Cooley Lauren Folgosa, Kielb Stephanie
Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Department of Urology, Northwestern University Feinberg School of Medicine, 303 E Chicago Ave, Tarry 16-703 Chicago, Illinois 60611.
PM R. 2019 Feb;11(2):192-200. doi: 10.1016/j.pmrj.2018.07.016. Epub 2019 Feb 13.
Prior to FDA approval of intradetrusor botulinum toxin (BoTA) injections for the treatment of neurogenic bladder, patients' treatment options were limited to use of pharmacotherapies such as antimuscarinics, alpha blockers, and more recently beta agonists (some off-label) or invasive interventions including bladder augmentation and urinary diversion procedures. Herein, we provide a comprehensive literature review detailing the salient clinical literature that led to FDA approval of intradetrusor BoTA for neurogenic bladder. Patients with neurogenic detrusor overactivity and detrusor sphincter dyssynergia have been shown in randomized studies to benefit significantly from intradetrusor BoTA injection with regard to the following parameters: improved voided volume, improved bladder pressure and urodynamic parameters, reduced incidence of urinary tract infection, and improved quality of life. Intradetrusor BoTA injection has revolutionized the treatment landscape for patients with neurogenic bladder by providing them with a safe, efficacious, and cost-effective means to reduce bladder dysfunction, preserve renal function, and reduce the need for invasive, surgical intervention. LEVEL OF EVIDENCE: I.
在美国食品药品监督管理局(FDA)批准膀胱内注射肉毒杆菌毒素(BoTA)用于治疗神经源性膀胱之前,患者的治疗选择仅限于使用抗胆碱能药物、α受体阻滞剂等药物疗法,以及最近使用的β受体激动剂(部分为非适应证用药),或采用包括膀胱扩大术和尿流改道术在内的侵入性干预措施。在此,我们提供一篇全面的文献综述,详细介绍促使FDA批准膀胱内注射BoTA用于治疗神经源性膀胱的重要临床文献。随机研究表明,患有神经源性逼尿肌过度活动症和逼尿肌括约肌协同失调的患者,在以下参数方面可从膀胱内注射BoTA中显著获益:排尿量增加、膀胱压力和尿动力学参数改善、尿路感染发生率降低以及生活质量提高。膀胱内注射BoTA为神经源性膀胱患者提供了一种安全、有效且经济高效的方法,以减少膀胱功能障碍、保护肾功能并减少侵入性手术干预的需求,从而彻底改变了该疾病的治疗格局。证据级别:I级。