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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| .林志杰 | 脂質小體包膜的肉毒桿菌毒素來治療膀胱過動症的小型研究：單一醫學中心的研究 | 2014/7/30 下午 06:29:18 | 0 |
| 原 文 | 題 目 | Pilot Study of Liposome-encapsulated Onabotulinumtoxin A for Patients with Overactive Bladder: A Single-center Study |
| 作 者 | Hann-Chorng Kuo, Hsin-Tzu Liu, Yao-Chi Chuang, Lori A. Birder, Michael B. Chancellor | |
| 出 處 | European Urology | |
| 出版日期 | 2014年2月份 | |
| 評 論 | 這篇文章是由花蓮慈濟醫院泌尿科主任郭漢崇醫師、高雄長庚泌尿科主任莊燿吉醫師及美國學者共同發表於European Urology的文章。首先須先瞭解脂質體，它是利用磷脂(phospholipid)雙分子層膜所形成的囊泡包裹藥物分子而形成的製劑。由於cell membrane的基本結構也是磷脂雙分子層膜，脂質體具有與生物體細胞相類似的結構，因此有很好的生物相容性。脂質體製成工藝相對簡單，它具有同時包裹脂溶性藥物和水溶性藥物的特性；製備脂質體所用到的脂材毒性小，生物相溶性好，沒有免疫反應。而文中提及已有文章發表以脂質體包覆肉毒桿菌於老鼠的研究比較，或是應用於膀胱炎的模型。關於真正應用在膀胱過動症病人的隨機雙盲性研究，此篇扮演重要角色。研究設計為共24位病人，分為兩組，一組有12個人脂質體包覆肉毒桿菌膀胱灌注，另一組12個人則灌注生理食鹽水，而一個月後評估症狀等，若是兩組內沒有效果反應的人，則再真正灌注脂質體包覆肉毒桿菌治療，後於三個月再評估。而文章的特色是17個病人在治療前及治療後三個月接受膀胱切片來分析。並以免疫組織染色來染synaptic vesicle glycoprotein 2A (SV2A; also known as SV2)，也染 synaptosomal associated protein, 25 kDa (SNAP25)。在結果是可見其在頻尿上是有明顯的差異，在灌注脂質體組是有改善，可是免疫染色染SV2A，SNAP25兩種protein，其治療前後在膀胱組織的表現並無明顯差異。雖然此篇文章的個案數還不夠多。但仍可讓讀者得知其在治療後一個月時是可以改善頻尿症狀，但不會增加餘尿量及泌尿道感染的情形。 | |
| abstract |
Background: Intradetrusor onabotulinumtoxinA (BoNT-A) injection benefits overactive bladder (OAB) patients, but increased postvoid residual (PVR) urine volume and urinary tract infection (UTI) remain risks. Intravesical instillation of liposomal BoNT-A instead of injection could prevent such adverse events. Objective: To evaluate instillation of liquid liposomal BoNT-A (Lipotoxin) for the treatment of OAB and to determine its mechanism of action. Design, setting, and participants: A double-blind randomized parallel controlled pilot trial in 24 OAB patients at a single tertiary center. Intervention: Patients were randomly assigned to intravesical instillation of Lipotoxin containing 80 mg liposomes and 200 U BoNT-A or normal saline (N/S). Patients were retreated with Lipotoxin 1 mo later if they failed the first treatment. Outcome measurement and statistical analysis: Voiding diaries, OAB symptom scores, urodynamic studies, and adverse events were monitored. The primary end point was change of total urinary frequency per 3 d at 1mo after treatment. Immunohistochemistry and Western blotting for synaptic vesicle glycoprotein 2A (SV2A) and synaptosomalassociated protein, 25 kDa (SNAP25) were performed at baseline and 3 mo after treatment. The Wilcoxon rank sum test and Wilcoxon signed rank test were used for statistical analysis. Results and limitations: At 1mo after treatment, the change of urinary frequency per 3 d significantly improved in the Lipotoxin group (n = 12; median: -6.50; inter quartile range [IQR]: -18.3 to -0.25; p = 0.008) but not in the N/S group. (n = 12.0; IQR: -7.75 to 8.0; p = 0.792). Urgency episodes also showed a significant decrease in the Lipotoxin group (-12.0; IQR: -20.3 to -2.75; p = 0.012) but not in the N/S group (-1.0; IQR: -11.0 to 2.5; p = 0.196). SV2A and SNAP25 were expressed in urothelial cells and suburothelial tissues. However, the protein expression did not significantly differ between responders and nonresponders at 3 mo after treatment. Conclusions: Intravesical Lipotoxin instillation effectively reduced frequency episodes 1 mo after treatment in OAB patients without any increase in PVR or risk of UTI. Patient summary: We demonstrated that intravesical Lipotoxin instillation reduced frequency episodes at 1 mo in overactive bladder patients. This procedure is safe, without an increase in postvoid residual or the risk of urinary tract infection. |
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