摘要
目的评估萘哌地尔(浦畅)治疗良性前列腺增生症的有效性和安全性。方法根据随机、双盲、双模拟、多中心阳性药物平行对照法,240例BPH患者随机分为试验组120例和对照组120例,试验组给予每晚口服萘哌地尔片50mg;对照组给予每晚口服盐酸特拉唑嗪片2mg,两组疗程均为2个月。以国际前列腺症状评分(IPSS)、最大尿流率(Qmax)和临床疗效评价作为主要疗效指标,以平均尿流率(Qave)、生活质量评分(QOL)和残余尿量的变化作为次要疗效指标。结果治疗8周后,共有236例进入统计分析。IPSS、Qmax、Qave、QOL、残余尿量治疗前后两组组内比较差异有统计学意义(P<0.01),治疗前后两组组间比较差异无统计学意义(P>0.05);不良反应率两组间比较差异无统计学意义(P>0.05),总的不良事件较少,但对照组有3例患者出现直立性低血压,试验组没有出现。结论萘哌地尔(浦畅)是治疗良性前列腺增生有效且安全的药物。
Objective To estimate the clinical efficacy and safety of Naflopidil tablet in treating benign prostatic hyperplasia （BPH）. Methods 240 BPH patients were sent into two groups with randomixed, double-simulated and active control parallel study trials： 120 patients of treatment group were given Naftopidil tablet 50mg,po qn for 2 months, and at last, 236 cases were sent into statistics anslysis. To estimate by the change of major indexes include international prostate symptom score （IPSS）, maximun flow rate （Qmax）, total estimation of the clinical efficacy and seconday indexes such as average flow rate （Qave）, quality of life （QOL）, residual urine and volume of prostate. Results There were significant differences between the changes of IPSS, Qmax, Qave, QOL, total estimation of the clinical efficacy and residual urine before and after treatment in two groups（P〈 0.01 ）, and there was no significant difference between two groups（P 〉 0.05）. The adverse reactions in both groups were mild,there was no significant difference between two groups（P〉0.05）. But Orthostatic hypotension happened in 3 cases of the control group while it didn＇t happen in the test group. Conclusion Nafiopidil tablet was safe and effective in treating benign prostatic hyperplasia.
出处
《中国男科学杂志》
CAS
CSCD
2005年第5期36-39,共4页
Chinese Journal of Andrology
