前列安通片治疗慢性前列腺炎多中心临床试验研究  

A Multi-center Clinical Trial of Qianlieantong Tablets for Chronic Prostatitis

作　　者：郭凯[1] 邱明星[1] 蔡松良[2] 冷静[3] 韩银发[3] 邵国兴[4] 王传航[5] 涂响安[6] 杨罗艳[7] 陈戈明[2] 周强[5] 邓勇[8] 王晓隆[8] 

机构地区：[1]四川省人民医院泌尿外科,四川成都610072 [2]浙江大学医学院附属第一医院泌尿外科,浙江杭州310003 [3]上海交通大学附属仁济医院泌尿外科,上海200001 [4]第四军医大学西京医院泌尿外科,陕西西安710032 [5]北京中日友好医院男科,北京100029 [6]中山大学附属黄埔医院泌尿外科,广东广州510070 [7]中南大学附属湘雅二院泌尿外科,湖南长沙410011 [8]泸州医学院附属医院泌尿外科,四川泸州646000

出　　处：《中华男科学杂志》2007年第10期950-952,共3页National Journal of Andrology

摘　　要：目的:评价前列安通片治疗慢性前列腺炎的疗效及安全性。方法:采用多中心、自身对照、开放性的临床研究方法,共纳入280例受试者,口服前列安通片,5片/次,3次/d。分别于治疗前、治疗后2周和4周按美国国立卫生研究院(NIH)慢性前列腺炎症状评分(NIH-CPSI)进行评分,并记录EPS中白细胞数。结果:纳入统计受试者共273例,治疗4周后,显效96例(35.2%),有效130例(47.6%),无效47例(17.2%),总有效率为82.8%。治疗4周后,受试者NIH-CPSI总评分、疼痛评分、排尿评分、生活质量评分及EPS中WBC计数与治疗前相比,差异有统计学意义(P<0.01)。试验期间未发现与治疗相关的不良反应事件发生及实验室检查异常。结论:前列安通片治疗慢性前列腺炎疗效确切,安全性高,尤其适合伴有盆腔疼痛的慢性前列腺炎治疗。Objective： To observe the efficacy and safety of Qianlieantong Tablets in the treatment of chronic prostatitis. Methods ： A multi-center, self-controlled open clinical trial was conducted. Atotal of 280 subjects with chronic prostatitis were enrolled and treated by Qianlieantong Tablets, 3 times a day, 5 tablets each time. Before and after 2 and 4 weeks after the administration, NIH-CPSI scores and white blood cell counts in the prostate secretion were recorded. Results ： Of the 273 subjects evaluated, the rates of excellence, effectiveness and ineffectiveness were 35.2% （n = 96） , 47.6% （ n = 130） and 17.2% （ n = 47 ） , respectively, with a total effectiveness rate of 82.8%. After 4 weeks＇medication, the scores of the subjects on NIH-CPSI pain, voiding and quality of life and white blood cell counts in prostate secretion were significantly decreased compared with pre-treatment （P 〈0.01 ）. No adverse events or laboratory abnormality related to the medication were observed. Conclusion ： Qianlieantong Tablets has a significant effect on chronic prostatitis with high safety, particularly indicated in chronic prostatitis with pelvic pain.

关 键 词：前列安通片 慢性前列腺炎 临床试验 

分 类 号：R277.5[医药卫生—中医学]