Liao Chun-Hou, Kuo Hann-Chorng
Department of Urology, Cardinal Tien Hospital and Fu-Jen Catholic University, New Taipei, Taiwan.
Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University, Hualien, Taiwan.
Urology. 2018 Jul;117:115-119. doi: 10.1016/j.urology.2018.03.038. Epub 2018 Apr 6.
To compare the therapeutic efficacy and safety of mirabegron monotherapy in male patients with overactive bladder (OAB) with and without bladder outlet obstruction (BOO).
Male patients with OAB aged ≥20 years, with or without BOO, receiving mirabegron 25 mg monotherapy once daily, were prospectively enrolled. The treatment results were assessed using global response assessment, international prostate symptom score and subscores, overactive bladder symptom score, patient perception on intensity of urgency scale, patient perception of bladder condition, and quality of life index at 1 and 3 months after treatment.
Of the 289 enrolled patients (mean age, 71.2 years), 207 did not have BOO (71.6%) and 82 had BOO (28.4%). The baseline OAB symptoms were similar between patients with and without BOO. After mirabegron treatment, the satisfactory rate (global response assessment score ≧1) were similar between those without BOO (61.3%) and with BOO (57.1%). The improvement of quality of life index and patient perception of bladder condition was also found in both groups. However, only patients without BOO had significantly improved international prostate symptom score and subscores, overactive bladder symptom score, and patient perception on intensity of urgency scale. Although most adverse events (AEs) were mild, patients with BOO had significantly higher AEs rate (18.6%) than those without BOO (8.2%, P = .026).
Mirabegron monotherapy in male patients with OAB and BOO was safe. However, the storage symptoms improvement was less in patients with BOO and AEs rate was higher.
比较米拉贝隆单药治疗对伴有和不伴有膀胱出口梗阻（BOO）的男性膀胱过度活动症（OAB）患者的疗效和安全性。
前瞻性纳入年龄≥20岁、伴有或不伴有BOO且接受米拉贝隆25mg每日一次单药治疗的男性OAB患者。在治疗后1个月和3个月，使用整体反应评估、国际前列腺症状评分及子评分、膀胱过度活动症症状评分、患者对尿急程度的感知、患者对膀胱状况的感知以及生活质量指数来评估治疗结果。
在289例纳入患者（平均年龄71.2岁）中，207例无BOO（71.6%），82例有BOO（28.4%）。有和无BOO患者的基线OAB症状相似。米拉贝隆治疗后，无BOO患者（61.3%）和有BOO患者（57.1%）的满意率（整体反应评估评分≧1）相似。两组患者的生活质量指数和患者对膀胱状况的感知也有所改善。然而，只有无BOO的患者国际前列腺症状评分及子评分、膀胱过度活动症症状评分和患者对尿急程度的感知有显著改善。尽管大多数不良事件（AE）为轻度，但有BOO的患者AE发生率（18.6%）显著高于无BOO的患者（8.2%，P = 0.026）。
米拉贝隆单药治疗男性OAB和BOO患者是安全的。然而，有BOO的患者储尿期症状改善较少，且AE发生率较高。
