达泊西汀治疗原发性早泄的随机对照临床研究

A randomized controlled clinical study on treatment of primary premature ejaculation with dapoxetine

目的观察按需口服达泊西汀治疗原发性早泄的疗效及安全性。方法将150例原发性早泄患者随机分成A、B、C组,每组50例。A组患者予以安慰剂治疗(每日晚餐后口服维生素C 0.1 g);B组帕罗西汀治疗(每日晚餐后口服20 mg);C组患者按需口服达泊西汀治疗(每次按需提前1～3 h服用30 mg)。疗程为4周。比较3组患者治疗前、首剂治疗后和治疗4周后阴道内射精潜伏时间(IELT)的变化,以及治疗前后早泄相关问卷调查表中各项指标评分变化情况,同时观察治疗期间的药物不良反应。结果 A、B组首剂治疗后IELT与治疗前比较无显著差异(P>0.05);C组与治疗前比较有非常显著差异(P=0.000),与A、B组比较均有非常显著差异(P=0.000)。B、C组治疗4周后IELT与治疗前比较均有非常显著差异(P=0.000),两组间比较无显著差异(P>0.05)。在早泄相关问卷调查表中,治疗后射精控制能力、性交满意度及治疗满意度评分3组间比较均有非常显著差异(P=0.000)。B、C组药物不良反应发生率无显著差异(P>0.05)。结论达泊西汀治疗原发性早泄的首剂效果显著,治疗4周后与帕罗西汀疗效及药物不良反应相似;射精控制能力明显改善,且有更高的性交满意度及治疗满意度,值得临床推广应用。

ATM To observe the therapeutic effects and safety of on- demand oral dapoxetine in treatment of primary premature ejaculation. METHODS A total of 150 patients were divided into three groups randomly（50 patients in each group）. Group A were orally given placebo（vitamin C 0.1 g after dinner daily）, group B were orally given paroxetine（20 mg after dinner daily）, and group C were orally given dapoxetine on demand（30 mg on demand 1- 3 hours in advance） for four weeks. The effects were evaluated by comparing the change in average intra- vaginal ejaculation latency time（ IELT） and scores of the relevant premature ejaculation questionnaire among the three groups before the treatment, after the first dose treatment, and after four weeks treatment. The adverse drug reactions were summarized during the treatment. RESULTS The mean IELT after the first dose treatment had no significant difference in group A and B compared wtih their baseline（P〉 0.05）,and it had significant difference in group C compared with the baseline（P = 0.000） with significant difference compared with group A or B（P = 0.000）. The mean IELT after four weeks treatments had significant difference in group B and C compared with their baseline（P = 0.000） with no significant difference between group B and C（ P〉 0.05）. In the relevant premature ejaculation questionnaire, there were significant differences in the mean scores of ejaculation control ability, satisfaction of sexual intercourse, and satisfaction of treatment among the three groups（ P = 0.000）. There were no significant difference in incidence of adverse reactions between group B and C（P 〉0.05）. CONCLUSION Dapoxetine has distinct effect to treat primary premature ejaculation in the first dose treatment. It＇s therapeutic effects and adverse reactions are similar to paroxetine after four weeks treatment. Dapoxetine has higher satisfaction of sexual intercourse and treatment and is more powerful to control the ejaculation, with worthy of clinical recommendation and application.