高频不可逆电穿孔技术治疗BPH的疗效和安全性:一项随机对照、开放标签、多中心试验  

The efficacy and safety of high-frequency irreversible electroporation for benign prostatic hyperplasia:a randomized controlled open-label multicenter trial

作　　者：董樑[1] 童臻[1] 史本康[2] 庄乾元[3] 李远伟[4] 龚旻 许晓明 周生财 陶绪来 杜新星 王海峰 黄健[9] 薛蔚[1] Dong Liang;Tong Zhen;Shi Benkang;Zhuang Qianyuan;Li Yuanwei;Gong Min;Xu Xiaoming;Zhou Shengcai;Tao Xulai;Du Xinxing;Wang Haifeng;Huang Jian;Xue Wei(Department of Urology,Renji Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai 200127,China;Department of Urology,Qilu Hospital of Shandong University,Jinan 250012,China;Department of Urology,Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430072,China;Department of Urology,Hunan Provincial Hospital,Changsha 410005,China;Department of Urology,Shanghai Pudong Hospital,Fudan University Pudong Medical Center,Shanghai 201399,China;Department of Urology,Hwa Mei Hospital,University of Chinese Academy of Sciences,Ningbo 315010,China;Department of Urology,Yiyuan County People's Hospital,Zibo 256100,China;Department of Urology,Shanghai East Hospital,Tongji University School of Medicine,Shanghai 200120,China;Department of Urology,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510120,China)

机构地区：[1]上海交通大学医学院附属仁济医院泌尿科,上海200127 [2]山东大学附属齐鲁医院泌尿外科,济南250012 [3]华中科技大学同济医学院附属同济医院泌尿外科,武汉430072 [4]湖南省人民医院泌尿外科,长沙410005 [5]上海市浦东医院泌尿外科,上海201399 [6]中国科学院大学附属宁波华美医院泌尿外科,宁波315010 [7]沂源县人民医院泌尿外科,淄博256100 [8]同济大学附属东方医院泌尿外科,上海200120 [9]中山大学附属孙逸仙纪念医院泌尿外科,广州510120

出　　处：《中华泌尿外科杂志》2025年第3期161-165,共5页Chinese Journal of Urology

摘　　要：目的探讨高频不可逆电穿孔技术(H-FIRE)治疗良性前列腺增生(BPH)的疗效和安全性。方法本研究为随机对照、开放标签、多中心临床试验。纳入2020年8月至2022年7月国内9个医疗中心的患者。纳入标准:年龄50~80岁,国际前列腺症状评分(IPSS)≥12分,最大尿流率(Q_(max))>5 ml/min且≤15 ml/min等。排除标准:有前列腺癌病史、手术及麻醉禁忌证等。采用分层区组随机化的方式,以1∶1的比例将患者随机分配至试验组和对照组。试验组使用H-FIRE治疗装置对患者前列腺组织进行消融;对照组患者每日口服0.2 mg盐酸坦索罗辛缓释胶囊,持续应用。主要观察指标包括Q_(max)、IPSS、前列腺体积和国际勃起功能指数(IIEF-5)评分,记录基线和治疗后1、3个月的上述指标,对比两组治疗后上述指标变化值的差异。结果本研究共纳入160例,其中试验组80例,对照组80例;上海交通大学医学院附属仁济医院30例,山东大学附属齐鲁医院7例,华中科技大学同济医学院附属同济医院8例,湖南省人民医院3例,上海市浦东医院13例,中国科学院大学附属宁波华美医院29例,沂源县人民医院18例,同济大学附属东方医院38例,中山大学附属孙逸仙纪念医院14例。治疗3个月时,试验组Q max较基线值升高7.50(3.55,14.50)ml/s,对照组较基线值升高1.70(-1.40,6.00)ml/s,二者差异有统计学意义(P<0.01,U=1083);治疗3个月时,试验组IPSS较基线值减少12.00(7.00,17.00)分,对照组较基线值减少6.00(2.00,11.00)分,试验组IPSS改善幅度显著高于对照组(P<0.01,U=1248);治疗3个月时,试验组前列腺体积较基线值减少12.16(5.69,18.27)ml,对照组减少0(-3.94,6.89)ml,提示H-FIRE可以显著减少前列腺体积(P<0.01,U=1111)。试验组与对照组治疗3个月时IIEF-5评分较基线的升高值差异无统计学意义[0(-2.00,1.00)分与0(-2.00,1.50)分;P=0.54,U=2338]。结论H-FIRE治疗BPH可显著改善患者的主、客观症状,且严重�Objective To investigate the efficacy and safety of high-frequency irreversible electroporation(H-FIRE)in treating benign prostatic hyperplasia(BPH).Methods This randomized controlled open-label multicenter clinical trial enrolled patients from nine medical centers in China between August 2020 and July 2022.Inclusion criteria:age 50–80 years,International Prostate Symptom Score(IPSS)≥12,maximum urinary flow rate(Q_(max))>5 ml/min and≤15 ml/min.Exclusion criteria:prostate malignancy,contraindications to surgery or anesthesia.Patients were randomized 1∶1 into the H-FIRE group(experimental)or the control group(daily oral 0.2 mg tamsulosin hydrochloride sustained-release capsules).Primary outcomes included Q_(max),IPSS,prostate volume,and International Index of Erectile Function-5(IIEF-5)scores,measured at baseline,1 and 3 months post-treatment.ResultsA total of 160 cases were included in this study,including 80 cases in the experimental group and 80 cases in the control group,30 cases in Renji Hospital,7 cases in Qilu Hospital of Shandong University,8 cases in Tongji Hospital,3 cases in Hunan Provincial Hospital,13 cases in Shanghai Pudong Hospital,29 cases in Hwa Mei Hospital,18 cases in Yiyuan County People's Hospital,and 38 cases in Shanghai East Hospital,and 14 cases in Sun Yat-sen Memorial Hospital.At 3 months of post-treatment,Q max in the experimental group increased by a median of 7.50(3.55,14.50)ml/s from the baseline value,whereas in the control group it increased by a median of 1.70(-1.40,6.00)ml/s,and the difference between the two groups was statistically significant(P<0.01,U=1083);and at 3 months of post-treatment,IPSS in the experimental group decreased by a median of 12.00(7.00,17.00)points in the test group and 6.00(2.00,11.00)points in the control group,and the magnitude of improvement in IPSS scores in the test group was significantly higher than that in the control group(P<0.01,U=1248);at 3 months of post-treatment,the prostate volume decreased by a median of 12.16(5.69,18.27)ml in the ex

关 键 词：前列腺增生 高频不可逆电穿孔 坦索罗辛 随机对照试验 

分 类 号：R699.8[医药卫生—泌尿科学]