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亚洲和高加索男性良性前列腺增生症治疗反应的比较:度他雄胺和坦索罗辛联合治疗的长期结果研究。

Comparison of the response to treatment between Asian and Caucasian men with benign prostatic hyperplasia: long-term results from the combination of dutasteride and tamsulosin study.

机构信息

Department of Urology, Yonsei University Health System, Seoul, Korea.

出版信息

Int J Urol. 2012 Nov;19(11):1031-5. doi: 10.1111/j.1442-2042.2012.03091.x. Epub 2012 Jul 9.

Abstract

The Combination of Avodart and Tamsulosin study was a 4-year, randomized, double-blind study of the efficacy and safety of dutasteride and tamsulosin, alone or in combination, in men with moderate-to-severe benign prostatic hyperplasia. In this post-hoc investigation, we analyzed primary and secondary end-points from the Combination of Avodart and Tamsulosin study in Asian (n = 325) and Caucasian men (n = 4259). The incidence of acute urinary retention or benign prostatic hyperplasia-related surgery did not differ significantly between treatment groups in the Asian subpopulation. In Caucasian men, the incidence of acute urinary retention/benign prostatic hyperplasia-related surgery was significantly lower in the combination therapy group compared with the tamsulosin monotherapy group (P < 0.001), but not compared with dutasteride monotherapy. Combination therapy significantly increased the time to benign prostatic hyperplasia clinical progression and resulted in improved International Prostate Symptom Score, maximum urinary flow rate, quality of life, and reduced prostate volume in Asian and Caucasian men who received combination therapy compared with tamsulosin monotherapy. Combination therapy also significantly improved (P < 0.05) time to benign prostatic hyperplasia clinical progression, International Prostate Symptom Score, maximum urinary flow rate and quality of life versus dutasteride in the Caucasian subpopulation. The adverse-event profile was comparable between subpopulations. In conclusion, Asian and Caucasian men respond similarly to these treatments, despite apparent racial differences in 5α-reductase activity.

摘要

度他雄胺和坦索罗辛联合治疗研究是一项为期 4 年的、随机、双盲研究,旨在评估度他雄胺和坦索罗辛单独或联合治疗中重度良性前列腺增生的疗效和安全性。在这项事后分析中,我们分析了度他雄胺和坦索罗辛联合治疗研究中亚洲(n = 325)和白种人(n = 4259)男性的主要和次要终点。在亚洲人群中,治疗组之间急性尿潴留或良性前列腺增生相关手术的发生率没有显著差异。在白种男性中,与坦索罗辛单药治疗组相比,联合治疗组急性尿潴留/良性前列腺增生相关手术的发生率显著降低(P < 0.001),但与度他雄胺单药治疗组相比无显著差异。与坦索罗辛单药治疗相比,联合治疗可显著延长良性前列腺增生临床进展时间,并改善国际前列腺症状评分、最大尿流率、生活质量,同时降低前列腺体积,亚洲和白种男性接受联合治疗后均观察到这些获益。联合治疗还显著改善(P < 0.05)白种人群的良性前列腺增生临床进展时间、国际前列腺症状评分、最大尿流率和生活质量,与度他雄胺相比。两个亚组的不良事件谱相似。总之,尽管 5α-还原酶活性存在种族差异,但亚洲和白种男性对这些治疗的反应相似。

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