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尿急失禁:戊噻嗪与安慰剂及丙胺太林的随机交叉试验

Urinary urge incontinence: randomised crossover trials of penthienate versus placebo and propantheline.

作者信息

Coombes G M, Millard R J

机构信息

Department of Urology, Prince Henry Hospital, Sydney, NSW.

出版信息

Med J Aust. 1996 Nov 4;165(9):473-6. doi: 10.5694/j.1326-5377.1996.tb138610.x.

DOI:10.5694/j.1326-5377.1996.tb138610.x
PMID:8937366
Abstract

OBJECTIVE

To compare the efficacy of penthienate with that of propantheline and placebo for treatment of primary idiopathic detrusor instability.

DESIGN

Two prospective, randomised, crossover trials (double-blind for penthienate versus placebo and non-blinded for penthienate versus propantheline).

SETTING

Urology Clinic of Prince Henry Hospital, Sydney, NSW (an outpatient clinic of a tertiary referral hospital), in 1993-1994.

PARTICIPANTS

Neurologically intact patients with urodynamically proven detrusor instability, urgency and urge incontinence, but no stress incontinence (20 participated in the penthienate/placebo trial and 23 in the penthienate/propanthelin trial).

OUTCOME MEASURES

Cystometrography results before and after treatment; frequency and volumes of urine voided in weeks 1 and 4 of treatment; and patient scores for degree of continence, side effects, efficacy and acceptability of treatment.

INTERVENTIONS

Penthienate (5 mg), propantheline (15 mg) or placebo (all three times a day) for 4 weeks.

RESULTS

Penthienate produced significantly greater improvements than placebo in frequency (daytime, P = 0.002; and night-time, P = 0.02), incontinence scores (P = 0.002) and amplitude of unstable detrusor contractions, when present (P = 0.01), and significantly increased diurnal and nocturnal bladder capacity, both on cystometrography (P = 0.003) and by voiding-diary records (P < 0.001). It also increased residual urine volume over the baseline level, but not significantly. Side effects, especially dry mouth, were common with penthienate, and one patient developed urinary retention. Penthienate was significantly better than propantheline in improving cystometric capacity (P = 0.03), and reducing the amplitude of unstable detrusor contractions (P = 0.01), and was perceived as more effective by patients for frequency, nocturia and incontinence.

CONCLUSIONS

Penthienate (5 mg three times a day) was objectively and subjectively significantly better than both placebo and propantheline (15 mg three times a day) for treatment of primary idiopathic detrusor instability.

摘要

目的

比较喷噻托酯与丙胺太林及安慰剂治疗原发性特发性逼尿肌不稳定的疗效。

设计

两项前瞻性、随机、交叉试验(喷噻托酯与安慰剂对比为双盲试验,喷噻托酯与丙胺太林对比为非盲试验)。

地点

1993 - 1994年,新南威尔士州悉尼亨利王子医院泌尿外科诊所(一家三级转诊医院的门诊诊所)。

参与者

神经功能正常、经尿动力学证实有逼尿肌不稳定、尿急及急迫性尿失禁但无压力性尿失禁的患者(20名参与喷噻托酯/安慰剂试验,23名参与喷噻托酯/丙胺太林试验)。

观察指标

治疗前后的膀胱测压结果;治疗第1周和第4周的排尿频率及尿量;患者的控尿程度、副作用、疗效及治疗可接受性评分。

干预措施

喷噻托酯(5毫克)、丙胺太林(15毫克)或安慰剂(均每日3次),疗程4周。

结果

喷噻托酯在改善排尿频率(日间,P = 0.002;夜间,P = 0.02)、尿失禁评分(P = 0.002)以及存在不稳定逼尿肌收缩时的收缩幅度(P = 0.01)方面显著优于安慰剂,并且在膀胱测压(P = 0.003)及排尿日记记录(P < 0.001)中均显著增加了日间和夜间膀胱容量。它还使残余尿量高于基线水平,但未达显著差异。喷噻托酯的副作用,尤其是口干较为常见,且有1例患者出现尿潴留。在改善膀胱测压容量(P = 0.03)及降低不稳定逼尿肌收缩幅度(P = 0.01)方面,喷噻托酯显著优于丙胺太林,且患者认为其在改善排尿频率、夜尿症及尿失禁方面更有效。

结论

对于原发性特发性逼尿肌不稳定的治疗,喷噻托酯(每日3次,每次5毫克)在客观和主观上均显著优于安慰剂及丙胺太林(每日3次,每次15毫克)。

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