Philippou Yiannis A, Jung Jae Hung, Steggall Martin J, O'Driscoll Stephen T, Bakker Caitlin J, Bodie Joshua A, Dahm Philipp
Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Headington, Oxford, UK, OX39DU.
Cochrane Database Syst Rev. 2018 Oct 23;10(10):CD012414. doi: 10.1002/14651858.CD012414.pub2.
Despite efforts to preserve the neurovascular bundles with nerve-sparing surgery, erectile dysfunction remains common following radical prostatectomy. Postoperative penile rehabilitation seeks to restore erectile function but results have been conflicting.
To evaluate the effects of penile rehabilitation strategies in restoring erectile function following radical prostatectomy for prostate cancer.
We performed a comprehensive search of multiple databases (CENTRAL, MEDLINE, Embase), the Cochrane Library, Web of Science, clinical trial registries (ClinicalTrials.gov, International Clinical Trials Registry Platform) and a grey literature repository (Grey Literature Report) from their inception through to 3 January 2018. We also searched the reference lists of other relevant publications and abstract proceedings. We applied no language restrictions.
We included randomised or quasi-randomised trials with a parallel or cross-over design.
We used standard Cochrane methodological procedures. Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence according to GRADE on a per-outcome basis. Primary outcomes were self-reported potency, erectile function measured by validated questionnaires (with potency defined as an International Index of Erectile Function (IIEF-EF) score of 19 or greater and or an IIEF-5 of score of 17 or greater) and serious adverse events. For all quality of life assessments on a continuous scale, higher values indicated better quality of life.
We included eight randomised controlled trials with 1699 participants across three comparisons. This abstract focuses on the primary outcomes of this review only.Scheduled phosphodiesterase type 5 inhibitors (PDE5I) versus placebo or no treatmentScheduled PDE5I may have little or no effect on short-term (up to 12 months) self-reported potency (risk ratio (RR) 1.13, 95% confidence interval (CI) 0.91 to1.41; very low quality evidence), which corresponds to 47 more men with self-reported potency per 1000 (95% CI 33 fewer to 149 more) and short-term erectile function as assessed by a validated instrument (RR 1.11, 95% CI 0.80 to 1.55; very low quality evidence), which corresponds to 28 more men per 1000 (95% CI 50 fewer to 138 more), but we are very uncertain of both of these findings. Scheduled PDE5I may result in fewer serious adverse events compared to placebo (RR 0.32, 95% CI 0.11 to 0.94; low quality evidence), though this does not appear biologically plausible and may represent a chance finding. We are also very uncertain of this finding. We found no long-term (longer than 12 months) data for any of the three primary outcomes.Scheduled PDE5I versus on-demand PDE5I Daily PDE5I appears to result in little to no difference in both short-term and long-term (greater than 12 months) self-reported potency (short term: RR 0.97, 95% CI 0.62 to 1.53; long term: RR 1.00, 95% CI 0.60 to 1.67; both very low quality evidence); this corresponds to nine fewer men with self-reported short-term potency per 1000 (95% CI 119 fewer to 166 more) and zero fewer men with self-reported long-term potency per 1000 (95% CI 153 fewer to 257 more). We are very uncertain of these findings. Daily PDE5I appears to result in little to no difference in short-term and long-term erectile function (short term: RR 1.00, 95% CI 0.65 to 1.55; long term; RR 0.74, 95% CI 0.48 to 1.14; both very-low quality evidence), which corresponds to zero men with short-term erectile dysfunction per 1000 (95% CI 80 fewer to 125 more) and 119 fewer men with long-term erectile dysfunction per 1000 (95% CI 239 fewer to 64 more). We are very uncertain of these findings. Scheduled PDE5I may result in little or no effects on short-term adverse events (RR 0.69 95% CI 0.12 to 4.04; very low quality evidence), which corresponds to seven fewer men with short-term serious adverse events (95% CI 18 fewer to 64 more), but we are very uncertain of these findings. We found no long-term data for serious adverse events.Scheduled PDE5I versus scheduled intraurethral prostaglandin E1At short-term follow-up, daily PDE5I may result in little or no effect on self-reported potency (RR 1.10, 95% CI 0.79, to 1.52; very low quality evidence), which corresponds to 46 more men per 1000 (95% CI 97 fewer to 241 more). Daily PDE5I may result in a small improvement of erectile function (RR 1.64, 95% CI 0.84 to 3.20; very low quality evidence), which corresponds to 92 more men per 1000 (95% CI 23 fewer to 318 more) but we are very uncertain of both these findings. We found no long-term (longer than 12 months) data for any of the three primary outcomes.We found no evidence for any other comparisons and were unable to perform any of the preplanned subgroup analyses based on nerve-sparing approach, age or baseline erectile function.
AUTHORS' CONCLUSIONS: Based on mostly very-low and some low-quality evidence, penile rehabilitation strategies consisting of scheduled PDE5I use following radical prostatectomy may not promote self-reported potency and erectile function any more than on demand use.
尽管在保留神经血管束的保留神经手术方面已做出努力,但根治性前列腺切除术后勃起功能障碍仍然很常见。术后阴茎康复旨在恢复勃起功能,但结果一直存在争议。
评估阴茎康复策略对前列腺癌根治性前列腺切除术后恢复勃起功能的效果。
我们对多个数据库(CENTRAL、MEDLINE、Embase)、Cochrane图书馆、科学网、临床试验注册库(ClinicalTrials.gov、国际临床试验注册平台)以及一个灰色文献库(灰色文献报告)进行了全面检索,检索时间从各库建库起至2018年1月3日。我们还检索了其他相关出版物的参考文献列表和摘要汇编。我们未设语言限制。
我们纳入了采用平行或交叉设计的随机或半随机试验。
我们采用标准的Cochrane方法学程序。两名综述作者独立筛选文献、提取数据、评估偏倚风险,并根据GRADE对每个结局按证据质量进行评级。主要结局包括自我报告的性功能、通过有效问卷测量的勃起功能(性功能定义为国际勃起功能指数(IIEF-EF)得分19分及以上或IIEF-5得分17分及以上)以及严重不良事件。对于所有连续性的生活质量评估,数值越高表明生活质量越好。
我们纳入了八项随机对照试验,共1699名参与者,涉及三项比较。本摘要仅关注本综述的主要结果。
定期使用5型磷酸二酯酶抑制剂(PDE5I)与安慰剂或不治疗相比
定期使用PDE5I对短期(最长12个月)自我报告性功能可能几乎没有影响(风险比(RR)1.13,95%置信区间(CI)0.91至1.41;极低质量证据),这相当于每1000名男性中自我报告性功能的人数多47人(95%CI少33人至多149人),以及通过有效工具评估的短期勃起功能(RR 1.11,95%CI 0.80至1.55;极低质量证据),这相当于每1000名男性中多28人(95%CI少50人至多138人),但我们对这两个结果都非常不确定。与安慰剂相比,但我们对这一结果也非常不确定。我们未找到三项主要结局中任何一项的长期(超过12个月)数据。
定期使用PDE5I与按需使用PDE5I相比
每日使用PDE5I在短期和长期(超过12个月)自我报告性功能方面似乎几乎没有差异(短期:RR 0.97,95%CI 0.62至1.53;长期:RR 1.00,95%CI 0.60至1.67;均为极低质量证据);这相当于每1000名男性中自我报告短期性功能的人数少9人(95%CI少119人至多166人),每1000名男性中自我报告长期性功能的人数少0人(95%CI少153人至多257人)。我们对这些结果非常不确定。每日使用PDE5I在短期和长期勃起功能方面似乎几乎没有差异(短期:RR 1.00,95%CI 0.65至1.55;长期:RR 0.74,95%CI 0.48至1.14;均为极低质量证据),这相当于每有短期勃起功能障碍的男性人数为0人(95%CI少80人至多125人),每1000名男性中患有长期勃起功能障碍的人数少119人(95%CI少239人至多64人)。我们对这些结果非常不确定。定期使用PDE5I对短期不良事件可能几乎没有影响(RR 0.69,95%CI 0.12至4.04;极低质量证据),这相当于每1000名男性中短期严重不良事件的人数少7人(95%CI少18人至多64人),但我们对这些结果非常不确定。我们未找到严重不良事件的长期数据。
定期使用PDE5I与定期尿道内注射前列腺素E1相比
在短期随访中,每日使用PDE5I对自我报告性功能可能几乎没有影响(RR 1.10,95%CI 0.79至1.52;极低质量证据),这相当于每1000名男性中多46人(95%CI少97人至多241人)。每日使用PDE5I可能会使勃起功能有小幅改善(RR 1.64,95%CI 0.84至3.20;极低质量证据),这相当于每1000名男性中多92人(95%CI少23人至多318人),但我们对这两个结果都非常不确定。我们未找到三项主要结局中任何一项的长期(超过12个月)数据。
我们未找到其他任何比较的证据,也无法根据保留神经方法、年龄或基线勃起功能进行任何预先计划的亚组分析。
基于大多为极低质量和一些低质量的证据,前列腺癌根治术后采用定期使用PDE5I的阴茎康复策略在促进自我报告的性功能和勃起功能方面可能并不比按需使用更有效。