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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。
To investigate the relationship between initial total prostate volume (TPV) and drug efficacy in patients with benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS). Kaplan SA and other analysis of drug treatment of prostate symptoms (MTOPS) data obtained. A total of 3047 BPH patients with LUTS were randomly divided into 4 groups: placebo group, 4 mg to 8 mg doxazosin group, 5 mg finasteride group, doxazosin and finasteride combined treatment group . The average treatment time is 4.5 years. The primary endpoint was overall BPH clinical progression, defined as an increase in AUA symptom score (AUA SS) ≥4 points, acute urinary retention, urinary incontinence, renal insufficiency or recurrent urinary tract infection. Secondary end point was required for surgical intervention BPH, AUA symptom scores and maximum flow rate over time. TPV was measured with transrectal B-ultrasound at the beginning and end of the study. The results showed that combination therapy group and doxazosin monotherapy in patients with smaller prostate volume (TPV <25ml) in reducing the risk of BPH clinical progression and the need for surgical intervention and improving the AUA symptom score and maximum flow rate No difference between groups. However, when the patient’s prostate volume is moderate (25ml to 40ml) or greater (40ml), the clinical benefit of combination therapy is higher than that of doxazosin alone or finasteride . Therefore concluded that combined treatment of doxazosin and finasteride in BPH patients with LUTS and TPV ≥ 25ml delayed the clinical progress of BPH more than each alone.