赛洛多辛治疗良性前列腺增生的随机双盲安慰剂对照多中心Ⅲ期临床研究  

A randomized, double-blind, placebo-controlled, multi-center, phase Ⅲ clinical trial to investigate silodosin in the treatment of benign prostatic hyperplasia

作　　者：李宁忱[1] 宋毅[2] 丁强[3] 张炜[4] 蔡松良[5] 陈仕平[6] 黄翼然[7] 叶章群[8] 孔垂泽[9] 那彦群[1] 

机构地区：[1]北京大学吴阶平泌尿外科医学中心北京大学首钢医院,100144 [2]北京大学第一医院泌尿外科 [3]复旦大学附属华山医院泌尿外科 [4]南京医科大学第一附属医院泌尿外科 [5]浙江大学医学院附属第一医院泌尿外科 [6]福建医科大学附属协和医院泌尿外科 [7]上海交通大学医学院附属仁济医院泌尿外科 [8]华中科技大学同济医学院附属同济医院泌尿外科 [9]中国医科大学附属第一医院泌尿外科

出　　处：《中华泌尿外科杂志》2013年第4期305-309,共5页Chinese Journal of Urology

摘　　要：目的验证超高选择性α_1A肾上腺能受体阻滞剂赛洛多辛治疗BPH引起的LUTS的有效性和安全性。方法2007年3月至2008年3月选取BPH患者516例，采用随机、双盲、安慰剂对照、多中心试验。符合入选／排除标准的患者随机（2：1）分为赛洛多辛8mg／d治疗组和安慰剂组，治疗期为12周。赛洛多辛组344例，安慰剂组172例。因不良事件、失访、缺乏疗效等脱落中止35例，其中包括未服药者5例；赛洛多辛组脱落中止17例，安慰剂组18例。至少服药〉1次者511例，进入安全性分析集（赛洛多辛组343例，安慰剂组168例）。进入全分析集（FAS）501例（赛洛多辛组338例，安慰剂组163例），进入符合方案集（PPS）479例（赛洛多辛组325例，安慰剂组154例）。两组患者基线IPSS评分为（20．87±5．03）分和（20．99±4．80）分；QOL评分为（4．95±0．67）分和（4．99±0．69）分；Qmax为（10．82±2．73）ml／s和（10．31±2．74）ml／s；Qave为（5．70±2．11）ml／s和（5．48±1．86）ml／s；残余尿量为（20．17±23．72）ml和（18．45±19．66）ml。以用药12周后受试者IPSS评分相对治疗前基线的变化量为主要疗效指标，治疗前后QOL评分、Qmax、Qave、残余尿量变化量为次要疗效指标，评价用药早期（1、2周后）IPSS评分的变化量。观察和记录治疗过程中的不良事件，进行安全性评价。结果赛洛多辛组和安慰剂组12周末IPSS评分和基线相比，分别下降了（7．17±6．44）分和（5．77±5．95）分，差异有统计学意义（P〈0．05）；用药1周末两组IPSS评分相对基线分别下降（2．29±3．53）分和（1．25±2．95）分，差异有统计学意义（P〈0．05），2周末时分别下降（3．42±4．43）分和（2．01±3．77）分，差异有统计学意义（P〈0．05）。两组用药后QOL评分分别下降（1．74±1．37）分和（1．40±1．31）分，差异有统计学意义�Objective To verify the efficacy and safety of the highly selective α_1A-adrenoceptor an-tagonist silodosin in the treatment of lower urinary tract symptoms caused by benign prostatic hyperplasia. Methods A randomized, double-blind, placebo-controlled, multi-center study was performed. Patients with benign prostatic hyperplasia who met the inclusion/exclusion criteria were randomly assigned to silodosin （8 mg/day） group or placebo group （2： 1）. A total of 501 subjects were enrolled and included in the Full Analysis Set （FAS） , 338 in silodosin group and 163 in placebo group. 479 subjects were included in the Per-Protocol （PP） Set, 325 in silodosin group and 154 in placebo group. The treatment duration was 12 weeks. The primary endpoint was IPSS change from baseline at Week 12. The secondary endpoints were QOL score before and after the treatment, maximuM flow rate （ Qmax ） , average urinary flow rate （Qave） , and the change in residual urine volume. At baseline, IPSS were 20.87 ± 5.03 in silodosin group and 20.99 ± 4.80 in placebo group. Meanwhile in both group, QOL score were 4.95 ± 0.67 and 4.99 ± 0.69 ; Qmax were （10.82±2.73） ml/s and （10.31±2.74） ml/s; Qave were （5.70±2. 11） ml/s and （5.48± 1.86） ml/s; residual urine volume were （20.17 ±23.72） ml and （18.45 ± 19.66） ml. The evaluation also in- cluded change of total IPSS in the early stage of drug administration （ i. e. Week 1 or 2）. Adverse events during the course of treatment were closely and recorded for safety evaluation. Results The change of IPSS from baseline at Week 12 was - 7.17 ± 6.44 for silodosin vs - 5.77 ± 5.95 for placebo （ P 〈 0.05 ）. In early stage of drug administration, there were statistically significant differences between silodosin and pla- cebo group in terms of IPSS changes from baseline at Week 1 （ - 2.29 ± 3.53 vs - 1.25 ± 2.95, P 〈 0.05） and Week 2 （ - 3.42 ± 4.43 vs - 2.01 ± 3.77, P 〈 0.05） , respectively. The change of QOL score before and a

关 键 词：良性前列腺增生 药物治疗 赛洛多辛 临床研究 

分 类 号：R6[医药卫生—外科学]