Comparison of prazosin, terazosin and tamsulosin in the treatment of symptomatic benign prostatic hyperplasia: A short-term open, randomized multicenter study

BACKGROUND: The objective of this open randomized clinical study was to compare the short-term efficacy and safety of three alpha-1 blockers, prazosin, terazosin and tamsulosin, in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS: The study comprised 121 patients with symptomatic BPH who were randomized to receive 0.5 mg of prazosin twice daily, 0.5 mg of terazosin twice daily or 0.1 mg of tamsulosin once daily for the initial 2 weeks. The doses were doubled for the next 2 weeks. The primary variables assessed were a symptom score, changes in maximum and average urinary flow rate (Qmax and Qave), postvoid residual urine volume and blood pressure. RESULTS: The percentage changes in the total symptom score from baseline were 38, 39 and 26% at 4 weeks by prazosin, terazosin and tamsulosin, respectively. Terazosin produced significantly higher improvement in four out of nine individual symptoms than tamsulosin (P < 0.05). A significant increase in Qmax or Qave in uroflowmetry was obtained in the prazosin and tamsulosin groups. Blood pressure remained unchanged in normotensive patients, but significantly decreased in hypertensive patients except for the tamsulosin group. Adverse events were minimal in all treatment groups. CONCLUSIONS: The efficacy and safety profiles were different among the alpha-1 blockers at standard doses. Tamsulosin appears to be safer than the others for aged patients or patients with hypertension who have impaired blood pressure regulation, while terazosin is significantly effective in improving symptomatic score when compared with the others examined. It is recommended that the alpha-1 blocking agent and its optimal dose are selected on the basis of the baseline characteristics of the patients with symptomatic BPH.     

坦索罗辛对前列腺增生症患者性功能的影响

目的探索坦索罗辛对前列腺增生症患者性功能的影响。方法60例良性前列腺增生症(BPH)患者,采用IPSS评分表和IIEF-5问卷表,在服用坦索罗辛前和服药后6月各填写一次,应用t检验对治疗前后评分进行统计学分析。并观察其射精功能。结果60例BPH患者治疗前ED发生率为88．3％,其中轻度11例,中度24例,重度18例;治疗后6月ED发生率为83．3％,其中轻度13例,中度26例,重度11例。IIEF-5评分由治疗前(11．1±2．8)增加至(14．6±3．5)(P<0．05)。1例出现逆行射精,2例出现延迟射精。结论坦索罗辛在改善BPH患者下尿路症状的同时,也可改善患者的勃起功能,但对射精功能有一定的影响。     

盐酸坦洛新（坦索罗辛）缓释片治疗良性前列腺增生症的临床疗效观察

目的探讨盐酸坦洛新（坦索罗辛）缓释片对良性前列腺增生症的治疗效果。方法自2006年9月～2007年8月,选择良性前列腺增生症患者83例,给予高选择性a,受体阻断剂盐酸坦洛新（坦索罗辛）缓释片0．2mg,每晚1次,连服4周。记录治疗前后患者的国际前列腺症状评分（IPSS）、最大尿流率（MFR）、平均尿流率（AFR）、残余尿量（Ru）、前列腺体积、血压等变化,并进行比较。结果经过4周服药治疗,患者的IPSS评分及残余尿量明显下降（P〈0．01）,而MFR与AFR均明显增加,差异有统计学意义（P〈0．01）。前列腺体积及血压治疗前后比较差异无统计学意义（P〉0．05）。结论盐酸坦洛新（坦索罗辛）对良性前列腺增生症的症状改善、提高患者的生活质量等方面具有良好的临床实用价值,且副作用较小,值得临床广泛应用。     

Long-term sustained improvement in symptoms of benign prostatic hyperplasia with the dual 5alpha-reductase inhibitor dutasteride: results of 4-year studies

OBJECTIVE: To report additional analyses of efficacy over the initial 2 years and during a 2-year open-label extension of the three pivotal phase 3 studies in which dutasteride, a dual inhibitor of type 1 and 2 5alpha-reductase, was shown to be effective and well tolerated. PATIENTS AND METHODS: All patients in the placebo and active groups were eligible for entry into the 2-year open-label extension, with all receiving dutasteride 0.5 mg daily. Mean changes from baseline were calculated for the American Urologic Association Symptom Index (AUA-SI) score at each scheduled time in the double-blind and open-label phase. The additional analyses included a breakdown of the AUA-SI score, including stratifying patients by symptom severity, assessment by baseline age and prostate volume, and the evaluation of symptoms responders. RESULTS: There was a clinically meaningful improvement in AUA-SI in patients on dutasteride in the double-blind phase, but not in those on placebo. At 48 months, patients on dutasteride in both study phases had greater improvements in AUA-SI score and individual question scores than those on dutasteride in the open-label phase only. The proportion of patients with severe symptoms declined in both study groups, although these changes were more profound in those receiving dutasteride for the 4-year duration of the study. CONCLUSION: In men with symptomatic benign prostatic hyperplasia, long-term (4-year) treatment with the dual isozyme 5alpha-reductase inhibitor dutasteride resulted in sustained and continued improvements in symptoms and flow rate. For 4 vs 2 years, longer dutasteride therapy resulted in greater symptom improvement.     

A randomized,double-blind crossover study of tamsulosin and controlled-release doxazosin in patients with benign prostatic hyperplasia

OBJECTIVE: To compare the effects of the doxazosin gastrointestinal therapeutic system, extended-release (doxazosin-GITS) formulation, and tamsulosin, another alpha1-antagonist, on total International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) in treating patients with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Data were analysed from a prospective, randomized, double-blind, crossover study of men aged 50-80 years with concomitant BPH and hypertension as inclusion criteria. Fifty-two men were treated in four phases: phase I, placebo run-in for 2 weeks; phase II, first study drug doxazosin-GITS or tamsulosin for 8 weeks; phase III, washout with placebo for 2 weeks; and phase IV, second study drug tamsulosin or doxazosin-GITS for 8 weeks. Doxazosin-GITS was started at 4 mg/day and tamsulosin at 0.4 mg/day, and then titrated to 8 mg/day and 0.8 mg/day, respectively, after 4 weeks of therapy if the increase in Qmax was < 3 mL/s or the reduction in total IPSS was < 30%. Efficacy assessments included the IPSS and Qmax. Changes in blood pressure were not analysed, as most patients were actually not hypertensive. Endpoint efficacy data were analysed using an analysis of covariance model, with terms for sequence, phase, patients and sequence within patients, in addition to the baseline as covariate. Forty-seven men were treated in both efficacy arms of the study and were evaluable for analysis. RESULTS: Doxazosin-GITS and tamsulosin significantly relieved lower urinary tract symptoms and significantly increased Qmax from baseline (P = 0.001). Doxazosin-GITS produced significantly greater improvements than tamsulosin in total IPSS (P = 0.019) and obstructive subscores (P = 0.004) at the last treatment visit. The difference between doxazosin-GITS and tamsulosin in improving Qmax approached significance in favour of the former (mean change from baseline 2.6 vs 1.7 mL/s, respectively; between-group difference P = 0.089). Both treatments were well tolerated. CONCLUSIONS: Treatment with doxazosin-GITS was significantly more effective than tamsulosin in relieving lower urinary tract symptoms.     

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。     

网状尿道支架治疗前列腺增生症的远期效果

目的总结应用网状尿道支架治疗前列腺增生症的临床疗效。方法１９９３年８月～１９９６年９月应用网状镍钛记忆合金尿道支架治疗前列腺增生引起的膀胱出口梗阻（ＢＯＯ）患者６１例,分别于术后６,１２,２４个月随访。结果术后２年成功率５０％,ＩＰＳＳ减少１９．３,平均尿流率（ＭＦＲ）增加５．４ｍｌ／ｓ,剩余尿（ＲＵＶ）减少９３．５ｍｌ。结论网状尿道支架治疗适合于部分由前列腺增生引起的ＢＯＯ的高危患者,随访期内未见严重副作用及并发症     

镍钛记忆合金网状支架治疗前列腺增生症远期疗效观察

目的：总结应用镍钛记忆合金网状支架治疗前列腺增生症(BPH)远期疗效。方法：对150例年龄63～88(平均73．5)岁BPH患者应用镍钛记忆合金网状支架治疗，术后6、12、24、36、48个月进行随访。结果：术后6、12、24、36、48个月的总有效率分别为85％、73％、62％、50％、42％。结论：应用镍钛记忆合金网状支架治疗前列腺增生症(BPH)远期疗效不佳，但适合部分高危BPH患者。     

Predictors of outcome in patients with benign prostatic hyperplasia maintained on alpha-blockers

Aim: To determine factors that could predict failure of medical treatment or the need for surgical intervention in patients with benign prostatic hyperplasia (BPH) who were maintained on alpha-blockers. Methods: 124 eligible patients aged 51–82 years (mean 66.8) with lower urinary tract symptoms attributable to BPH treated with alpha-blockers were included in the study. Initial assessments included a complete medical history, physical examination, blood biochemistry, serum prostate-specific antigen and urinalysis. Baseline symptoms were assessed by International Prostate Symptoms Score (IPSS) questionnaire, peak urine flow rate (Qmax) and post-void residual urine volume (PVR). Transrectal ultrasound (TRUS), prostate biopsy, cystoscopy and urodynamic study were carried out when indicated. Mean follow-up was 47.7 months. Baseline parameters were compared between the cohort of patients requiring surgical intervention and the remaining cohort who were still maintained on alpha-blockers. Results: Forty-four patients (35.5%) demanded surgical intervention despite treatment with alpha-blockers. Patients requiring surgical intervention had significantly worse baseline IPSS, quality-of-life score, Qmax and PVR when compared with those not requiring surgery. Risk analysis using binary logistic regression model showed that IPSS (odds ratio: 1.096; P = 0.001) and PVR (odds ratio: 1.006; P = 0.008) were independent predictors for surgical intervention. Receiver–operating characteristics curves further demonstrated that IPSS was slightly better than PVR as a single predictor. Kaplan–Meier cumulative risk analyses showed that patients with baseline IPSS ≥ 14 or PVR ≥ 100 mL were more likely to require subsequent surgical intervention than their counterparts. Conclusions: In patients with BPH who were maintained on alpha-blockers, baseline IPSS and PVR were two useful independent predictors for failure of medical treatment and the need for surgical intervention.     

Laser treatment of symptomatic benign prostatic hyperplasia

The treatment of lower urinary symptoms secondary to benign prostatic hyperplasia (BPH) after failure of medical therapies remains controversial for most urologic surgeons. The complications of traditional surgery are the driving force behind the development of several minimally invasive treatments of symptomatic BPH. Laser prostatectomy is one of the most investigated such modalities. In this article we reviewed the results of the most common types of lasers used in prostatic surgery.     

Long-term follow-up study to evaluate the efficacy and safety of the doxazosin gastrointestinal therapeutic system in patients with benign prostatic hyperplasia with or without concomitant hypertension

OBJECTIVE: To assess the long-term efficacy and safety of extended-release doxazosin gastrointestinal therapeutic system (GITS) under routine clinical care conditions over 12 months in Korean men with benign prostatic hyperplasia (BPH) with and without coexisting hypertension. PATIENTS AND METHODS: In this open-label, multicentre, uncontrolled, flexible-dose study, 475 men (> or =40 years old) with clinical evidence of BPH were enrolled from 40 centres. Patients were evaluated at baseline and at 1, 2, 6 and 12 months of treatment. The primary efficacy variable was the Clinicians Global Assessment of Change (CGAC; improved, no change, or worse). Secondary efficacy variables were International Prostate Symptom Score (IPSS), quality of life (QoL), maximum urinary flow rate (Q(max)), and postvoid residual (PVR) urine volume. Adverse events (AEs) and blood pressure (BP) were also recorded. RESULTS: In all, 186 patients completed the study; based on the CGAC, most patients (155, 83.8%) improved and 31 (16.2%) had no change in symptoms. The mean (sd) change in the IPSS and QoL from baseline were -9.0 (6.8) and -1.6 (1.4), respectively (both P < 0.05). The Q(max) and PVR urine volume were significantly better than at baseline, with means of 10.5 (4.3) vs 13.7 (6.3), and 39.1 (37.0) vs 23.2 (33.7); P < 0.05). The decrease in systolic BP (SBP) and diastolic BP (DBP) from baseline in 52 hypertensive patients was significantly greater than in 134 normotensive patients, at (SBP/DBP) -9.5 (18.4)/-13.4 (10.9) vs -3.3 (12.5)/-1.4 (9.5); P < 0.05). A total of 47 AEs were reported in 41 of 475 patients (8.6%); the most common were dizziness (2.7%), erectile dysfunction (1.1%), dry mouth (1.1%), prostatic disorder (0.6%), and postural hypotension (0.4%). CONCLUSIONS: After 12 months, treatment with doxazosin GITS resulted in an improvement in > 83% of patients based on the CGAC, with significant improvements in IPSS, QoL, Q(max,) and PVR urine volume. Doxazosin GITS was effective and well tolerated as long-term therapy for Korean patients with BPH.     

Non-inferiority of silodosin to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)

Study Type – Therapy (RCT) Level of Evidence 1b What’s known on the subject? and What does the study add? Silodosin administered by 4 mg twice daily is as effective as tamsulosin 0.2 mg daily in treating patients with LUTS associated with BPH. Relative to tamsulosin, silodosin has less cardiovascular side effects as judged by the minimal changes of blood pressure and pulse rats after treatment.

OBJECTIVE

? To test the hypothesis that the efficacy of silodosin would not be inferior to tamsulosin in treating patients with lower urinary tract symptoms associated with benign prostate hyperplasia (BPH).

PATIENTS AND METHODS

? At nine medical centres, 209 patients with an International Prostate Symptom Score (IPSS) of ≥13 were randomized to silodosin (4 mg twice daily) or tamsulosin (0.2 mg once daily) for 12 weeks. ? The primary efficacy measure was the mean change from baseline to endpoint in IPSS. ? The non‐inferiority margin of the IPSS change was set at 1.0. ? Secondary efficacy measures included change in maximal urinary flow rate (Q_max) and health‐related quality of life (HRQL) score.

RESULTS

? Of the 170 (81.3%) patients who completed the study, 86.2% in the silodosin group vs 81.9% in the tamsulosin group achieved a ≥25% decrease in IPSS (P= 0.53). ? The mean difference (silodosin minus tamsulosin) in IPSS change from baseline was ?0.60 (95% confidence interval ?2.15, 0.95), inferring the non‐inferiority of silodosin to tamsulosin. ? The mean changes in the Q_max and HRQL score from baseline were comparable between the groups (both, P > 0.05). Although patients receiving silodosin had a significantly higher incidence of abnormal ejaculation (9.7% vs tamsulosin 1.0%, P= 0.009), only 1.9% discontinued treatment. ? Tamsulosin treatment resulted in a significant reduction in mean systolic blood pressure (?4.2 mmHg, within‐group P= 0.004) relative to the negligible change of silodosin (?0.1 mmHg, within‐group P= 0.96)

CONCLUSION

? The trial shows the non‐inferiority of silodosin 4 mg twice daily to tamsulosin 0.2 mg once daily in patients with symptoms of BPH.     

How frequent are invasive therapies required in patients receiving tamsulosin for benign prostatic hyperplasia? A retrospective long‐term study

Three hundred Japanese patients with benign prostatic hyperplasia (BPH) who started an alpha1-adrenoceptor blocker, tamsulosin, between 1993 and 1996 were followed for 3.0+/-3.3 years (mean+/-SD) to determine whether an association existed between the disease severities measured prior to the tamsulosin treatment and the timing at which the invasive therapy was implemented. Patients with a lower quality of life (QOL) index or maximum urinary flow rate (Qmax) were transferred for invasive therapy earlier than those with less severe BPH. The International Prostate Symptom Score (I-PSS) was also associated, but apparently to a lesser extent, with the timing of the invasive therapy. Finally, the overall severity evaluated using all of the above three indices, I-PSS, QOL index, and Qmax, in accordance with the 'Severity Criteria for BPH' issued by the Japanese Urological Association, was found to be a good measure for predicting the prognosis of patients with BPH treated with tamsulosin.     

Tamsulosin in the management of patients in acute urinary retention from benign prostatic hyperplasia

OBJECTIVE: To evaluate the efficacy of tamsulosin compared to placebo for treating catheterized patients with acute urinary retention (AUR) caused by benign prostatic hyperplasia (BPH), by comparing the numbers of patients who voided successfully after removing their catheter. PATIENTS AND METHODS: This was a randomized, double-blind, placebo-controlled, parallel-group, multicentre study. Men with AUR secondary to BPH were catheterized and then, if they fulfilled the entry criteria, were randomly assigned to receive either 0.4 mg tamsulosin hydrochloride in a modified-release capsule once daily, or a placebo. After up to eight doses the catheter was removed and the ability to void unaided assessed. RESULTS: In all, 149 men (mean age 69.4 years) were randomly assigned to receive tamsulosin (75) or placebo (74); eight were not evaluable, so the intent-to-treat population was 141 men. Thirty-four men taking tamsulosin and 18 taking placebo did not require re-catheterization on the day of the trial without catheter (48% and 26% respectively, P = 0.011; odds ratio 2.47, 95% confidence interval, CI, 1.23-4.97). Success using free-flow variables was also higher in the men who received tamsulosin, at 37 (52%) vs 24 (34%) on placebo (P = 0.019; odds ratio 2.34, 95% CI 1.15-4.75). Withdrawals were high (120 men, 81%), mostly because of a need for re-catheterization (89 men, 60%). Dizziness and somnolence occurred in seven (10%) and four (6%) men who received tamsulosin, and two (3%) who received placebo, but overall the incidence of adverse events was similar in the two groups. One patient died from carcinomatosis. CONCLUSION: Men catheterized for AUR can void more successfully after catheter removal if treated with tamsulosin, and are less likely to need re-catheterization. The side-effect profile was similar for tamsulosin and placebo, and consistent with known pharmacology. From these results tamsulosin can be recommended for treating men after catheterization for AUR, and can reduce the likelihood of the need for re-catheterization.     

Long-term therapy with the dual 5alpha-reductase inhibitor dutasteride is well tolerated in men with symptomatic benign prostatic hyperplasia

OBJECTIVE: To examine the long-term (4-year) safety and tolerability of dutasteride in the treatment of symptomatic benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Patients who completed the double-blind phase of three dutasteride Phase III studies were eligible to enter a 2-year open-label extension, during which all patients received dutasteride 0.5 mg. Safety was assessed, including adverse-event reporting, clinical laboratory assessments, yearly physical examinations, and vital sign assessments. RESULTS: In all, 2340 patients entered the open-label phase, 1188 of whom previously received dutasteride during the double-blind phase of the study. The most common drug-related adverse events (occurring in > or = 1%) were effects on sexual function, which decreased with a longer duration of therapy. Gynaecomastia was reported in a small percentage of men throughout the 4-year study period. The incidence of individual sexual functional adverse events that led to withdrawal was < or = 1% (0.3-1.0%) during the 4-year study period. Dutasteride had no relevant effects on vital signs or clinical laboratory variables. CONCLUSION: These data show that dutasteride is well tolerated during long-term use for the treatment of symptomatic BPH.     

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。     

Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia

OBJECTIVE: To evaluate the efficacy and safety of two doses (10 and 15 mg) of alfuzosin once daily and tamsulosin (0.4 mg) once daily, compared with placebo, in men with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In this randomized, double-blind, placebo-controlled, multicentre study, 625 patients were randomized to receive alfuzosin 10 or 15 mg once daily, tamsulosin 0.4 mg once daily (active reference), or matching placebo for 12 weeks, with no initial dose titration. The study was designed to compare each of the three active treatments with the placebo group. Primary outcome measures were mean changes from baseline in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (Qmax) at 12 weeks, compared with placebo, using one-way analysis of variance. Because Qmax data were not normally distributed, median changes from baseline were also compared for Qmax. Pair-wise comparisons were conducted using the Dunnett correction for quantitative variables and Bonferroni-Holm correction for categorical variables, allowing for multiple treatment group comparisons. RESULTS: Alfuzosin 10 mg significantly improved urinary tract symptoms compared with placebo, with a mean (sd) change from baseline in the IPSS of -6.5 (5.2) vs -4.6 (5.8) for placebo (adjusted P = 0.007); there was a trend toward a difference between alfuzosin 15 mg, with a mean (sd) change from baseline in IPSS of -6.0 (5.6), and placebo (adjusted P = 0.050). The mean change from baseline in IPSS with tamsulosin 0.4 mg, at -6.5 (5.6), vs placebo was also significant (adjusted P = 0.014). The median change from baseline in Qmax was significantly increased with both alfuzosin doses and with tamsulosin (all adjusted P = 0.02 vs placebo). Both doses of alfuzosin were well tolerated, with dizziness the most frequent adverse event (placebo, 4%; alfuzosin 10 mg, 6%; 15 mg, 7%; tamsulosin, 2%); the respective incidence rates of sexual function adverse events were 0%, 3%, 1% and 8%. CONCLUSION: Treatment with alfuzosin 10 mg significantly improved urinary symptoms and Qmax compared with placebo and was well tolerated. There were also significant improvements over placebo with the active reference, tamsulosin 0.4 mg. The incidence of sexual function adverse events was higher with tamsulosin than with placebo. The benefit-to-risk profile of alfuzosin 10 mg once daily appeared to be reduced with a higher dose (15 mg).     

前列腺增生症合并腹股沟疝的手术治疗(附18例报告)

目的：探讨前列腺增生症合并腹股沟疝一次性手术方法。方法：采用下腹部弧形切口作结扎前列腺动脉尿道外前列腺切除术，并在切除增生前列腺组织的同时进行了疝修补术治疗前列腺增生合并腹股沟疝患者１８例。结果：效果良好，随访２个月￣４年，未见疝复发及尿失禁、尿道狭窄等并发症发生，生活质量评分０￣２分。结论：前列腺增生症合并腹股沟疝可作为前列腺切除术的手术适应证，并可一次性完成手术，使患者免受二次手术痛苦。     

Risk stratification for benign prostatic hyperplasia (BPH) treatment

? Benign prostatic hyperplasia (BPH) is a common cause of bothersome lower urinary tract symptoms. In the past, the aim of drug treatment was to relieve symptoms until surgery became necessary, predominantly using an α-blocker or a 5α-reductase inhibitor (5ARI) as monotherapy. ? Together with improving knowledge about the pathogenesis of BPH, there is now strong evidence from large randomized trials that risk stratification and appropriate treatment with combined α-blocker/5ARI therapy can significantly reduce the risk of disease progression and avoid long-term complications such as acute urinary retention and surgery. ? BPH will increasingly be managed in primary care in the future and, if new management strategies based on this evidence are to be implemented cost effectively, there is a need to introduce shared care between the primary and secondary care sectors to optimise use of resources and expertise.     

Doxazosin gastrointestinal therapeutic system versus tamsulosin for the treatment of benign prostatic hyperplasia: A study in Chinese patients

AIM: The efficacy and safety profiles of two alpha1-adrenoceptor antagonists, doxazosin gastrointestinal therapeutic system, a controlled-release formulation of doxazosin, and tamsulosin, were compared in Chinese men with confirmed benign prostatic hyperplasia. METHODS: After a 2-week placebo run-in phase, 117 patients were randomized to daily treatment with doxazosin gastrointestinal therapeutic system (4 mg doxazosin) (n = 60) or 0.2 mg tamsulosin (n = 57) for 6 weeks with no titration of study medications. Efficacy was measured by the International Prostate Symptom Score, maximum urinary flow rate, postvoid residual urine volume, and quality-of-life score from the International Prostate Symptom Score. Adverse events were recorded. RESULTS: Both drugs significantly improved the International Prostate Symptom Score (total, irritative subscore and obstructive subscore) and maximum urinary flow rate. Doxazosin gastrointestinal therapeutic system reduced postvoid residual urine volume significantly more than tamsulosin (-25 +/- 5 mL vs 2 +/- 5 mL, P = 0.041) in patients with residual volume >0 mL at baseline. Other differences between groups were not statistically significant. CONCLUSIONS: The doxazosin gastrointestinal therapeutic system and tamsulosin were effective and well tolerated for the treatment of benign prostatic hyperplasia in Chinese men.