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發表人 | 討論主題 | 發表時間 | 討論數 |
陳妤甄 | 針對帕金森氏症合併膀胱過動症的病人, 評估Mirabegon的治療效果: 雙盲隨機試驗 | 2021/11/1 下午 03:23:21 | 0 |
原 文 | 題 目 | Mirabegron for treatment of overactive bladder symptoms in patients with Parkinson's disease: A double‐blind, randomized placebo‐controlled trial (Parkinson's Disease Overactive bladder Mirabegron, PaDoMi Study) |
作 者 | Sung Yong Cho, Seong Jin Jeong, Sangchul Lee, Janghwan Kim, Seong Ho Lee, Min Soo Choo, Seung‐June Oh1 | |
出 處 | Neurourology and Urodynamics | |
出版日期 | 2021/1/3 | |
評 論 |
帕金森氏症是個很常見的神經退化疾病,研究顯示約有24-96%的帕金森氏症的患者承受著下泌尿道症狀的痛苦,在這些當中,帕金森氏症患者最常見的下泌尿道症狀為:夜尿、急尿、頻尿、甚至是急迫性尿失禁 (也就是膀胱過動症的症狀)。 一般膀胱過動症病患常常都會有來不及去廁所的急迫感和無助感,這種感覺在帕金森氏症病人身上更是難過,由於帕金森氏症患者動作緩慢,無法很快地前往去廁所解小便,也因此若帕金森氏症患者合併膀胱過動症,其生活品質將大受影響。 治療膀胱過動症的藥物現今有兩大類:抗膽鹼藥物和Beta腎上腺作用劑;在過去,抗膽鹼藥物是治療膀胱過動症的主流,也因此也有很多研究著墨在抗膽鹼藥物的副作用,研究顯示抗膽鹼藥物可能會有排尿困難或急性尿滯留的風險,甚至可能對病人的認知功能造成影響;抗膽鹼藥物對認知功能的影響會讓醫師在對帕金森式症患者使用上更加小心與斟酌;最近根據一些Beta腎上腺作用劑 (Mirabegron藥物) 的研究報告,Mirabegron可透過活化 β3 腎上腺素受體放鬆膀胱逼尿肌,進而增加膀胱容量來讓膀胱過動症患者得到良好的治療結果,同時,研究也顯示Mirabegron藥物可安全地與抗膽鹼藥物(Solifenacin)一起合併使用;整體看來,Beta腎上腺作用劑的效果是很令人期待的,然而目前還沒有大型研究針對Beta腎上腺作用劑用在帕金森氏症合併膀胱過動症患者的效果與安全性,因此本篇為一隨機、雙盲、安慰劑對照、多中心研究的臨床試驗在探討這塊。 這篇總共收錄117個帕金森氏症合併膀胱過動症的病人,其中59人被分到安慰劑組,58人被分到Beta腎上腺作用劑 (Mirabegon組),評估兩組在用藥使用後症狀改善差異與安全性;我們從這篇中看到在用藥後的第 4 週和第 8 週時,兩組間的症狀具有顯著的差異 (本篇使用OABSS症狀評估表,發現Mirabegon組的OABSS分數較安慰劑組低),也代表著Mirabegon是有效的;在安全性上,研究中有 27 名患者 (23.1%) 發生了不良事件,其中19件不良事件發生在安慰劑組,14件發生在Mirabegon組,兩組間對於不良事件的發生沒有明顯差異;在殘餘尿方面,Mirabegron組 (相較於安慰劑組) 的排尿後殘餘尿量有輕度增加至 64 ml (有達到統計學上的差異);在治療滿意度上,滿意度問卷顯示兩組間沒有顯著的差異。 整體而言,此篇研究告訴我們: Mirabegron可以有效使用在帕金森氏症合併膀胱過動症患者的治療,其不良事件可接受,也有高比例的患者願意繼續使用Mirabegron。 |
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abstract |
Aims: This study aimed to investigate the efficacy and safety of mirabegron for Parkinsonism patients with overactive bladder (OAB) symptoms in a randomized, placebo‐controlled, multicenter study. Materials and Methods: Inclusion criteria are Parkinsonism with OAB symptoms for 4 weeks or more, OAB symptom score (OABSS) questionnaire scores greater than 2, and OABSS urgency question scores greater than 1. After a 2‐week wash‐out period, the patients were randomized into placebo and mirabegron groups at visit 2. Visit 3 was performed after 4 weeks of medication. Mirabegron was prescribed to the two groups for the rest of the study period at visit 4. Result: The mean age was 68.1± 8.1 years and 72 males and 64 females were included. A total of 136 patients were screened, 117 patients were randomized, and 25 patients dropped out. The OABSS scores were significantly different between the two groups at Weeks 4 and 8. The OABSS scores became the same in the two groups at Week 12 (visit 5). The postvoid residual urine volume showed a mild increase to 64 ml in the mirabegron group compared to the placebo group at visit 4. Adverse events occurred in 27 patients (23.1%). The degree was mild in 26 cases (78.8%), moderate in five (15.2%), and severe in two (6.1%). Only 13 cases (39.4%) showed medication‐related adverse events. Acute urinary retention occurred in a single case. The treatment satisfaction questionnaires showed no significant differences between the two groups. Conclusion: Mirabegron was effective in treating OAB symptoms in patients with Parkinsonism with acceptable adverse events. |
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