Prospective randomized controlled trial on treatment of primary premature ejaculation with dapoxetine hydrochloride and tadalafil
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摘要: 目的:评价盐酸达泊西汀联合小剂量他达拉非治疗原发性早泄(PE)的临床疗效。方法:收集原发性PE患者97例,随机分成对照组(n=46)和治疗组(n=51),对照组性交前按需口服盐酸达泊西汀30mg;治疗组性交前按需口服盐酸达泊西汀片30mg,同时每日服用(OAD)小剂量他达拉非片5mg,疗程12周。嘱患者在治疗期间规律性生活,每月性生活≥4次,治疗前后行中国早泄患者性功能评价表5(CIPE-5)评分及阴道内射精潜伏期(IELT)测评并做好相关记录。结果:与治疗前比较,治疗后两组CIPE-5评分及IELT均明显提高,差异有统计学意义(P<0.05)。与对照组比较,治疗后治疗组的CIPE-5评分及IELT改善更为明显,差异有统计学意义(P<0.05)。两组患者治疗期间不良事件发生率差异无统计学意义(P>0.05),不良事件可自行缓解。结论:盐酸达泊西汀联合小剂量他达拉非治疗原发性PE安全有效。Abstract: Objective:To assess the clinical efficacy of dapoxetine hydrochloride combined with tadalafil at low dosage in the treatment of primary premature ejaculation.Method:Ninety-seven male outpatients with primary premature ejaculation were divided randomly into 2 groups.The control group (46 cases) was only treated with on-demand 30 mg dapoxetine hydrochloride orally before sexual intercourse.The treatment group (51 cases) was treated with dapoxetine hydrochloride in the same way and 5 mg tadalafil orally once a day.All treatments were given for 12 weeks.During the treatment, the patients were required for regular sex no less than 4 times a month, and to make records for CIPE-5 scores and IELT before and after treatment.Result:In both groups, CIPE-5 scores and IELT were improved significantly after treatment (P<0.05).However, CIPE-5 scores and IELT of the treatment group were improved more significantly than those of the control group (P<0.05).There was no statistical difference in incidence of adverse events between two groups (P>0.05), and all of adverse events could be relieved by themselves.Conclusion:The treatment of dapoxetine hydrochloride combined with tadalafil at low dosage is safe and effective for primary premature ejaculation.
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Key words:
- primary premature ejaculation /
- dapoxetine hydrochloride /
- tadalafil
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