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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。
Objective To observe the efficacy and safety of oral dapoxetine in treatment of primary premature ejaculation. Methods 150 patients with primary premature ejaculation were randomly divided into A, B, C group, 50 cases in each group. Patients in group A were given placebo (0.1 g daily after oral administration of vitamin C); in group B, paroxetine (20 mg daily after dinner); patients in group C were treated with oral dapoxetine 1 ~ 3 h before taking 30 mg). Treatment for 4 weeks. The change of intravaginal latent ejaculation latency (IELT), pre-treatment and post-treatment IELT before and after the first treatment and the pre-and post-treatment premature ejaculation related questionnaire were compared between the three groups before and after treatment, reaction. Results There was no significant difference in IELT between the first group and the first group (P> 0.05). There was a significant difference between the C group and the pre-treatment group (P = 0.000), and there was a significant difference between the A and B groups (P = 0.000). After 4 weeks of treatment in group B and group C, the IELT was significantly different from that before treatment (P = 0.000). There was no significant difference between the two groups (P> 0.05). In the questionnaire of premature ejaculation, the ejaculation control ability, sexual intercourse satisfaction and treatment satisfaction score after treatment were all significantly different (P = 0.000). There was no significant difference in adverse drug reaction between group B and group C (P> 0.05). Conclusion Dapoxetine is effective in the treatment of primary premature ejaculation for the first dose. After 4 weeks of treatment, the efficacy and side effects of paroxetine are similar. The ejaculation control ability is significantly improved with higher sexual intercourse satisfaction and treatment satisfaction. Clinical application.