国产低能冲击波设备治疗勃起功能障碍的多中心随机对照研究  

A multicenter,prospective,randomized,double-blind,controlled trial of domestic linear low-intensity shock wave therapy for erectile dysfunction

作　　者：杨林[1] 蔡剑[2] 王小宁[1] 李广森[2] 贺大林[1] YANG Lin;CAI Jian;WANG Xiao-ning;LI Guang-sen;HE Da-lin(Department of Urology,First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061;Department of Urology,Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China)

机构地区：[1]西安交通大学第一附属医院泌尿外科,陕西西安710061 [2]成都中医药大学附属医院泌尿外科,四川成都611137

出　　处：《现代泌尿外科杂志》2020年第5期409-411,共3页Journal of Modern Urology

摘　　要：目的评估国产线性低能冲击波设备(E100)治疗勃起功能障(ED)的安全性和有效性。方法本研究为一多中心、随机双盲对照研究。病史、国际勃起功能评分(IIEF-6)及夜间阴茎勃起监测确诊的ED患者,按照2︰1的顺序随机分为治疗组及对照组,接受低能冲击波治疗每周1次,共4周,能量0.09mJ/mm2;分4个部位,每部位冲击900次,共3600次,对照组在探头内置铁片阻挡冲击波输出,其余与治疗组完全相同。治疗结束后12周随访,内容包括IIEF-6及夜间阴茎勃起监测。结果治疗组40例中的35例,对照组20例中的16例完成治疗及随访。治疗组与对照组在基线年龄、身高、IIEF-6等均无显著差异;治疗组IIEF-6随访结果显著优于对照组(17.60±6.18 vs.14.00±6.13);治疗组有效率显著高于对照组(68.6%vs.12.5%)。两组均无副作用报告。结论国产低能冲击波设备(E100)治疗勃起功能障碍安全、有效。Objective To evaluate the safety and efficacy of domestic linear low-intensity shock wave equipment(E100)in the treatment of erectile dysfunction(ED).Methods In this multicenter,prospective,randomized,double-blind,controlled study,60 patients with ED diagnosed by history,International Index of Erectile Function6(IIEF-6)and nocturnal penile tumescence(NPT)were randomly divided into2 groups(ratio2∶1).The treatment group received low-intensity shock wave therapy once a week for 4 weeks,energy 0.09 mJ/mm2,each of the 4 sites 900 times for a total of 3600 times.In the control group,an iron plate was built into the probe to block the output of shock wave,and the rest were the same as the treatment group.After 12 weeks of treatment,IIEF-6 and NPT were followed up.Results Altogether 35 patients in the treatment group and 16 in the control group were followed up on time.There were no significant differences in baseline age,height and IIEF-6 between the 2 groups.After treatment,the treatment group had significantly higher IIEF-6(17.60±6.18 vs.14.00±6.13)and higher effective rate(68.6%vs.12.5%)than the control group.No side effects were reported.Conclusion The domestic low-intensity shock wave device(E100)is safe and effective in the treatment of erectile dysfunction.

关 键 词：勃起功能障碍 低能冲击波 国际勃起功能评分 阴茎勃起硬度评分 夜间阴茎勃起监测 

分 类 号：R698.1[医药卫生—泌尿科学]