百令胶囊联合他达拉非治疗脾肾两虚型勃起功能障碍的临床研究

Clinical Study of Bailing Capsules Combined with Tadalafil in the Treatment of Erectile Dysfunction with Spleen-kidney Deficiency

目的:观察百令胶囊联合他达拉非治疗脾肾两虚型勃起功能障碍(ED)的效果。方法:选择江西医学高等专科学校第一附属医院2020年2月—2023年2月收治的68例脾肾两虚型ED患者为研究对象,采用随机数字表法分为他达拉非组(n=34)与联合治疗组(n=34),他达拉非组给予他达拉非片口服治疗,联合治疗组给予百令胶囊联合他达拉非片口服治疗。连续治疗30 d,观察两组用药后临床疗效、中医症候积分、国际勃起功能指数-5(IIEF-5)评分与勃起硬度等级(EHS)评分、睾酮(T)水平及雌二醇(E2)水平、不良反应。结果:联合治疗组治疗总有效率为94.12%,高于他达拉非组的76.47%,差异有统计学意义(P<0.05);治疗后,联合治疗组中医主证症候积分与次证症候积分均低于他达拉非组,差异均有统计学意义(P<0.05);治疗后,联合治疗组IIEF-5评分与EHS评分均高于他达拉非组,差异均有统计学意义(P<0.05);治疗后,联合治疗组T水平高于他达拉非组,E2水平低于他达拉非组,差异均有统计学意义(P<0.05);治疗后,联合治疗组阴茎夜间勃起硬度检测(NPTRT)各项指标均高于他达拉非组,差异均有统计学意义(P<0.05);联合治疗组不良反应总发生率为14.71%,高于他达拉非组的8.82%,但差异无统计学意义(P>0.05)。结论:百令胶囊联合他达拉非在脾肾两虚型ED的治疗中可以有效改善患者勃起功能与勃起硬度,提高睾酮水平,降低雌二醇水平。

Objective:To observe the effect of Bailing Capsules combined with Tadalafil on erectile dysfunction(ED)with spleen-kidney deficiency.Method:A total of 68 cases of ED with spleen-kidney deficiency patients treated in the First Affiliated Hospital of Jiangxi Medical College from February 2020 to February 2023 were selected as the study objects.They were divided into Tadalafil group(n=34)and combined treatment group(n=34)by random number table method.The Tadalafil group was given oral treatment with Tadalafil Tablets,and the combined treatment group was given oral treatment with Bailing Capsules combined with Tadalafil Tablets.Continuous treatment of 30 d.Clinical efficacy,traditional Chinese medicine(TCM)syndrome score,international index of erectile function-5(IIEF-5)score,erectile hardness score(EHS),testosterone(T)level and estradiol(E2)level and adverse reactions were observed in two groups after medication.Result:The total effective rate in combined treatment group was 94.12%,which was higher than 76.47%of Tadalafil group(P<0.05).After treatment,the main and secondary syndrome scores of traditional Chinese medicine of combined treatment group were lower than those of the Tadalafil group(P<0.05).After treatment,IIEF-5 score and EHS score in the combined treatment group were higher than those in the Tadalafil group(P<0.05).After treatment,the level of T in the combined treatment group was higher than that in the Tadalafil group,the level of E2 was lower than that in the Tadalafil group(P<0.05).After treatment,all the indexes of nocturnal penile tumescence and rigidity test(NPTRT)in the combined treatment group were higher than those in the Tadalafil group(P<0.05).The total incidence of adverse reactions in the combined treatment group was 14.71%,which was higher than 8.82%in the tadalafil group,but the difference was not statistically significant(P>0.05).Conclusion:In the treatment of ED with spleen-kidney deficiency,Bailing Capsules combined with Tadalafil can effectively improve erectile function and erectile hardness,increase testosterone level and reduce estradiol level.