Singh Iqbal, Agarwal Vivek, Garg Gaurav
Professor, Department of Surgery, University College of Medical Sciences (University of Delhi) & GTB Hospital , Delhi, India .
Junior Resident, Department of Surgery, University College of Medical Sciences (University of Delhi) & GTB Hospital , Delhi, India .
J Clin Diagn Res. 2015 Jun;9(6):PC08-11. doi: 10.7860/JCDR/2015/12526.6019. Epub 2015 Jun 1.
To evaluate the efficacy/safety of 'tamsulosin and darifenacin' (TD) vs. 'tamsulosin and placebo' (TP) for patients with symptomatic benign prostrate hyperplasia (BPH) with accompanying overactive bladder (OAB) symptoms.
This study included symptomatic patients of BPH with one or more of the following OAB symptoms; micturition frequency >8, nocturnal frequency > 2, urgency > 1 per 24 hour between November 2012 and February 2014. After protocol approval by ethics committee and obtaining informed consent, patients were randomly assigned to receive tamsulosin 0.4mg plus placebo (TP) (n=30) or tamsulosin 0.4 mg plus darifenacin 7.5 mg (TD) (n=30) for 8 weeks. The mean change from baseline in urinary frequency and incontinence episodes/24 hour (primary end points), and nocturnal frequency; mean change in PVR and changes in IPSS (secondary end points) were compared between groups at 0/eight week using voiding diary and ultrasonography.
The mean change in frequency, incontinence, nocturnal frequency/24 hour and IPSS (International prostrate symptom score) were (-4.83 vs. -3.93, p=0.023), (-1.50 vs. 1.08, p=0.001), (-2.20 vs. -1.87, p<0.001) and (-7.90 vs. -6.27, p<0.001) in the TD/TP group respectively (significant). Apart from some minor side effects (12 vs. 9) all interventions appeared to be safe and well tolerated. The mean change in the PVR (Postvoid residual) was marginal (+10.84ml and -16.93) and the incidence of urinary retention was 13% and 3% in the TD and TP groups respectively (p=0.35).
Treatment with tamsulosin and darifenacin for 8 weeks is an effective and safe treatment modality in select patients of BPH with accompanying OAB symptoms.
评估坦索罗辛与达非那新（TD）对比坦索罗辛与安慰剂（TP）治疗伴有膀胱过度活动症（OAB）症状的有症状良性前列腺增生（BPH）患者的疗效/安全性。
本研究纳入了在2012年11月至2014年2月期间患有BPH且伴有以下一种或多种OAB症状的有症状患者；排尿频率>8次、夜间排尿频率>2次、每24小时尿急>1次。经伦理委员会批准方案并获得知情同意后，患者被随机分配接受坦索罗辛0.4mg加安慰剂（TP）（n = 30）或坦索罗辛0.4mg加达非那新7.5mg（TD）（n = 30）治疗8周。使用排尿日记和超声检查在0/8周时比较两组间尿频率和失禁发作次数/24小时（主要终点）以及夜间排尿频率的基线平均变化；残余尿量（PVR）的平均变化和国际前列腺症状评分（IPSS）的变化（次要终点）。
TD/TP组中，频率、失禁、夜间排尿频率/24小时和IPSS（国际前列腺症状评分）的平均变化分别为（-4.83对-3.93，p = 0.023）、（-1.50对1.08，p = 0.001）、（-2.20对-1.87，p<0.001）和（-7.90对-6.27，p<0.001）（具有显著性）。除了一些轻微副作用（12例对9例）外，所有干预措施似乎都是安全且耐受性良好的。残余尿量（PVR）的平均变化很小（分别为+10.84ml和-16.93），TD组和TP组尿潴留的发生率分别为13%和3%（p = 0.35）。
对于伴有OAB症状的特定BPH患者，坦索罗辛与达非那新联合治疗8周是一种有效且安全的治疗方式。
