摘要
目的 探讨新型α1 肾上腺素能受体阻滞剂萘哌地尔 (naftopidil)治疗良性前列腺增生(BPH)的有效性及安全性。 方法 采用随机、双盲双模拟、平行对照、多中心的临床试验方法 ,对2 2 4例BPH患者进行了为期 6周的观察。治疗组服用萘哌地尔 2 5mg ,每日 1次 ;对照组服用盐酸坦索罗辛 0 .2mg ,每日 1次。 结果 服药 6周后 ,治疗组与对照组国际前列腺症状评分 (IPSS)、生活质量评分 (QOL)、最大尿流率 (Qmax)、平均尿流率 (Qave)均较治疗前有显著改善 ,治疗组IPSS较治疗前平均降低 11.0 3分 (P <0 .0 0 1) ,QOL平均降低 1.4 6分 (P <0 .0 0 1) ,Qmax较治疗前平均增加3.4 0ml/s(P <0 .0 0 1) ,Qave平均增加 1.13ml/s(P <0 .0 0 1) ;对照组IPSS较治疗前平均降低 9.5 6分 (P <0 .0 0 1) ,QOL平均降低 1.2 2分 (P <0 .0 0 1) ,Qmax较治疗前平均增加 2 .32ml/s(P <0 .0 0 1) ,Qave平均增加 0 .6 7ml/s(P <0 .0 1) ;两组间比较差异均无显著性意义 (P >0 .0 5 )。剩余尿量治疗组平均减少 4 .3ml(P <0 .0 5 ) ,而对照组则增加 5 .1ml,组间比较差异有显著性意义 (P <0 .0 5 )。临床不良反应发生率治疗组为 3例 (2 .6 8% ) ,对照组为 10例 (8.93% ) ,两组差异有显著性意义 (P <0 .0 5 )。
Objective To study the efficacy and safety of naftopidil,a new α 1-adrenoceptor antagonist for treatment of benign prostatic hyperplasia(BPH). Methods A randomized,double-blind,double-simulant,parallel-controlled,multicentral clinical trial was conducted in 224 patients with BPH.Patients of treatment group received naftopidil (25 mg,once a day) and the controls received tamsulosin (0.2 mg,once a day). Results After 6-week therapy,IPSS,quality of life (QOL) score,maximum urinary flow rate (Qmax) and average urinary flow rate(Qave) were significantly improved both in naftopidil group and tamsulosin (control) group.In naftopidil group,IPSS was averagely decreased by 11.03 (P< 0.001);QOL score was averagely decreased by 1.46(P< 0.001);Qmax was averagely increased by 3.40 ml/s (P< 0.001);Qave was averagely increased by 1.13 ml/s (P< 0.001);while in tamsulosin group, IPSS and QOL score were decreased by 9.56 (P<0.001) and 1.22 (P<0.001),respectively;Qmax and Qave were increased by 2.32 ml/s (P<0.001) and 0.67 ml/s (P<0.01),respectively. No significant difference was found between the two groups(P>0.05).The clinical adverse event rate was 2.68% in naftopidil group, which was significantly lower than that in tamsulosin group (8.93%,P<0.05). Conclusions Naftopidil, as a new α 1-adrenoceptor antagonist for the treatment of patients with BPH,is effective and safe.It can improve the subjective symptoms and objective measures of the patients.
出处
《中华泌尿外科杂志》
CAS
CSCD
北大核心
2004年第9期637-640,共4页
Chinese Journal of Urology
