Chapple C R, Carter P, Christmas T J, Kirby R S, Bryan J, Milroy E J, Abrams P
Middlesex Hospital, London, UK.
Br J Urol. 1994 Jul;74(1):50-6. doi: 10.1111/j.1464-410x.1994.tb16546.x.
To evaluate the efficacy and tolerability of doxazosin in the treatment of bladder outflow obstruction resulting from benign prostatic hyperplasia (BPH).
One-hundred and thirty-five patients with symptomatic urodynamically confirmed obstructive BPH were treated for 12 weeks with either doxazosin (67 patients) or placebo (68 patients) after an initial 2 week baseline evaluation. The main outcome measures were urodynamic and symptomatic evaluation for efficacy. Blood pressure and adverse events were monitored.
Data were obtained in 122 patients (60 doxazosin, 62 placebo). Doxazosin produced increases in both mean and maximum urinary flow rates of 1.01 ml/s and 3.2 ml/s respectively, compared with 0.21 ml/s and 2.2 ml/s on placebo. The increase in mean flow rate was statistically significant (P = 0.04), while that for maximum flow rate approached significance (P = 0.09). The maximum subtracted voiding pressure was substantially reduced (P = 0.007) and 19 of 53 (36%) patients had an increase in maximum flow rate of 50% or more compared with 9 of 54 (17%) on placebo (P = 0.024). Twelve weeks' therapy with doxazosin resulted in significant improvements (compared with placebo) in: hesitancy (doxazosin 26 of 46, placebo 11 of 43; P = 0.003), impaired urinary stream (doxazosin 31 of 55, placebo 16 of 48; P = 0.019) nocturia (doxazosin 22 of 56, placebo 10 of 54; P = 0.017) and urgency (doxazosin 27 of 45, placebo 16 of 42; P = 0.041). Frequency improved with doxazosin therapy (doxazosin 26 of 59, placebo 15 of 55; P = 0.062). Adverse events, most frequently dizziness and headache, were usually mild and transient and led to a discontinuation of doxazosin therapy in one patient. No clinically significant changes in sexual function or blood pressure were seen.
Doxazosin was well-tolerated and produced both urodynamic and symptomatic improvement in men with BPH, thereby providing a satisfactory alternative to existing drugs with the additional benefit of once daily dosage.
评估多沙唑嗪治疗良性前列腺增生（BPH）所致膀胱流出道梗阻的疗效和耐受性。
135例有症状且经尿动力学证实为梗阻性BPH的患者，在经过2周的初始基线评估后，67例患者接受多沙唑嗪治疗，68例患者接受安慰剂治疗，为期12周。主要结局指标为尿动力学和症状评估以判断疗效。监测血压和不良事件。
122例患者（60例多沙唑嗪组，62例安慰剂组）获得数据。多沙唑嗪使平均尿流率和最大尿流率分别增加1.01 ml/s和3.2 ml/s，而安慰剂组分别增加0.21 ml/s和2.2 ml/s。平均尿流率的增加具有统计学意义（P = 0.04），最大尿流率的增加接近显著水平（P = 0.09）。最大排尿压差显著降低（P = 0.007），53例患者中有19例（36%）最大尿流率增加50%或更多，而安慰剂组54例中有9例（17%）（P = 0.024）。多沙唑嗪治疗12周后，在以下方面与安慰剂相比有显著改善：排尿犹豫（多沙唑嗪组46例中的26例，安慰剂组43例中的11例；P = 0.003）、尿流不畅（多沙唑嗪组55例中的31例，安慰剂组48例中的16例；P = 0.019）、夜尿（多沙唑嗪组56例中的22例，安慰剂组54例中的10例；P = 0.017）和尿急（多沙唑嗪组45例中的27例，安慰剂组42例中的16例；P = 0.041）。尿频在多沙唑嗪治疗后有所改善（多沙唑嗪组59例中的26例，安慰剂组�5例中的15例；P = 0.062）。不良事件最常见的是头晕和头痛，通常较轻且短暂，并导致1例患者停用多沙唑嗪治疗。未观察到性功能或血压有临床显著变化。
多沙唑嗪耐受性良好，可使BPH男性患者的尿动力学和症状均得到改善，从而为现有药物提供了令人满意的替代方案，且具有每日一次给药的额外益处。
