Akkoc Yesim
Department of Physical Medicine and Rehabilitation, Ege University Medical Faculty, Izmir, Turkey.
Spinal Cord. 2022 Oct;60(10):854-861. doi: 10.1038/s41393-022-00853-3. Epub 2022 Sep 9.
Systematic review.
To evaluate the efficacy and safety of mirabegron in patients with neurogenic detrusor overactivity due to SCI or MS.
A comprehensive search of the Pubmed, Cochrane, Scopus, and Embase databases was performed. Studies evaluating adult patients with neurogenic detrusor overactivity due to SCI or MS were analyzed according to clinical and urodynamic outcome parameters.
A total of 488 patients were included in 11 studies, with sample sizes ranging from 15 to 91. The duration of the treatments varied from 4 weeks to 12 months. Mirabegron was used as a secondline treatment after anticholinergics in most of the studies. While clinical outcome parameters are used in studies involving only MS patients, urodynamic outcome parameters are also used in studies involving patients with SCI. The efficacy of mirabegron was found not to be different than anticholinergics when compared in MS patients. Comprehensive urodynamic evaluation was performed in 2 randomized, double-blind, placebo-controlled studies and no satisfactory results were obtained compared to placebo. In retrospective studies there were some significant improvements in P, MCC and compliance. The major safety concern with mirabegron is cardiovascular safety. In one study, tachyarrhythmia and palpitations reported in a patient with SCI at C6 level, in another study tachycardia reported in one patient with MS.
Although mirabegron demonstrates similar clinical efficacy to anticholinergics in MS patients, its effect on urodynamic parameters in patients with SCI cannot be considered satisfactory. It has a good safety profile with mild cardiovascular side effects.
系统评价。
评估米拉贝隆对脊髓损伤(SCI)或多发性硬化症(MS)所致神经源性逼尿肌过度活动患者的疗效和安全性。
全面检索了PubMed、Cochrane、Scopus和Embase数据库。根据临床和尿动力学结果参数,对评估SCI或MS所致神经源性逼尿肌过度活动成年患者的研究进行分析。
11项研究共纳入488例患者,样本量从15例至91例不等。治疗持续时间从4周至12个月不等。在大多数研究中,米拉贝隆在抗胆碱能药物之后用作二线治疗。仅涉及MS患者的研究使用临床结果参数,而涉及SCI患者的研究也使用尿动力学结果参数。在MS患者中比较时,发现米拉贝隆的疗效与抗胆碱能药物无异。在2项随机、双盲、安慰剂对照研究中进行了全面尿动力学评估,与安慰剂相比未获得满意结果。在回顾性研究中,在膀胱压力、最大膀胱容量和依从性方面有一些显著改善。米拉贝隆的主要安全问题是心血管安全性。在一项研究中,一名C6级SCI患者报告了快速性心律失常和心悸,在另一项研究中,一名MS患者报告了心动过速。
尽管米拉贝隆在MS患者中显示出与抗胆碱能药物相似的临床疗效,但其对SCI患者尿动力学参数的影响不能认为是令人满意的。它具有良好的安全性,心血管副作用轻微。