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干细胞治疗勃起功能障碍的有效性及安全性:一项系统综述和Meta分析

Efficacy and safety of stem cell therapy for erectile dysfunction:A systematic review and Meta-analysis
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摘要 目的:评估干细胞治疗(SCT)在改善勃起功能障碍(ED)方面的安全性、有效性和潜在影响。方法:采用系统综述和Meta分析的方法,搜索PubMed、Embase、Web of science等数据库,检索时限为从数据库建立至2024年7月4日。纳入分析的研究包括评估干细胞治疗ED的安全性和有效性的人体临床试验,排除标准包括综述、会议摘要、动物实验、重复样本文献等。结果:初步筛选出1773篇文献,17篇纳入最终分析。这些研究共涉及269例ED患者,多种来源的干细胞被用于ED的治疗,包括脂肪来源干细胞、骨髓来源干细胞、胎盘基质来源干细胞、脐带来源干细胞、牙髓来源干细胞、口腔黏膜来源干细胞;所有研究均选择在阴茎海绵体内注射干细胞,但注射剂量、注射部位及注射次数并没有固定标准,仍在探索最优治疗模式;患者国际勃起功能指数问卷评分和勃起硬度评分、收缩期峰值流速、舒张末期流速在治疗后有所改善,但部分研究显示随着时间增加疗效有所降低;所有研究均未报告严重不良反应,且所有不良反应均未长期持续,最常见的不良反应包括注射部位的反应,干细胞治疗显示出较好的安全性和耐受性。结论:干细胞治疗有可能成为ED患者一种有前景的、创新的再生疗法选择。未来随着干细胞技术的进步,需要继续开展更大规模的随机对照研究,探索标准化的治疗方法,从而进一步评估干细胞治疗ED的长期有效性和安全性。 Objective:To assess the safety,efficacy and potential impact of stem cell therapy(SCT)in improving erectile dysfunction(ED).Methods:A comprehensive search strategy was used to search the literatures on safety and efficacy evaluation of stem cell(SC)in the treatment of ED by human clinical trials from PubMed,Embase and Web of science databases with a search time frame from database creation to July 4,2024.The exclusion criteria were as follows:reviews,conference abstracts animal experiments,and duplicate sample literature.Results:The study initially screened 1773 papers,and 17 were included in the final analysis.These studies involved a total of 269 ED patients,and a variety of sources of stem cells had been used in the treatment of ED,including adipose-derived stem cells,bone marrow-derived stem cells,placental stroma-derived stem cells,umbilical cord-derived stem cells,dental pulp-derived stem cells,and oral mucosa-derived stem cells.All studies were conducted by injecting stem cells into the cavernous body of the penis,but there is no fixed standard for the amount of injection,injection site and number of injections.The optimal treatment mode was still being explored.Patients'International Index of Erectile Function(IIEF)scores and Erection Hardness Score(EHS),peak systolic velocity(PSV),and end diastolic velocity(EDV)improved after treatment.But some studies showed that the efficacy of the treatment diminished with increasing time.No serious adverse effects were reported in any of the studies and none of the adverse effects persisted for a long period of time.The most common adverse effects included injection site reactions,and SCT showed a good safety and tolerability profile.Conclusion:SCT has the potential to be a promising and innovative regenerative therapy option for ED patients.In the future,with the advancement of stem cell technology,larger randomized controlled studies should continue to be conducted to explore standardized treatments,so as to further evaluate the long-term efficacy and safety of SCT for ED.
作者 黄明辉 赵佳钰 商学军 刘永军 HUANG Ming-hui;ZHAO Jia-yu;SHANG Xue-jun;LIU Yong-jun(Faculty of Continuing Education,China Pharmaceutical University,Nanjing,Jiangsu 211198,China;School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing,Jiangsu 211198,China;Department of Urology,Jinling Hospital,Affiliated Hospital of Medical School,Nanjing University/General Hospital of Eastern Theater Command,Nanjing,Jiangsu 210002,China)
出处 《中华男科学杂志》 2025年第6期535-546,共12页 National Journal of Andrology
关键词 勃起功能障碍 干细胞疗法 META分析 erectile dysfunction stem cell therapy Meta-analysis
作者简介 黄明辉(1983-),男,江苏南京市人,硕士研究生,从事临床研究工作;通信作者:刘永军,Email:yongjunliu@163.com;商学军,Email:shangxj98@163.com。
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