Robinson J M, Brocklehurst J C
Br J Urol. 1983 Aug;55(4):371-6. doi: 10.1111/j.1464-410x.1983.tb03325.x.
A 4-week randomised, double-blind, cross-over study is described which compared the effects of a combination of emepronium bromide and flavoxate hydrochloride with placebo on incontinence and cystometrogram findings in 20 female patients aged 59 to 88 years. All patients initially had detrusor instability demonstrated on cystometrography: 14 patients completed the study; on placebo 10 still had unstable bladders and on active drugs seven were unstable. The number of wettings over a 48-h period before the study commenced and at the end each course of tablets showed no significant differences; also the patients' opinions about the effect on their incontinence indicated that the majority had the same opinion of each course. Active drugs significantly increased residual urine but did not significantly alter the values obtained for maximum cystometric capacity or effective cystometric capacity (the latter volume being maximum cystometric capacity minus the residual urine). No correlation was found, on either course of treatment, between the change to detrusor stability and the amount of improvement in incontinence. Some side effects are described. Despite evidence of a pharmacological effect on the bladder and patients' opinions tending to favour the active combination, nonetheless the main results of this small study do not suggest that the combination of emepronium bromide and flavoxate hydrochloride is an effective treatment of urinary incontinence associated with detrusor instability in elderly women.
本文描述了一项为期4周的随机、双盲、交叉研究,该研究比较了溴化依米普明和盐酸黄酮哌酯联合用药与安慰剂对20名年龄在59至88岁之间女性患者尿失禁及膀胱测压结果的影响。所有患者最初在膀胱测压时均表现为逼尿肌不稳定:14名患者完成了研究;服用安慰剂的10名患者膀胱仍不稳定,服用活性药物的7名患者膀胱不稳定。研究开始前及每个疗程结束时48小时内的遗尿次数无显著差异;患者对尿失禁治疗效果的看法表明,大多数患者对每个疗程的看法相同。活性药物显著增加残余尿量,但未显著改变最大膀胱测压容量或有效膀胱测压容量(后者为最大膀胱测压容量减去残余尿量)的值。在任何一个疗程中,均未发现逼尿肌稳定性的变化与尿失禁改善程度之间存在相关性。文中描述了一些副作用。尽管有证据表明该药物对膀胱有药理作用,且患者的意见倾向于支持联合活性药物,但这项小型研究的主要结果并不表明溴化依米普明和盐酸黄酮哌酯联合用药是治疗老年女性逼尿肌不稳定相关尿失禁的有效方法。