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首页> 外文期刊>BJU international >Dysfunctional voiding confirmed by transdermal perineal electromyography, and its effective treatment with baclofen in women with lower urinary tract symptoms: a randomized double-blind placebo-controlled crossover trial.
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Dysfunctional voiding confirmed by transdermal perineal electromyography, and its effective treatment with baclofen in women with lower urinary tract symptoms: a randomized double-blind placebo-controlled crossover trial.

机译:经皮会阴肌电图检查证实功能障碍性排尿功能低下,并用巴氯芬对下尿路症状的妇女有效治疗:一项随机双盲安慰剂对照交叉试验。

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摘要

OBJECTIVES To assess the activity of baclofen, a potent gamma-aminobutyric acid-ergic agonist, against dysfunctional voiding (DV) and lower urinary tract symptoms (LUTS) in a clinical trial, as DV is a leading cause of LUTS in women, but there is no effective treatment. PATIENTS AND METHODS We conducted a randomized double-blind placebo-controlled crossover trial in 60 women with DV and LUTS between January 2003 and January 2006; patients were randomly assigned either baclofen 10 mg three times daily, then matching placebo for 4 weeks, or matching placebo then baclofen 10 mg three times daily for 4 weeks, separated by a 2-week washout period. Voiding diaries and multichannel urodynamics (at baseline, 4 and 10 weeks) were used to record the changes of voids/24 h and urodynamic variables. The primary efficacy endpoint was the change in voids/24 h, and the TL value (log[T/L]), a new electromyographic variables showing the extent of DV. Efficacy outcomes at 4 and 10 weeks were compared with the baseline data, using a crossover-designed analysis of variance model. RESULTS The efficacy analysis of the treatment showed that baclofen was associated with significantly fewer voids/24 h than placebo (mean difference from baseline 5.53 vs 2.70; P = 0.001) and a significant increase in TL (mean difference from baseline -1.78 vs 0.01, P = 0.001). No significant adverse events were reported. CONCLUSIONS A 4-week course of baclofen significantly reduced the number of voids/24 h and increased the TL value in women with DV confirmed by transdermal perineal electromyography. These encouraging results suggest that baclofen could be used for treating DV in women.
机译:目的在临床试验中评估强效的γ-氨基丁酸激动剂巴氯芬对功能障碍性排尿(DV)和下尿路症状(LUTS)的活性,因为DV是女性导致LUTS的主要原因,但是没有有效的治疗方法。患者与方法我们在2003年1月至2006年1月间对60例患有DV和LUTS的女性进行了一项随机双盲安慰剂对照交叉试验。随机分配患者,每天3次,每次10毫克巴氯芬,然后匹配安慰剂4周,或者随机匹配,然后再3次,每天3次巴氯芬10毫克,持续4周,间隔2周。使用空腹日记和多通道尿动力学(在基线,第4周和第10周)记录空洞/ 24小时的变化和尿动力学变量。主要功效终点是空隙/ 24 h的变化和TL值(log [T / L]),这是一个新的肌电图变量,显示了DV的程度。使用交叉设计的方差分析模型,将第4周和第10周的疗效与基线数据进行比较。结果治疗效果分析表明,与安慰剂相比,巴氯芬与24h的空洞率显着减少(与基线相比平均差异5.53比2.70; P = 0.001)和TL显着增加(与基线相比平均差异-1.78对0.01), P = 0.001)。没有重大不良事件的报道。结论经皮会阴肌电图证实,DV的女性在4周疗程中使用了巴氯芬,可显着减少24小时的排尿次数,并提高TL值。这些令人鼓舞的结果表明巴氯芬可用于治疗女性的DV。

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