症状性BPH剩余尿及最大尿流率的临床价值再探讨

目的：探讨症状性BPH剩余尿（PVR）、最大尿流率（Qmax）在临床诊疗中的作用。方法：对173例BPH症患者进行IPSS、并测定Qmax、PVR及前列腺体积。应用相关分析评价各检变量间的相关性及其不同组间各指标的比较。结果：PVR与IPSS、前列腺移行带体积均呈正相关,与Qmax呈负相关。与年龄、前列总腺体积（P〉0．05）之间均无相关。PVR〈10ml组与10-30ml组在年龄、IPSS、前列腺移行带体积和Qmax比较差异均无统计学意义。PVR10-30ml组与≥30ml组在年龄、前列腺移行带体积比较差别均无统计学意义,而IPSS、Qmax比较差别有统计学意义。在Qmax〈10mL／s组,Qmax与年龄、IPSS、PVR、前列腺总体积和前列腺移行带体积均呈负相关;在Qmax〉10ml／s组,Qmax与上述指标均呈无相关（P〉0．05）;除年龄外,两组间上述指标均差异有统计学意义（P〈0．01）。结论：症状性BPH患者PVR≥30ml,Qmax〈10ml／s时,在排除其他因素引起逼尿肌损害所致的PVR增加及Qmax降低后,应及早解除膀胱出口梗阻。     

症状性前列腺增生剩余尿及最大尿流率的临床价值再探讨

目的：探讨症状性前列腺增生剩余尿（PVR）、最大尿流率（Qmax）在临床诊疗中的作用。方法：对173例BPH患者进行IPSS评分、并测定Qmax、PVR及前列腺体积。应用相关分析评价各检变量间的相关性及其不同组问各指标的比较。结果：PVR与IPSS、前列腺移行带体积均呈正相关，与Qmax呈负相关。与年龄、前列总腺体积之问均无相关（P〉O．05）。PVR＜10ml组与10～30ml组在年龄、IPSS、前列腺移行带体积和Qmax比较差异均无统计学意义。PVR 10～30ml组与≥30ml组在年龄、前列腺移行带体积比较差异均无统计学意义,而IPSS、Qmax比较差异有统计学意义。在Qmax〈10ml／s组，Qmax与年龄、IPSS、PVR、前列腺总体积和前列腺移行带体积均呈负相关；在Qmax〉10ml／s组，Qmax与上述指标均呈无相关（P〉0.05）；除年龄外，两组问上述指标均有显著的统计学意义（P＜0．001）。结论：症状性BPH患者PVR≥30ml，Qmax〈10ml／s时，在排除其他因素引起逼尿肌损害所致的PVR增加及Qmax降低后,应及早解除畴胱出口梗阻。     

爱普列特治疗Ⅱ型糖尿病患者BPH的临床疗效观察

目的：观察爱普列特治疗Ⅱ型糖尿病患者BPH的临床疗效与安全性.方法：选择合并BPH的Ⅱ型糖尿病患者60例,口服爱普列特片5 mg,每天2次,疗程4个月;同时按中国糖尿病防治指南进行规则的降糖治疗.采用国际前列腺症状评分（IPSS）、生活质量评分（QOL）、剩余尿量（Ru）、最大尿流率（Qmax）、前列腺体积（PV）和前列腺特异抗原（PSA）等指标评价其临床疗效.结果：与治疗前比较,治疗4个月后入选患者的IPSS、QOL、Ru、Qmax、PV和PSA均得到显著改善（P＜0.05）,总有效率为86.7%.治疗过程中,患者的血糖水平控制良好,未观察到明显的不良反应.结论：爱普列特治疗Ⅱ型糖尿病患者BPH具有较好的疗效与安全性.     

盐酸坦索罗辛治疗良性前列腺增生的疗效观察

目的：观察盐酸坦索罗辛治疗我国良性前列腺增生（BPH）患者的临床有效性和安全性。方法：对31例BPH患者,按国际前列腺症状评分（IPSS）分成中度组和重度组,给予盐酸坦索罗辛0．2mg口服,每晚一次,连续服用3个月。记录各组患者治疗前后国际前列腺症状评分（IPSS）、生活质量指数评分（QOL）、最大尿流率（Qmax）、前列腺体积（V）、剩余尿量（Ru）的变化。观察治疗过程中血压的改变及不良反应的发生率。结果：服药1个月后,两组患者IPSS、QOL、Qmax、Ru均改善明显（P〈0．001）。服药3个月后两组患者的IPSS、QOL、Qmax、Ru与服药前比较有显著性差异（P〈0．001）,与服药1个月比较无显著性差异（P〉0．05）。两组间各指标改变无明显差异（P〉0．05）。治疗前后。两组患者前列腺体积、血压无明显变化（P〉0．05）。无明显不良反应发生。结论：盐酸坦索罗辛是治疗我国BPH患者安全有效的药物,且无明显副反应发生。     

多沙唑嗪和非那雄胺联合治疗前列腺总体积≥25ml且伴有LUTS的BPH患者更具优势

为探讨伴有下尿路症状(LUTS)的良性前列腺增生症(BPH)患者中初始前列腺总体积(TPV)与药物疗效的关系。Kaplan SA等分析了药物治疗前列腺症状(MTOPS)研究得到的数据。入选的3047位伴有LUTS的BPH患者随机分为4组,分别为安慰剂组,4mg到8mg多沙唑嗪组,5mg非那雄胺组,多沙唑嗪及非那雄胺联合治疗组。平均治疗时间为4．5年。一级终点为BPH总体临床进展,定义为出现AUA症状评分(AUA SS)增加≥4分、急性尿潴留、尿失禁、肾功能不全或反复尿路感染。二级终点是需手术介入治疗BPH,AUA症状评分及最大尿流率随时间而变化。在研究开始及结束时用经直肠B超测量TPV。结果显示,对于前列腺体积较小患者(TPV＜25ml),在减少BPH临床进展的风险和需手术介入的机率以及改善AUA症状评分和最大尿流率方面,联合治疗组与多沙唑嗪单独治疗组无差异。但是,当患者前列腺体积为中度(25ml～40ml)或更大(≥40ml)时,在上述观察指标上,联合治疗带来的临床受益要高于单用多沙唑嗪或非那雄胺。因此得出结论,在伴有LUTS且TPV≥25ml的BPH患者中,多沙唑嗪和非那雄胺联合治疗较之各自单独使用更能延缓BPH临床进展。     

前列腺移行区体积和移行区指数在诊断良性前列腺增生中的作用

目的 :评价前列腺移行区体积 (TZV)和移行区指数 (TZI)在诊断良性前列腺增生 (BPH)中的作用。方法 :采用经直肠超声测量 2 62例患者的前列腺体积 (TPV)和TZV ,其中A组 2 2 0例为有症状 ,未出现过尿潴留的BPH患者 ,B组 19例为反复出现尿潴留的BPH患者 ,对照组 2 3例为非BPH患者 ,并推算TZI(TZI =TZV/TPV)。以上患者同时接受了国际前列腺症状评分 (IPSS)、生活质量评分 (QOL)、最大尿流率 (Qmax)检查。所得数据进行统计学处理。结果 :A组、B组和对照组之间的TPV、TZV、TZI、IPSS、QOL、Qmax比较差异均有显著性意义 ,年龄与TPV和TZV有非常显著相关性 (分别r =0 .2 4,P <0 .0 1;r =0 .2 5 ,P <0 .0 1) ,与Qmax有非常显著负相关性 (r =- 0 .2 7,P <0 .0 1) ,与IPSS有显著相关性 (r =0 .15 ,P <0 .0 5 ) ,与QOL无相关性 (r =0 .11,P >0 .0 5 )。TPV与IPSS、QOL、Qmax有显著相关性 (r =0 .2 6,r =0 .2 0 ,r =- 0 .2 9,P均 <0 .0 5 ) ,而TZV和TZI与IPSS ,QOL ,Qmax均有非常显著相关性 (分别r =0 .40 ,r =0 .3 2 ,r =- 0 .43 ,P均 <0 .0 1;r =0 .5 1,r =0 .41,r =- 0 .5 2 ,均P <0 .0 1)。结论 :BPH患者随着年龄的增加 ,TPV、TZV、IPSS、QOL增加 ,Qmax减小。发生尿潴留的BPH患者 ,其TPV、TZV和TZI大于没有出现过     

前列腺增生症相关下尿路症状与各临床影响因素关系的研究

目的 探讨不同的临床因素与前列腺增生症(BPH)相关下尿路症状(LUTS)之间的关系,了解影响BPH有关LUTS的危险因素.方法 对2003年7月至2009年10月收治的548例前列腺增生症患者的资料进行回顾性研究.分析不同年龄、病史、最大尿流率(Qmx)、前列腺总体积、移行区体积、移行区指数、总PSA、游总比(f/tPSA)、组织炎症对IPSS值的影响,并进行多元线性回归分析.结果 年龄、移行带体积、Qmax、PSA及前列腺组织炎症对IPSS评分影响显著.随着年龄增大和移行带体积的增加,IPSS值变大;随着最大尿流率的减少,IPSS值显著增加(P＜0.05).当PSA ≥4 ng/mL时,IPSS值要显著大于＜4 ng/mL组(P＜0.05),但是介于4～10 ng/mL组和≥10 ng/mL组的IPSS评分并无差异(P＞0.05).合并前列腺组织炎症患者的IPSS值要显著高于非炎症组(P＜0.05).进一步通过多元线性回归分析,发现所有可能影响IPSS评分的因素中,Qmax和前列腺组织炎症与IPSS评分密切相关(β=-0.807,5.736;P＜0.001).结论 前列腺组织炎症和Qmax对下尿路症状的影响最显著.其他的临床因素如患者年龄、移行带体积和PSA值对BPH患者的下尿路症状影响有限,经过多因素回归分析发现并无显著性.     

盐酸坦索罗辛治疗BPH24例临床疗效观察

目的：观察盐酸坦索罗辛治疗BPH的临床疗效。方法：对22例患者均予盐酸坦索罗辛0．2mg，口服，QN，连服6周。观察治疗前、后的国际前列腺症状评分（IPSS）、生活质量评分（QOL）、膀胱剩余尿（RV）及最大尿流率（Qmax）等指标。结果：与治疗前相比，患者的IPSS评分明显下降（12．4±3．5VS22．4±6．8），QOL、Qmax、RV等亦得以明显改善。结论：对于前列腺体积中、轻度增大者，单用哈乐即可达到理想疗效，从而降低患者经济负担，提高长期用药的依从性。     

萘哌地尔联合舍尼亭治疗女性膀胱过度活动症的疗效观察

目的探讨萘哌地尔联合舍尼亭治疗女性膀胱过度活动症的疗效。方法对31例诊断为女性膀胱过度活动症的患者行萘哌地尔加舍尼亭治疗。以自由尿流率的主要参数如最大尿流率（Qmax）、平均尿流率（Qave）、排尿量（VV）和尿道综合征症状评分（FUSS）、生活质量评分（QOL）为主要疗效指标，来观察治疗效果。砖栗治疗前后的尿流率参数值（Qmax、Qave、VV）、FUSS、QOL相比较，差异显著（P〈0．05），总有效率为83．88％。砖论萘哌地尔加舍尼亭联合应用可作为女性膀胱过度活动症的一种有效治疗手段。     

经尿道前列腺电切加膀胱颈内切开治疗小体积前列腺增生

目的：探讨小体积BPH的治疗方法。方法：回顾分析56例小体积BPH患者经尿道前列腺电切（TURP）加膀胱颈内切开的临床资料。结果：最大尿流率（Qmax）治疗前（9．54±1．74）ml／s上升至治疗后的（16．23±4．52）ml／s;国际前列腺症状评分（IPSS）由治疗前（21．58±3．12）分下降至治疗后（10．87±3．42）分。Qmax、IPSS治疗前后比较差异均有统计学意义（均P〈0．01）。结论：TURP加膀胱颈内切开治疗小体积BPH,疗效确切,值得临床推广。     

The effectiveness of naftopidil in patients with benign prostatic hyperplasia evaluated by QOL index

We examined the effectiveness of naftopidil in 81 patients with lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). We examined quality of life (QOL) and determined which symptoms improved as a result of naftopidil administration. The findings indicated that storage symptoms, voiding symptoms, total International Prostate Sympotom Score (IPSS), QOL index, Qmax and residual urine volume were significantly improved after treatment when compared to baseline. Improvement of nocturia and incomplete emptying by naftopidil contributed to improvement in QOL, odds ratio between the good response group and poor response group were 3.6 and 2.3, respectively. During naftopidil treatment, two of the 81 patients complained of adverse events. The results show that naftpidil is effective for LUTS caused by BPH, and that improvement of nocturia and incomplete emptying contributed to the improvement in QOL.     

Efficacy and safety of tamsulosin hydrochloride compared to doxazosin in the treatment of Indonesian patients with lower urinary tract symptoms due to benign prostatic hyperplasia

AIM: The objective of the study was to compare the efficacy and safety of tamsulosin hydrochloride and doxazosin in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). METHODS: The safety and efficacy of tamsulosin (0.2 mg) and doxazosin (2 mg) was determined after once daily administration for 6 weeks in an open-label, randomized, multicenter study of 101 men with BPH. The International Prostatic Symptom Score (IPSS), maximal urinary flow rates (Qmax), average urinary flow rates (Qave) and residual urine were determined at baseline and again at 6 weeks as efficacy parameters. The primary parameters used for safety evaluation were vital signs (blood pressure and heart rate) and adverse events. The number of patients with a clinically significant response to treatment with tamsulosin or doxazosin was determined and defined as those with >20% improvement from the baseline Qmax or >20% decrease in total IPSS. RESULTS: The total IPSS decreased significantly in both the tamsulosin and doxazosin groups compared to baseline. There was a significant difference in the decrease in total IPSS between two groups. Qmax, Qave and residual urine significantly improved only in the tamsulosin group. There were no significant differences in systolic blood pressure, diastolic blood pressure or heart rate profile in the tamsulosin group; however, doxazosin resulted in a significant difference in systolic and diastolic blood pressure. Tamsulosin was well tolerated; only three patients (6%) in the tamsulosin group reported an adverse event (dizziness) while 11 patients (22%) in the doxazosin group reported an adverse event (dizziness), one of whom withdrew from the study. CONCLUSIONS: Tamsulosin was shown to be more effective than doxazosin in the treatment of LUTS due to BPH.     

M受体阻滞剂与α受体阻滞剂联合治疗良性前列腺增生的有效性及安全性研究

目的 评价M受体阻滞剂托特罗定与α受体阻滞剂多沙唑嗪联合治疗良性前列腺增生(BPH)患者的有效性及安全性.方法 2009年5月至2010年4月,选择刺激症状明显的BPH患者76例,主要的排除标准为最大尿流率(Qmax)＜10 ml/s、残余尿＞100 ml、前列腺体积＞50 ml.将患者随机分成2组:多沙唑嗪组(给予多沙唑嗪治疗,36例),联合用药组(给予托特罗定与多沙唑嗪联合治疗,40例).用药时间8周,评估内容包括国际前列腺症状评分(IPSS)、尿流率和残余尿量等,并登记不良事件.结果 两组间基线资料比较差异无统计学意义.用药8周后联合用药组IPSS评分由18.7±2.2降低到12.7±3.9(P=0.000),刺激症状评分由14.2±2.3降至9.1±3.1(P=0.000).多沙唑嗪组IPSS评分由18.6±3.0降低到15.2±3.8(P=0.033),刺激症状评分由12.7±3.0降至11.8±2.7(P=0.001).治疗后两组间比较显示:联合用药组IPSS评分的改善优于多沙唑嗪组(P＜0.01),联合用药组刺激评分的改善优于多沙唑嗪组(P＜0.01),而梗阻症状评分的改善两组间差异无统计学意义(P=0.168).治疗8周后两组间Qmax、残余尿差异无统计学意义(P＞0.05).联合用药组无急性尿潴留和其他严重并发症发生.结论 托特罗定与多沙唑嗪联合应用降低BPH患者IPSS评分,使其刺激症状获得明显的改善;未见严重不良反应和急性尿潴留出现.     

Clinical effects of naftopidil on nocturia associated with benign prostatic hyperplasia

We studied the efficacy of naftopidil (50 mg/day) on nocturia associated with benign prostatic hyperplasia in 35 patients (62-80 years old). The patients had BPH > 20 ml, nocturia, more than 3 times, international prostate symptom score (IPSS) > 7, quality of life score (QOL) < 1, and maximum flow rate (Qmax) < 15 ml/sec. They received naftopidil for more than 6 weeks. IPSS, QOL, Qmax, micturition volume, and side effects were analyzed. Naftopidil was effective for nocturia associated with benign prostatic hyperplasia, especially when taken at night.     

Baseline factors as predictors of clinical progression of benign prostatic hyperplasia in men treated with placebo

PURPOSE: We analyzed data from the placebo arm of the MTOPS trial to determine clinical predictors of BPH progression. MATERIALS AND METHODS: A total of 3,047 patients with LUTS were randomized to either placebo, doxazosin (4 to 8 mg), finasteride (5 mg), or a combination of doxazosin and finasteride. Average length of followup was 4.5 years. The primary outcome was time to overall clinical progression of BPH, defined as either a confirmed 4-point or greater increase in AUA SS, acute urinary retention, incontinence, renal insufficiency, or recurrent urinary tract infection. We analyzed BPH progression event data from the 737 men who were randomized to placebo. RESULTS: The rate of overall clinical progression of BPH events in the placebo group was 4.5 per 100 person-years, for a cumulative incidence (among men who had at least 4 years of followup data) of 17%. The risk of BPH progression was significantly greater in patients on placebo with a baseline TPV of 31 ml or greater vs less than 31 ml (p <0.0001), a baseline PSA of 1.6 ng/dl or greater vs PSA less than 1.6 ng/dl (p = 0.0009), a baseline Qmax of less than 10.6 ml per second vs 10.6 ml per second or greater (p = 0.011), a baseline PVR of 39 ml or greater vs less than 39 ml (p = 0.0008) and baseline age 62 years or older vs younger than 62 years (p = 0.0002). CONCLUSIONS: Among men in the placebo arm, baseline TPV, PSA, Qmax, PVR and age were important predictors of the risk of clinical progression of BPH.     

良性前列腺增生症临床症状参数与组织学成分间的相关关系

目的：探讨良性前列腺增生（BPH）临床症状参数与组织学成分间的相关关系。方法：对86例BPH患者的年龄、前列腺体积、国际前列腺症状评分（IPSS）和最大尿流率（Qmax）进行回顾性分析,应用HE染色结合计算机图像分析对前列腺组织构成成分进行形态学定量分析,并与临床参数间进行相关分析。结果：BPH患者年龄与前列腺体积和IPSS呈密切正相关,与Qmax和组织学成分间无显著相关。前列腺体积与IPSS和Qmax间也无相关,但与间质面积和腺腔面积之间密切相关。间质面积和间质／上皮比例分别与IPSS和Qmax之间密切相关。前列腺体积＞30ml者间质面积显著低于前列腺体积≤30ml者,但腺腔面积前者显著高于后者。结论：BPH患者的临床症床参数及组织构成成分之间存在相关性,可为临床药物治疗选择提供依据。     

Terazosin and doxazosin in the treatment of BPH: results of a randomized study with crossover in non-responders

OBJECTIVE: To compare the effects of the doxazosin and terazosin on total International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) in treating patients with lower urinary tract symptoms (LUTS) and compare this effectivity by switching the drugs in the patients who did not benefit from either the first or the second drug. METHODS: This is a prospective randomized study of the patients with LUTS suggestive of benign prostatic hyperplasia (BPH). Fifty male patients (mean age 59.4 +/- 7.6 years) received either doxazosin (n = 25) or terazosin (n = 25) once daily every night. The patients were evaluated in the 1st, 2nd and 3rd months of treatment. Minimum 20% improvement in IPSS and Qmax in the 3rd month was considered as improvement. The patients with no improvement in any of the parameters switched the drugs, and they were followed up in the next 3 months. The patients whose only one parameter improved were excluded from the study. RESULTS: Eleven (44%) out of 25 patients using doxazosin and 10 (40%) out of 25 patients using terazosin showed improvement in both IPSS and Qmax at the end of the 3rd month and continued using the drug. After 3 months of treatment, increase in Qmax (p < 0.001) and decrease in IPSS (p < 0.01) was significant for both doxazosin and terazosin. Nineteen patients, who did not show improvement in any of the parameters, switched the drug. Of the patients who switched the drug, 2 (4%) showed improvement both in IPSS and in Qmax, while 2 (4%) showed improvement only in IPSS but not in Qmax. The remaining 15 (30%) patients did not show improvement in any of the parameters. CONCLUSION: The results of the study suggest that alpha-blockade with either doxazosin or terazosin is effective in males with LUTS. The two alpha-blocking drugs showed equal effectiveness in the treatment of LUTS. If one of the drugs is ineffective in the treatment of LUTS, then the other drug will probably be ineffective.     

The clinical efficacy and tolerability of doxazosin standard and gastrointestinal therapeutic system for benign prostatic hyperplasia

The therapeutic goal of treating benign prostatic hyperplasia (BPH) through early detection and effective therapy is to relieve the symptoms, improve patients' quality of life, decrease postvoid residual urine volume, and prevent the associated morbidity when the condition remains untreated. Alpha1-adrenoreceptor antagonists, e.g. doxazosin, terazosin, tamsulosin and alfuzosin, relax the bladder outlet to improve urinary flow, by reducing prostatic smooth muscle tone through the blockade of sympathetic adrenergic receptors. Doxazosin gastrointestinal therapeutic system (GITS) is a controlled-release formulation developed to enhance the pharmacokinetic profile of the drug while simultaneously minimizing possible adverse effects and reducing the need for dose titration. While both doxazosin standard and GITS are indicated for hypertension, they are also useful in the pharmacologically or naturally normotensive patient with BPH. In a cross-over trial comparing doxazosin GITS and tamsulosin, doxazosin gave a significantly greater improvement from baseline in symptoms. Results from recent trials (e.g. Medical Therapy of Prostatic Symptoms, MTOPS) showed that doxazosin was significantly more effective than the 5alpha-reductase inhibitor finasteride in relieving lower urinary tract symptoms, irrespective of prostate volume. The MTOPS trial showed clearly that over the long term, the combination of doxazosin and finasteride was more effective than either agent alone in significantly improving symptoms and reducing the clinical progression of BPH. Both doxazosin standard and GITS are well-tolerated, long-term therapies that are equally effective in younger and older men, and not associated with causing sexual dysfunction.     

Additional effect of propiverine for naftopidil-resistant nocturia in the patient with benign prostate hypertrophy

The efficacy and safety of additional administration of propiverine were prospectively studied for naftopidil-resistant nocturia in patients with benign prostatic hypertrophy (BPH). Patients of 50 years and over with BPH who experienced nocturia twice a night or more and an overall International Prostate Symptom Score (IPSS) of 8 or more were first administered naftopidil (50 or 75 mg/day) for 4 weeks. Thirty subjects who did not show improvement in nocturia and requested further treatment were enrolled in the present study. Propiverine was then administered concomitantly 10 mg/day for 8 weeks. Significant improvement was observed with additional propiverine in the frequency of nocturia on voiding diary, total IPSS, voiding symptom, storage symptom and nocturnal voiding scores. No significant change was observed in the peak urinary flow rate (Qmax), mean urinary flow rate (Qave), voided urine volume, or residual urine volume. Adverse events were dysuria (2 cases), increased residual urine (6 cases), weak urine flow (1 case), thirsty (2 cases), angular cheilitis (1 case). Administration of propiverine was suspended in 7 subjects, 1 following dysuria and 6 following increased residual urine volume. The suspension of propiverine following increased residual urine volume was significantly more prevalent in subjects with pretreatment Qmax values of less than 10 ml/second or in subjects whose prostate specific antigen (PSA) levels were 2 ng/ml or more. In conclusion, the results indicate that additional administration of propiverine may be useful for the patients with BPH who have naftopidil-resistant nocturia. However, caution must be exercised regarding Qmax and PSA levels.     

A combined analysis of double-blind trials of the efficacy and tolerability of doxazosin-gastrointestinal therapeutic system, doxazosin standard and placebo in patients with benign prostatic hyperplasia

OBJECTIVE: To report an integrated analysis of two previous studies fully characterizing the clinical utility of the controlled-release gastrointestinal therapeutic system (GITS) formulation of doxazosin in the treatment of benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Two pivotal randomized, double-blind studies of doxazosin GITS for BPH were assessed by an integrated analysis. Both studies included a 2-week washout period, a 2-week single-blind placebo run-in phase, and a 13-week double-blind treatment phase. One study compared doxazosin GITS, doxazosin standard (-S) and placebo in 795 men; the other compared doxazosin GITS and doxazosin-S in 680 men. Doxazosin GITS was initiated at 4 mg once daily and titrated to 8 mg once daily after 7 weeks, and doxazosin-S was initiated at 1 mg once daily and titrated to a maximum of 8 mg once daily over 7 weeks as needed to achieve optimal symptom control. The primary outcome measures were mean changes from baseline to the final visit for the International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) in the per-protocol population. Numerous symptom- and urinary-related secondary outcomes were assessed, as were effects of therapy on male erectile dysfunction measured using the International Index of Erectile Function (IIEF) in one study. RESULTS: Both doxazosin GITS and doxazosin-S significantly improved the symptoms of BPH, as shown by a 45% reduction for each in total IPSS from baseline to final visit, compared with a 34% reduction in patients on placebo. Doxazosin GITS and doxazosin-S produced comparable improvements in Qmax that were significantly greater than with placebo, with a greater improvement sooner after treatment with doxazosin GITS than with doxazosin-S. Nearly half of the patients on doxazosin GITS had symptom relief at the 4-mg starting dose. A similar number of patients in both doxazosin groups were titrated to the maximum dose. Secondary outcomes were consistent with the primary effects. Both doxazosin GITS and doxazosin-S produced significant improvements in sexual function according to IIEF scores among those with dysfunction at baseline. The overall incidence of adverse events was similar among patients treated with doxazosin GITS and placebo, and slightly lower than those on doxazosin-S. There was no apparent difference in the type of adverse events reported for the two formulations of doxazosin, although most adverse events were reported at a lower frequency with doxazosin GITS. CONCLUSION: Doxazosin GITS is significantly more effective than placebo in reducing the clinical symptoms of BPH and improving Qmax, and as effective as doxazosin-S. Both doxazosin formulations improved sexual function in patients with BPH and sexual dysfunction at baseline. Doxazosin GITS produced a therapeutic effect equivalent to that of doxazosin-S, but with fewer titration steps and a slightly lower overall incidence of adverse events.