联合应用坦索罗辛和托特罗定治疗男性顽固性下尿路症状的临床研究

目的:探讨及对比联合应用高选择性α受体阻滞剂(坦索罗辛)和M受体阻滞剂(托特罗定)及单用高选择性α受体阻滞剂治疗男性顽固性下尿路症状的临床疗效及安全性。方法:2009年4月至2009年12月期间收集我院184例顽固性下尿路症状(LUTS)的男性前列腺增生患者,病程4周至2年。所有患者均为应用高选择性α受体阻滞剂(坦索罗辛)0.2 mg,1次/d,治疗1周后LUTS症状无改善。入选病例随机分成2组,其中坦索罗辛组89例继续应用坦索罗辛0.2 mg,1次/d,治疗4周;联合治疗组95例联合应用高选择性α受体阻滞剂(坦索罗辛)和M受体阻滞剂(托特罗定),给予坦索罗辛0.2 mg 1次/d+托特罗定2 mg 2次/d,治疗4周。分组治疗前后分别进行国际前列腺症状储尿期症状评分(储尿期IPSS)、生活质量评分(QOL)和最大尿流率(Qmax)检测,评估治疗后LUTS症状的改善情况。结果:坦索罗辛组储尿期IPSS、QOL总体评分分别由治疗前的(13.23±4.39)、(4.23±1.27)分下降到治疗后的(12.21±4.07)、(3.53±0.9)分,Qmax由治疗前的(12.31±8.39)ml/s上升到治疗后的(14.12±8.62)ml/s,与治疗前相比差异均无显著性(P>0.05)。联合治疗组储尿期IPSS、QOL总体评分分别由治疗前的(14.45±5.31)、(4.45±0.79)分降到治疗后的(6.56±2.03)、(2.34±0.73)分,Qmax由治疗前的(11.41±9.21)ml/s上升到治疗后的(15.52±8.35)ml/s,与联合治疗前相比差异均有显著性(P<0.01)。184例患者均无严重并发症出现。结论:联合应用坦索罗辛和托特罗定能明显缓解男性顽固性下尿路症状,改善患者的生活质量。未见严重不良反应和急性尿潴留发生。     

坦索罗辛联合索利那新在治疗轻中度良性前列腺增生合并膀胱过度活动症中的疗效分析

目的:探讨坦索罗辛联合索利那新在治疗轻中度BPH合并膀胱过度活动症(OAB)中的有效性及安全性。方法:选取在我院诊治的轻中度良性BPH合并OAB患者166例,分为轻度梗阻症状组(88例)(联合用药组48例及坦索罗辛组40例)和中度梗阻症状组(78例)(联合用药组36例及坦索罗辛组42例)。坦索罗辛组均服用坦索罗辛0.2mg,每日1次。联合用药组均口服坦索罗辛0.2mg,每日1次,索利那新5mg,每日1次,共12周。比较两组治疗前后国际前列腺症状评分(IPSS)、排尿期症状评分、储尿期症状评分、最大尿流率(Qmax)、残余尿量、膀胱过度活动症症状评分(OABSS)、尿常规检查、不良事件等。结果:在轻度梗阻症状组中,联合用药组治疗后在IPSS、储尿期症状评分、Qmax、OABSS明显优于治疗前(P0.05),而残余尿无明显变化(P0.05),坦索罗辛组治疗后仅IPSS较治疗前有所改善,而其他方面无明显变化(P0.05);而治疗后联合用药组IPSS[(9.7±3.0)分vs(15.8±3.3)分]、储尿期症状评分[(8.1±1.7)分vs(12.3±3.1)分]、Qmax[(18.6±4.1)ml/s vs(14.2±2.3)ml/s]、OABSS[(5.3±1.3)分vs(9.7±2.7)分]等方面明显优于坦索罗辛组(P均0.05),而残余尿、尿常规检查及不良事件无明显差异(P0.05);在中度梗阻症状组,联合用药组治疗后IPSS、排尿期症状评分、Qmax、OABSS明显优于治疗前,而残余尿无明显差异;坦索罗辛组治疗后IPSS、排尿期症状评分、Qmax、OABSS及残余尿较治疗前改善明显;联合用药组的OABSS优于坦索罗辛组[(4.8±1.5)分vs(6.5±2.5)分,P0.05],而在IPSS、Qmax、排尿期症状评分、尿常规检查及不良事件等方面与坦索罗辛组无明显差异(P均0.05)。结论:坦索罗辛联合索利那新在治疗BPH轻中度梗阻症状合并OAB均有明显疗效,其疗效优于单用坦索罗辛,而不良反应无明显增加。     

不同α受体阻滞剂联合M受体阻滞剂治疗伴有下尿路症状的前列腺增生的疗效比较

目的比较不同α受体阻滞剂与M受体阻滞剂联合用药治疗合并下尿路症状(LUTs)的前列腺增生(BPH)的临床疗效。方法选取确诊为BPH的门诊患者220例,随机分为两组,其中一组给予坦索罗辛和酒石酸托特罗定缓释剂联合治疗(坦索罗辛组),另一组给予多沙唑嗪和酒石酸托特罗定缓释剂联合治疗(多沙唑嗪组),分别在用药0、6、12周时进行国际前列腺症状(IPSS)、生活质量指数(QOL)、最大尿流率(Qmax)的测定。结果 192例完成了实验。两组0周时各项指标比较均未见统计学差异。服药6周IPSS、Qmax两组之间差异无统计学意义(P0.05),服药6周QOL、服药12周IPSS、Qmax、QOL两组相比,多沙唑嗪组优于坦索罗辛组(P0.05)。两组患者在用药期间均无尿潴留、头痛、便秘、皮肤过敏等不良反应发生,3人出现轻微血压下降,可耐受并坚持服药。结论α受体阻滞剂与M受体阻滞剂联合用药能够有效缓解前列腺增生患者的下尿路症状,改善最大尿流率。服药12周多沙唑嗪与酒石酸托特罗定缓释胶囊联合组优于坦索罗辛与酒石酸托特罗定缓释胶囊联合组,联合用药时患者无明显不良反应发生。     

西地那非联合坦索罗辛治疗LUTS/BPH的对比研究

目的 观察西地那非联合坦索罗辛及单独应用坦索罗辛治疗良性前列腺增生症(BPH)所致下尿路症状(LUTS)的临床疗效.方法 国际前列腺症状评分(IPSS)≥12分的本院2010年7月～2011年6月BPH患者50例,随机分为两组,每组25例.治疗组口服西地那非25mg,每日一次+坦索罗辛0.2mg,每日两次;对照组服用坦索罗辛0.2mg,每日两次,疗程8周.治疗后组间比较IPSS、最大尿流率(Qmax)、残余尿量(PVR)、生活质量(QOL)和勃起功能国际问卷(IIEF-5),并进行统计学分析.结果 与对照组比较,治疗组IPSS明显下降,IIEF-5明显改善,QOL明显改善(P＜0.05),两组Qmax和PVR无明显差异(P＞0.05).结论 西地那非联合坦索罗辛治疗前列腺增生症所致下尿路症状优于单独应用坦索罗辛,并可以改善患者的勃起功能.     

托特罗定联合坦索罗辛在改善输尿管支架管相关症状中的作用

目的探讨托特罗定联合坦索罗辛在改善输尿管镜术后输尿管支架管相关症状中的作用。 方法2017年11月到2018年4月，收集于本院行输尿管镜碎石取石术的患者，将符合入选标准的患者随机分为三组，组1接受坦索罗辛治疗，每日0.4 mg，于睡前一次口服；组2接受坦索罗辛联合托特罗定治疗，其中坦索罗辛每日0.4 mg，于睡前一次口服，托特罗定每日4 mg，分两次口服；组3为空白组。所有患者在术后第二天进行膀胱过度活动症患者自我评价量表（OABSS）评分及视觉模拟量表（VAS）评分后开始接受药物治疗，于术后4周拔管前再次进行OABSS评分及VAS评分并拔除双J管。 结果共116例患者进入本研究，其中组1共39例，组2共39例，组3共38例。各组间药物治疗前各观察指标差异无统计学意义（P>0.05）。组1和组2于拔管前的OABSS评分和VAS评分较治疗前显著改善，OAB发生率显著减少（P<0.05）；组2的OABSS评分改善程度优于组1（P<0.05），而VAS评分改善程度与组1差异无统计学意义（P>0.05）。研究期间无明显药物不良反应。 结论坦索罗辛联合托特罗定能有效改善支架管相关症状，改善储尿期症状效果优于单用坦索罗辛，且具有良好的安全性，但对腰痛症状改善与单用坦索罗辛相比无明显优势。     

盐酸坦索罗辛在TURP围手术期的应用价值初探

目的 :探讨盐酸坦索罗辛在经尿道前列腺电切 (TURP)围手术期的应用价值。方法 :5 7例接受TURP手术治疗的良性前列腺增生患者分用药组 (2 5例 )与对照组 (32例 )。用药组围手术期服用盐酸坦索罗辛 ,对照组则不用 ;比较两组术后留置尿管时间、一次拔管成功率、最大尿流率、国际前列腺症状评分 (IPSS)、生活质量评分 (QOL)。结果 :用药组一次拔管成功率 92 % ,术后留置尿管天数 3～ 7(4.9± 1.4 )d ,术前IPSS评分 15～ 32(2 4 .1± 4 .9)分 ,术后下降 8～ 2 5 (17.4± 4 .2 )分 ,QOL评分术前 3～ 6 (4.5± 0 .8)分 ,术后下降 0～ 5 (2 .4± 1.2 )分 ,MFR 10～ 2 1(14 .9± 2 .9)ml/s ;对照组一次拔管成功率 75 % ,术后留置尿管天数 1～ 14 (6 .2± 2 .8)d ,术前IPSS评分 16～ 36 (2 4 .6± 5 .0 )分 ,术后下降 8～ 2 1(15 .0± 4 .4 )分 ,术前QOL评分 3～ 6 (4.7± 0 .8)分 ,术后下降 0～ 4 (1.9± 1.1)分 ,MFR 7～ 2 0 (12 .5± 2 .8)ml/s。统计分析显示两组间留置尿管天数、术后IPSS、QOL评分、MFR下降分值差异有显著性意义 (P <0 .0 5 ) ,一次拔管成功率与术后QOL下降分值差异无显著性意义。结论 :TURP围手术期应用坦索罗辛 ,可有效缩短术后留置尿管时间 ,改善术后早期下尿路症状 ,提高患者生活质量     

不同α受体阻滞剂联合M受体阻滞剂治疗BPH下尿路症状的尿流动力学研究

目的:比较多沙唑嗪联合托特罗定与坦索罗辛联合托特罗定治疗良性前列腺增生(BPH)下尿路症状(LUTS)的尿流动力学变化的研究。方法:选取诊断明确的BPH患者50例,采用随机非双盲方法平均分为A、B两组,A组患者服用多沙唑嗪联合酒石酸托特罗定缓释剂、B组患者服用坦索罗辛联合酒石酸托特罗定缓释剂联合治疗12周,于治疗前后对潴尿期与排尿期的相关尿流动力学指标,如最大尿流率(Qmax)、膀胱剩余尿量、最大膀胱容量、排尿开始时膀胱压、膀胱顺应性等进行比较。结果:两组在治疗前的各项指标无统计学意义。服药治疗12周后,两组Qmax、排尿开始时膀胱压、膀胱顺应性均较治疗前有明显改善。而剩余尿量和最大膀胱容量较治疗前无明显变化。治疗后两组间比较,A组Qmax、排尿开始时膀胱压、膀胱顺应性均优于B组(P0.05),而两治疗组之间的剩余尿量及最大膀胱容量差异无统计学意义(P0.05)。结论:α受体阻滞剂联合M受体阻滞剂治疗BPH能明显提高Qmax,降低排尿开始时膀胱压力,改善膀胱顺应性,且多沙唑嗪联合应用M受体阻滞剂优于坦索罗辛联合应用M受体阻滞剂。     

坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症的临床观察

目的 探讨坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症的有效性及安全性。 方法 本组良性前列腺增生伴膀胱过度活动症患者82例。年龄50～75岁,平均57岁。入选标准：平均每天排尿次数≥8次,夜间≥2次,每次尿量＜200 ml;膀胱过度活动症症状评分(OABSS)：第3项评分＞2分,总分＞3分。采用随机对照方法,分为对照组（38例）和实验组(44例)。2组临床指标比较差异无统计学意义(P＞0.05)。对照组口服坦索罗辛0.2 mg,每日1次,共12周;实验组口服坦索罗辛0.2 mg,每日1次,索利那新5 mg,每日1次,共12周。比较2组治疗前后国际前列腺症状评分(IPSS)、排尿期症状评分、储尿期症状评分、最大尿流率(Qmax)、残余尿量、OABSS、尿常规检查、不良事件登记等。 结果 ①对照组治疗前后IPSS评分(19.5±2.2 vs 15.6±2.4)、排尿期症状评分(15.6±2.4 vs3.4±1.7)、Qmax(13.7±3.8 vs16.6±4.1),治疗前后比较差异有统计学意义（P值均＜0.05）。②实验组治疗前后IPSS评分(19.7±2.3 vs9.7±3.0)、储尿期症状评分（13.8±1.9 vs5.6±1.6）、OABSS( 10.3±1.8 vs5.3±1.3)、Qmax(14.1±4.1 vs 17.2±3.5),治疗前后比较差异有统计学意义（P值均＜0.05）。③治疗后实验组与对照组IPSS评分(9.7±3.0 vs15.6±2.4)、储尿期症状评分(5.6±1.6 vs 12.0±1.6,)、OABSS(5.3±1.3 vs9.7±2.7)比较差异有统计学意义（P值均＜0.05）。实验组与对照组排尿期症状评分(3.4±1.1 vs3.4±1.7)、Qmax (17.2±3.5 vs 16.6±4.1)、残余尿量(36.7±17.1 vs 35.7±12.5)比较差异无统计学意义(P值均＞0.05)。2组均无急性尿潴留发生,对照组总体不良反应发生率为7.9％( 3/38),实验组总体不良反应发生率为20.5％ (9/44)。 结论 坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症有效、安全,疗效优于单用坦索罗辛。     

西帕依麦孜彼子胶囊联合盐酸坦索罗辛胶囊治疗BPH的临床观察

目的:探讨西帕依麦孜彼子胶囊联合盐酸坦索罗辛胶囊治疗良性前列腺增生(BPH)的有效性及安全性。方法:选取2013年7月至2014年6月在我院诊治为BPH的患者60例,分为对照组和联合用药组各30例。其中对照组年龄(62.03±10.19)岁,病程(3.24±2.18)年;联合用药组年龄(64.77±10.33)岁,病程(4.09±2.63)年,对照组单用盐酸坦索罗辛胶囊0.2 mg,每日1次。联合用药组均口服盐酸坦索罗辛胶囊0.2 mg,每日1次,西帕依麦孜彼子胶囊0.5 g,每日3次,共4周。比较两组治疗前后夜尿次数、最大尿流率(Qmax)、残余尿量、国际前列腺症状(IPSS)评分、生存质量量表(QOL)评分等,并记录不良反应发生。结果:治疗前,对照组夜尿次数(3.60±1.81)次、Qmax(10.40±3.53)ml/min、IPSS(22.47±8.58)分、QOL(4.43±1.50)分,联合用药组夜尿次数(3.43±1.61)次、Qmax(10.14±3.43)ml/min、IPSS(21.93±8.79)分、QOL(4.73±1.31)分。治疗4周后,对照组夜尿次数(2.27±1.60)次、Qmax(14.36±3.03)ml/min、IPSS(17.20±8.43)分、QOL(2.93±1.68)分,联合用药组夜尿次数(1.30±1.18)次、Qmax(13.85±3.15)ml/min、IPSS(13.00±1.53)分、QOL(2.57±1.61)分。两组在治疗后其夜尿次数、Qmax、IPSS、QOL均优于治疗前(P均0.05),而治疗前后联合用药组改善情况:夜尿次数[-(2.13±1.11)]次、IPSS[-(8.93±6.01)]分、QOL[-(2.17±1.12)分]优于对照组:夜尿次数[-(1.73±1.07)]次、IPSS[-(4.80±3.87)分]、QOL[-(1.50±1.01)分](P0.05),而Qmax:对照组(3.95±2.53)ml/min,联合用药组(3.72±2.28)ml/min及残余尿量:对照组[-(26.43±30.49)ml],联合用药组[-(34.30±37.43)ml]改善情况无明显差异(P0.05)。对照组中发生不良反应3例(10.00%),联合用药组发生不良反应5例(16.67%),两组中不良反应发生率比较无统计学差异(P0.05)。结论:西帕依麦孜彼子胶囊联合盐酸坦索罗辛胶囊可改善BPH患者症状,提高生活质量。     

伴有下尿路症状的良性前列腺增生患者勃起功能状况及坦索罗辛的干预研究

目的:研究伴有下尿路症状(LUTS)的良性前列腺增生(BPH)对患者性功能的影响及坦索罗辛干预的效果。方法:192例典型的伴有LUTS的BPH患者治疗前进行国际前列腺症状评分(IPSS)、生活质量评分(QOL)、勃起功能障碍国际问卷5(IIEF-5)调查,同时检测最大尿流率(Qm ax)。然后随机分两组,治疗组(103例)给予坦索罗辛0.2 mg,对照组(89例)应用安慰剂,1次/d,疗程8周。分析治疗前不同因素对性功能的影响和治疗后LUTS及性功能改善情况。结果:192例患者治疗前IPSS评分3~32(20.20±6.81)分,QOL评分0~6(4.51±0.76)分,Qm ax 8~30(9.6±8.79)m l/s,IIEF-5评分1~24(9.80±8.62)分。勃起功能障碍(ED)发生率75%(144/192)。统计学显示:IPSS和IIEF-5有明显的相关性(r=-0.312,P<0.001)。年龄与IPSS和IIEF-5均有明显的相关性(r=0.203,P<0.005和r=-0.571,P<0.001)。对照组治疗后各项指标变化差异无显著性,治疗组治疗后各项指标较治疗前有明显改善(P<0.001),好于对照组(P<0.001)。结论:年龄和LUTS是性功能障碍的危险因素,LUTS的严重程度与性功能障碍的发展密切相关。坦索罗辛在改善LUTS的同时可明显改善患者的性功能状况。     

Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective,randomized, controlled study

PURPOSE: We evaluate the effect of tolterodine combined with tamsulosin on quality of life in patients with bladder outlet obstruction and concomitant detrusor instability. MATERIALS AND METHODS: The study included 50 consecutive patients with urodynamically proven mild or moderate bladder outlet obstruction and concomitant detrusor instability. All patients were initially treated with 0.4 mg. tamsulosin orally once a day. A week later the patients were randomly allocated into group 1-25 who continued treatment with tamsulosin only and, group 2-25 who also received 2 mg. tolterodine orally twice daily. Reevaluation with a quality of life questionnaire and urodynamic study was performed after 3 months. RESULTS: Two patients from group 2 stopped tolterodine while 1 patient from each group stopped tamsulosin because of hypotension. Analysis revealed statistically significant improvement in quality of life scores only in group 2 patients (mean score 525.0 and 628.4 before and after treatment, respectively, 2-sided t test p = 0.0003). A significant difference was noted in both groups after treatment for maximum flow rate and volume at first contraction. Additionally, in group 2, a statistically significant difference was observed for maximum detrusor pressure and maximum unstable contraction pressure after treatment. CONCLUSIONS: Combination treatment with an alpha-blocker (tamsulosin) plus an anticholinergic (tolterodine) improves quality of life in patients with bladder outlet obstruction and concomitant detrusor instability. Interestingly, no acute urinary retention was observed and tolterodine did not affect the quality of urine flow or residual urine volume. The proposed combination appears to be an effective and relatively safe treatment option in patients with bladder outlet obstruction and detrusor instability.     

Extended-release tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder: effects on urinary symptoms assessed by the International Prostate Symptom Score

OBJECTIVE

To evaluate the efficacy of tolterodine extended‐release (ER) plus tamsulosin on lower urinary tract symptoms (LUTS) as assessed by changes in the International Prostate Symptom Score (IPSS) in men who met symptom entry criteria for both overactive bladder (OAB) and benign prostatic hyperplasia (BPH) trials.

PATIENTS AND METHODS

Men aged ≥40 years with an IPSS of ≥12 and diary‐documented OAB symptoms (≥8 voids/24 h and ≥3 urgency episodes/24 h, with or without urgency urinary incontinence) who reported at least moderate problems related to their bladder condition were randomized to receive placebo, tolterodine ER (4 mg), tamsulosin (0.4 mg), or tolterodine ER (4 mg) + tamsulosin (0.4 mg) once daily for 12 weeks. Patients completed the IPSS at baseline and at 1, 6 and 12 weeks.

RESULTS

Patients receiving tolterodine ER + tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS (urinary frequency, urgency, and nocturnal micturitions) by 12 weeks. Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks, whereas frequency scores were significantly improved at 6 weeks. Changes in IPSS storage subscale and individual storage item scores in the tolterodine ER and tamsulosin monotherapy groups were not significantly different from placebo at most time points. IPSS voiding subscale scores and scores for three of four individual voiding items (sensation of incomplete emptying, intermittency, and weak stream) were significantly improved by 12 weeks for patients receiving tamsulosin monotherapy vs placebo. Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week; weak stream scores were significantly improved at 1 and 6 weeks. The IPSS voiding subscale and individual voiding item scores in the tolterodine ER + tamsulosin and tolterodine ER groups were not significantly different from placebo at most time points.

CONCLUSIONS

In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials, tolterodine ER + tamsulosin was significantly more effective than placebo in treating storage LUTS, including OAB symptoms. Tamsulosin monotherapy produced significant improvements in voiding LUTS.     

A comparative study of terazosin and tamsulosin for symptomatic benign prostatic hyperplasia in Japanese patients

OBJECTIVE: To compare the efficacy and safety of an incremental-dose regimen of terazosin (1-2 mg daily) and a fixed-dose regimen of tamsulosin (0.2 mg daily), on Japanese patients with symptomatic benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: This multicentre, single-blind, randomized trial compared terazosin and tamsulosin over 4 weeks, in 61 patients with symptomatic BPH randomly assigned to terazosin (n = 31) or tamsulosin (n = 30). Terazosin 0.5 mg twice daily was administered for 2 weeks, followed by 1 mg twice daily for 2 weeks. Tamsulosin (0.2 mg) was administered once daily for 4 weeks. Symptoms were evaluated using the International Prostate Symptom Score (IPSS), and quality of life (QOL) was assessed subjectively before treatment, and again after 2 and 4 weeks of treatment. Objective measurements taken before and after the treatment period were the maximum (Qmax) and average (Qave) urinary flow rates, and the percentage residual urine volume. Improvement was defined as a 25% decrease from baseline in IPSS, > 1 point increase in QOL score, and > 2.5 mL/s increase in Qmax. Adverse reactions potentially related to the study drugs were recorded throughout the treatment period. RESULTS: Both terazosin and tamsulosin produced statistically significant improvements in subjective and objective variables. Neither treatment affected systolic or diastolic blood pressure or pulse rate. Adverse reactions were noted in four patients (three in the terazosin group and one in the tamsulosin group). However, there was no statistically significant difference in the incidence of adverse effects between the groups. CONCLUSIONS: Despite the limitations of small sample size and relatively short treatment periods, terazosin and tamsulosin were equally effective in the treatment of symptomatic BPH in Japanese patients, using relatively lower doses than those used in Western countries.     

坦索罗辛联合索利那新治疗BPH伴膀胱过度活动症的临床观察

目的:探讨坦索罗辛联合索利那新治疗BPH伴膀胱过度活动症(OAB)患者的临床疗效及安全性。方法:2009年12月～2011年6月期间收集BPH伴有OAB患者262例,随机分成试验组(134例)和对照组(128例)。试验组患者口服坦索罗辛0.2mg,每天一次,同时口服索利那新5mg,每天一次;对照组患者仅口服坦索罗辛,用量用法同实验组。两组患者均药物治疗4周。观察两组患者治疗前后主观指标IPSS评分、OABSS评分及QOL评分和客观指标最大尿流率(Qmax)、24h排尿次数、尿急次数、急迫性尿失禁次数、夜尿次数、每次排尿量的变化,评估治疗后BPH患者OAB症状的改善情况及其安全性。结果:两组患者主观指标和客观指标治疗前后组内对比,差异均有统计学意义(P<0.05)。试验组治疗前后的主观指标和客观指标变化值与对照组相比,除Qmax和每次排尿量外,差异均有统计学意义(P<0.05)。两组患者的Qmax和每次排尿量治疗前后的变化值相比,差异均无统计学意义(P>0.05)。试验组和对照组不良事件总发生率较低,分别为4.58%和2.47%,无严重不良事件发生。结论:坦索罗辛联合索利那新治疗BPH伴有OAB患者的疗效,较单用坦索罗辛的疗效显著,且安全性好。     

Initial combined treatment with anticholinergics and α-blockers for men with lower urinary tract symptoms related to BPH and overactive bladder: a prospective, randomized, multi-center, double-blind, placebo-controlled study

We aimed to evaluate the efficacy and safety of combination treatment using anticholinergics with α-blocker for initial treatment of both overactive bladder (OAB) and other lower urinary tract symptoms (LUTS), secondary to BPH. A 12-week, randomized, double-blind, placebo-controlled trial was conducted at four urology clinics in Korea, involving men, aged 50 years or older, with LUTS related to BPH and OAB. A total of 176 patients were randomly assigned to receive doxazosin (4 mg) plus placebo or doxazosin (4 mg) plus tolterodine SR (4 mg), once a day for 12 weeks. Changes from baseline in total International Prostate Symptom Score (IPSS), bladder diary variables, patient perception of bladder condition (PPBC), uroflowmetry, postvoid residual volume and IPSS subscores (voiding and storage) were analyzed. Of the 176 enrolled patients, 91 had doxazosin gastrointestinal therapeutic system (GITS) and placebo, and 85 had combined medication with doxazosin GITS and tolterodine SR. Compared with the doxazosin plus placebo group, the doxazosin plus tolterodine group showed significant reductions in IPSS storage subscore and improvement in the quality of life item, urgency episodes, as well as in micturition frequency at weeks 4 and 12. However, it failed to improve PPBC at week 4 as well as at week 12. Earlier intervention with anticholinergics plus α-blocker was tolerated well, including the questions about urinary retention (n=1) and dry mouth (n=2). Initial combination treatment of anticholinergics plus α-blocker showed positive results for men with LUTS related to BPH and OAB symptoms and did not increase the risk of urinary retention.     

Short‐term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia

Objectives: To compare the efficacy and safety of silodosin and tamsulosin in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) by a randomized crossover method. Methods: BPH patients with the complaint of LUTS were included in this study, and were randomly divided into two groups: a silodosin‐preceding group (4 weeks of twice‐daily administration of silodosin at 4 mg, followed by 4 weeks of once‐daily administration of tamsulosin at 0.2 mg) or a tamsulosin‐preceding group (4 weeks' administration of tamsulosin, followed by 4 weeks' administration of silodosin). No drug withdrawal period was provided when switching the drug. Results: In the first treatment period, both drugs significantly improved the International Prostate Symptom Score total score, but the improvement by silodosin was significantly superior to that by tamsulosin. After crossover treatment, significant improvement was observed only with silodosin treatment. Moreover, intergroup comparison of changes revealed that silodosin showed significant improvement of straining and nocturia with first and crossover treatments, respectively, compared with tamsulosin. Silodosin also significantly improved quality of life (QOL) score in both treatment periods, while tamsulosin significantly improved QOL score only in the first treatment period. The most frequent adverse drug reaction was ejaculatory disorder with silodosin; however, the incidence of dizziness with silodosin was similar to that with tamsulosin. Conclusions: In BPH/LUTS patients, silodosin exhibits excellent efficacy in improving subjective symptoms in both initial and crossover treatment, and it appears to improve the QOL of patients.