF-EF) score of 18 or higher before BNS-RALP, those who developed postoperative erectile dysfunction (IIEF-EF score 14 or less at 4 weeks after BNS-RALP) were enrolled. Enrolled patients were randomly assigned to the udenafil 75 mg daily group or the placebo group in a 2:1 ratio. Each subject was followed up at 8 weeks (V2), 20 weeks (V3), and 32 weeks (V4) to evaluate the efficacy and safety of udenafil.

RESULTS

In all, 101 patients were screened, of whom 99 were enrolled. Of the 99 patients, 67 were assigned to the experimental group and 32 to the control group. Ten (14.93%) patients in the experimental group and 10 (31.25%) in the control group dropped out of the study. After 32 weeks of treatment, IIEF-EF score of 22 or higher was seen in 36.51% (23/63) of patients in the experimental group and 13.04% (3/23) patients in the control group (p=0.021). The proportion of patients with IIEF-EF improvement of 25% or more compared to the baseline was 82.54% (52/63) in the experimental group and 62.96% (17/27) in the control group (p=0.058).

CONCLUSIONS

Udenafil 75 mg once daily after BNS-RALP improved the erectile function without any severe adverse effects.

目的

评估伐地那非每日一次75毫克对双侧保留神经机器人辅助腹腔镜根治性前列腺切除术（BNS-RALP）后勃起功能障碍患者的疗效和安全性。

材料与方法

进行了一项多中心、前瞻性、随机、对照、双盲研究。在BNS-RALP术前国际勃起功能指数-勃起功能领域（IIEF-EF）评分18或更高的局限性前列腺癌患者中，纳入术后出现勃起功能障碍（BNS-RALP术后4周IIEF-EF评分14或更低）的患者。纳入的患者按2:1的比例随机分配至伐地那非每日75毫克组或安慰剂组。在第8周（V2）、20周（V3）和32周（V4）对每个受试者进行随访，以评估伐地那非的疗效和安全性。

结果

共筛选出101例患者，其中99例被纳入研究。在这99例患者中，67例被分配至试验组，32例被分配至对照组。试验组有10例（14.93%）患者和对照组有10例（31.25%）患者退出研究。治疗32周后，试验组36.51%（23/63）的患者IIEF-EF评分达到22或更高，对照组为13.04%（3/23）的患者（p=0.021）。试验组与基线相比IIEF-EF改善25%或更多的患者比例为82.54%（52/63），对照组为62.96%（17/27）（p=0.058）。