Xue Zhaoying, Zhang Yuanfang, Ding Qiang, He Zhishong, Wang Jiangong, Xu Ke
The Institute of Urology, Peking University, Beijing, China.
Int J Urol. 2007 Feb;14(2):118-22. doi: 10.1111/j.1442-2042.2007.01502.x.
The efficacy and safety profiles of two alpha1-adrenoceptor antagonists, doxazosin gastrointestinal therapeutic system, a controlled-release formulation of doxazosin, and tamsulosin, were compared in Chinese men with confirmed benign prostatic hyperplasia.
After a 2-week placebo run-in phase, 117 patients were randomized to daily treatment with doxazosin gastrointestinal therapeutic system (4 mg doxazosin) (n = 60) or 0.2 mg tamsulosin (n = 57) for 6 weeks with no titration of study medications. Efficacy was measured by the International Prostate Symptom Score, maximum urinary flow rate, postvoid residual urine volume, and quality-of-life score from the International Prostate Symptom Score. Adverse events were recorded.
Both drugs significantly improved the International Prostate Symptom Score (total, irritative subscore and obstructive subscore) and maximum urinary flow rate. Doxazosin gastrointestinal therapeutic system reduced postvoid residual urine volume significantly more than tamsulosin (-25 +/- 5 mL vs 2 +/- 5 mL, P = 0.041) in patients with residual volume >0 mL at baseline. Other differences between groups were not statistically significant.
The doxazosin gastrointestinal therapeutic system and tamsulosin were effective and well tolerated for the treatment of benign prostatic hyperplasia in Chinese men.
比较两种α1肾上腺素能受体拮抗剂多沙唑嗪胃肠治疗系统(一种多沙唑嗪控释制剂)和坦索罗辛在中国确诊为良性前列腺增生的男性患者中的疗效和安全性。
在为期2周的安慰剂导入期后,117例患者被随机分为两组,分别接受多沙唑嗪胃肠治疗系统(4毫克多沙唑嗪)每日治疗(n = 60)或0.2毫克坦索罗辛每日治疗(n = 57),为期6周,研究药物不进行滴定。通过国际前列腺症状评分、最大尿流率、排尿后残余尿量以及国际前列腺症状评分中的生活质量评分来衡量疗效。记录不良事件。
两种药物均显著改善了国际前列腺症状评分(总分、刺激性子评分和梗阻性子评分)以及最大尿流率。在基线时残余尿量>0毫升的患者中,多沙唑嗪胃肠治疗系统比坦索罗辛更显著地降低了排尿后残余尿量(-25±5毫升对2±5毫升,P = 0.041)。两组之间的其他差异无统计学意义。
多沙唑嗪胃肠治疗系统和坦索罗辛在治疗中国男性良性前列腺增生方面有效且耐受性良好。