中华泌尿外科杂志
中華泌尿外科雜誌
중화비뇨외과잡지
CHINESE JOURNAL OF UROLOGY
2013年
4期
305-309
,共5页
李宁忱%宋毅%丁强%张炜%蔡松良%陈仕平%黄翼然%叶章群%孔垂泽
李寧忱%宋毅%丁彊%張煒%蔡鬆良%陳仕平%黃翼然%葉章群%孔垂澤
리저침%송의%정강%장위%채송량%진사평%황익연%협장군%공수택
良性前列腺增生%药物治疗%赛洛多辛%临床研究
良性前列腺增生%藥物治療%賽洛多辛%臨床研究
량성전렬선증생%약물치료%새락다신%림상연구
Benign prostatic hyperplasia%Drug therapy%Silodosin%Clinical research
目的 验证超高选择性α1A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8 mg/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,差异有统汁学意义(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(P＜0.05).赛洛多辛组不良事件发生率为35.86％ (123/343),主要为射精障碍、口干、头晕、心动过缓;安慰剂组为23.21％ (39/168),主要为头晕、皮疹、心动过缓、口干.结论 赛洛多辛起效快,能够明显改善BPH患者的自觉症状,提高生活质量,治疗BPH引起的排尿障碍安全有效.
目的 驗證超高選擇性α1A腎上腺能受體阻滯劑賽洛多辛治療BPH引起的LUTS的有效性和安全性.方法 2007年3月至2008年3月選取BPH患者516例,採用隨機、雙盲、安慰劑對照、多中心試驗.符閤入選/排除標準的患者隨機(2∶1)分為賽洛多辛8 mg/d治療組和安慰劑組,治療期為12週.賽洛多辛組344例,安慰劑組172例.因不良事件、失訪、缺乏療效等脫落中止35例,其中包括未服藥者5例;賽洛多辛組脫落中止17例,安慰劑組18例.至少服藥＞1次者511例,進入安全性分析集(賽洛多辛組343例,安慰劑組168例).進入全分析集(FAS)501例(賽洛多辛組338例,安慰劑組163例),進入符閤方案集(PPS) 479例(賽洛多辛組325例,安慰劑組154例).兩組患者基線IPSS評分為(20.87 ±5.03)分和(20.99 ±4.80)分;QOL評分為(4.95±0.67)分和(4.99±0.69)分;Qmax為(10.82±2.73) ml/s和(10.31±2.74) ml/s;Qave為(5.70±2.11) ml/s和(5.48±1.86) ml/s;殘餘尿量為(20.17 ±23.72)ml和(18.45±19.66)ml.以用藥12週後受試者IPSS評分相對治療前基線的變化量為主要療效指標,治療前後QOL評分、Qmax、Qave、殘餘尿量變化量為次要療效指標,評價用藥早期(1、2週後)IPSS評分的變化量.觀察和記錄治療過程中的不良事件,進行安全性評價.結果 賽洛多辛組和安慰劑組12週末IPSS評分和基線相比,分彆下降瞭(7.17±6.44)分和(5.77±5.95)分,差異有統汁學意義(P＜0.05);用藥1週末兩組IPSS評分相對基線分彆下降(2.29±3.53)分和(1.25±2.95)分,差異有統計學意義(P＜0.05),2週末時分彆下降(3.42±4.43)分和(2.01±3.77)分,差異有統計學意義(P＜0.05).兩組用藥後QOL評分分彆下降(1.74±1.37)分和(1.40±1.31)分,差異有統計學意義(P＜0.05).賽洛多辛組不良事件髮生率為35.86％ (123/343),主要為射精障礙、口榦、頭暈、心動過緩;安慰劑組為23.21％ (39/168),主要為頭暈、皮疹、心動過緩、口榦.結論 賽洛多辛起效快,能夠明顯改善BPH患者的自覺癥狀,提高生活質量,治療BPH引起的排尿障礙安全有效.
목적 험증초고선택성α1A신상선능수체조체제새락다신치료BPH인기적LUTS적유효성화안전성.방법 2007년3월지2008년3월선취BPH환자516례,채용수궤、쌍맹、안위제대조、다중심시험.부합입선/배제표준적환자수궤(2∶1)분위새락다신8 mg/d치료조화안위제조,치료기위12주.새락다신조344례,안위제조172례.인불량사건、실방、결핍료효등탈락중지35례,기중포괄미복약자5례;새락다신조탈락중지17례,안위제조18례.지소복약＞1차자511례,진입안전성분석집(새락다신조343례,안위제조168례).진입전분석집(FAS)501례(새락다신조338례,안위제조163례),진입부합방안집(PPS) 479례(새락다신조325례,안위제조154례).량조환자기선IPSS평분위(20.87 ±5.03)분화(20.99 ±4.80)분;QOL평분위(4.95±0.67)분화(4.99±0.69)분;Qmax위(10.82±2.73) ml/s화(10.31±2.74) ml/s;Qave위(5.70±2.11) ml/s화(5.48±1.86) ml/s;잔여뇨량위(20.17 ±23.72)ml화(18.45±19.66)ml.이용약12주후수시자IPSS평분상대치료전기선적변화량위주요료효지표,치료전후QOL평분、Qmax、Qave、잔여뇨량변화량위차요료효지표,평개용약조기(1、2주후)IPSS평분적변화량.관찰화기록치료과정중적불량사건,진행안전성평개.결과 새락다신조화안위제조12주말IPSS평분화기선상비,분별하강료(7.17±6.44)분화(5.77±5.95)분,차이유통즙학의의(P＜0.05);용약1주말량조IPSS평분상대기선분별하강(2.29±3.53)분화(1.25±2.95)분,차이유통계학의의(P＜0.05),2주말시분별하강(3.42±4.43)분화(2.01±3.77)분,차이유통계학의의(P＜0.05).량조용약후QOL평분분별하강(1.74±1.37)분화(1.40±1.31)분,차이유통계학의의(P＜0.05).새락다신조불량사건발생솔위35.86％ (123/343),주요위사정장애、구간、두훈、심동과완;안위제조위23.21％ (39/168),주요위두훈、피진、심동과완、구간.결론 새락다신기효쾌,능구명현개선BPH환자적자각증상,제고생활질량,치료BPH인기적배뇨장애안전유효.
Objective To verify the efficacy and safety of the highly selective α1A-adrenoceptor antagonist 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,maximun 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 included 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 placebo group in terms of IPSS changes from baseline at Week 1 (-2.29 ± 3.53 vs-1.25 ± 2.95,P ＜ 0.05)and Week2 (-3.42±4.43 vs-2.01 ±3.77,P＜0.05),respectively.The change of QOL score before and after treatment was-1.74 ± 1.37 for silodosin vs-1.40 ± 1.31 for placebo (P ＜ 0.05).123 adverse events occurred in silodosin group with the occurrence rate of 35.86％,including ejaculation failure,dry mouth,dizziness and bradycardia,and 39 adverse events occurred in placebo group with the occurrence rate of 23.21％,including dizziness,skin rash,bradycardia,and dry mouth.Conclusions Silodosin is a fast acting medication,which can significantly improve self-reported symptoms in patients with benign prostatic hyperplasia and enhance their quality of life.Silodosin is effective and safe in the treatment of voiding disorders caused by benign prostatic hyperplasia.
