Response to daily 10 mg alfuzosin predicts acute urinary retention and benign prostatic hyperplasia related surgery in men with lower urinary tract symptoms

PURPOSE: We analyzed the influence of treatment response on the risk of acute urinary retention and benign prostatic hyperplasia related surgery in 5,792 men complaining of lower urinary tract symptoms who were treated for 6 months with the selective alpha1-blocker alfuzosin at 10 mg once daily. MATERIALS AND METHODS: The influence of dynamic variables (International Prostate Symptom Score change and bother during treatment) and baseline variables (patient age, prior acute urinary retention managed conservatively, prostate specific antigen, International Prostate Symptom Score and bother severity) on the risk of acute urinary retention and benign prostatic hyperplasia related surgery was estimated using the Kaplan-Meier method and log rank test. The associated HR and 95% CI were calculated using Cox proportional hazard models. RESULTS: During alfuzosin treatment International Prostate Symptom Score improved by 3 or greater and greater than 6 points in 74.8% and 50.3% of men, respectively. In this unselected population, including 3.8% with prior unoperated acute urinary retention, the rate of acute urinary retention and benign prostatic hyperplasia related surgery events during treatment was low (0.5% and 1.1%, respectively). Men with stable or worsening International Prostate Symptom Score were at increased risk for acute urinary retention or surgery (HR 3.75, 95% CI 1.58 to 8.89, p = 0.003 and HR 4.71, 95% CI 2.69 to 8.24, p <0.001, respectively). Prior acute urinary retention was a strong predictor of acute urinary retention relapse and surgery (HR 10.35, 95% CI 4.29 to 26.08, p <0.001 and HR 3.57, 95% CI 1.59 to 7.98, p = 0.002, respectively). Bother score greater than 3 during treatment was the strongest predictor of surgery (HR 7.61, 95% CI 4.16 to 13.93, p <0.001). Prostate specific antigen had much less predictive value. CONCLUSIONS: This 6-month real life practice study shows that alfuzosin is associated with a low incidence of acute urinary retention and benign prostatic hyperplasia related surgery. It also suggests that responder status is the most important predictor of acute urinary retention and benign prostatic hyperplasia related surgery. Thus, first line treatment with alfuzosin may help select patients at risk for benign prostatic hyperplasia progression to optimize treatment.     

Intermittent tamsulosin therapy in men with lower urinary tract symptoms

PURPOSE: We investigated in what is to our knowledge the first prospective study the safety and efficacy of intermittent tamsulosin therapy in patients with lower urinary tract symptoms. MATERIALS AND METHODS: This study was performed between January 2001 and February 2003 in 140 patients. In phase 1 of this study patients received 1, 0.4 mg tamsulosin capsule daily for 3 months and were reevaluated after 3 months. At this assessment uroflowmetry, International Prostate Symptom Score and ultrasonographic estimation of residual urine were determined. In phase 2 responders to tamsulosin therapy were then randomized into 1 of 3 groups, namely group 1--continued 4 mg tamsulosin once daily every day, group 2--0.4 mg tamsulosin once daily every other day and group 3--discontinued tamsulosin. Efficacy assessments were done again at 4, 12 and 24 weeks. RESULTS: There were no statistically differences among the patients in groups 1 and 2 at 6 months for International Prostate Symptom Score, maximum or average urine flow, or residual urine. Differences between patients in groups 1 and 3 were statistically significant at 6 months. Differences between patients in groups 2 and 3 were also statistically significant at 6 months for these parameters. CONCLUSIONS: Tamsulosin at a dose of 0.4 mg once daily and 0.4 mg once daily every other day for lower urinary tract symptoms provide comparable improvements in urinary flow and symptoms. Each treatment was well tolerated.     

Doxazosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects

OBJECTIVE: To evaluate the efficacy and adverse effects of doxazosin for treating lower urinary tract symptoms (LUTS) compatible with benign prostatic obstruction (BPO). METHODS: Randomized controlled trials were included in the meta-analysis if: the study duration was > or = 1 month; the study involved men with symptomatic BPO; and doxazosin was compared with placebo or active controls. Study and patient characteristics and outcome data were extracted in duplicate onto standardized forms using a prospectively developed protocol. RESULTS: Thirteen studies involving 6033 men with (mean age 64 years) met the inclusion criteria; 10 were placebo-controlled, including two with combined doxazosin/finasteride therapy and finasteride monotherapy arms. Three trials were a comparison with other alpha-blockers. The study duration was 1-54 months. The mean baseline symptom scores and peak urinary flow (PUF) rates were indicative of moderate BPO. Doxazosin gave significant improvements in LUTS, assessed by symptom scores, vs placebo and finasteride in the short- to long-term. Two long-term studies (1 and 4 years) reported mean changes from baseline for the International Prostate Symptom Score of - 8.3 and - 6.6 points (-49% and - 39%) for doxazosin and - 5.7 and - 4.9 points (-33% and - 29%) for placebo, respectively. Doxazosin significantly increased PUF rates vs placebo. In pooled results from three studies, the weighted mean difference in the mean change from baseline vs placebo was 1.6 mL/s (95% confidence interval 1.2-2.1). Efficacy was comparable with other alpha1-blockers. In the long-term (>4 years) doxazosin was no better then finasteride in improving PUF. Combined doxazosin and finasteride significantly reduced the risk of overall clinical progression of BPO vs each drug separately in men followed for >4 years. Absolute risk reductions vs placebo were 11.3%, 6.9% and 6.4% for combined therapy, doxazosin and finasteride, respectively (P < 0.001). Improvements in symptom scores and PUF were also significantly greater with combined than monotherapy, and the former reduced the need for invasive treatment for BPO and the risk of long-term urinary retention, although the absolute reductions in risk vs placebo were small (<4%). Dizziness and fatigue were significantly more common with doxazosin than placebo (11% vs 7%, and 6% vs 3%, respectively). Adverse events reported for combined therapy were similar to those with each monotherapy. CONCLUSION: The evidence indicates that doxazosin is effective and generally well tolerated for improving LUTS and PUF in men with symptomatic BPO. Combined therapy was better than doxazosin alone in reducing the risk of clinical progression of BPO and other long-term complications related to BPO.     

Long-term use of tamsulosin to treat lower urinary tract symptoms/benign prostatic hyperplasia

PURPOSE: The long-term efficacy and safety of 0.4 mg. tamsulosin once daily were assessed in patients with lower urinary tract symptoms/benign prostatic hyperplasia treated for up to 4 years. MATERIALS AND METHODS: A total of 516 patients were enrolled from 2 European open label studies that were extensions of 3 double-blind controlled studies. RESULTS: Significant improvement in maximum urine flow and total Boyarsky symptom score during the controlled trials was sustained throughout the extension study for up to 4 years in patients who remained on therapy. The increase in mean maximum urine flow from baseline was 1.2 to 2.2 ml. per second (p <0.001) and it remained 11.5 to 12 ml. per second during followup. Total Boyarsky symptom score was decreased from baseline by 4.1 to 4.7 points (p <0.001). The incidence of treatment responders, defined as a 25% or greater decrease in total symptom score, remained stable throughout the 4-year period. Increasing the dose of tamsulosin from 0.4 to 0.8 mg. seemed to have no substantial additional benefit. During the 4 years of treatment 26% of patients had side effects that were considered possibly or probably drug related. However, only 5% of patients discontinued treatment because of drug related side effects. No clinically significant changes in blood pressure or pulse rate occurred during the study. CONCLUSIONS: Long-term treatment with tamsulosin is safe and well tolerated in patients with lower urinary tract symptoms/benign prostatic hyperplasia. Improved efficacy was sustained during 4 years of followup.     

Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia

PURPOSE: We assessed the efficacy and safety of tadalafil dosed once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: Following a 4-week, single-blind, placebo run-in 281 men were randomly assigned (1:1) to 5 mg tadalafil for 6 weeks, followed by dose escalation to 20 mg for 6 weeks or 12 weeks of placebo. RESULTS: Tadalafil significantly improved the mean change from baseline in International Prostate Symptom Score at 6 weeks (5 mg tadalafil -2.8 vs placebo -1.2) and at 12 weeks (5/20 mg tadalafil -3.8 vs placebo -1.7). Larger changes were observed with inclusion of the placebo run-in at 12 weeks (5/20 mg tadalafil -7.1 vs placebo -4.5). Significant improvements were also seen in the International Prostate Symptom Score irritative and obstructive domains, the International Prostate Symptom Score quality of life index, a question about urinary symptom improvement and the Benign Prostatic Hyperplasia Impact Index (significant at 12 weeks) vs placebo. International Prostate Symptom Score and International Index of Erectile Function erectile function domain scores significantly improved in the 56% of men with lower urinary tract symptoms/benign prostatic hyperplasia who were sexually active and had erectile dysfunction. Changes in uroflowmetry parameters were similar in the placebo and tadalafil groups. Commonly reported (2% or greater) treatment emergent adverse events were "erection increased," dyspepsia, back pain, headache, nasopharyngitis and upper respiratory tract infection (each 5.1% or less). No change in post-void residual volume was seen with tadalafil treatment. CONCLUSIONS: Tadalafil once daily was well tolerated and demonstrated clinically meaningful and statistically significant symptomatic improvement for lower urinary tract symptoms/benign prostatic hyperplasia. Tadalafil also improved erectile function in men with lower urinary tract symptoms and erectile dysfunction.     

Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia

Purpose

In this open label, prospective study we determined the efficacy and tolerability of tolterodine extended release (ER) in men with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) in whom previous α-blocker therapy had failed.

Materials and Methods

A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of α-blocker therapy had failed due to adverse events (11) or a lack of efficacy (32) received tolterodine ER (4 mg daily) for 6 months. Primary efficacy end points were American Urological Association symptom score, and mean daytime and nighttime micturition frequency. Secondary end points were the peak urinary flow rate, post-void residual volume, the incidence of urinary retention, total score on the erectile function domain of the International Index of Erectile Function and adverse events.

Results

A total of 39 men (91%) with a mean age of 61 years completed the 6-month trial. Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly. Significant changes in mean American Urological Association symptom scores (-6.1), the peak urinary flow rate (1.9 ml per second) and post-void residual volume (-22 ml) were also observed. Of the men 27 (63%) were potent at baseline and 29 (67%) were potent after 6 months of tolterodine ER treatment. Mean International Index of Erectile Function erectile function domain scores increased (6.9). Four men (9%) discontinued therapy because of intolerable dry mouth. There were no reports of urinary retention.

Conclusions

Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with α-blockers.     

Modifiable risk factors for benign prostatic hyperplasia and lower urinary tract symptoms: new approaches to old problems

PURPOSE: Benign prostatic hyperplasia is generally not regarded as a preventable disease. However, accumulating evidence suggests that modifiable factors may influence the risk of benign prostatic hyperplasia and lower urinary tract symptoms. MATERIALS AND METHODS: A structured, comprehensive literature review was done to identify modifiable risk factors for benign prostatic hyperplasia and lower urinary tract symptoms among observational studies of older men. RESULTS: Outcome measures used to define benign prostatic hyperplasia in clinical studies include histological analysis of prostate tissue, radiographically determined prostate enlargement, acute urinary retention, decreased urinary flow rate, pressure flow studies consistent with bladder outlet obstruction, history of benign prostatic hyperplasia surgery, physician diagnosed benign prostatic hyperplasia and American Urological Association symptom score or International Prostate Symptom Score. Factors that potentially increase the risk of benign prostatic hyperplasia and lower urinary tract symptoms include obesity and diabetes. Factors that potentially decrease the risk include increased physical activity and moderate alcohol consumption. Other candidate factors for which clear risk patterns have not yet emerged are dyslipidemia, hypertension, smoking, diet and environment. CONCLUSIONS: Obesity, diabetes, physical activity and alcohol intake may substantially influence the risk of benign prostatic hyperplasia and lower urinary tract symptoms in older men. Further analyses of these and other potential modifiable risk factors may identify novel interventions for the prevention, diagnosis and treatment of these highly prevalent conditions.     

Long-term risk of re-treatment of patients using alpha-blockers for lower urinary tract symptoms

PURPOSE: The efficacy of alpha-adrenoceptor blockers for the treatment of lower urinary tract symptoms has been proven in numerous studies. However, little is known about the efficacy of the longer term. We investigated the long-term risk of re-treatment in patients using alpha-adrenoceptor blockers for lower urinary tract symptoms and the parameters that influence this risk. MATERIALS AND METHODS: We reviewed the files of 316 patients with lower urinary tract symptoms treated at our department with the alpha-blockers terazosin, alfuzosin or tamsulosin. Using followup data up to 3 years, we calculated re-treatment percentages in each treatment group. Using extended followup of 5 years, we calculated the predictive value of various baseline characteristics for re-treatment. RESULTS: The re-treatment rates were 27% for tamsulosin, 37% for alfuzosin and 49% for terazosin. The re-treatment rates of patients with mild, moderate and severe lower urinary tract symptoms were 27%, 33% and 70%, respectively. Patients with a maximum urine flow of less or more than 10 ml. per second had a re-treatment rate of 58% and 47%, respectively. Patients with a prostate volume of less or more than 40 ml. had a re-treatment rate of 48% and 72%, respectively. Patients who were urodynamically unobstructed versus obstructed patients had a re-treatment rate of 44% and 59%, respectively. CONCLUSIONS: Patients given alpha-blockers for lower urinary tract symptoms have a high risk of re-treatment. Tamsulosin has a markedly lower re-treatment percentage than alfuzosin and terazosin. Severe symptoms, poor urine flow, an enlarged prostate and urodynamically proven bladder outlet obstruction increase the risk of treatment failure. Preselection of the most suitable candidates for alpha-blockade may reduce this risk.     

Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial

PURPOSE: We evaluated sildenafil for erectile dysfunction and lower urinary tract symptoms in men with the 2 conditions. MATERIALS AND METHODS: This was a 12-week, double-blind, placebo controlled study of sildenafil in men 45 years or older who scored 25 or less on the erectile function domain of the International Index of Erectile Function and 12 or greater on the International Prostate Symptom Score. Men with confirmed or suspected prostate malignancy, or prostate specific antigen 10 ng/ml or more were excluded. End points were changes in International Index of Erectile Function domain scores, International Prostate Symptom Score (irritative, obstructive and quality of life), the Benign Prostatic Hyperplasia Impact Index, the Self-Esteem And Relationship questionnaire and Erectile Dysfunction Inventory of Treatment Satisfaction Index Score. RESULTS: The 189 men receiving sildenafil had significant improvements in erectile function domain score vs the 180 on placebo (9.17 vs 1.86, p<0.0001) and on all other International Index of Erectile Function domains. In men on sildenafil vs placebo significant improvements were observed in International Prostate Symptom Score (-6.32 vs -1.93, p<0.0001), Benign Prostatic Hyperplasia Impact Index (-2.0 vs -0.9, p<0.0001), mean International Prostate Symptom Score quality of life score (-0.97 vs -0.29, p<0.0001) and total Self-Esteem And Relationship questionnaire scores (24.6 vs 4.3, p<0.0001). There was no difference in urinary flow between the groups (p=0.08). Significantly more sildenafil vs placebo treated patients were satisfied with treatment (71.2 vs 41.7, p<0.0001). Sildenafil was well tolerated. CONCLUSIONS: Improved erectile dysfunction and lower urinary tract symptoms with sildenafil in men with the 2 conditions were associated with improved quality of life and treatment satisfaction. Daily dosing with sildenafil may improve lower urinary tract symptoms. However, the lack of effect on urinary flow rates may mean that a new basic pathophysiology paradigm is needed to explain the etiology of lower urinary tract symptoms.     

Phosphodiesterase 5 inhibitors for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a systematic review

Study Type – Therapy (systematic review)
Level of Evidence 1a What’s known on the subject? and What does the study add? Phosphodiesterase 5 inhibitors improve lower urinary tract symptoms (LUTS), however the maximum urinary flow rate is not significantly affected. Also, the underlying mechanism of action of these drugs on LUTS is not well understood. This systematic review confirms the findings of the individual studies included; however the high heterogeneity between them precluded meta‐analysis and further recommendations.

OBJECTIVE

? To review the evidence in support of the effectiveness of phosphodiesterase 5 inhibitors in lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).

METHODS

? Relevant studies were identified by performing a literature search using MEDLINE® and The Cochrane Library®. The criteria used during the search included randomized, placebo‐controlled trials of treatment for LUTS secondary to BPH using the International Prostate Symptom Score as an outcome measure.

RESULTS

? Four trials that included a total of 1928 patients met the inclusion criteria. All four studies showed a statistically significant difference in the International Prostate Symptom Score, quality of life and erectile function in favour of phosphodiesterase 5 inhibitors. ? No study showed a statistically significant improvement of the maximum urinary flow. ? Meta‐analysis of the results was not possible because of heterogeneity across the studies.

CONCLUSIONS

? Phosphodiesterase 5 inhibitors used in the clinical setting can significantly improve LUTS secondary to BPH, erectile function and quality of life. Maximum urinary flow improvement is not statistically significant. ? Future research should focus on pathophysiological principles and cost analysis.     

Urodynamic effects of terazosin treatment for Japanese patients with symptomatic benign prostatic hyperplasia

PURPOSE: For treating benign prostatic hyperplasia (BPH) 5 or 10 mg. terazosin hydrochloride daily has been routinely used in North America and Europe. We investigated the urodynamic effects of 2 mg. terazosin daily on Japanese patients with symptomatic BPH using pressure flow study. MATERIALS AND METHODS: A total of 20 Japanese patients 50 years old or older with symptomatic BPH underwent symptomatic and urodynamic evaluations, including pressure flow study, before and after terazosin treatment. Patients were given 1 mg. terazosin once daily for the first 7 days and they continued to receive 1 mg. terazosin twice daily for the following 3 weeks. RESULTS: At 4 weeks after terazosin treatment the International Prostate Symptom Score, quality of life index and maximum and average flow rates were significantly improved. Pressure flow study demonstrated decreased detrusor pressure at maximum flow, and minimum detrusor pressure during voiding and urethral resistance factor after terazosin treatment. Of the 20 patients 13 (65%) showed improvement in the linear passive urethral resistance relation. There was no significant difference in the maximum W. factor before and after terazosin treatment. CONCLUSIONS: Terazosin treatment, even 2 mg. daily, urodynamically relieved bladder outlet obstruction in Japanese patients with symptomatic BPH without any changes in detrusor contractility.     

Alpha1-adrenergic receptors and their inhibitors in lower urinary tract symptoms and benign prostatic hyperplasia

PURPOSE: We provide a comprehensive overview of the role of alpha1-adrenergic receptors (alpha1ARs) as critical mediators of lower urinary tract symptoms (LUTS) and pathophysiology in benign prostatic hyperplasia (BPH), and we review the pharmacological antagonists of alpha1ARs. MATERIALS AND METHODS: A review was performed of pertinent studies in the literature relating to the pathophysiology of LUTS and BPH, focusing on the role of alpha1ARs, and of clinical trial and practice data evaluating the different agents that inhibit these receptors. RESULTS: Further characterization of the alpha1AR gene family indicates that 3 receptor subtypes exist in humans. Their different distribution between urinary tract and cardiovascular tissues has provided a strategy for the development of improved therapeutic agents. Since excessive activity of the alpha1aAR and alpha1dAR subtypes appears to be a common feature in symptomatic BPH and alpha1aARs are enriched in prostatic tissue, drugs that demonstrate high alpha1aAR selectivity have attracted attention. Tamsulosin, which has high affinity for alpha1aAR and alpha1dAR subtypes but not for alpha1bAR, shows efficacy similar to the nonsubtype selective agents terazosin and doxazosin. It is associated with fewer cardiovascular side effects, although it has some ejaculatory side effects. The nonsubtype selective agent alfuzosin also demonstrates efficacy and offers an enhanced side effect profile, particularly minimizing hypotension. Other agents with super selective specificity for the alpha1aAR subtype are under investigation. CONCLUSIONS: Further advances in the treatment of LUTS associated with BPH may depend not only on receptor subtype selectivity, but also on other pharmacokinetic and pharmacodynamic factors.     

Alfuzosin for symptomatic benign prostatic hyperplasia: long-term experience

PURPOSE: Evidence of the long-term efficacy and safety of alfuzosin treatment for LUTS indicative of BPH was examined. MATERIALS AND METHODS: An English literature search of MEDLINE, PubMed and proceedings from scientific meetings from 1974 to 2004 was done. Search terms included benign prostatic hyperplasia, alfuzosin, treatment, alpha(1)-adrenergic receptor blocker, long-term, followup, lower urinary tract symptoms, complications or adverse events, sexual, retention and cardiovascular. RESULTS: Currently alpha(1)-adrenergic receptor blocking agents are first line treatment for BPH. Although all alpha-blocking compounds show similar levels of efficacy for LUTS treatment, newer agents such as alfuzosin tend to demonstrate improved selectivity for the prostate and bladder with few vasodilatory effects and they have tolerability advantages over older alpha-blocking compounds. Immediate, sustained and newer extended release alfuzosin formulations significantly improve LUTS indicative of BPH but extended release alfuzosin may be more convenient to administer and it tends to show better vasodilatory tolerability than the older immediate release formulation. CONCLUSIONS: When used to treat BPH, alfuzosin provides symptom relief, decreased residual post-void urine volume and a decreased risk of acute urinary retention, which are maintained during long-term use. Most vasodilatory side effects occur early in treatment and they become less frequent thereafter. Patient quality of life also improves with maximal improvements observed after 12 months of treatment. Continued study will further clarify the physiological, clinical and personal benefits produced by alfuzosin when used for the management of LUTS indicative of BPH.     

The association between lower urinary tract symptoms and renal function in men: a cross-sectional and 5-year longitudinal analysis

PURPOSE: We assessed the association between LUTS and renal function in men in a cross-sectional and a longitudinal study. MATERIALS AND METHODS: Men participating in health investigation in Vienna entered this study. In the cross-sectional analysis a consecutive series of men were studied and in the longitudinal analysis men were reevaluated after 5 years. LUTS were assessed by I-PSS and renal function was evaluated by GFR, as calculated by the Cockcroft-Gault equation. RESULTS: A total of 2.469 men with a mean age of 47.1 years (range 30 to 80) entered the cross-sectional study and 439 with a mean age of 51.7 years (range 45 to 79) could be assessed in longitudinal analysis. In the cross-sectional study there was no association between the degree of LUTS and GFR during 5 life decades (p = 0.55). An identical pattern was observed for irritative and obstructive scores. In the longitudinal cohort mean GFR +/- SD decreased from 84.3 +/- 20.2 ml per minute at baseline to 79.2 +/- 18.7 ml per minute after 5 years (-6.0%, p <0.0001). The mean decrease in GFR after 5 years was 4.5 ml per minute (-5.4%) in men without/mild LUTS (I-PSS 7 or less at ages 55.4 +/- 11.0 years), 3.9 ml per minute (-4.9%) in those with moderate LUTS (I-PSS 8 to 20 at ages 61.3 +/- 11.6 years) and 4.2 ml per minute (-5.2%) in those with severe LUTS (I-PSS greater than 20 at ages 64.3 +/- 7.4 years). On linear regression analysis in the 2 study cohorts neither I-PSS, nor obstructive or irritative score affected GFR (p >0.05). The only determinants for GFR less than 90 ml per minute were age (p <0.0001) and hypertension (p <0.0001). CONCLUSIONS: LUTS do not represent an independent risk factor for impaired renal function in men.     

坦索罗辛和特拉唑嗪治疗BPH的系统评价

目的:系统评价坦索罗辛(tamsulosin)和特拉唑嗪(terazosin)对照治疗BPH的疗效。方法:搜集世界范围内运用坦索罗辛和特拉唑嗪两种药物对比治疗BPH的随机对照试验(Randomized controlled trials,RCTs)和半随机临床对照试验(Clinical controlled trials,CCTs)的英文及中文文献,并追查已纳入文献的参考文献。由至少两位系统评价员做独立文献筛查、质量评价和资料提取,并交叉核对,不同意见请第三者裁决。使用统计软件Rev Man4.2完成Meta分析。结果:经筛选,最后纳入8篇文献,其中6篇RCT,2篇CCT,包括受试患者806例,排除失访人数,实际纳入763例进行Meta分析,其基线情况具有可比性。随访时间4~20周不等。通过比较用药前后6个判效指标,即国际前列腺症状评分(IPSS)、最大尿流率(MFR)、平均尿流率(AFR)、剩余尿量、生活质量(QOL)、前列腺体积的改善程度,发现在改善IPSS方面,坦索罗辛优于特拉唑嗪Z=2.09(P=0.04),WMD=0.75(0.07,1.43)。有证据支持在长期治疗后,坦素罗辛在改善QOL方面优于特拉唑嗪。除此之外,两者的疗效均无明显差异。结论:在改善IPSS方面,坦索罗辛效果优于特拉唑嗪;经长期治疗后,坦索罗辛在改善QOL方面优于特拉唑嗪。除此之外,二者差别无统计学意义。建议进行大样本、长期随访的高质量临床试验,提供更佳循证证据。