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A型肉毒杆菌毒素与口服疗法(抗胆碱能药物和米拉贝隆)治疗膀胱过度活动症的疗效比较评估:一项系统评价和网状Meta分析

Comparative assessment of the efficacy of onabotulinumtoxinA and oral therapies (anticholinergics and mirabegron) for overactive bladder: a systematic review and network meta-analysis.

作者信息

Drake Marcus J, Nitti Victor W, Ginsberg David A, Brucker Benjamin M, Hepp Zsolt, McCool Rachael, Glanville Julie M, Fleetwood Kelly, James Daniel, Chapple Christopher R

机构信息

University of Bristol and Bristol Urological Institute, Southmead Hospital, Bristol, UK.

Department of Urology, New York University Langone Medical Center, New York, NY, USA.

出版信息

BJU Int. 2017 Nov;120(5):611-622. doi: 10.1111/bju.13945. Epub 2017 Aug 2.

Abstract

OBJECTIVES

To compare the efficacy of onabotulinumtoxinA, mirabegron, and anticholinergics in adults with idiopathic overactive bladder (OAB) using network meta-analysis (NMA).

PATIENTS AND METHODS

Information sources were searched for blinded randomised controlled trials (RCTs), of ≥2 weeks duration, comparing any dose of onabotulinumtoxinA, eligible oral/transdermal anticholinergics, or mirabegron, with each other or placebo, in adults with OAB. Bayesian random-effects models were used to synthesise the results at week 12: NMA for responder analyses and network meta-regression (NMR) for change from baseline analyses. The NMR was used to adjust for differences in baseline severity between studies. Sensitivity analysis, excluding studies considered to be at a high risk of methodological bias, was conducted.

RESULTS

In all, 56 RCTs were included in the networks. For each outcome, results are reported for all licensed treatment doses. For each NMR, results are based on patients with an average number of episodes of the outcome at baseline. After 12 weeks, all treatments were more efficacious than placebo. Patients who received onabotulinumtoxinA (100 U) had, on average, the greatest reductions in urinary incontinence episodes (UIE), urgency episodes, and micturition frequency, and the highest odds of achieving decreases of 100% and ≥50% from baseline in UIE/day. When comparing onabotulinumtoxinA with other pharmacotherapies, mean differences favoured onabotulinumtoxinA 100 U over all comparators for UIE and urgency episodes (credible intervals excluded zero) and all but two of the comparators for micturition frequency. OnabotulinumtoxinA 100 U was also associated with higher odds of achieving a 100% and ≥50% decrease in UIE/day than most other licensed treatments in the network. The exclusion of studies with a high risk of bias had little impact on the conclusions.

CONCLUSION

The results indicate that, after 12 weeks, onabotulinumtoxinA 100 U provides greater relief of OAB symptoms compared with most other licensed doses of other pharmacotherapies in the network.

摘要

目的

采用网状Meta分析(NMA)比较成人特发性膀胱过度活动症(OAB)患者中A型肉毒毒素、米拉贝隆和抗胆碱能药物的疗效。

患者与方法

检索信息源,查找持续时间≥2周的盲法随机对照试验(RCT),这些试验比较了任何剂量的A型肉毒毒素、合格的口服/经皮抗胆碱能药物或米拉贝隆,相互之间或与安慰剂相比,在成人OAB患者中的疗效。采用贝叶斯随机效应模型在第12周时综合结果:用于反应者分析的NMA和用于基线分析变化的网状Meta回归(NMR)。NMR用于调整研究间基线严重程度的差异。进行了敏感性分析,排除了被认为存在高方法学偏倚风险的研究。

结果

总共56项RCT被纳入网状分析。对于每个结局,报告了所有获批治疗剂量的结果。对于每个NMR,结果基于基线时结局发作次数平均的患者。12周后,所有治疗均比安慰剂更有效。接受A型肉毒毒素(100 U)治疗的患者,平均尿失禁发作次数(UIE)、尿急发作次数和排尿频率减少最多,且从基线时UIE/天减少100%和≥50%的几率最高。将A型肉毒毒素与其他药物疗法比较时,对于UIE和尿急发作次数,平均差值支持100 U的A型肉毒毒素优于所有对照(可信区间不包括零),对于排尿频率,除两个对照外,在所有对照中均如此。100 U的A型肉毒毒素与网络中大多数其他获批治疗相比,从基线时UIE/天减少100%和≥50%的几率也更高。排除高偏倚风险的研究对结论影响不大。

结论

结果表明,12周后,与网络中大多数其他获批剂量的其他药物疗法相比,100 U的A型肉毒毒素能更有效地缓解OAB症状。

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