规律性真空负压吸引联合他达拉非OAD方案治疗ED的临床效果观察

The safety and efficacy of regular vacuum aspiration combined with orally administration daily of Tadalafil in the treatment of erectile dysfunction

目的探讨规律性真空负压吸引联合他达拉非每日小剂量(OAD)方案治疗勃起功能障碍(ED)的安全性和有效性。方法选取2017年1月至2018年1月合肥市第二人民医院泌尿外科门诊诊治的60例ED患者为研究对象。其年龄范围20岁~60岁,根据不同治疗方案将其随机分为联合治疗组和单药治疗组,每组30例患者。联合治疗组患者在他达拉非OAD方案基础上,联合规律性真空负压吸引(第1个月每日1次,第2个月每周3次,第3个月每周1次)。单药治疗组患者组采用他达拉非OAD方案:5mg,每晚1次,治疗期为3个月。分别在治疗前、治疗3个月结束时、停止治疗3个月后,记录和比较两组患者的国际勃起功能评分(IIEF-5)、视频刺激勃起检测(AVSS)、性生活日记(SEP-2、SEP-3)指标变化,评估联合治疗的安全性和有效性。结果两组患者治疗前的IIEF-5评分、阴茎头端、根部硬度≥60%维持时间、插入成功率和性交成功率的差异均无统计学意义(均P>0.05);两组患者治疗3个月结束时IIEF-5评分、阴茎头端、根部硬度≥60%维持时间、插入成功率和性交成功率均比治疗前有所提高(均P<0.05);在治疗3个月结束时,两组患者随访IIEF-5评分、阴茎头端、根部硬度≥60%维持时间的差异均无统计学意义(均P>0.05);在治疗停止3个月后,两组患者随访IIEF-5评分、阴茎头端、根部硬度≥60%维持时间的差异均具有统计学意义(均P<0.05),联合治疗组疗效优于单药治疗组;在停止治疗3个月时,两组患者插入成功率和性交成功率均比治疗前有所提高(均P<0.05);两组患者安全性差异无统计学意义(P>0.05)。结论规律性真空负压吸引联合他达拉OAD方案治疗ED安全有效,联合治疗组与单药治疗组相比,其长期疗效更为显著,联合治疗有望成为ED治疗的新选择。

Objective To investigate the safety and efficacy of vacuum aspiration combined with orally administration daily(OAD) of Tadalafil in the treatment of erectile dysfunction(ED). Methods 60 patients with ED diagnosed and treated in the Second People′s Hospital of Hefei from January 2017 to January 2018 were enrolled. The age ranged from 20 to 60 years old, and they were randomly divided into two groups according to different treatment options, 30 cases in each group. Group A was given Tadalafil OAD regimen:5 mg once every night for a treatment period of 3 months;Group B was combined with regular vacuum aspiration on the basis of the Tadalafil OAD regimen(Once a day in the first month, 3 times a week in the second month, once a week in the third month). Changes in International Index of Erectile Function(IIEF-5), Audio Visual Sexual Stimulation(AVSS), and Sexual Encounter Profile(SEP-2, SEP-3) were compared between the two groups before treatment, at the end of 3 months of treatment and 3 months after treatment, in order to assess the safety and efficacy of combination therapy. Results Before treatment, there was no significant difference in the IIEF-5 score, the penile tip/base hardness ≥60% maintenance time, the insertion success rate and the sexual success rate between the two groups(all P>0.05). At the end of 3 months of treatment, the IIEF-5 score, penile tip/base hardness ≥60% maintenance time, insertion success rate and sexual intercourse success rate were higher than those before treatment in both groups(all P<0.05). At the end of 3 months of treatment, there was no significant difference in the IIEF-5 score and penile tip/base hardness≥60%(all P>0.05). At 3 months after treatment, there was significant differences in the IIEF-5 score and penile tip/base hardness ≥60% between the two groups(all P<0.05). The success rate of insertion and sexual success rate of the two groups were higher than those before treatment(all P<0.05). There was no statistically significant difference in safety between the two groups(P>0.05). Conclusions Regular vacuum aspiration combined with OAD of Tadalafil is safe and effective in treating ED with better long-term efficacy, which is expected to become a new option for ED treatment.