Roehrborn Claus G, Kaplan Steven A, Kraus Stephen R, Wang Joseph T, Bavendam Tamara, Guan Zhonghong
Department of Urology, University of Texas Southwestern, Medical Center at Dallas, Texas 75390-9110, USA.
Urology. 2008 Nov;72(5):1061-7; discussion 1067. doi: 10.1016/j.urology.2008.06.067. Epub 2008 Sep 25.
To evaluate the efficacy of tolterodine extended release (ER), tamsulosin, and tolterodine ER plus tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen (PSA) level.
We performed a post hoc analysis of data from men >or=40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume <200 mL, maximal urinary flow rate >5 mL/s, International Prostate Symptom Score (IPSS) of >or=12, and quality-of-life score of >or=3. They had been randomized to placebo, tolterodine ER (4 mg), tamsulosin (0.4 mg), or tolterodine ER plus tamsulosin for 12 weeks. The men were stratified by the median baseline PSA level (>or=1.3 vs <1.3 ng/mL). Assessments included changes in bladder diary variables and IPSSs. The men rated the urgency level of each micturition, and the frequency-urgency sum was defined as the total of these ratings.
The PSA level correlated significantly with prostate size. Men with a PSA level of >or=1.3 ng/mL receiving tolterodine ER plus tamsulosin showed significantly greater improvements in 24-hour frequency, daytime frequency, the frequency-urgency sum, total IPSS, and IPSS storage score compared with those receiving placebo. Tamsulosin significantly improved the IPSS voiding scores, but tolterodine ER was ineffective. In men with a PSA level <1.3 ng/mL, tolterodine ER alone and tolterodine ER plus tamsulosin significantly improved the 24-hour frequency, daytime frequency, frequency-urgency sum, and IPSS storage scores compared with those receiving placebo; tamsulosin alone was ineffective. No significant changes were found in the postvoid residual urine volume or maximal urinary flow rate in any group, and the acute urinary retention rates were low.
The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms, including overactive bladder, who had lower PSA levels (<1.3 ng/mL).
评估托特罗定缓释片（ER）、坦索罗辛以及托特罗定ER联合坦索罗辛对患有膀胱过度活动症和良性前列腺增生症状且根据前列腺特异性抗原（PSA）水平分层的男性患者的疗效。
我们对年龄≥40岁、有尿频和尿急症状（伴或不伴有急迫性尿失禁）、排尿后残余尿量<200 mL、最大尿流率>5 mL/s、国际前列腺症状评分（IPSS）≥12且生活质量评分≥3的男性患者的数据进行了事后分析。他们被随机分为接受安慰剂、托特罗定ER（4 mg）、坦索罗辛（0.4 mg）或托特罗定ER联合坦索罗辛治疗12周。这些男性患者根据基线PSA水平中位数（≥1.3 vs <1.3 ng/mL）进行分层。评估包括膀胱日记变量和IPSS的变化。男性患者对每次排尿时的急迫程度进行评分，频率-急迫总和定义为这些评分的总和。
PSA水平与前列腺大小显著相关。PSA水平≥1.3 ng/mL且接受托特罗定ER联合坦索罗辛治疗的男性患者，与接受安慰剂治疗的患者相比，在24小时排尿频率、白天排尿频率、频率-急迫总和、总IPSS以及IPSS储尿期评分方面改善更为显著。坦索罗辛显著改善了IPSS排尿期评分，但托特罗定ER无效。在PSA水平<1.3 ng/mL的男性患者中，与接受安慰剂治疗的患者相比，单独使用托特罗定ER以及托特罗定ER联合坦索罗辛均显著改善了24小时排尿频率、白天排尿频率、频率-急迫总和以及IPSS储尿期评分；单独使用坦索罗辛无效。任何组的排尿后残余尿量或最大尿流率均未发现显著变化，急性尿潴留发生率较低。
我们的研究结果表明，托特罗定ER对PSA水平较低（<1.3 ng/mL）的下尿路症状（包括膀胱过度活动症）男性患者有效。
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