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趙宸偉 針對難治型膀胱過動症,使用膀胱內肉毒桿菌素注射及藥物複方療法的成效及安全性評估:隨機對照試驗 2025/10/30 下午 08:30:18 0
原 文 題  目 The Efficacy and Safety Between Intradetrusor OnabotulinumtoxinA Injection and Combined Pharmacotherapy in Patients With Refractory Overactive Bladder: A Randomized Controlled Trial
作  者 Meng-Hsuen Hsieh, Jiun-Chyi Hwang, Tsung-Hsien Su, and Hui-Hsuan Lau
出  處 The Journal of Urology Vol. 214, 344-353
出版日期 October 2025
評 論

膀胱過動症患者在單一藥物治療反應不佳時,複方的藥物(抗膽鹼藥物及β3-腎上腺素受體激動劑)的使用或是膀胱內A型肉毒桿菌毒素注射皆是可選擇的後線治療方式,本篇研究提供這兩種治療方式在療效及安全性上的比較,兩種療法均有效改善了膀胱過動症的症狀及患者的生活品質。但對於因藥物而造成全身性副作用的患者而言,膀胱內肉毒桿菌素注射雖侵入性較高但能有效降低藥物所造成的不適,透過本篇研究可以在治療前與患者進行更好的共享決策討論。

abstract

Purpose: We investigated whether intradetrusor onabotulinumtoxinA injection demonstrates superior efficacy and fewer side effects compared with combined pharmacotherapy in patients with refractory overactive bladder.
Materials and Methods: In this single-center, open-label, randomized trial, patients with urodynamically confirmed detrusor overactivity and persistent symptoms despite at least 2 months of single pharmacotherapy were randomized to receive onabotulinumtoxinA injection (100 U) or combined pharmacotherapy with solifenacin 5 mg and mirabegron 25 mg. Assessments at baseline and 12 weeks included voiding parameters, adverse events, and patient-reported outcomes using the Urogenital Distress Inventory, Incontinence Impact Question-naire, and the Overactive Bladder Symptom Score
Results: Of 74 patients enrolled, 66 completed the study (33 per group). Both treatments reduced urgency episodes to a median of 2.0 per 24 hours at 12 weeks.The mean difference between groups was 0.1 (95% CI: 1.5 to 1.4; P [ .925),indicating no significant difference. Improvements in urinary frequency, nocturia, urge incontinence, and quality-of-life measures were observed in both groups, without significant differences. However, adverse effects such as dry mouth, constipation, and blurred vision were significantly more common with pharmacotherapy (all P < .05).
Conclusions: Both intradetrusor onabotulinumtoxinA and combined pharmacotherapy improved symptoms in women with refractory overactive bladder. OnabotulinumtoxinA demonstrated a more favorable safety profile and represents an appropriate option for patients sensitive to systemic anticholinergic effects or preferring nondaily interventions.

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