达泊西汀治疗早泄的疗效与安全性

[Efficacy and safety of dapoxetine in the treatment of premature ejaculation].

作者信息

Chen Xiao-yu, Qu Ying-wei, Wang Suo-gang

出版信息

Zhonghua Nan Ke Xue. 2016 May;22(5):411-4.

PMID:27416664

Abstract

OBJECTIVE

To evaluate the clinical effect and safety of dapoxetine in the treatment of premature ejaculation (PE).

METHODS

We randomly assigned 116 PE patients to receive dapoxetine on demand at 30 mg qd (dapoxetine group, n = 60, aged 23-49 years) or oral tamsulosin at 20 mg qd (control group, n = 56, aged 24-46 years). After 4 weeks of medication, we compared the clinical global impression of change (CGIC) , PE profile (PEP) scores, intravaginal ejaculation latency time (IELT) , and adverse reactions between the two groups of patients.

RESULTS

Compared with the baseline, the IELT was remarkably prolonged after treatment both in the dapoxetine group ([0.86 ± 0.17] vs [4.32 ± 2.23] min, P < 0.05) and the control ([0.88 ± 0.15] vs [4.17 ± 2.26] min, P < 0.05), with no statistically significant difference between the two groups (P > 0. 05). The post-treatment rate of CGIC in the dapoxetine group had no statistically significant difference from that in the control (85.00% vs 82.14%, P > 0.05). In comparison with pre-treatment, the patients of both the dapoxetine and control groups showed dramatically improved scores after medication in perceived control over ejaculation (0.85 ± 0.23 vs 2.13 ± 0.97 and 0.88 ± 0.21 vs 2.06 ± 0.34, both P < 0.05), ejaculation-related personal distress (1.15 ± 0.64 vs 2.89 ± 0.26 and 1.19 ± 0.53 vs 2.82 ± 0.69, both P < 0.05), satisfaction with sexual intercourse (0.81 ± 0.33 vs 2.58 ± 0.37 and 0.79 ± 0.28 vs 2.45 ± 0.32, both P < 0.05), and ejaculation-related interpersonal difficulty (2.05 ± 0.61 vs 3.24 ± 0.35 and 2.03 ± 0.65 vs 3.18 ± 0.76, both P < 0.05), with no significant differences between the two groups (P > 0.05). The incidence of adverse reactions was significantly lower in the dapoxetine than in the control group (3.33% vs 30.36%, P < 0.05).

CONCLUSION

Dapoxetine is effective for the treatment of PE, with its advantages of prolonging the intravaginal ejaculation latency time, improving the quality of sexual life, and low incidence of adverse reactions.

摘要

目的

评估达泊西汀治疗早泄（PE）的临床疗效和安全性。

方法

我们将116例PE患者随机分为按需服用30mg达泊西汀每日1次组（达泊西汀组，n = 60，年龄23 - 49岁）或口服20mg坦索罗辛每日1次组（对照组，n = 56，年龄24 - 46岁）。用药4周后，比较两组患者的临床总体印象变化（CGIC）、早泄概况（PEP）评分、阴道内射精潜伏期（IELT）及不良反应。

结果

与基线相比，达泊西汀组（[0.86 ± 0.17] vs [4.32 ± 2.23]分钟，P < 0.05）和对照组（[0.88 ± 0.15] vs [4.17 ± 2.26]分钟，P < 0.05）治疗后IELT均显著延长，两组间差异无统计学意义（P > 0.05）。达泊西汀组治疗后的CGIC率与对照组相比差异无统计学意义（85.00% vs 82.14%，P > 0.05）。与治疗前相比，达泊西汀组和对照组患者用药后在射精自我控制感（0.85 ± 0.23 vs 2.13 ± 0.97以及0.88 ± 0.21 vs 2.06 ± 0.34，均P < 0.05）、射精相关个人困扰（1.15 ± 0.64 vs 2.89 ± 0.26以及1.19 ± 0.53 vs 2.82 ± 0.69，均P < 0.05）、性交满意度（0.81 ± 0.33 vs 2.58 ± 0.37以及0.79 ± 0.28 vs 2.45 ± 0.32，均P < 0.05）和射精相关人际困难（2.05 ± 0.61 vs 3.24 ± 0.35以及2.03 ± 0.65 vs 3.18 ± 0.76，均P < 0.05）方面的评分均显著改善，两组间差异无统计学意义（P > 0.05）。达泊西汀组不良反应发生率显著低于对照组（3.33% vs 30.36%，P < 0.05）。