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如何评估和预测经尿道内注射肉毒毒素 A 治疗逼尿肌内注射的成败。

How to assess and predict success or failure of intra-detrusor injections with onabotulinumtoxinA.

机构信息

Department of Urology, Jagiellonian University Medical College, Kraków, Poland.

出版信息

Adv Clin Exp Med. 2019 Apr;28(4):555-567. doi: 10.17219/acem/90764.

Abstract

Intra-detrusor injection therapy with onabotulinumtoxinA is generally accepted as a highly effective, minimally invasive and well-tolerated day procedure for patients with refractory overactive bladder (OAB) and neurogenic detrusor overactivity (NDO). The aim of this study was to summarize currently available methods of assessing treatment efficacy and risk factors that may influence the therapeutic effect of this approach. We found that there are discrepancies in the assessment methods. The evaluation of intra-detrusor injections with onabotulinumtoxinA in clinical trials are not always transposable into day-to-day practice. Moreover, the primary endpoints in clinical trials do not explore the entirety of meaningful patient-centered outcomes. Therefore, in daily clinical practice with patients with overactive bladder syndrome, the therapy should be assessed with objective measures (bladder diaries) and patient-oriented outcomes analyzing the quality of life (questionnaires). In neurogenic individuals, therapeutic efficacy should be additionally evaluated with urodynamic studies. Potential risk factors that may influence the treatment outcomes include urodynamically proven detrusor overactivity, elevated maximum detrusor pressure, greater maximum cystometric capacity, impaired bladder compliance, older age, male gender, a higher baseline bother score, previous anticholinergic treatment, and repeated injections with a subsequent decline in efficacy. The risk of intermittent catheterization following injections seems to depend on the etiology of detrusor overactivity, the injected dose, the injection technique, and the definition of significant post-void residual urine requiring catheterization.

摘要

经尿道内注射肉毒毒素 A 治疗逼尿肌过度活动症是一种安全有效的微创治疗方法,适用于治疗难治性膀胱过度活动症(OAB)和神经源性逼尿肌过度活动(NDO)患者。本研究旨在总结目前评估治疗效果的方法和可能影响该方法治疗效果的危险因素。我们发现,评估方法存在差异。临床试验中对肉毒毒素 A 经尿道内注射的评估并不总是适用于日常实践。此外,临床试验中的主要终点并不能探索有意义的以患者为中心的结局的全部内容。因此,在伴有膀胱过度活动症的患者的日常临床实践中,应使用客观指标(膀胱日记)和分析生活质量(问卷)的患者为导向的结局来评估治疗。在神经源性个体中,应通过尿动力学研究来评估治疗效果。可能影响治疗结果的潜在危险因素包括:经尿动力学证实的逼尿肌过度活动、最大逼尿肌压升高、最大膀胱容量增加、膀胱顺应性降低、年龄较大、男性、较高的基线困扰评分、先前的抗胆碱能治疗、以及随着疗效的下降而反复注射。注射后间歇性导尿的风险似乎取决于逼尿肌过度活动的病因、注射剂量、注射技术和需要导尿的显著残余尿量的定义。

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