国产与原研盐酸达泊西汀片治疗早泄的临床研究  

Clinical study of generic and original dapoxetine hydrochloride tablets in the treatment of premature ejaculation

作　　者：史复 陆阳 刘元元[2] 段永刚 Shi Fu;Lu Yang;Liu Yuanyuan;Duan Yonggang(Department of Reproductive Medicine and Prenatal Diagnosis Center,The University of Hong Kong-Shenzhen Hospital,Shenzhen 518053,China;Department of Epidemiology and Health Statistics,West China School of Public Health and West China Fourth Hospital,Sichuan University,Chengdu 610041,China)

机构地区：[1]香港大学深圳医院生殖与产前诊断医学中心,深圳518053 [2]四川大学华西公共卫生学院/四川大学华西第四医院流行病与卫生统计学系,成都610041

出　　处：《中国男科学杂志》2022年第3期71-79,共9页Chinese Journal of Andrology

摘　　要：目的 探究国产与原研盐酸达泊西汀片治疗早泄的有效性、药物经济学方面是否存在差异。方法 选取2020年1月10日至2022年1月10日就诊于香港大学深圳医院生殖与产前诊断医学中心男科的87例早泄患者,分为治疗组55例,治疗方案为艾时达~?30mg,对照组32例,治疗方案为必利劲?30mg,均为按需口服,通过早泄诊断量表(PEDT)、国际勃起功能指数-5(IIEF-5)评分观察比较二组患者治疗的有效性以及治疗相关的费用等。结果 两组患者治疗前各项指标无统计学差异(P>0.05),治疗后1月两组患者PEDT均较前明显改善,治疗组效果与对照组无统计学差异(P>0.05);治疗后1月两组患者IIEF-5均较前略有改善,治疗组效果与对照组无统计学差异(P>0.05);进一步对PEDT与IIEF-5两个指标的治疗前后差值进行相关分析,二者为正相关,即随着PEDT评分的改善,IIEF-5评分亦改善;治疗组药品治疗费用明显低于对照组(P<0.05)。结论 国产艾时达?与原研盐酸达泊西汀片治疗早泄的疗效相当,但国产艾时达?治疗费用明显低于原研产品,证明国家集采中标国产产品更具有药物经济学方面优势,对提高患者依从性、满意度和可及性具有重要意义;同时,两组患者随着早泄的显著改善,勃起功能亦改善。Objective To explore clinical efficacy and drug economy of generic and original dapoxetine hydrochloride tablets in the treatment of premature ejaculation. Methods Total of 87 patients with premature ejaculation who were treated in Andrology Department of Reproductive Medicine Center of Shenzhen Hospital of the University of Hong Kong from January 10, 2020 to January 10, 2022 were divided into two groups including the treatment group(55cases) and the control group(32 cases). The treatment scheme of the treatment group was 30mg of Aishida?, and the treatment scheme of the control group was 30mg of Priligy, which was taken orally as needed. The efficacy of the two groups were observed and compared by the scores of premature ejaculation diagnostic tool(PEDT) and international index of erectile function-5(IIEF-5), and their treatment-related costs were also comparatively analyzed. Results There were no significant differences in all indexes between the two groups before treatment(P>0.05). One month after treatment, the PEDT of the two groups was significantly improved, and the effect of the treatment group was not significantly different from that of the control group(P>0.05);One month after treatment, IIEF-5 in the two groups was slightly improved compared with that before treatment, and there was no significant difference between the treatment group and the control group(P>0.05);Further, the correlation analysis between PEDT and IIEF-5 before and after treatment showed that they were positively correlated, that is, the IIEF-5 score also improved with the improvement of PEDT score;The cost of drug treatment in the treatment group was significantly lower than that in the control group(P<0.05). Conclusion The efficacy of generic and original dapoxetine hydrochloride tablets in the treatment of premature ejaculation is equivalent, but the treatment cost of generic product is significantly lower than that of original product, indicating that the national centralized purchase of generic product has more drug economic adv

关 键 词：早泄 达泊西汀 国产药物 原研药物 阴茎勃起 

分 类 号：R698.9[医药卫生—泌尿科学] R979.9[医药卫生—外科学]