α受体激动剂盐酸米多君治疗女性压力性尿失禁的临床研究

目的　评价盐酸米多君 (管通 )治疗女性压力性尿失禁的有效性和安全性。　方法　采用多中心、随机、双盲、安慰剂平行对照方法对 136例女性压力性尿失禁患者进行管通与安慰剂的对比研究。试验组 6 8例 ,服管通 2 .5mg/次 ,3次 /d ,疗程 4周 ;对照组 6 8例 ,以安慰剂替代管通。 　结果　完成试验 12 9例 ,,管通组 (6 6例 )平均尿失禁量减少 9.9g ,安慰剂组 (6 3例 )减少 3.1g ;管通组尿失禁等级评分减少 1.0 2分 ,安慰剂组减少 0 .35分 ;管通组的客观有效率和主观有效率分别为 6 6 .7%和 80 .3% ,安慰剂组分别为 31.7%和 33.3% ,两组比较 ,差异均有显著性意义 (P均 <0 .0 0 1)。管通组患者副作用发生率 15 .0 % ,安慰剂组 17.1% ,两组间差异无显著性意义 (P >0 .0 5 )。　结论　盐酸米多君治疗女性压力性尿失禁疗效明显 ,优于安慰剂 ,安全性和耐受性与安慰剂相似。

Midodrine hydrochloride for the treatment of female patients with stress incontinence

Objective To evaluate the efficacy and tolerability of midodrine (Gutron) in female patients with stress incontinence. Methods A randomized,double-blind,parallel,placebo-controlled,multicentric study was carried out.136 female patients with stress incontinence.68 cases in study group received Gutron (2.5 mg,thrice daily) for a course of 4 weeks.68 cases in control group received placebo in the same manner. Results 129 cases completed the treatment.The mean quantity of incontinent urine decreased by 9.9 g in those receiving Gutron ( n =66) and by 3.1 g in placebo ( n =63),respectively ( P < 0.001 ).The mean scores of grade of incontinence decreased by 1.02 and 0.35 in the 2 groups,respectively ( P < 0.001 ).The objective and subjective effective rates for Gutron group were 66.7% and 80.3%,while those for placebo group were 31.7% and 33.3%.The differences between the 2 groups were statistically significant ( P < 0.001 ).In the Gutron group, the total incidence of adverse events was 15.0%,while that in the placebo group was 17.1% ( P >0.05). Conclusions Midodrine hydrochloride at the dose of 2.5 mg thrice daily has greater efficacy on female patients with stress incontinence than placebo, and the tolerability of midodrine was equivalent to that of placebo.