【摘要】 目的:盐酸达泊西汀和帕罗西汀两种药物通过交叉对比试验对原发性早泄进行治疗，比较两药的临床疗效及不良反应。方法:将148例原发性早泄患者按照就诊时间随机分为两组做交叉对比试验，每组74例。A组帕罗西汀，20 mg/次，每晚1次；B组达泊西汀组，30 mg,按需服用。连续服用6周，观察两组疗效及不良反应。停药4周为清洗期，不做任何处理。第10周后A组患者改服达泊西汀，30 mg,按需服用；B组帕罗西汀，20 mg/次，每晚1次。6周后再次观察疗效及不良反应。对比两组患者使用帕罗西汀和达泊西汀的有效性及安全性。结果:两组受试者初始特征差异无显著性(P>0.05);对比观察：IELT改善情况：A、B两组的IELT平均值(A组：4.43 min, B组：7.12 min)和增加倍数(A组：3.99,B组，6.72)均显著高于治疗前(两组P<0.001)。两组服用帕罗西汀患者均显著高于达泊西汀患者(P<0.001)。PEP量表及配偶情况调查结果：两组患者早泄量表射精控制能力，性交满意度，早泄相关苦恼及早泄相关两性沟通困难4项指标评分的平均值，在治疗后较治疗前均有显著提高，治疗后整体感觉情况、性伴侣的满意情况和性交高潮频度也明显提高。不良反应：绝大部分患者可耐受(不良反应A组20.8%,B组9.7%),两组患者均未出现严重的不良反应。(4)偏好性调查：在两组患者经过16周治疗停药后，分别对两组患者进行偏好性调查，大多数认为帕罗西汀(61.9%)比达泊西汀(26.8%)更好，个别患者认为二药差不多或者无效。结论:本次试验的总体改善情况，帕罗西汀优于达泊西汀，对患者的偏好性调查也显示，患者更倾向于服用帕罗西汀。达泊西汀价格也是造成患者偏好于帕罗西汀的一个因素。更多还原

【Abstract】 Objective: To investigate the clinical effect and adverse reactions of dapoxetine hydrochloride versus paroxetine in the treatment of primary premature ejaculation by cross-comparison. Methods: Based on the clinic-visit time, we equally randomized 148 patients with primary premature ejaculation into groups A and B for a cross-comparison test, the former treated with paroxetine at 20 mg once nightly and the latter with dapoxetine hydrochloride at 30 mg on demand, both for 6 successive weeks, during which we observed the therapeutic effects and adverse reactions. Following 4 weeks of drug discontinuance, we administered dapoxetine hydrochloride at 30 mg on demand for group A and paroxetine at 20 mg once nightly for group B, both for another 6 successive weeks, followed by observation and comparison of the therapeutic effects and adverse reactions. Results: There were no statistically significant differences in the initial characteristics of the two groups of patients(P > 0.05). Compared with the baseline, the mean intra-vaginal ejaculation latency time(IELT) was dramatically improved after treatment in both groups A(4.43 min) and B(7.12 min), increased by 3.99% and 6.72%, respectively(P<0.001). The patients treated with paroxetine showed significantly longer IELT than those taking dapoxetine hydrochloride in both groups(P<0.001). Findings of the Premature Ejaculation Profile(PEP) and spouses’ conditions indicated significant improvement after treatment in the average scores of the four indicators of PEP, that is, perceived control over ejaculation, ejaculation-related personal distress, satisfaction with sexual intercourse and ejaculation-related interpersonal difficulty, as well as in the overall experience and partner’s satisfaction and orgasm frequency. Adverse reactions to medication were found in 20.8% of the cases in group A and 9.7% in group B, but none was serious. Preference survey following drug withdrawal revealed a preference for paroxetine(61.9%) over dapoxetine(26.8%), and that only a few of the patients thought of the two drugs as comparable or both ineffective. Conclusion: In term of overall effectiveness, paroxetine was superior to dapoxetine in the treatment of primary premature ejaculation. And the patients obviously preferred the former to the latter, which might be partly attributed to the higher price of dapoxetine.更多还原