中西药联合治疗早泄合并轻中度勃起功能障碍的多中心、随机对照临床研究

A multicenter, randomized controlled clinical study on combination of Chinese and Western medicine in the treatment of early mild to moderate erectile dysfunction

目的评价盐酸达泊西汀联合枸椽酸西地那非及乌灵胶囊联合运用治疗早泄(PE)合并轻中度勃起功能障碍(ED)的安全性和有效性。方法140例PE合并轻中度ED患者随机分为对照组和治疗组各70例,对照组给予枸椽酸西地那非与乌灵胶囊治疗,治疗组在对照组基础上加用盐酸达泊西汀进行治疗,疗程4周。以国际勃起功能问卷调查表-5(IIEF-5)、阴道内射精潜伏时间(IELT)、早泄诊断量表(PEDT)分别评价患者的勃起功能障碍和早泄的临床疗效,并应用PHQ-9.GAD-7量表评估患者治疗前后的抑郁、焦虑程度。结果治疗过程中治疗组脱落2例,对照组脱落3例,最终有效病例135例,治疗组68例,对照组67例。治疗组、对照组在治疗后IELT、IIEF-5评分较治疗前均明显增加,差异具统计学意义(P<0.05);PEDT、PHQ-9、GAD-7评分较治疗前均明显下降,差异具统计学意义(P<0.05);组间相比,治疗组与对照组在治疗HEF-5评分改善方面无显著差异(P>0.05),在IELT、PEDT、PHQ-9、GAD-7评分的改善方面,差异具统计学意义(P<0.05);不良反应方面,对照组头痛2例,治疗组背部肌肉酸痛1例,头痛2例,均为轻度,可耐受,自行缓解,未做特殊处理。结论盐酸达泊西汀联合枸椽酸西地那非及乌灵胶囊治疗PE合并轻中度ED,可以安全有效地改善患者勃起功能,并进一步改善患者IELT以及缓解其焦虑抑郁情绪。

Objective To evaluate the safety and efficacy of dapoxetine hydrochloride combined with sildenafil citrate and wuling capsule in the treatment of premature ejaculation (PE) with mild to moderate erectile dysfunction (ED). Methods All 140 patients with PE and mild ED were randomly divided into the control group and the treatment group, 70 cases in each group. The patients in the control group were treated with sildenafil citrate and Wuling capsules, and the patients in the treatment group were treated with same medications plus dapoxetine hydrochloric acid on the basis of the control group. The course lasted for 4 weeks. The clinical efficacy of erectile dysfunction and premature ejaculation were evaluated by the International Erectile Function Questionnaire-5 (HEF-5), intravaginal ejaculation latency (IELT), and premature ejaculation diagnostic scale (PEDT), and the degree of depression and anxiety before and after treatment were assessed by PHQ-9 and the GAD-7 scale. Results During the treatment, 2 patients died in the treatment group, and 3 patients in the control group. The final effective case was 135 patients including, 68 patients in the treatment group, and 67 patients in the control group. The IELT and HEF-5 scores in the treatment group and the control group were all increased significantly as compared with that before treatment. The scores ofPEDT, PHQ-9 and GAD-7 were significantly decreased as compared with that before treatment (P<0.05). There was no improvement in the treatment of HEF-5 score between the control group and the treatment group. Significant difference (P>0.05), but there were significant differences in IELT, PEDT, PHQ-9, GAD-7 scores (P<0.05);About adverse reactions, 2 cases of headache occurred in the control group, 1 case of back muscle soreness in the treatment group. Two cases of headache were all mild and tolerable. They did not receive any special treatment and self-relieved. Conclusion Dapoxetine hydrochloride combined with sildenafil citrate and Wuling capsules for the treatment of PE with mild to moderate ED can safely and effectively improve the erectile function of patients and the EELT patients without affecting erectile function, relieve their anxiety and depression.