勃起功能障碍修复疗法安全性和有效性的系统评价
勃起功能障碍修复疗法安全性和有效性的系统评价
Systematic Review on the Safety and Effectiveness of Restorative Therapies for Erectile Dysfunction
——《性医学杂志》第23卷第7期，2026年7月——
【摘要】引言：过去15年间，人们提出了多种旨在逆转勃起功能障碍相关潜在病理生理机制的修复性（或再生性）疗法。目的：本综述由国际性医学会（ISSM）委托开展，旨在系统评估针对勃起功能障碍的修复性疗法的文献，以确定这些疗法的安全性和有效性。方法：研究人员对MEDLINE、EMBASE、CINAHL及Cochrane CENTRAL对照试验数据库进行了系统检索，筛选了2010年1月至2023年11月期间发表的比较研究。由两名评审员负责研究筛选和数据提取。评估的修复性疗法包括五种：低强度体外冲击波疗法（聚焦式或放射式）、海绵体内干细胞注射、海绵体内富血小板血浆（PRP）注射以及低强度脉冲超声疗法。关注的结局指标包括不良事件及经临床验证的勃起功能症状评分的变化。研究分别采用Cochrane偏倚风险评估工具和ROBINS-I工具，对随机对照试验和观察性研究的偏倚风险进行了评估。结果：共纳入36项研究，包括30项随机对照试验和6项非随机研究。其中大多数研究（n = 23）评估的是聚焦式冲击波疗法。关于聚焦式冲击波疗法与假治疗（安慰剂对照）相比的疗效，结果不尽一致。尽管部分假治疗对照试验报告称，聚焦式冲击波疗法在改善勃起功能评分方面具有统计学意义的优势，但其他试验则未发现组间存在显著差异。此外，许多研究（78%）未报告或比较勃起功能的“最小临床重要差异”（MCID）。在报告了MCID的研究中，存在一些方法学上的问题，例如将MCID阈值应用于尚未经过MCID验证的评估工具（如IIEF-5），以及在勃起功能严重程度不一的队列中报告综合MCID值，这些问题限制了对研究结果的信心。针对其他修复性疗法的证据也较为有限且不一致。结论：关于聚焦式冲击波疗法治疗勃起功能障碍的数据尚无定论，部分试验显示其优于假治疗，而另一些试验则显示无差异。治疗方案的异质性、各项研究的方法学局限性以及MCID报告的不一致性，使得无法就其临床疗效得出明确结论。包括聚焦冲击波疗法在内的所有修复性疗法，在推荐用于常规临床应用之前，均需通过采用标准化方案及经证实有效的结局指标的严谨设计试验进行进一步研究。
【关键词】勃起功能障碍；修复性疗法；低强度冲击波疗法；富血小板血浆；干细胞；低强度脉冲超声
[Abstract] Introduction: Several restorative (or regenerative) therapies have been proposed in the past 15 years to reverse the underlying pathophysiology associated with erectile dysfunction.
Objectives: The aim of this International Society for Sexual Medicine-commissioned review of restorative therapies for erectile dysfunction was to systematically review the literature to determine the safety and efficacy of these therapies. Methods: A systematic review of MEDLINE, EMBASE, CINAHL, and the Cochrane CENTRAL database of controlled trials was performed to identify comparative studies published from January 2010 through November 2023. Two reviewers performed study selection and data extraction. Five restorative therapies were assessed: low-intensity extracorporeal shockwave therapy (focused or radial), intracorporal stem cell injections, intracorporal platelet-rich plasma injections, and low-intensity pulsed ultrasound. Outcomes of interest included adverse events and changes in validated erectile function symptom scores. The Cochrane Risk of Bias and ROBINS-I tools were used to evaluate the risk of bias of randomized controlled trials and observational studies, respectively. Results: A total of 36 studies were included, 30 randomized controlled trials and 6 non-randomized studies. Most of these studies (n?=?23) evaluated focused shockwave therapy. Results for focused shockwave therapy compared to sham were mixed. While some sham-controlled trials reported statistically significant improvements in erectile function scores favoring focused shockwave therapy, other trials found no significant difference between groups. Additionally, many studies (78%) did not report or compare the minimal clinically important difference (MCID) in erectile function. Among those that did, further methodological concerns including the use of MCID thresholds with instruments for which no MCID has been validated (ie, IIEF-5) and reporting a combined MCID in cohorts with mixed severity of erectile function limit confidence in the result. Other restorative therapies also report limited and inconsistent evidence. Conclusions: The data regarding focused shockwave therapy for erectile dysfunction remains mixed, with some trials showing benefit compared to sham and others showing no difference. The heterogeneity of treatment protocols, methodological limitations across studies, and inconsistent MCID reporting preclude definitive conclusions about clinical efficacy. All restorative therapies, including focused shockwave therapy, require further investigation in well-designed trials with standardized protocols and validated outcome measures before routine clinical use can be recommended.
[Key words] erectile dysfunction, restorative therapies, low intensity shockwave therapy, platelet-rich plasma, stem cells, low intensity pulse ultrasound
论文原文：Taylor Kohn, Ahmed El-Sakka, Fernando Facio, et al. (2026). Systematic review on the safety and effectiveness of restorative therapies for erectile dysfunction. The Journal of Sexual Medicine, Volume 23, Issue 7, July 2026.
https://doi.org/10.1093/jsxmed/qdag145
（翻译兼责任编辑：MARY）
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