使用减少注射部位范例治疗膀胱过度活动的患者对肉毒杆菌毒素的持久性:一项回顾性图表回顾研究。

IF 1.8 3区 医学 Q3 UROLOGY & NEPHROLOGY Neurourology and Urodynamics Pub Date : 2025-02-01 Epub Date: 2024-12-11 DOI:10.1002/nau.25634
Steven Bernstein, Marc Schwartz, Kimberly Becker Ifantides
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引用次数: 0

摘要

目的:onabotuinumtoxina (onabotA)是一种被批准的治疗膀胱过动症(OAB)的药物。这项图表回顾研究旨在通过分布在≤3个注射部位的减少注射部位范式来确定接受onabotA (100 U)的患者的治疗持久性。方法:本研究是一项单地点、非介入性、回顾性图表回顾,评估2017年7月至2021年6月期间接受1-3次注射onabotA (100 U)≥1次治疗前难以进行行为改变和药物治疗的成年女性OAB患者。排除有神经性OAB、以压力性尿失禁为主或在研究期间死亡的患者。记录和评估基线人口统计学、治疗模式、治疗持续时间、治疗间隔、利多卡因预处理、患者报告的治疗反应和泌尿系统不良事件。持续性定义为在研究期间通过三次或更少的注射接受≥3次治疗的患者的百分比。用样本量、平均值(标准差[SD])和中位数(第一和第三个四分位数)总结连续变量;分类变量以频率和百分比计算。结果:本研究纳入的90例患者中,55例(61.1%)坚持使用onabotA治疗OAB,在数据收集期结束时完成了3次治疗。尿路感染发生率为18/370(4.9%)。在90例患者中,15例(16.7%)在任何治疗后报告了尿路感染,没有人需要清洁的间歇导尿。结论:当onabotA通过减少注射部位的模式给药时,61.1%的患者持续接受OAB治疗。考虑到本研究中纳入的患者数量有限,以及后期时间点的样本量相对较低,结果可能无法推广。使用减少注射部位范例,没有发现新的安全信号。临床试验注册:由于本研究的性质,不需要临床试验注册。
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Patient Persistence to OnabotulinumtoxinA Treatment for Overactive Bladder Using a Reduced Injection-Site Paradigm: A Retrospective Chart Review Study.

Aims: OnabotulinumtoxinA (onabotA) is an approved treatment for overactive bladder (OAB). This chart review study aims to determine treatment persistence in patients receiving onabotA (100 U) via a reduced injection-site paradigm distributed across ≤ 3 injection sites.

Methods: This study was a single site, noninterventional, retrospective chart review evaluating adult female OAB patients refractory to behavioral modification and pharmacotherapy before receiving ≥ 1 treatment with onabotA (100 U) via 1-3 injections between July 2017 and June 2021. Patients with neurologic OAB, predominance of stress incontinence, or who expired during the study were excluded. Baseline demographics, treatment patterns, treatment persistence, treatment intervals, lidocaine pretreatment, patient-reported treatment response, and adverse urological events were documented and evaluated. Persistence was defined as the percent of patients receiving ≥ 3 treatments during the study period via three or fewer injections. Continuous variables were summarized with sample size, mean (standard deviation [SD]), and median (1st and 3rd quartiles); categorical variables were calculated as frequencies and percentages.

Results: Of the 90 patients included in this study, 55 (61.1%) were persistent to treatment with onabotA for OAB, completing 3 treatments by the end of the data collection period. Urinary tract infection (UTI) was reported after 18/370 (4.9%) treatments. Of 90 patients,15 (16.7%) reported UTI after any treatment, and none required clean intermittent catheterization.

Conclusion: When onabotA was administered via a reduced injection-site paradigm, 61.1% of patients were persistent to OAB treatment. Given the limited pool of patients included in this study and relatively low sample sizes at later timepoints, results may not be generalizable. No new safety signals were identified using the reduced injection-site paradigm.

Clinical trial registration: Due to the nature of this study, no clinical trial registration was required.

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来源期刊
Neurourology and Urodynamics
Neurourology and Urodynamics 医学-泌尿学与肾脏学
CiteScore
4.30
自引率
10.00%
发文量
231
审稿时长
4-8 weeks
期刊介绍: Neurourology and Urodynamics welcomes original scientific contributions from all parts of the world on topics related to urinary tract function, urinary and fecal continence and pelvic floor function.
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