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 medication of Yimusake Tablets at 1.5 g per night (group A), dapoxetine hydrochloride at 30 mg at 1－3 hours before anticipated sexual activity (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］ min), 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 difficult 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 severe adverse events occurred in any of the patients during the study.
Conclusions: Combined medication of Yimusake Tablets and dapoxetine hydrochloride, with its advantages of effectiveness and safety, deserves to be recommended for the treatment of PE.
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： 按照纳入标准筛选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，1.5 g/次，共计8周；B组每次性生活前1-3 h给予盐酸达泊西汀30 mg，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PE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。.
Keywords: Yimusake Tablets; dapoxetine hydrochloride; intravaginal ejaculation latency time; premature ejaculation; premature ejaculation profile.