Department of Urology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
World J Urol. 2011 Apr;29(2):217-23. doi: 10.1007/s00345-011-0654-7. Epub 2011 Feb 16.
Comparison of efficacy of propiverine extended release (ER) 30 mg o.d. in the treatment of male OAB administered as monotherapy (MT) or add-on to α-blockers (combination treatment, CT) in relation to maximum urinary flow (Q(max)) in a non-interventional study.
Men ≥40 years with OAB symptoms, Q(max) ≥10 ml/s, prostate volume <40 ml, post-void residuals (PVR) <100 ml, and IPSS <20 were included. OAB symptoms, IPSS, and PVR were recorded before and after 12 weeks of treatment. Participants were stratified by Q(max) (group A ≥15 ml/s, group B <15 ml/s) and CT vs. MT. Safety parameters were monitored.
A total of 2,219 men participated and were involved in safety analysis; 1,849 men (mean age 66 years) fulfilled the inclusion criteria and were involved in efficacy analysis. In group A, 291 men received MT and 479 CT; in group B, 184 men received MT and 895 CT. OAB symptoms improved significantly in all groups throughout the study without differences between MT and CT. IPSS improvement in group B was less with MT than with CT (-3.9 vs. -5.2; P < 0.001), whereas IPSS improvement was similar in group A (-4.6 vs. -5.1). Mean PVR change was not clinically relevant, but two men (0.1%) experienced urinary retention.
Under real-life conditions, treatment of OAB symptoms with propiverine ER is equally effective in men with MT or CT regardless of baseline Q(max). In men with reduced Q(max), IPSS improvement is significantly smaller with MT. The incidence of urinary retention during propiverine ER treatment is low.
在一项非干预性研究中，比较每日一次口服普罗维林缓释片（ER）30mg 对男性 OAB 的疗效，该药作为单一疗法（MT）或联合 α 受体阻滞剂（联合治疗，CT）的最大尿流率（Q(max)）。
纳入年龄≥40 岁、OAB 症状、Q(max)≥10ml/s、前列腺体积<40ml、残余尿量（PVR）<100ml、国际前列腺症状评分（IPSS）<20 的男性。在治疗前和治疗后 12 周记录 OAB 症状、IPSS 和 PVR。根据 Q(max)（A 组≥15ml/s，B 组<15ml/s）和 CT 与 MT 进行分层。监测安全性参数。
共 2219 名男性参与了安全性分析；1849 名男性（平均年龄 66 岁）符合纳入标准并进行了疗效分析。在 A 组中，291 名男性接受 MT，479 名男性接受 CT；在 B 组中，184 名男性接受 MT，895 名男性接受 CT。在整个研究过程中，所有组的 OAB 症状均显著改善，MT 和 CT 之间无差异。B 组的 MT 治疗后 IPSS 改善程度低于 CT（-3.9 比-5.2；P<0.001），而 A 组的 IPSS 改善程度相似（-4.6 比-5.1）。平均 PVR 变化无临床意义，但有 2 名男性（0.1%）发生尿潴留。
在真实环境下，无论基线 Q(max)如何，男性 OAB 症状用普罗维林 ER 治疗，MT 或 CT 同样有效。在 Q(max)降低的男性中，MT 治疗后 IPSS 改善程度明显较小。普罗维林 ER 治疗期间尿潴留的发生率较低。
