爱活尿通治疗100例良性前列腺增生症的临床研究

The own control clinical study on treating 100 cases of BPH with Eviprostat

目的评估爱活尿通对良性前列腺增生症排尿困难等症状的有效性和安全性。方法进行为期12周的开放性、多中心、自身前后对照的临床研究。100例以国际前列腺症状评分(IPSS),最大尿流率(Qmax),经腹B超测定膀胱残余尿量(Ru)以及经腹B超测定前列腺体积(V)为主要评价指标;生活质量评分(QoL),平均尿流率(Qave)或前列腺直肠指诊为次要评价指标。对每位患者随访12周后观察治疗效果和药物安全性。结果100例患者均完成临床观察。治疗12周后显效36例(36%),有效53例(53%),改善9例(9%),无效2例(2%),总有效率89%。只有1例患者服药后出现头晕、乏力、走路不稳,3天后自行缓解,其余患者未出现与药物有关的不良反应。结论爱活尿通治疗良性前列腺增生症安全、有效,患者依从性高。

Objectives To evaluate the efficacy and safety of Eviprostat when treating the Benigh Prostatic Hyperplasia （BPH）. Methods A multi-centre, open, own-controlled clinic trial was carried out for 12 weeks. The efficacy of 100 cases was evaluated mainly by the International Prostate Syndrome Score （IPSS）, the maximum flow rate, the volume of the residual urine and the prostate; secondarily by the Qualily of Life score （QoL）, the average flow rate and the rectal touch of prostate. After treated for 12 weeks, the patients were evaluated the efficacy and safety of Eviprostat. Results All had completed the follow-up. Of 100 cases, 36 cases （36%） were remarkably effective, 53 cases （53%） were effective, 9 cases （9%） were improved and 2 cases （2%） were ineffective. Only one patient was found to be dizzy, but was relieved after 3 days. Conclusion The Eviprostat is effective and safe on treating BPH.