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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 周永強 | Mirabegron與Tamsulosin合併使用及Tamsulosin單獨使用於良性攝護腺阻塞引發之膀胱過動患者之隨機分派實驗 | 2015/3/31 上午 11:43:28 | 0 |
| 原 文 | 題 目 | A Randomized Controlled Study of the Efficacy of Tamsulosin Monotherapy and its Combination with Mirabegron for Overactive Bladder Induced by Benign Prostatic Obstruction |
| 作 者 | Koji Ichihara, Naoya Masumori, Fumimasa Fukuta, Taiji Tsukamoto, Akihiko Iwasawa and Yoshinori Tanaka | |
| 出 處 | The journal of urology, Vol. 193, 921-926 | |
| 出版日期 | March 2015 | |
| 評 論 |
Mirabegron 這項使用在膀胱過動症的藥物作用在β3-adrenoceptor，以達到促使膀胱放鬆及增加尿液儲存的效果。在之前的研究中已可得知其藥效與傳統抗膽鹼藥物相當，並且有著副作用較少的優點。近期的研究多走向臨床應用，包含使用於不同的疾病狀態、與其他藥物合併的藥效以及安全性為主流研究方向。 本文為日本北海道的數家醫院共同進行，主要針對的研究對象是良性攝護腺阻塞造成膀胱過動的患者。這些患者在使用 α-blocker治療六周後膀胱過動的症狀改善有限。研究團隊將患者分為兩組，一組持續單獨使用Tamsulosin治療，而另一組加Mirabegron (50mg，每日一次)，追蹤8週後再次評估膀胱過動的症狀。採用OABSS及IPSS分別做評量。 研究結果發現，在頻尿、日間急尿以及生活品質的得分上，合併使用Mirabegron及Tamsulosin的組別改善的幅度達到統計上的顯著差異。OABSS的得分在合併藥物的組別平均可以降低2.2分，優於單用Tamsulosin組別的0.8分。在副作用方面，43位接受合併藥物治療的病患中共有6位回報副作用，分別有便秘、尿滯留、急尿症狀、頭暈、肝功能異常、及胸悶。其中頭暈的患者持續使用藥物後症狀自行緩解，其餘的患者則在停藥後症狀改善。 |
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| abstract |
PURPOSE: We evaluated the efficacy and safety of add-on treatment with a β3-adrenoceptor agonist (mirabegron) for overactive bladder symptoms remaining after α1-blocker (tamsulosin) treatment in men with benign prostatic obstruction. MATERIALS AND METHODS: Patients with benign prostatic obstruction with urinary urgency at least once per week and a total OABSS of 3 or more points after 8 or more weeks of treatment with tamsulosin were enrolled in the study. They were randomly allocated to receive 0.2 mg tamsulosin daily or 0.2 mg tamsulosin and 50 mg mirabegron daily for 8 weeks. The primary end point was change in total OABSS. Safety assessments included change in post-void residual urine volume and adverse events. RESULTS: From January 2012 through September 2013 a total of 94 patients were randomized. Of these patients 76 completed the protocol treatment. In the full analysis set the change in total OABSS during the treatment period was significantly greater in the combination group than in the monotherapy group (-2.21 vs -0.87, p=0.012). The changes in scores for urinary urgency, daytime frequency, International Prostate Symptom Score storage symptom subscore and quality of life index at 8 weeks were significantly greater in the combination group. The change in post-void residual urine volume was significantly greater in the combination group. Although 6 patients experienced adverse events in the combination group, urinary retention was observed in only 1 patient. CONCLUSIONS: Combined tamsulosin and mirabegron treatment is effective and safe for patients with benign prostatic obstruction who have overactive bladder symptoms after tamsulosin monotherapy. |
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