基线参数对有症状的良性前列腺增生和前列腺肿大男性使用度他雄胺、坦索罗辛及联合治疗后国际前列腺症状评分变化的影响：CombAT研究的2年数据

The influence of baseline parameters on changes in international prostate symptom score with dutasteride, tamsulosin, and combination therapy among men with symptomatic benign prostatic hyperplasia and an enlarged prostate: 2-year data from the CombAT study.

作者信息

Roehrborn Claus G, Siami Paul, Barkin Jack, Damião Ronaldo, Becher Edgardo, Miñana Bernardino, Mirone Vicenzo, Castro Ramiro, Wilson Timothy, Montorsi Francesco

机构信息

Department of Urology, UT Southwestern Medical Center, Dallas, TX 75390-9110, USA.

出版信息

Eur Urol. 2009 Feb;55(2):461-71. doi: 10.1016/j.eururo.2008.10.037. Epub 2008 Nov 6.

DOI:10.1016/j.eururo.2008.10.037

PMID:19013011

Abstract

BACKGROUND

Knowledge of baseline factors that influence outcomes for men with benign prostatic hyperplasia (BPH) receiving medical therapy may help to improve outcomes and cost effectiveness.

OBJECTIVES

To examine the influence of baseline parameters on changes in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Q(max)) in men with BPH receiving dutasteride, tamsulosin, or a combination of the two using 2-yr Combination of Avodart and Tamsulosin (CombAT) study data.

DESIGN, SETTING, AND PARTICIPANTS: CombAT is an ongoing, 4-yr, multicentre, randomised, double-blind study in 4844 men aged >or=50 yr with clinical diagnosis of BPH, IPSS >or=12, prostate volume >or=30 cm(3), prostate-specific antigen (PSA) 1.5-10 ng/ml, and Q(max) >5 and <or=15 ml/s with minimum voided volume >or=125 ml.

INTERVENTION

Daily tamsulosin 0.4 mg, dutasteride 0.5 mg, or the combination.

MEASUREMENTS

Post hoc analyses of mean IPSS and Q(max) changes from baseline by treatment group and by baseline prostate volume, PSA, age, body mass index (BMI), IPSS, IPSS quality of life (QoL) score, BPH Impact Index score, Q(max), and previous BPH medical therapy.

RESULTS AND LIMITATIONS

Combination therapy was more effective than either monotherapy after 24 mo in improving IPSS in all baseline subgroups, with benefit onset varying by baseline prostate volume. Combination therapy was also more effective in improving Q(max) versus tamsulosin in all subgroups and versus dutasteride in 10 of 18 subgroups. At 24 mo, dutasteride monotherapy resulted in significantly greater IPSS improvements versus tamsulosin in men with lower age, worse symptoms, worse QoL, less bother, higher BMI, greater Q(max), higher prostate volume, and higher PSA at baseline. Post hoc analyses, the lack of placebo control, and the exclusion of men with unsuccessful medical BPH treatment are study limitations.

CONCLUSIONS

Combination therapy with tamsulosin and dutasteride affords the greatest and the most rapid symptomatic benefit among men with higher baseline prostate volume and is effective regardless of previous BPH medical therapy. Dutasteride monotherapy is more effective than tamsulosin in men with higher baseline prostate volume or PSA and worse symptoms.

摘要

背景

了解影响接受药物治疗的良性前列腺增生（BPH）男性患者治疗效果的基线因素，可能有助于改善治疗效果和成本效益。

目的

利用阿夫唑嗪和坦索罗辛联合用药（CombAT）研究的2年数据，研究基线参数对接受度他雄胺、坦索罗辛或两者联合治疗的BPH男性患者国际前列腺症状评分（IPSS）和最大尿流率（Qmax）变化的影响。

设计、设置和参与者：CombAT是一项正在进行的为期4年的多中心随机双盲研究，纳入4844名年龄≥50岁、临床诊断为BPH、IPSS≥12、前列腺体积≥30 cm³、前列腺特异性抗原（PSA）1.5 - 10 ng/ml、Qmax＞5且≤15 ml/s且最小排尿量≥125 ml的男性。

干预措施

每日服用坦索罗辛0.4 mg、度他雄胺0.5 mg或两者联合用药。

测量指标

按治疗组以及按基线前列腺体积、PSA、年龄、体重指数（BMI）、IPSS、IPSS生活质量（QoL）评分、BPH影响指数评分、Qmax和既往BPH药物治疗情况，对IPSS和Qmax自基线的变化进行事后分析。

结果与局限性

联合治疗在改善所有基线亚组的IPSS方面，24个月后比单药治疗更有效，获益开始时间因基线前列腺体积而异。联合治疗在改善Qmax方面，在所有亚组中也比坦索罗辛更有效，在18个亚组中的10个亚组中比度他雄胺更有效。在24个月时，度他雄胺单药治疗在基线时年龄较小、症状较差、QoL较差、困扰较少、BMI较高、Qmax较高、前列腺体积较大和PSA较高的男性中，导致IPSS改善明显大于坦索罗辛。事后分析、缺乏安慰剂对照以及排除BPH药物治疗失败的男性是本研究的局限性。