[多肽药物 Vesusten 治疗多发性硬化症神经源性 LUTS 的有效性和安全性。试点研究结果]。

Q4 Medicine Urologiia Pub Date : 2024-07-01
N Abdallah Nemer M, I Belousov I, I Kogan M, A Goncharova Z, E Belousova M
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引用次数: 0

摘要

研究目的本研究旨在评估索利那新和维苏丁这两种药物治疗多发性硬化症(MS)神经源性膀胱过度活动的有效性:进行了一项前瞻性、单地点、单中心、安慰剂对照、平行组比较临床试验。研究对象包括 41 名经尿动力学证实有逼尿肌过度活动的多发性硬化症患者,男女患者年龄均为 18-50 岁。数据通过填写排尿日记获得。临床数据在服药前、每月疗程期间和疗程结束后的一个月观察期间进行评估。结果采用非参数统计分析方法进行处理:结果:这两种药物对多发性硬化症患者都能有效纠正神经源性膀胱过度活动。同时,与索利那新相比,维苏丁在膀胱过度活动症(OAB)的临床表现方面显示出更好的临床疗效。排尿困难和尿急症状也明显减轻。在尿失禁频率和膀胱过度活动综合征方面,维苏丁的疗效维持情况最好。研究结果表明,索利那新和维苏坦可引起不良反应,其频率和性质与生产商公布的数据相符:讨论:考虑到多发性硬化症的临床特征,治疗的首要任务除了有效性之外,就是最大限度地采取保守疗法。目前推荐的神经源性膀胱过度活动治疗仅限于使用 M-anticholinergics 和 A 型肉毒毒素药物的尿道内给药。与此同时,这种治疗方法还经常出现多种副作用。新的有效治疗药物的出现是治疗多发性硬化症患者神经源性膀胱过度活动的一个有希望的方向:结论:索利非那新和维舒婷都是治疗多发性硬化症神经源性膀胱过度活动的有效疗法。然而,维苏丁的治疗效果更显著,表现在对花粉尿、急迫性尿失禁和尿急的纠正上。治疗结束后,与索利那新相比,维苏丁仍能保持较强的治疗效果。综合排尿日记的各种评估参数,维苏丁是一种优先治疗药物,可为多发性硬化症患者带来最佳的生活质量。
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[Efficacy and safety of the polypeptide drug Vesusten in the correction of neurogenic LUTS in Multiple Sclerosis. Results of the pilot study].

Objective: The purpose of this study was to evaluate the effectiveness of the drugs Solifenacin and Vesusten in relation to the treatment of neurogenic bladder overactivity in multiple sclerosis (MS).

Materials and methods: A prospective, single-site, single-center, placebo-controlled, parallel-group, comparative clinical trial was conducted. The study included 41 MS patients of both sexes aged 18-50 years with urodynamically confirmed detrusor overactivity. Data were obtained by completing a voiding diary. Clinical data were assessed before taking the drugs, during a monthly course of therapy and after a month of observation after the end of treatment. The results were processed by nonparametric methods of statistical analysis.

Results: Both drugs are effective in patients with MS to correct neurogenic bladder overactivity. At the same time, in comparison with Solifenacin, Vesusten showed better clinical efficacy in relation to clinical manifestations of overactive bladder (OAB). Pollakiuria and urgency also decreased significantly. The best profile of maintaining the therapeutic effect was observed with Vesusten in relation to the frequency of urinary incontinence and OAB syndrome. The results of the study established that Solifenacin and Vesusten can cause adverse events, the frequency and nature of which correspond to the data declared by the manufacturers.

Discussion: Considering the clinical features of MS, the priority in treatment, in addition to effectiveness, is maximum conservative therapy. The currently recommended therapy for neurogenic bladder overactivity is limited to the use of M-anticholinergics and intradetrusor administration of botulinum toxin type A drugs. At the same time, multiple side effects of such treatment are observed with a high frequency. The emergence of a new effective therapeutic agent is a promising direction for the treatment of neurogenic bladder overactivity in patients with MS.

Conclusions: Both Solifenacin and Vesusten are effective therapeutic options for the management of neurogenic bladder overactivity in MS. However, Vesusten has a more significant therapeutic profile, expressed in the correction of pollakiuria, urge incontinence and urgency. After completion of therapy, Vesusten, in comparison with Solifenacin, demonstrates the retention of a strong therapeutic effect. Based on the combination of various assessment parameters of a voiding diary, Vesusten is a priority therapeutic agent that determines the best quality of life profile for patients with MS.

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来源期刊
Urologiia
Urologiia Medicine-Medicine (all)
CiteScore
0.80
自引率
0.00%
发文量
160
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