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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 陳進利 | Mirabegron用於患有神經源性逼尿肌過動症的兒童和青少年的療效與安全性: 第三期臨床試驗劑量調整報告 | 2021/7/6 下午 03:11:49 | 0 |
| 原 文 | 題 目 | Efficacy and safety of mirabegron in children and adolescents with neurogenic detrusor overactivity: An open‐label, phase 3, dose‐titration study |
| 作 者 | Małgorzata Baka‐Ostrowska, David T. Bolong, Cristian Persu, Camilla Tøndel, Achim Steup, Christopher Lademacher, Nancy Martin | |
| 出 處 | Neurourology Urodynamics. 2021;1–10 | |
| 出版日期 | 2021 May 31 | |
| 評 論 |
神經源性逼尿肌過動症(NDO)的定義為在膀胱儲尿過程中產生不自主的逼尿肌收縮，常見原因為神經疾患。最常見的病因為先天性脊椎缺損，其他原因包括脊椎損傷或神經系統疾病。若未加以治療，可能導致膀胱順應性減低，甚至造成上尿路系統損傷。臨床治療主要目的為在膀胱儲尿及排尿過程中維持膀胱處在低壓的狀態並且避免尿路感染、膀胱結石或膀胱纖維化的產生。傳統的治療方式包括清潔間歇導尿及有或無使用抗膽鹼藥物，其他治療方式還有肉毒桿菌素治療。由於抗膽鹼藥物有許多副作用，包括口乾、便祕、尿滯留; 再者，抗膽鹼藥物使用於小兒身上會影響其認知功能及學習的發展以及其他中樞神經的影響; 目前來說，mirabegron此一β3-腎上腺接受體作用劑已證實在成人膀胱過動症的安全有效性，因此本文作者目的在評估mirabegron使用於患有神經源性逼尿肌過動症(NDO)的兒童和青少年（3至<18 歲）的療效和安全性。
在此一多醫學中心的 III 期研究 ( NCT02751931 ) 中，參與者每天服用一次mirabegron，相當於成人劑量 25 毫克。在沒有安全性或耐受性問題的考量下，其劑量會增加至 50毫克。總共有 86 名參與者（55位3至<12歲，31位12至18歲）接受mirabegron治療；68個被納入療效評估。觀察到
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| abstract |
Aims: To evaluate the efficacy and safety of mirabegron in children and adolescents (aged 3 to <18 years) with neurogenic detrusor overactivity (NDO) using clean intermittent catheterization.
Methods: In this open‐label, multicenter, baseline‐controlled, Phase III study (NCT02751931), participants received once‐daily mirabegron at an adult dose equivalent of 25 mg. Dose was increased to 50 mg equivalent unless there were safety/tolerability concerns. The primary efficacy endpoint was change from baseline to Week 24 in maximum cystometric capacity (MCC). Secondary urodynamic assessments, Pediatric Incontinence Questionnaire (PIN‐Q), Patient Global Impression of Severity (PGI‐S), Clinician Global Impression of Change (CGI‐C), and Acceptability questionnaires were included. Results: Overall, 86 participants (55 aged 3 to <12 years, 31 aged 12 to <18years) received treatment; 68 were included in efficacy assessments. A statis-tically significant increase in MCC from baseline to Week 24 was observed (87.20 ml, 95% confidence interval: 66.07, 108.33; p < .001); this increase was apparent from Week 4. Significant increases in bladder compliance, bladder volume until first detrusor contraction, average volume per catheterization, maximum daytime catheterized volume and number of dry days per week. Significant decreases in detrusor pressure and number of leakage episodes per day were also observed. Significant improvement in PGI‐S but not PIN‐Q was observed. Most participants reported their condition had either much or very much improved using the CGI‐C. Mirabegron was well tolerated in this population with a profile aligned with that in adults. Conclusions: Mirabegron was effective and well‐tolerated in the treatment of pediatric patients with NDO. |
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