艾灸联合小剂量他达拉非治疗糖尿病性勃起功能障碍临床研究:一项前瞻性、单中心、三臂随机对照试验  

Moxibustion combined with low-dose tadalafil for diabetes mellitus-induced erectile dysfunction:A prospective,single-center,three-arm randomized controlled trial

作　　者：刘涛[1] 杨朝旭 徐琰 赵琦 刘学 黄新飞[1] 孙志兴[1] 陈赟[1] 陈建淮 LIU Tao;YANG Zhao-xu;XU Yan;ZHAO Qi;LIU Xue;HUANG Xin-fei;SUN Zhi-xing;CHEN Yun;CHEN Jian-huai(Department of Andrology,Jiangsu Province Hospital of Traditional Chinese Medicine/The Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing,Jiangsu 210029,China)

机构地区：[1]江苏省中医院/南京中医药大学附属医院男科,江苏南京210029

出　　处：《中华男科学杂志》2025年第1期55-60,共6页National Journal of Andrology

基　　金：江苏省卫健委重点项目(ZDA2020025);江苏省科技计划专项(BK20231379);江苏省中医药科技发展计划项目-面上项目(MS2022023);江苏省中医院“优秀青年博士培养计划”项目(2023QB0126);江苏省中医院院内课题(Y21008);江苏省研究生科研与实践创新计划项目-校助面上项目(SJCX23_0804)。

摘　　要：目的:观察艾灸联合小剂量他达拉非治疗糖尿病性勃起功能障碍(气虚血瘀证)患者的临床疗效。方法:将符合纳排标准的90例糖尿病性勃起功能障碍患者随机分为艾灸组、他达拉非组、艾灸联合他达拉非组各30例。艾灸组采用温和灸,选穴足三里、三阴交、阴陵泉,隔日1次;他达拉非组采用小剂量他达拉非口服5 mg/次,每日1次;艾灸联合他达拉非组采用艾灸足三里、三阴交、阴陵泉(方法同前)+每日口服他达拉非片5 mg;疗程均为4周。观察3组治疗前后国际勃起功能指数问卷-5(IIEF-5)、中医证候积分、勃起硬度评分(EHS)及阴茎海绵体血流动力学指标:阴茎海绵体动脉收缩期峰值流速(PSV)、舒张末期流速(EDV)和阻力指数(RI)。结果:艾灸联合他达拉非组总有效率(90.0%)高于艾灸组(46.7%)、他达拉非组(60.0%)(P<0.05)。治疗后3组IIEF-5评分、EHS较治疗前均升高,中医证候积分较治疗前降低,艾灸联合他达拉非组优于艾灸组、他达拉非组(P<0.05)。治疗后3组PSV、RI较治疗前均升高(P<0.05),EDV较治疗前均降低(P<0.05);治疗后艾灸联合他达拉非组PSV高于艾灸组、他达拉非组(P<0.05)。结论:艾灸联合他达拉非片能有效提高糖尿病性勃起功能障碍患者勃起功能,且能有效增加阴茎血供,发挥益气活血作用,疗效确切,安全性好。Objective:To investigate the clinical efficacy of moxibustion(Mox)combined with low-dose tadalafil(TAD)in the treatment of diabetes mellitus-induced erectile dysfunction(DMED)with the syndrome of Qi deficiency and blood stasis.Methods:According to the inclusion and exclusion criteria,we selected 90 patients with DMED for this trial and equally randomized them into a Mox,a TAD,and a Mox combined with TAD(Mox+TAD)group to be treated by mild Mox applied to the acupoints Zusanli,Sanyinjiao and Yinlingquan qd alt,oral medication with low-dose TAD at 5 mg per dose qd,and combination of the above two therapies,respectively,all for 4 weeks.We obtained from the patients their IIEF-5 scores,traditional Chinese medicine(TCM)symptoms scores,Erectile Hardness Scale(EHS)scores,corpus cavernosal hemodynamic indexes,and the peak systolic velocity(PSV),end diastolic velocity(EDV)and resistance index(RI)of the corpus cavernosal arteries before and after treatment,and compared them among the three groups.Results:The total effectiveness rate was significantly higher in the Mox+TAD(90.0%)than in the Mox(46.7%)and TAD groups(60.0%)(P<0.05).Compared with the baseline,the IIEF-5 and EHS scores were increased,while the TCM symptoms scores decreased in all the three groups after treatment,more significantly in the Mox+TAD group than in the other two(P<0.05).And the PSV and RI were remarkably increased,while the EDV decreased(P<0.05)in all the three groups(P<0.05)after treatment,with PSV even higher in the Mox+TAD than in the Mox and TAD groups(P<0.05).Conclusion:Moxibustion combined with tadalafil has a definite efficacy and safety for the treatment of DMED,which can effectively improve the erectile function of the patients by increasing penile blood supply,benefiting qi and activating blood circulation.

关 键 词：糖尿病性勃起功能障碍 艾灸 他达拉非 

分 类 号：R698.1[医药卫生—泌尿科学] R243[医药卫生—外科学]