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目的探讨M3受体阻滞剂索利那新联合α1受体阻滞剂盐酸坦索罗辛治疗神经源性逼尿肌过度活动疗效和安全性。方法采用前瞻性、多中心、单盲、随机对照的试验方法,2011年12月至2014年8月,将172例神经源性逼尿肌过度活动患者随机分为试验组和对照组,试验组口服索利那新片5mg/d和盐酸坦索罗辛胶囊0.2mg/d,对照组口服琥珀酸索利那新片5mg/d和安慰剂,记录治疗前,服药后3月的尿失禁生活质量评分表(I-QoL)、每次排尿量(导尿+自然排尿)、储尿期膀胱逼尿肌最大压力、膀胱顺应性、膀胱安全容量,并记录相关不良事件并对数据进行统计分析。结果 162例患者完成试验,其中试验组80例,对照组82例。服药12周后,实验组和对照组I-QoL、每次排尿量、储尿期最大逼尿肌压力、膀胱顺应性、膀胱安全容量分别为(68.21±12.67,62.15±15.63)、(380.56±47.89,359.84±59.42)mL、(35.56±18.94,42.32±22.18)cmH2O、(7.38±3.84,5.84±4.12)mL/cmH2O、(225.65±54.61,207.32±48.56)mL,与治疗前比较差异均有统计学意义(P<0.00 1)。两组间I-QoL、每次排尿量、储尿期最大逼尿肌压力、膀胱顺应性、膀胱安全容量比较均有统计学差异(P=0.02,0.02,0.04,0.02,0.03)。结论索利那新联合盐酸坦索罗辛服用较单一索利那新更能保护NDO患者上尿路功能和提高患者生活质量,且副作用较少。
Objective To investigate the efficacy and safety of M3 receptor blocker Solifenacin in combination with tamsulosin hydrochloride, an α1-blocker, in the treatment of neurogenic detrusor overactivity. Methods A prospective, multicenter, single-blind and randomized controlled trial was conducted. From December 2011 to August 2014, 172 patients with neurogenic detrusor overactivity were randomly divided into test group and control group. The experimental group Oral solifenacin tablets 5mg / d and tamsulosin hydrochloride capsules 0.2mg / d, the control group oral administration of succinarol succinate 5mg / d and placebo, recorded before treatment, 3 months after taking the urinary incontinence quality of life score (I-QoL), urinary volume per patient (catheterization + spontaneous voiding), maximal detrusor pressure during bladder storage, bladder compliance, bladder safety capacity, and related adverse events were recorded and the data analyzed statistically. Results 162 patients completed the trial, 80 cases in the test group, 82 cases in the control group. After 12 weeks of medication, I-QoL, maximum detrusor pressure, bladder compliance and bladder safety capacity in each group were (68.21 ± 12.67,62.15 ± 15.63) and (380.56 ± 47.89,359.84 ± 59.42) mL, (35.56 ± 18.94,42.32 ± 22.18) cmH2O, (7.38 ± 3.84,5.84 ± 4.12) mL / cmH2O, (225.65 ± 54.61, 207.32 ± 48.56) mL, respectively Statistical significance (P <0.00 1). The I-QoL, urinary output, maximal detrusor pressure during storage, bladder compliance and bladder safety capacity were statistically different between the two groups (P = 0.02,0.02,0.04,0.02,0.03). CONCLUSIONS: Solifenacin combined with tamsulosin hydrochloride is more effective than single solifenacin in protecting upper urinary tract function and improving patient quality of life in NDO patients with fewer side effects.