摘要
目的:评价中医综合疗法治疗湿热瘀滞型勃起功能障碍(ED)的临床疗效和安全性。方法:选取同期在河南中医药大学第一附属医院就诊的,且符合纳入标准的湿热瘀滞型ED患者108例。对照组采用他达拉非治疗,治疗组加用中医综合疗法治疗。疗程为8周,治疗8周后根据国际勃起功能指数5(IIEF-5)评分、中医证候积分、勃起质量(EQS)评分、9条目病人健康问卷(PHQ-9)、广泛性焦虑量表-7(GAD-7)观察指标评价疗效,记录安全性指标和不良反应。研究的第16周对两组患者进行电话随访并记录疗效指标、安全性指标及不良反应。结果:最终纳入103例,治疗组52例,对照组51例。与治疗前相比,两组治疗8周后IIEF-5评分、EQS评分均有升高(P<0.05),与对照组[(15.88±3.86)分,56.0(49,64)分]相比,治疗组IIEF-5评分、EQS评分[(18.36±2.82)分,67.5(54.5,76.75)分]改善情况均优于对照组(P<0.05)。与治疗前相比,两组治疗8周后中医证候积分、PHQ-9评分、GAD-7评分均有下降(P<0.05),与对照组[5.0(3,6)分,4.0(2,5)分]相比,治疗组中医证候积分、GAD-7评分[4.0(2.25,5)分,2.5(1,4.76)分]改善情况均优于对照组(P<0.05)。治疗组PHQ-9评分[3.0(2,5)分]与对照组[3.0(2,5)分]相比,无显著差异(P>0.05)。随访时,两组IIEF-5评分较治疗前均有升高(P<0.05),治疗组IIEF-5评分[(17.04±2.60)分]改善情况优于对照组[(14.16±3.34)分],差异有统计学意义(P<0.05)。研究期间,两组患者均未发生明显的安全性指标异常和不良反应,本研究具有较好的安全性。结论:中医综合疗法治疗湿热瘀滞型ED与他达拉非相比,可以获得更好的临床疗效,且具有更好的远期疗效和较好的安全性。
Objective:To assess the clinical effect and safety of comprehensive therapy of traditional Chinese medicine(TCM)in the treatment of erectile dysfunction(ED)with damp-heat stasis.Methods:We selected 108 cases of ED with damp-heat stasis meeting the inclusion criteria and treated with tadalafil(the control group,n=54)or tadalafil+comprehensive TCM therapy(the trial group,n=54)in the First Affiliated Hospital of Henan University of Chinese Medicine in the same period.After 8 weeks of treatment,we recorded the patients'scores on IIEF-5,TCM syndrome,erectile quality(EQS),9-Item Patient Health Questionnaire(PHQ-9)and Generalized Anxiety Scale 7(GAD-7).At 16 weeks of our study,we collected the efficacy parameters,safety indicators and adverse reactions by telephone follow-up and compared the data obtained between the two groups of patients.Results:Totally,103 of the patients completed the study,51 in the control and 52 in the trial group.Compared with the baseline,the IIEF-5 and EQS scores were both markedly increased after 8 weeks of treatment in the trial group(12.35±3.00 vs 18.36±2.82,P<0.05;39.5[30.25-43]vs 67.5[54.5-76.75],P<0.05)and the control(11.96±2.79 vs 15.88±3.86,P<0.05;38.0[29-42]vs 56[49-64],P<0.05),even more significantly in the former than in the latter(P<0.05);the TCM syndrome and GAD-7 scores were remarkably decreased in the trial(9.5[8-12]vs 4.0[2.25-5],P<0.05;5[2.25-6.75]vs 2.5[1-4.75],P<0.05)and the control group(10.0[8-12]vs 5.0[3-6],P<0.05;5.0[3-6]vs 4.0[2-5],P<0.05),even more significantly in the former than in the latter(P<0.05),so were the PHQ-9 scores(P<0.05),but with no statistically significant difference between the two groups(P>0.05).The IIEF-5 scores of the two groups remained significantly higher than the baseline during the follow-up(P<0.05),even higher in the trial than in the control group(17.04±2.60 vs 14.16±3.34,P<0.05).No obvious abnormal safety indicators or adverse events were observed during the study.Conclusion:Comprehensive TCM therapy combined with tadalafil is superior to tadalafil alone in the treatment of ED with damp-heat stasis,and has a better long-term efficacy and a higher safety.
作者
姚均超
琚保军
李霄
李鲁豫
马苗苗
张永涛
YAO Jun-chao;JU Bao-jun;LI Xiao;LI Lu-yu;MA Miao-miao;ZHANG Yong-tao(Department of Traditional Chinese Medicine,Xuzhou First People's Hospital,Xuzhou,Jiangsu 221000,China;Department of Andrology,The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou,Henan 450000,China)
出处
《中华男科学杂志》
CAS
CSCD
2024年第3期233-240,共8页
National Journal of Andrology
基金
河南省中医药科学研究专项课题(2018ZY2065)
河南中医药大学2021年度研究生科研创新类项目(2021KYCX033)
关键词
勃起功能障碍
湿热瘀滞
中医综合疗法
临床观察
erectile dysfunction
damp-heat stasis
comprehensive therapy of traditional Chinese medicine
clinical observation
作者简介
姚均超(1996-),男,江苏徐州市人,中医师,硕士,从事中医药防治男科疾病的研究;通讯作者:琚保军,Email:7743857@qq.com
