萘哌地尔片治疗良性前列腺增生症的临床研究  

Efficacy of Naftopidil in patients with benign prostatic hyperplasia

作　　者：刘玉强[1] 徐祗顺[1] 史本康[1] 王传运[1] 

机构地区：[1]山东大学齐鲁医院泌尿外科,山东济南250012

出　　处：《山东大学学报（医学版）》2005年第12期1170-1172,1177,共4页Journal of Shandong University:Health Sciences

摘　　要：目的:观察新型α1-肾上腺素能受体阻滞剂萘哌地尔片治疗良性前列腺增生症的安全性和有效性。方法:采用随机、双盲双模拟、阳性药物平行对照的临床研究方法,对60例良性前列腺增生症(BPH)患者进行为期6周的治疗观察。治疗组服用萘哌地尔片25mg,每日1次;对照组服用盐酸坦索罗辛0.2mg,每日1次。结果:两组治疗前后国际前列腺症状评分(IPSS)、生活质量评分(QOL)、最大尿流率(Qmax)和平均尿流率(Qave)均有显著改善,但两组间治疗前后的差值比较无显著差异(P>0.05);两组治疗前后膀胱残余尿量比较无统计学意义(治疗组P=0.1233,对照组P=0.0820),两组间治疗前后残余尿量的差值比较也无显著性意义(P>0.05)。治疗组无不良反应发生,对照组不良反应发生率为6.67%。结论:萘哌地尔片能明显改善BPH患者的主、客观症状,增加最大尿流率和平均尿流率,提高生活质量,不良反应发生率低,是一种安全有效的治疗BPH的新药。Objective： To study the efficacy and safety of Naftopidil , a new α1-adrenoceptor antagonist in benign prostatic hyperplasia （BPH）. Methods： A random, double blind, double-simulant, parallel-controlled clinical trial was performed in 60 patients with BPH. Patients in treatment group （n=30） were given Naftopidil（ 25 mg, once a day）, and the controls（n=30） tamsulosin（0.2 mg, once a day） for 6 weeks. Results： The international prostate symptom score （IPSS）, quality of life （QOL）score, maximum urinary flow rate（Qmax） and average urinary flow rate（Qave） were significantly improved in both groups, but these were not significantly different between the two groups （P〉0.05）. The residual urinary was not significantly improved after 6-week therapy both in Naftopidil and tamsulosin groups （P = 0.1233, P = 0.0820,respectively）, and was not different between the two groups yet （P 〉0.05）.The clinical adverse event was not found in Naftopidil group, while it＇s rate was 6.67% in tamsulosin group. Conclusion： Naftopidil, as a new α1-adrenoceptor antagonist for patients with BPH, is effective and safe. It can significantly improve the subjective symptoms and objective assessment of the patients.

关 键 词：萘哌地尔 α肾上腺素能受体阻滞剂 前列腺增生 盐酸坦索罗辛 生活质量 

分 类 号：R697.3[医药卫生—泌尿科学]