Abstract：
BACKGROUND: Overactive bladder symptoms (OABSs) affect patients\' quality of life (QOL) worldwide. This pooled analysis compared the efficacy and safety of mirabegron add-on tamsulosin with those of tamsulosin add-on placebo in OABS treatment.
METHODS: PubMed, Embase, MEDLINE, and the Cochrane Controlled Trial Register databases were searched for randomized controlled trials (RCTs) examining the efficacy of mirabegron add-on therapy to tamsulosin in the treatment of OABS. Moreover, references from the selected studies were screened. Review Manager 5.4 was used to analyze data.
RESULTS: Four RCTs involving 1,397 patients with OABS were selected. Of the total, 697 patients receiving mirabegron add-on tamsulosin constituted the experimental group, and 700 patients receiving tamsulosin add-on placebo constituted the control group. The efficacy endpoints were as follows: mean number of micturition per day (mean difference [MD] = -0.26, 95% confidence interval [CI] = -0.41 to -0.10, p = 0.0001), urgency episodes per day (MD = -0.67, 95% CI = -1.02 to -0.32, p = 0.0002), urgency urinary incontinence (UUI) episodes per day (MD = -0.42, 95% CI = -0.66 to -0.19, p = 0.0005), mean volume voided/micturition (MD = 10.84, 95% CI = 4.97-16.71, p = 0.0003), total International Prostate Symptom Score (IPSS) (MD = -2.01, 95% CI = -4.02 to -0.01, p = 0.05), and IPSS QOL index (MD = -0.65, 95% CI = -0.94 to -0.35, p < 0.0001). Mirabegron therapy, an add-on therapy to tamsulosin, was effective in treating patients with OABS. Moreover, mirabegron might reduce the total IPSS (MD = -2.01, 95% CI = -4.02 to -0.01, p = 0.05). The safety endpoint, treatment-emergent adverse events (odds ratio = 0.94, 95% CI = 0.78-1.13, p = 0.49), suggested that although mirabegron was well-tolerated, it possibly increased the post-void residual urine volume (MD = 10.28, 95% CI = 1.82-18.75, p = 0.02).
CONCLUSIONS: Combination therapy using mirabegron and tamsulosin may be effective in treating patients with non-neurogenic OABS in terms of UUI episodes, total IPSS, and IPSS QOL index. However, its effectiveness must be verified by analyzing additional factors for OABS through further RCTs.
METHODS: PubMed, Embase, MEDLINE, and the Cochrane Controlled Trial Register databases were searched for randomized controlled trials (RCTs) examining the efficacy of mirabegron add-on therapy to tamsulosin in the treatment of OABS. Moreover, references from the selected studies were screened. Review Manager 5.4 was used to analyze data.
RESULTS: Four RCTs involving 1,397 patients with OABS were selected. Of the total, 697 patients receiving mirabegron add-on tamsulosin constituted the experimental group, and 700 patients receiving tamsulosin add-on placebo constituted the control group. The efficacy endpoints were as follows: mean number of micturition per day (mean difference [MD] = -0.26, 95% confidence interval [CI] = -0.41 to -0.10, p = 0.0001), urgency episodes per day (MD = -0.67, 95% CI = -1.02 to -0.32, p = 0.0002), urgency urinary incontinence (UUI) episodes per day (MD = -0.42, 95% CI = -0.66 to -0.19, p = 0.0005), mean volume voided/micturition (MD = 10.84, 95% CI = 4.97-16.71, p = 0.0003), total International Prostate Symptom Score (IPSS) (MD = -2.01, 95% CI = -4.02 to -0.01, p = 0.05), and IPSS QOL index (MD = -0.65, 95% CI = -0.94 to -0.35, p < 0.0001). Mirabegron therapy, an add-on therapy to tamsulosin, was effective in treating patients with OABS. Moreover, mirabegron might reduce the total IPSS (MD = -2.01, 95% CI = -4.02 to -0.01, p = 0.05). The safety endpoint, treatment-emergent adverse events (odds ratio = 0.94, 95% CI = 0.78-1.13, p = 0.49), suggested that although mirabegron was well-tolerated, it possibly increased the post-void residual urine volume (MD = 10.28, 95% CI = 1.82-18.75, p = 0.02).
CONCLUSIONS: Combination therapy using mirabegron and tamsulosin may be effective in treating patients with non-neurogenic OABS in terms of UUI episodes, total IPSS, and IPSS QOL index. However, its effectiveness must be verified by analyzing additional factors for OABS through further RCTs.
摘要：
背景：膀胱过度活动症（OABS）影响全球患者的生活质量（QOL）。该汇总分析比较了米拉贝隆附加坦索罗辛与坦索罗辛附加安慰剂在OABS治疗中的疗效和安全性。
方法：PubMed，Embase,MEDLINE,并在Cochrane对照试验注册数据库中搜索了随机对照试验(RCT),这些试验检查了米拉贝隆加用坦索罗辛治疗OABS的疗效.此外，筛选所选研究的参考文献。ReviewManager5.4用于分析数据。
结果：选择了四个RCT，涉及1397例OABS患者。在总数中，697名接受米拉贝隆添加坦索罗辛的患者构成实验组，700名接受坦索罗辛添加安慰剂的患者构成对照组。疗效终点如下：每天平均排尿次数（平均差[MD]=-0.26，95％置信区间[CI]=-0.41至-0.10，P=0.0001），每天紧急发作（MD=-0.67，95％CI=-1.02至-0.32，P=0.0002），每天尿失禁（UUI）发作次数（MD=-0.42，95％CI=-0.66至-0.19，P=0.0005），平均排尿/排尿量（MD=10.84，95%CI=4.97至16.71，P=0.0003），国际前列腺症状总评分（IPSS）（MD=-2.01，95％CI=-4.02至-0.01，P=0.05），IPSSQOL指数(MD=-0.65，95%CI=-0.94至-0.35，P<0.0001)。Mirabegron疗法坦索罗辛的附加疗法可有效治疗OABS患者。此外，mirabegron可能会降低总IPSS（MD=-2.01，95％CI=-4.02至-0.01，P=0.05）。安全终点,治疗引起的不良事件（比值比=0.94，95％CI=0.78至1.13，P=0.49），表明尽管米拉贝隆的耐受性很好，它可能增加排尿后残余尿量（MD=10.28，95％CI=1.82至18.75，P=0.02）。
结论：米拉贝隆和坦索罗辛联合治疗可有效治疗非神经源性OABS患者的UUI发作，总IPSS,和IPSSQOL指数。然而,其有效性必须通过进一步的RCT分析OABS的其他因素来验证。
方法：PubMed，Embase,MEDLINE,并在Cochrane对照试验注册数据库中搜索了随机对照试验(RCT),这些试验检查了米拉贝隆加用坦索罗辛治疗OABS的疗效.此外，筛选所选研究的参考文献。ReviewManager5.4用于分析数据。
结果：选择了四个RCT，涉及1397例OABS患者。在总数中，697名接受米拉贝隆添加坦索罗辛的患者构成实验组，700名接受坦索罗辛添加安慰剂的患者构成对照组。疗效终点如下：每天平均排尿次数（平均差[MD]=-0.26，95％置信区间[CI]=-0.41至-0.10，P=0.0001），每天紧急发作（MD=-0.67，95％CI=-1.02至-0.32，P=0.0002），每天尿失禁（UUI）发作次数（MD=-0.42，95％CI=-0.66至-0.19，P=0.0005），平均排尿/排尿量（MD=10.84，95%CI=4.97至16.71，P=0.0003），国际前列腺症状总评分（IPSS）（MD=-2.01，95％CI=-4.02至-0.01，P=0.05），IPSSQOL指数(MD=-0.65，95%CI=-0.94至-0.35，P<0.0001)。Mirabegron疗法坦索罗辛的附加疗法可有效治疗OABS患者。此外，mirabegron可能会降低总IPSS（MD=-2.01，95％CI=-4.02至-0.01，P=0.05）。安全终点,治疗引起的不良事件（比值比=0.94，95％CI=0.78至1.13，P=0.49），表明尽管米拉贝隆的耐受性很好，它可能增加排尿后残余尿量（MD=10.28，95％CI=1.82至18.75，P=0.02）。
结论：米拉贝隆和坦索罗辛联合治疗可有效治疗非神经源性OABS患者的UUI发作，总IPSS,和IPSSQOL指数。然而,其有效性必须通过进一步的RCT分析OABS的其他因素来验证。
