摘要
目的:评估单独或联合应用伊木萨克片和盐酸达泊西汀治疗原发性早泄(PE)的临床疗效及安全性。方法:按照纳人标准筛选2014年1-12月因PE就诊的患者180例,随机分成3组,A组给予伊木萨克片每晚1次,1.5g/次,共计8周;B组每次性生活前1~3h给予盐酸达泊西汀30mg,共计8周;C组同时给予伊木萨克片和盐酸达泊西汀,剂量及疗程同A、B组。于服药后第4周及第8周记录并比较患者治疗前后阴道内射精潜伏期(IELT)及早泄量表(PEP)中各项指标的改变,同时记录治疗期间出现的不良事件。结果:180例PE患者中最终完成观察并获得完整信息的有154例(A组56例、B组52例、C组46例)。各组治疗4、8周后IELT均较治疗前有明显提高(P均〈0.01),C组治疗8周后IELT改善最明显[(2.08±0.68)min],其次是B组[(1.76±0.52)min]和A组[(1.47±0.44)min],各组间差异有统计学意义(P〈0.01)。A组治疗8周后PEP各指标均值较治疗前有明显改善(P〈0.05);B组和C组治疗4周和8周后PEP各指标均值较治疗前有显著提高(P〈0.05);C组治疗8周后改善最明显,射精控制能力评分(1.96±0.77)分,性生活满意度评分(2.62±0.98)分,早泄相关苦恼评分(3.04±0.62)分,早泄相关伴侣沟通困难评分(3.57±0.80)分,均显著高于A、B组(P〈0.05)。治疗期间A组发生不良事件2例(3.6%)、B组6例(9.6%)、C组5例(10.9%),3组均未出现严重不良反应。结论:伊木萨克片和盐酸达泊西汀联合应用治疗原发性PF比单独用药具有更好的临床疗效,且安全性良好,具有一定的临床推广价值和应用前景。
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 medica- tion of Yimusake Tablets at 1.5 g per night ( group A) , dapoxetine hydroehloride at 30 mg at 1 - 3 hours before anticipated sexual ac- tivity ( 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 ] rain), 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 difficuh 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 se- vere adverse events occurred in any of the patients during the study. Conclusion: Combined medication of Yimusake Tablets and dapoxetine hydrochloride, with its advantages of effectiveness and safety, deserves to be recommended for the treatment of PE.
出处
《中华男科学杂志》
CAS
CSCD
北大核心
2016年第9期817-822,共6页
National Journal of Andrology
关键词
早泄
伊木萨克片
盐酸达泊西汀
阴道内射精潜伏期
早泄量表
premature ejaculation
Yimusake Tablets
dapoxetine hydroehloride
intravaginal ejaculation latency time
prema- ture ejaculation profile