Goh Hyeok Jun, Sung Jeong Min, Lee Kwang Hyun, Jo Jung Ki, Kim Kyu Nam
Department of Urology, Dong-A University, College of Medicine, Busan, Korea.
Department of Anesthesiology and Pain Medicine, College of Medicine, Hanyang University, Seoul, Korea.
Transl Androl Urol. 2022 Feb;11(2):124-138. doi: 10.21037/tau-21-881.
Nerve-sparing radical prostatectomy (NSRP) had to be performed because approximately 94% of patients are diagnosed with localized prostate cancer (PCa). Although NSRP is generally done to improve functional outcomes, erectile dysfunction (ED) is one of the most prevailing complications after radical prostatectomy (RP). Phosphodiesterase type 5 inhibitors (PDE5-Is) are the most well-known treatment agent for postoperative ED. This study aimed to assess the efficacy of PDE5-Is in patients with ED after NSRP.
In this systematic literature review, randomized controlled trials on the efficacy and safety of PDE5-Is in patients who underwent NSRP were searched in MEDLINE, EMBASE, and the Cochrane Controlled Trials Register using the OVID platform. This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane Review Methods. The quality of the evidence of the outcome data was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.
A total of 14 trials involving 2,822 patients were included. Significant improvements in the International Index of Erectile Function-Erectile Function (IIEF) domain score [mean difference (MD) =4.93; 95% confidence interval (CI): 4.14-5.71; P<0.00001] and erectile function recovery events [odds ratio (OR) =2.06; 95% CI: 1.45-2.94; P<0.0001] were observed after PDE5-I treatment. A higher positive response to Sexual Encounter Profile (SEP) question 2 (OR =2.27; 95% CI: 1.80-2.86; P<0.00001) and question 3 (OR =2.78; 95% CI: 1.97-3.91; P<0.00001) was also found after PDE5-I treatment. However, the incidence of treatment-emergent adverse events (TEAEs) was higher after PDE5-I treatment than after placebo treatment (OR =2.91; 95% CI: 1.84-4.61). Furthermore, the incidence of headache (OR =3.38; 95% CI: 2.40-4.75) and flushing (OR =9.44; 95% CI: 4.30-20.70) was also significantly higher after PDE5-I treatment (P<0.00001). In terms of the quality of the evidence of the outcome data, inconsistency problems were detected in all outcomes and imprecision problems in most outcomes.
PDE5-I treatment was more effective to placebo treatment in patients with ED after NSRP. No clinically serious complications were found in spite of the incidence of TEAEs being higher after PDE5-I treatment.
由于约94%的患者被诊断为局限性前列腺癌（PCa），因此必须进行保留神经的根治性前列腺切除术（NSRP）。尽管NSRP通常旨在改善功能结局，但勃起功能障碍（ED）是根治性前列腺切除术（RP）后最常见的并发症之一。5型磷酸二酯酶抑制剂（PDE5-Is）是术后ED最知名的治疗药物。本研究旨在评估PDE5-Is对NSRP术后ED患者的疗效。
在本系统文献综述中，使用OVID平台在MEDLINE、EMBASE和Cochrane对照试验注册库中检索关于PDE5-Is对接受NSRP患者疗效和安全性的随机对照试验。本研究按照系统评价和Meta分析的首选报告项目以及Cochrane综述方法进行。使用推荐分级、评估、制定和评价（GRADE）方法评估结局数据的证据质量。
共纳入14项试验，涉及2822例患者。PDE5-I治疗后，国际勃起功能指数-勃起功能（IIEF）领域评分[平均差（MD）=4.93；95%置信区间（CI）：4.14-5.71；P<0.00001]和勃起功能恢复事件[比值比（OR）=2.06；95%CI：1.45-2.94；P<0.0001]有显著改善。PDE5-I治疗后，对性接触概况（SEP）问题2（OR =2.27；95%CI：1.80-2.86；P<0.00001）和问题3（OR =2.78；95%CI：1.97-3.91；P<0.00001）的阳性反应也更高。然而，PDE5-I治疗后的治疗中出现的不良事件（TEAE）发生率高于安慰剂治疗（OR =2.91；95%CI：1.84-4.61）。此外，PDE5-I治疗后头痛（OR =3.38；95%CI：2.40-4.75）和潮红（OR =9.44；95%CI：4.30-20.70）的发生率也显著更高（P<0.00001）。就结局数据的证据质量而言，在所有结局中均检测到不一致问题，在大多数结局中存在不精确问题。
PDE5-I治疗对NSRP术后ED患者比安慰剂治疗更有效。尽管PDE5-I治疗后TEAE发生率较高，但未发现临床严重并发症。
