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成人神经源性下尿路功能障碍的非侵入性和膀胱内治疗的有效性和安全性:一项随机对照试验的系统评价和网状Meta分析

Efficiency and Safety of Noninvasive and Intravesical Therapy for Adult Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.

作者信息

Wang Qiang, Li Canyong, Long Yongfu, Cao Bin, Lu Yangbo, Luo Gang, Huang Yaqiang, Huang Guiyan, Huang Hongxing

机构信息

Zhongshan People's Hospital, Zhongshan, China.

出版信息

Drugs. 2025 May;85(5):677-693. doi: 10.1007/s40265-025-02171-3. Epub 2025 Apr 1.

DOI:10.1007/s40265-025-02171-3
PMID:40167970
Abstract

BACKGROUND

Neurogenic lower urinary tract dysfunction (NLUTD), a complex abnormality caused by multiple neurologic disorders, is a serious threat to patients' prognosis and quality of life. However, benefit and safety for various treatments are inconsistent. The aim of the current study was to investigate the available trials of adult NLUTD treatments and provide valuable insights for clinical practice.

METHODS

The data sources were Medline, Embase, and Cochrane databases up to 31 December 2023. A Bayesian network meta-analysis was conducted with randomized controlled trials in patients who were diagnosed with NLUTD, reporting clinical symptoms and urodynamic data. The main outcomes were incontinence episodes frequency (IEF) and maximum cystometric capacity (MCC). Secondary outcomes included frequency, maximum detrusor pressure, bladder compliance, volume of involuntary detrusor contraction, voided volume, incontinence, quality of life, and adverse events.

RESULTS

A total of 54 articles were eligible, evaluating 28 treatments and 4478 patients for efficacy and safety. Compared with the control group, the oxybutynin instillation demonstrated a mean reduction in IEF of - 2.65 episodes (95% confidence interval [CI]: - 4.64 to - 0.67), with a surface under the cumulative ranking curve (SUCRA) value of 85.8%. Botulinum toxin trigone-combined injection resulted in a reduction of -2.30 episodes (95% CI: -3.23 to - 1.44; SUCRA 84.2%). Additionally, intravesical therapies significantly increased MCC: oxybutynin instillation (mean 227.75 mL, 95% CI 147.00 to 311.42, SUCRA 99.1%) and BTX300U (mean 147.88 mL, 95% CI 100.45-190.32, SUCRA 83.2%). Botulinum toxin injection emerged as the preferred option for improving most urodynamic outcomes and quality of life. However, the incidence of adverse events associated with intravesical injections was higher compared with oral medications and other noninvasive therapies. The three types of botulinum toxins (onabotulinum toxin, abobotulinum toxin, and incobotulinum toxin) demonstrated consistent efficacy in treating both IEF and MCC. Individual studies were sequentially excluded for analysis of network stability. Most results from the alternative networks were consistent with the original analysis, although specific trials influenced certain therapy rankings.

CONCLUSIONS

Overall, oxybutynin instillation and intravesical botulinum toxin injection demonstrated significant advantages in improving symptoms and urodynamic parameters. Our findings support intravesical treatment as a safe and effective option, provided that patients are fully informed about their treatment choices. Clinically, intravesical therapies, oral medications, nerve stimulation, and other treatments should be integrated into shared decision-making processes, while some options require further research to bolster the supporting evidence.

摘要

背景

神经源性下尿路功能障碍(NLUTD)是一种由多种神经系统疾病引起的复杂异常,对患者的预后和生活质量构成严重威胁。然而,各种治疗方法的疗效和安全性并不一致。本研究的目的是调查成人NLUTD治疗的现有试验,并为临床实践提供有价值的见解。

方法

数据来源为截至2023年12月31日的Medline、Embase和Cochrane数据库。对诊断为NLUTD的患者进行随机对照试验,采用贝叶斯网络荟萃分析,报告临床症状和尿动力学数据。主要结局为尿失禁发作频率(IEF)和最大膀胱测压容量(MCC)。次要结局包括排尿频率、最大逼尿肌压力、膀胱顺应性、逼尿肌不自主收缩体积、排尿量、尿失禁、生活质量和不良事件。

结果

共有54篇文章符合纳入标准,评估了28种治疗方法和4478例患者的疗效和安全性。与对照组相比,奥昔布宁膀胱灌注使IEF平均降低2.65次发作(95%置信区间[CI]:-4.64至-0.67),累积排名曲线下面积(SUCRA)值为85.8%。肉毒杆菌毒素三角区联合注射使发作次数减少2.30次(95%CI:-3.23至-1.44;SUCRA 84.2%)。此外,膀胱内治疗显著增加了MCC:奥昔布宁膀胱灌注(平均227.75 mL,95%CI 147.00至311.42,SUCRA 99.1%)和BTX300U(平均147.88 mL,95%CI 100.45 - 190.32,SUCRA 83.2%)。肉毒杆菌毒素注射成为改善大多数尿动力学结局和生活质量的首选方案。然而,与口服药物和其他非侵入性治疗相比,膀胱内注射相关不良事件的发生率更高。三种肉毒杆菌毒素(A型肉毒毒素、B型肉毒毒素和C型肉毒毒素)在治疗IEF和MCC方面显示出一致的疗效。为分析网络稳定性,依次排除了个别研究。尽管特定试验影响了某些治疗方法的排名,但替代网络的大多数结果与原始分析一致。

结论

总体而言,奥昔布宁膀胱灌注和膀胱内肉毒杆菌毒素注射在改善症状和尿动力学参数方面显示出显著优势。我们的研究结果支持膀胱内治疗作为一种安全有效的选择,前提是患者充分了解其治疗选择。临床上,膀胱内治疗、口服药物、神经刺激和其他治疗应纳入共同决策过程,而一些选择需要进一步研究以加强支持证据。

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