Thüroff J W, Bunke B, Ebner A, Faber P, de Geeter P, Hannappel J, Heidler H, Madersbacher H, Melchior H, Schäfer W
Department of Urology, Johannes-Gutenberg University Medical School, Mainz, Federal Republic of Germany.
J Urol. 1991 Apr;145(4):813-6; discussion 816-7. doi: 10.1016/s0022-5347(17)38459-8.
Clinical efficacy and adverse effects of oxybutynin and propantheline in the treatment of symptoms related to detrusor hyperactivity were studied in a randomized, controlled, double-blind multicenter trial. Of 169 patients entered into the study 154 were evaluable for statistical analysis. Mean grade of improvement (visual analogue scale) was significantly higher with oxybutynin (58.2%) versus propantheline (44.7%) and placebo (43.4%). Mean bladder volume at first involuntary cystometric contraction was significantly increased with oxybutynin (+57.0 ml.) versus placebo (-9.7 ml.). Mean maximum cystometric bladder capacity was also significantly increased with oxybutynin (+80.1 ml.) versus placebo (+22.5 ml.). Rate of inquired possible adverse effects was significantly higher for oxybutynin (63%) versus propantheline (44%) and placebo (33%). However, only 5 patients dropped out of the study because of adverse effects (oxybutynin 2 and propantheline 3). No serious or lasting adverse effects were encountered with dryness of the mouth being the major complaint. Oxybutynin has statistically significant effects on subjective symptoms and objective urodynamic parameters in patients with detrusor hyperactivity compared to propantheline.
在一项随机、对照、双盲多中心试验中，研究了奥昔布宁和丙胺太林治疗逼尿肌活动亢进相关症状的临床疗效和不良反应。纳入研究的169例患者中，154例可进行统计学分析。奥昔布宁（58.2%）的平均改善程度（视觉模拟量表）显著高于丙胺太林（44.7%）和安慰剂（43.4%）。与安慰剂（-9.7 ml）相比，奥昔布宁使首次非自愿膀胱测压收缩时的平均膀胱容量显著增加（+57.0 ml）。与安慰剂（+22.5 ml）相比，奥昔布宁也使最大膀胱测压容量显著增加（+80.1 ml）。奥昔布宁的可能不良反应询问率（63%）显著高于丙胺太林（44%）和安慰剂（33%）。然而，只有5例患者因不良反应退出研究（奥昔布宁2例，丙胺太林3例）。未出现严重或持久的不良反应，主要抱怨为口干。与丙胺太林相比，奥昔布宁对逼尿肌活动亢进患者的主观症状和客观尿动力学参数具有统计学显著影响。
