经皮神经肌肉电刺激联合六味地黄丸治疗勃起功能障碍肾阴亏虚证的临床疗效及安全性观察

Clinical efficacy and safety observation of percutaneous neuromuscular electrical stimulation combined with Liuwei Dihuang Pills in the treatment of renal Yin deficiency syndrome of erectile dysfunction

目的探讨经皮神经肌肉电刺激联合六味地黄丸治疗勃起功能障碍肾阴亏虚证的临床疗效及安全性。方法选取2023年3月至2023年12月重庆市九龙坡区人民医院与重庆市渝北区中医院泌尿外科明确诊断为肾阴亏虚型勃起功能障碍的患者进行前瞻性研究,共计60例,按照随机数字表法分为3组,每组各20例。服药组口服六味地黄丸单药治疗,电刺激组使用经皮神经肌肉电刺激单独治疗,联合组在经皮神经肌肉电刺激基础上联合六味地黄丸口服治疗,均连续治疗4周。比较3组治疗前、治疗4周后的国际勃起功能指数(IIEF-5)、中医证候评分、视听性刺激下RigiScan阴茎硬度、勃起硬度级数(EHS)评分差异,记录治疗期间不良反应。结果治疗4周后,3组IIEF-5评分、EHS评分均较治疗前升高,差异均有统计学意义(P<0.05);且联合组治疗4周后的IIEF-5评分、EHS评分均高于服药组和电刺激组,差异均有统计学意义(P<0.05)。治疗4周后,3组性欲减退、勃起痿软、腰膝酸软3项主要症状评分和五心烦热、潮热盗汗、发脱齿摇、失眠健忘、耳鸣耳聋5项次要症状评分均较治疗前降低,差异均有统计学意义(P<0.05);联合组治疗4周后的中医证候评分均低于服药组和电刺激组,服药组治疗4周后的中医证候评分均低于电刺激组,差异均有统计学意义(P<0.05)。治疗4周后,3组勃起时间、阴茎头端平均硬度和最大硬度、阴茎根部最大硬度较治疗前升高,联合组阴茎根部平均硬度、阴茎头端和根部周径变化均较治疗前升高,差异均有统计学意义(P<0.05);联合组治疗4周后的视听性刺激下RigiScan阴茎硬度中除阴茎根部周径变化外其他参数均高于服药组和电刺激组,差异均有统计学意义(P<0.05)。3组不良反应比较,差异无统计学意义(P>0.05)。结论经皮神经肌肉电刺激联合六味地黄丸治疗勃起功能障碍肾阴亏虚证可改善阴茎勃起功能,降低中医证候评分,提高勃起硬度,且不增加不良反应。

Objective To investigate the clinical efficacy and safety of percutaneous neuromuscular electrical stimulation combined with Liuwei Dihuang Pills in the treatment of renal Yin deficiency syndrome of erectile dysfunction.Methods Sixty patients with erectile dysfunction of kidney yin deficiency type were selected from the Department of Urology,The People's Hospital of Jiulongpo District and Yubei District Hospital of Traditional Chinese Medicine from March 2023 to December 2023 for prospective study.They were divided into the three groups according to the random number table method,with 20 cases in each group.The medication group was treated with Liuwei Dihuang Pills alone orally,the electrical stimulation group was treated with transcutaneous neuromuscular electrical stimulation alone,and the combination group was treated with Liuwei Dihuang Pills orally on the basis of transcutaneous neuromuscular electrical stimulation.All groups were treated continuously for 4 weeks.The differences of international index of erectile function(IIEF-5),penile hemodynamics,TCM syndrome score,and RigiScan penile hardness and erectile hardness series(EHS)score under audiovisual stimulation before and after treatment among the 3 groups were compared,and adverse reactions during treatment were recorded.Results After 4 weeks of treatment,the scores of IIEF-5 and EHS in the three groups were higher than those before treatment,the differences were statistically significant(P<0.05).After 4 weeks of treatment,the IIEF-5 score and EHS score of the combined group were higher than those of the medication group and the electrical stimulation group,and the differences were statistically significant(P<0.05).After 4 weeks of treatment,the scores of the three main symptoms of hyposexuality,erectile weakness,and soreness and weakness of waist and knees,and the scores of the five secondary symptoms of dysphoria,hot flashes,night sweats,loss of teeth,insomnia,forgetfulness,tinnitus and deafness in the three groups were lower than those before treatment,and the differences were statistically significant(P<0.05).After 4 weeks of treatment,the scores of TCM syndromes in the combined group were lower than those in the medication group and the electrical stimulation group,and the scores of TCM syndromes in the medication group were lower than those in the electrical stimulation group,the differences were statistically significant(P<0.05).After 4 weeks of treatment,the erectile time,the average hardness and maximum hardness of the penis tip,and the maximum hardness of the penis root in the three groups were higher than those before treatment,the average hardness of the penis root,the changes of the penis tip and the circumference of the root in the combined group were higher than those before treatment,and the differences were statistically significant(P<0.05).After 4 weeks of treatment,the other parameters of RigiScan penis hardness under audiovisual stimulation in the combined group were higher than those in the medication group and the electrical stimulation group except for the change of penis root circumference,and the differences were statistically significant(P<0.05).There was no statistically significant difference in adverse reactions among the three groups(P>0.05).Conclusion Percutaneous neuromuscular electrical stimulation combined with Liuwei Dihuang Pills in the treatment of erectile dysfunction and kidney yin deficiency syndrome can improve penile erectile function,reduce TCM pattern scores,improve erection hardness,and do not increase adverse reactions.