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抗胆碱能药物与非药物活性疗法治疗成人非神经源性膀胱过度活动症

Anticholinergic drugs versus non-drug active therapies for non-neurogenic overactive bladder syndrome in adults.

作者信息

Rai Bhavan Prasad, Cody June D, Alhasso Ammar, Stewart Laurence

机构信息

Department of Urology, Aberdeen Royal Infirmary, Aberdeen, UK.

出版信息

Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD003193. doi: 10.1002/14651858.CD003193.pub4.

Abstract

BACKGROUND

Overactive bladder syndrome is defined as urgency with or without urgency incontinence, usually with frequency and nocturia. Pharmacotherapy with anticholinergic drugs is often the first line medical therapy, either alone or as an adjunct to various non-pharmacological therapies after conservative options such as reducing intake of caffeine drinks have been tried. Non-pharmacologic therapies consist of bladder training, pelvic floor muscle training with or without biofeedback, behavioural modification, electrical stimulation and surgical interventions.

OBJECTIVES

To compare the effects of anticholinergic drugs with various non-pharmacologic therapies for non-neurogenic overactive bladder syndrome in adults.

SEARCH METHODS

We searched the Cochrane Incontinence Group Specialised Register (searched 4 September 2012), which includes searches of the Cochrane Central Register of Controlled Trials (CENTRAL) and MEDLINE, and the reference lists of relevant articles.

SELECTION CRITERIA

All randomised or quasi-randomised, controlled trials of treatment with anticholinergic drugs for overactive bladder syndrome or urgency urinary incontinence in adults in which at least one management arm involved a non-drug therapy. Trials amongst patients with neurogenic bladder dysfunction were excluded.

DATA COLLECTION AND ANALYSIS

Two authors evaluated the trials for appropriateness for inclusion and risk of bias. Two authors were involved in the data extraction. Data extraction was based on predetermined criteria. Data analysis was based on standard statistical approaches used in Cochrane reviews.

MAIN RESULTS

Twenty three trials were included with a total of 3685 participants, one was a cross-over trial and the other 22 were parallel group trials. The duration of follow up varied from two to 52 weeks. The trials were generally small and of poor methodological quality. During treatment, symptomatic improvement was more common amongst those participants on anticholinergic drugs compared with bladder training in seven small trials (73/174, 42% versus 98/172, 57% not improved: risk ratio 0.74, 95% confidence interval 0.61 to 0.91). Augmentation of bladder training with anticholinergics was also associated with more improvements than bladder training alone in three small trials (23/85, 27% versus 37/79, 47% not improved: risk ratio 0.57, 95% confidence interval 0.38 to 0.88). However, it was less clear whether an anticholinergic combined with bladder training was better than the anticholinergic alone, in three trials (for example 74/296, 25% versus 95/306, 31% not improved: risk ratio 0.80, 95% confidence interval 0.62 to 1.04). The other information on whether combining behavioural modification strategies with an anticholinergic was better than the anticholinergic alone was scanty and inconclusive. Similarly, it was unclear whether these complex strategies alone were better than anticholinergics alone.In this review, seven small trials comparing an anticholinergic to various types of electrical stimulation modalities such as Intravaginal Electrical Stimulation (IES), transcutaneous electrical nerve stimulation (TENS), the Stoller Afferent Nerve Stimulation System (SANS) neuromodulation and percutaneous posterior tibial nerve stimulation (PTNS) were identified. Subjective improvement rates tended to favour the electrical stimulation group in three small trials (54% not improved with the anticholinergic versus 28/86, 33% with electrical stimulation: risk ratio 0.64, 95% confidence interval 1.15 to 2.34). However, this was statistically significant only for one type of stimulation, percutaneous posterior tibial nerve stimulation (risk ratio 2.21, 95% confidence interval 1.13 to 4.33), and was not supported by significant differences in improvement, urinary frequency, urgency, nocturia, incontinence episodes or quality of life.The most commonly reported adverse effect among anticholinergics was dry mouth, although this did not necessarily result in withdrawal from treatment. For all comparisons there were too few data to compare symptoms or side effects after treatment had ended. However, it is unlikely that the effects of anticholinergics persist after stopping treatment.

AUTHORS' CONCLUSIONS: The use of anticholinergic drugs in the management of overactive bladder syndrome is well established when compared to placebo treatment. During initial treatment of overactive bladder syndrome there was more symptomatic improvement when (a) anticholinergics were compared with bladder training alone, and (b) anticholinergics combined with bladder training were compared with bladder training alone. Limited evidence from small trials might suggest electrical stimulation is a better option in patients who are refractory to anticholinergic therapy, but more evidence comparing individual types of electrostimulation to the most effective types of anticholinergics is required to establish this. These results should be viewed with caution in view of the different classes and varying doses of individual anticholinergics used in this review. Anticholinergics had well recognised side effects, such as dry mouth.

摘要

背景

膀胱过度活动症综合征的定义为尿急,伴或不伴有急迫性尿失禁,通常还伴有尿频和夜尿症。抗胆碱能药物的药物治疗通常是一线药物治疗,可单独使用,也可在尝试过如减少咖啡因饮料摄入量等保守方法后,作为各种非药物治疗的辅助手段。非药物治疗包括膀胱训练、有或无生物反馈的盆底肌训练、行为改变、电刺激和手术干预。

目的

比较抗胆碱能药物与各种非药物疗法对成人非神经源性膀胱过度活动症综合征的疗效。

检索方法

我们检索了Cochrane尿失禁小组专业注册库(2012年9月4日检索),其中包括对Cochrane对照试验中央注册库(CENTRAL)和MEDLINE的检索,以及相关文章的参考文献列表。

入选标准

所有针对成人膀胱过度活动症综合征或急迫性尿失禁使用抗胆碱能药物治疗的随机或半随机对照试验,其中至少一个治疗组涉及非药物治疗。排除神经源性膀胱功能障碍患者的试验。

数据收集与分析

两位作者评估试验是否适合纳入以及偏倚风险。两位作者参与数据提取。数据提取基于预先确定的标准。数据分析基于Cochrane系统评价中使用的标准统计方法。

主要结果

纳入23项试验,共3685名参与者,1项为交叉试验,其他22项为平行组试验。随访时间从2周到52周不等。试验规模一般较小,方法学质量较差。在治疗期间,与膀胱训练相比,抗胆碱能药物治疗的参与者症状改善更为常见,在7项小型试验中(73/174,42% 与98/172,57% 未改善:风险比0.74,95% 置信区间0.61至0.91)。在3项小型试验中,抗胆碱能药物联合膀胱训练也比单纯膀胱训练有更多改善(23/85,27% 与37/79,47% 未改善:风险比0.57,95% 置信区间0.38至0.88)。然而,在3项试验中,抗胆碱能药物联合膀胱训练是否优于单独使用抗胆碱能药物尚不清楚(例如74/296,25% 与95/306,31% 未改善:风险比0.80,95% 置信区间0.62至1.04)。关于将行为改变策略与抗胆碱能药物联合使用是否优于单独使用抗胆碱能药物的其他信息很少且无定论。同样,不清楚这些复杂策略单独使用是否优于单独使用抗胆碱能药物。在本综述中,识别出7项小型试验,比较了抗胆碱能药物与各种类型的电刺激方式,如阴道内电刺激(IES)、经皮神经电刺激(TENS)、斯托勒传入神经刺激系统(SANS)神经调节和经皮胫后神经刺激(PTNS)。在3项小型试验中,主观改善率倾向于电刺激组(抗胆碱能药物治疗未改善者占54%,电刺激治疗者占28/86,33%:风险比0.64,95% 置信区间1.15至2.34)。然而,仅对一种刺激类型经皮胫后神经刺激有统计学意义(风险比2.21,95% 置信区间1.13至4.33),且在改善、尿频、尿急、夜尿、尿失禁发作次数或生活质量方面无显著差异支持。抗胆碱能药物中最常报告的不良反应是口干,尽管这不一定导致停药。对于所有比较,治疗结束后比较症状或副作用的数据太少。然而,抗胆碱能药物的作用在停药后不太可能持续。

作者结论

与安慰剂治疗相比,抗胆碱能药物在膀胱过度活动症综合征的管理中应用已得到充分证实。在膀胱过度活动症综合征的初始治疗中,当(a)抗胆碱能药物与单独的膀胱训练相比,以及(b)抗胆碱能药物联合膀胱训练与单独的膀胱训练相比时,有更多的症状改善。小型试验的有限证据可能表明,电刺激对于对抗胆碱能治疗难治的患者是更好的选择,但需要更多比较个体类型电刺激与最有效的抗胆碱能药物类型的证据来证实这一点。鉴于本综述中使用的抗胆碱能药物种类不同且剂量各异,应谨慎看待这些结果。抗胆碱能药物有公认的副作用,如口干。

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