勃起功能障礙修復療法安全性和有效性的系統評價 Systematic Review on the Safety and Effectiveness of Restorative Therapies for Erectile Dysfunction ——《性醫學雜誌》第23卷第7期，2026年7月—— <The Journal of Sexual Medicine>, Volume 23, Issue 7, July 2026 【摘要】引言：過去15年間，人們提出了多種旨在逆轉勃起功能障礙相關潛在病理生理機制的修復性（或再生性）療法。目的：本綜述由國際性醫學會（ISSM）委託開展，旨在系統評估針對勃起功能障礙的修復性療法的文獻，以確定這些療法的安全性和有效性。方法：研究人員對MEDLINE、EMBASE、CINAHL及Cochrane CENTRAL對照試驗數據庫進行了系統檢索，篩選了2010年1月至2023年11月期間發表的比較研究。由兩名評審員負責研究篩選和數據提取。評估的修復性療法包括五種：低強度體外衝擊波療法（聚焦式或放射式）、海綿體內幹細胞注射、海綿體內富血小板血漿（PRP）注射以及低強度脈衝超聲療法。關注的結局指標包括不良事件及經臨床驗證的勃起功能症狀評分的變化。研究分別採用Cochrane偏倚風險評估工具和ROBINS-I工具，對隨機對照試驗和觀察性研究的偏倚風險進行了評估。結果：共納入36項研究，包括30項隨機對照試驗和6項非隨機研究。其中大多數研究（n = 23）評估的是聚焦式衝擊波療法。關於聚焦式衝擊波療法與假治療（安慰劑對照）相比的療效，結果不盡一致。儘管部分假治療對照試驗報告稱，聚焦式衝擊波療法在改善勃起功能評分方面具有統計學意義的優勢，但其他試驗則未發現組間存在顯著差異。此外，許多研究（78%）未報告或比較勃起功能的“最小臨床重要差異”（MCID）。在報告了MCID的研究中，存在一些方法學上的問題，例如將MCID閾值應用於尚未經過MCID驗證的評估工具（如IIEF-5），以及在勃起功能嚴重程度不一的隊列中報告綜合MCID值，這些問題限制了對研究結果的信心。針對其他修復性療法的證據也較為有限且不一致。結論：關於聚焦式衝擊波療法治療勃起功能障礙的數據尚無定論，部分試驗顯示其優於假治療，而另一些試驗則顯示無差異。治療方案的異質性、各項研究的方法學局限性以及MCID報告的不一致性，使得無法就其臨床療效得出明確結論。包括聚焦衝擊波療法在內的所有修復性療法，在推薦用於常規臨床應用之前，均需通過採用標準化方案及經證實有效的結局指標的嚴謹設計試驗進行進一步研究。 【關鍵詞】勃起功能障礙；修復性療法；低強度衝擊波療法；富血小板血漿；幹細胞；低強度脈衝超聲 [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 論文原文：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 （翻譯兼責任編輯：MARY） （需要英文原文的朋友，請聯繫微信：millerdeng95或iacmsp）
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