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目的探讨α1受体阻滞剂治疗男性神经原性逼尿肌尿道外括约肌功能失调(NDSD)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,2012年6月~2014年10月男性神经原性逼尿肌尿道外括约肌功能失调患者,分为实验组和对照组,实验组予患者口服盐酸坦索罗辛缓释胶囊0.2mg/d,对照组予安慰剂治疗,观察服药后4周和12周的泌尿生殖系困扰调查的6项短表(UDI-6)、平均膀胱剩余尿量(PVR)、间歇导尿(IC)患者例数、平均每日IC次数,服药后12周平均最大尿流率(Qmax)、平均最大尿流率时膀胱逼尿肌压力(Pdet.Qmax)、平均最大尿道闭合压(MUCP),并记录相关不良事件。采用SPSS13.0统计学软件。计量资料采用t检验,计数资料采用卡方检验。结果入选患者94例,88例患者完成试验(实验组46例,对照组42例)。实验组和对照组的基线数据比较差异无统计学意义(P>0.05)。服药后4和12周实验组和对照组间UDI-6、PVR、IC患者例数、平均每日IC次、Qmax、Pdet.Qmax和MUCP比较差异均有统计学意义(P<0.05)。服药后4和12周实验组UDI-6、PVR、IC患者例数、平均每日IC次、Qmax、Pdet.Qmax和MUCP和基线值比较差异也均有统计学意义(P<0.05)。结论α1受体阻滞剂能改善男性NDSD排尿,提高患者生命质量。
Objective To investigate the efficacy and safety of α1-blocker in the treatment of male neurogenic detrusor external sphincter dysfunction (NDSD). Methods A prospective, multicenter, single-blind and randomized controlled trial was conducted. From June 2012 to October 2014, male patients with neurogenic detrusor external sphincter dysfunction were divided into experimental group and control group. Experimental group Patients were given oral tamsulosin hydrochloride 0.2mg / d, the control group was treated with placebo, observation of 4 weeks and 12 weeks after taking the genitourinary tract of 6 troubled survey (UDI-6), the average bladder Left ventricular ejection fraction (PVR), intermittent catheterization (IC) patients, average daily IC frequency, 12-week average maximum flow rate (Qmax) and average detrusor pressure (Pdet. Qmax, mean maximal urethral closure pressure (MUCP), and record related adverse events. Using SPSS13.0 statistical software. Measurement data using t test, count data using chi-square test. Results 94 patients were enrolled, and 88 patients completed the experiment (experimental group 46 cases, control group 42 cases). There was no significant difference in baseline data between experimental group and control group (P> 0.05). The number of patients with UDI-6, PVR and IC, the average daily IC times, Qmax, Pdet.Qmax and MUCP between the experimental group and the control group after 4 and 12 weeks of treatment were significantly different (P <0.05). At 4 and 12 weeks after treatment, the number of patients with UDI-6, PVR and IC, the average daily IC times, Qmax, Pdet.Qmax, and MUCP were also significantly different from baseline (P <0.05). Conclusion α1 blockers can improve male NDSD urination and improve patient quality of life.