M受体阻滞剂与α受体阻滞剂联合治疗良性前列腺增生的有效性及安全性研究

摘要

目的 评价M受体阻滞剂托特罗定与α受体阻滞剂多沙唑嗪联合治疗良性前列腺增生(BPH)患者的有效性及安全性.方法 2009年5月至2010年4月,选择刺激症状明显的BPH患者76例,主要的排除标准为最大尿流率(Qmax)＜10 ml/s、残余尿＞100 ml、前列腺体积＞50 ml.将患者随机分成2组:多沙唑嗪组(给予多沙唑嗪治疗,36例),联合用药组(给予托特罗定与多沙唑嗪联合治疗,40例).用药时间8周,评估内容包括国际前列腺症状评分(IPSS)、尿流率和残余尿量等,并登记不良事件.结果 两组间基线资料比较差异无统计学意义.用药8周后联合用药组IPSS评分由18.7±2.2降低到12.7±3.9(P=0.000),刺激症状评分由14.2±2.3降至9.1±3.1(P=0.000).多沙唑嗪组IPSS评分由18.6±3.0降低到15.2±3.8(P=0.033),刺激症状评分由12.7±3.0降至11.8±2.7(P=0.001).治疗后两组间比较显示:联合用药组IPSS评分的改善优于多沙唑嗪组(P＜0.01),联合用药组刺激评分的改善优于多沙唑嗪组(P＜0.01),而梗阻症状评分的改善两组间差异无统计学意义(P=0.168).治疗8周后两组间Qmax、残余尿差异无统计学意义(P＞0.05).联合用药组无急性尿潴留和其他严重并发症发生.结论 托特罗定与多沙唑嗪联合应用降低BPH患者IPSS评分,使其刺激症状获得明显的改善;未见严重不良反应和急性尿潴留出现.%Objective To evaluate the effectiveness and safety of the combined therapy of doxazosin and tolerodine for BPH patients with dominant storage symptoms. Methods From May 2009 to April 2010,76 patients diagnosed as benign prostatic hyperplasia (BPH) by International Prostate Symptom Score (IPSS), flowmetry, ultrasound for prostate volume, residual urine and other methods were included in the study,all of them fulfilled the study's inclusive/exclusive criteria. The principal exclusive criteria were prostate volume ＞50 ml, maximum flow rate(Qmax) ＜ 10 ml/s and residual urine ＞ 100 ml. All 76 patients had bothering storage symptoms and devided randomly into two groups: doxazosin group ( n = 36) in which patients were treated with doxazosin 2 mg once daily for 8 weeks, and combination group(n = 40 ) in which patients were treated with doxazosin 2 mg once daily and tolerodine 2 mg twice daily for 8 weeks. Results At baseline,there was no significant differences. The IPSS was significantly improved in the two groups after treatment, but the reduction of IPSS in combination group was significantly greater (18.7 ±2. 2 vs 12.7±3.9) than that in doxazosin group( 18. 6 ±3.0 vs 15.2 ±3. 8) (P ＜0. 05), and the decreased storage IPSS was the main contribution to the reduction of IPSS in combination group. There was no difference between the groups for Qmax and residual urine. Conclusions Combined therapy with doxazosin plus tolerodine for BPH patients with dominant storage symptoms can improve the IPSS, especially the storage IPSS, without any negative effects on uroflow rate and residual urine.