益慕萨克片联合盐酸达泊西汀治疗早泄的疗效与安全性

[Efficacy and safety of Yimusake Tablets plus dapoxetine hydrochloride in the treatment of premature ejaculation].

作者信息

Yan Xiang-Qian, Li Yan-Feng, Yang Deng-Ke, Jiao Xiang

机构信息

Department of Urology, The 159th Hospital of the People's Liberation Army, Zhumadian, Henan 463000, China.

Department of Urology, Research Institute of Field Surgery, Daping Hospital, The Third Military Medical University, Chongqing 400042, China.

出版信息

Zhonghua Nan Ke Xue. 2016 Sep;22(9):817-822.

PMID:29071880

Abstract

OBJECTIVE

To evaluate the effect and safety of Yimusake Tablets combined with dapoxetine hydrochloride and either of them used alone in the treatment of premature ejaculation (PE).

METHODS

We randomly assigned 180 PE patients to oral medication of Yimusake Tablets at 1.5 g per night (group A), dapoxetine hydrochloride at 30 mg at 1－3 hours before anticipated sexual activity (group B), the Yimusake Tablets plus dapoxetine hydrochloride simultaneously (group C), all for 8 weeks. After 4 and 8 weeks of medication, we recorded and compared the changes in the intravaginal ejaculation latency time (IELT), measures of the PE profile (PEP), and adverse events among the three groups of patients.

RESULTS

The treatment was accomplished and complete data obtained from 154 of the patients, 56 in group A, 52 in group B, and 46 in group C. After 4 and 8 weeks of medication, the mean IELT was dramatically prolonged in all the three groups as compared with the baseline (P<0.01), most significantly at 8 weeks in group C (［2.08±0.68］ min), followed by B (［1.76±0.52］ min) and A (［1.47±0.44］ min), with statistically significant differences among the three groups (P<0.01). The PEP measures were remarkably improved in group A at 8 weeks (P<0.05), and both in B and C at 4 and 8 weeks (P<0.05), most significantly at 8 weeks in group C (P<0.05), in which the patients scored 1.96±0.77 in perception of control over ejaculation, 2.62±0.98 in satisfaction with sexual intercourse, 3.04±0.62 in PE-related distress, and 3.57±0.80 in PE-induced difficult relationship with their partners, all markedly improved as compared with groups A and B (P<0.05). Adverse reactions were observed in 2 cases (3.6%) in group A, 6 cases (9.6%) in B, and 5 cases (10.9%) in C. No severe adverse events occurred in any of the patients during the study.

CONCLUSIONS

Combined medication of Yimusake Tablets and dapoxetine hydrochloride, with its advantages of effectiveness and safety, deserves to be recommended for the treatment of PE.

摘要

目的

评估伊木萨克片联合盐酸达泊西汀及二者单独使用治疗早泄（PE）的疗效及安全性。

方法

将180例PE患者随机分为三组，A组每晚口服伊木萨克片1.5 g；B组在预期性活动前1 - 3小时口服盐酸达泊西汀30 mg；C组同时口服伊木萨克片和盐酸达泊西汀，疗程均为8周。用药4周和8周后，记录并比较三组患者的阴道内射精潜伏期（IELT）、早泄概况量表（PEP）评分及不良事件的变化。

结果

154例患者完成治疗并获得完整数据，其中A组56例，B组52例，C组46例。用药4周和8周后，三组患者的平均IELT均较基线显著延长（P<0.01），8周时C组延长最为显著（［2.08±0.68］分钟），其次为B组（［1.76±0.52］分钟）和A组（［1.47±0.44］分钟），三组间差异有统计学意义（P<0.01）。8周时A组的PEP评分显著改善（P<0.05），4周和8周时B组和C组均显著改善（P<0.05），8周时C组改善最为显著（P<0.05），C组患者在射精控制感方面评分为1.96±0.77，性交满意度评分为2.62±0.98，与早泄相关的苦恼评分为3.04±0.62，因早泄导致与伴侣关系困难评分为3.57±0.80，与A组和B组相比均显著改善（P<0.05）。A组有2例（3.6%）出现不良反应，B组有6例（9.6%），C组有5例（10.9%）。研究期间所有患者均未发生严重不良事件。