摘要
目的:探讨爱活尿通(Eviprostat)治疗良性前列腺增生(BPH)的安全性及有效性。方法:采用开放、多中心的临床试验方法,对100例BPH患者进行了为期12周的观察。患者服用爱活尿通每次2片,每天3次,共12周。主要疗效指标为国际前列腺症状评分(IPSS),最大尿流率(Qm ax),膀胱残余尿量(Ru)和前列腺体积(V);次要指标为生活质量评分(QOL)和平均尿流率(Qave)。结果:服药12周后,IPSS评分较治疗前平均降低5.67分(P<0.001),QOL评分平均降低1.44分(P<0.001),Qm ax较治疗前平均增加1.70 m l/s(P<0.001),Qave平均增加1.15 m l/s(P<0.001),膀胱残余尿量(Ru)平均减少5.07 m l(P=0.046),PSA平均下降0.129μg/L(P<0.017)。临床不良反应发生率为1%。结论:爱活尿通可明显改善BPH患者的排尿症状、增加尿流率、减少残余尿量,不良反应发生率低,是一种安全、有效的治疗BPH的药物。
Objective ： To study the efficacy and safety of Eviprostat for the treatment of benign prostatic hyperplasia （BPH）. Methods： An open, muhicentral clinical trial was conducted in 100 patients with BPH. Patients received a 12-week oral administration of Eviprostat 2 tablets per-time, 3 times a day. The main indexes of efficacy include international prostatic symptom score （IPSS） , maximum urinary flow rate （ Qmax ） , residual urine （ Ru ） and prostatic volume （ V ）. The additional indexes are quality of life score （QOL） and average urinary flow rate （Qave）. Results： After a 12-week therapy, IPSS, QOL score, Qmax and Qave were significantly improved. IPSS was averagely decreased by 5.67 （P〈0.001） ; QOL score was averagely decreased by 1.44 （P〈0.001 ） ; Qmax was averagely increased by 1.70 ml/s （P〈0. 001） ; Qave was averagely increased by 1.15 ml/s （P 〈0. 001 ） ; Ru was averagely decreased by 5.07 ml （ P=0.046） , PSA level was averagely decreased by 0.129μg/L （ P〈0.017 ）. The clinical adverse event rate was 1%. Conclusion： Eviprostat is a kind of safe, effective and preferable drug for treating BPH. It can improve the subjective symptoms and objective measures of the patients.
出处
《中华男科学杂志》
CAS
CSCD
2005年第9期674-676,共3页
National Journal of Andrology
关键词
爱活尿通
临床试验
良性前列腺增生
Eviprostat
clinical trials
benign prostatic hyperplasia
作者简介
宋毅（1971-），男，辽宁丹东市人，主治医师，博士，从事泌尿外科专业。
通讯作者：那彦群
