M-受体与α-受体阻滞剂联合用药治疗良性前列腺增生及下尿路症状的临床观察

目的 评价M-受体阻滞剂与α-受体阻滞剂联合用药治疗良性前列腺增生（BPH）下尿路症状（LUT）的有效性及安全性。方法 选择经1周特拉唑嗪治疗后,梗阻症状缓解,但刺激症状仍明显的BPH／LUT患者69例,主要的排除标准为最大尿流率（Qmax）〈10ml／s、残余尿〉50ml、前列腺体积〉50ml。随机分成两组,特拉唑嗪组给予特拉唑嗪治疗,联合用药组给予托特罗定与特拉唑嗪联合治疗。用药时间6周,评估内容包括总症状评分（IPSS）及梗阻症状评分及刺激症状评分、尿流率和残余尿量等,并登记不良事件。结果 两组间基础临床指标比较差异无统计学意义。用药6周后联合用药组IPSS评分由19．1±2．9降低到14．0±4．2,P〈0．001。刺激症状评分由13．2±3．2降至9．2±2．9,P〈0．001。特拉唑嗪组IPSS评分由18．5±3．2降低到17．3±4．1,P=0．033。刺激症状评分由12．7±3．1降至11．7±3．0,P=0．001。治疗后两组间比较显示：（1）联合用药组IPSS评分的改善优于特拉唑嗪组（-5．09 vs-1．19,P〈0．001）,联合用药组刺激评分的改善优于特拉唑嗪组（-4 vs-1,P〈0．001）,而梗阻症状评分的改善两组间差异无统计学意义（-1．09 vs-0．2,P〈0．168）。（2）治疗6周后两组间Qmax、残余尿差异无统计学意义。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α-受体阻滞剂联合应用于前列腺轻中度肥大、轻中度肥大的患者,可不同程度降低患者IPSS评分,其中以刺激症状评分的改善更明显。未见严重不良反应和急性尿潴留出现。

Clinical effectiveness and safety study of combined therapy with an alpha-blocker and an anticholinergic for patients with LUT/BPH

OBJECTIVES: The effectiveness and safety of the combined therapy of terazosin and tolerodine for LUT/BPH patients with dominant storage symptoms was evaluated. METHODS: The present study included 69 patients diagnosed as LUT/BPH by IPSS, flowmetry, ultrasound for prostate volume, residual urine, serum PSA and other methods, all of them fulfilled the study's inclusive/exclusive criteria. The principal exclusive criteria were prostate volume > 50 ml, Qmax < 10 ml/s and residual urine > 50 ml. All 69 patients had bothering storage symptoms after initial treatment with terazosin 2 mg once daily for one week., they were divided randomly into two groups. Terazosin group in which patients were treated with terazosin 2 mg once daily for six weeks, and combination group in which patients were treated with terazosin 2 mg once daily and tolerodine 2 mg twice daily for 6 weeks. RESULTS: Sixty-nine patients with LUT/BPH were recruited with inclusive/exclusive criteria of our study, thirty-six patients were in terazosin group and 33 were in combination group. At baseline there were no significant differences between the groups, in mean age, body weight, prostate volume, IPSS, storage IPSS, voiding IPSS, Qmax and residual urine. The results showed that the IPSS was significantly improved in the two groups after treatment, but the reduction of IPSS in combination group was significantly greater than that in terazosin group (P < 0.001), and the decreased storage IPSS was the main contribution to the reduction of IPSS in combination group. There were no differences between the groups for Qmax and residual urine. CONCLUSION: Combined therapy with terazosin plus tolerodine for LUT/BPH patients with dominant storage symptoms can improve the IPSS, especially the storage IPSS, without any negative effects on uroflow rate and residual urine. Combining with inclusion/exclusion criteria of the study, we believe that combined therapy with alpha-blocker plus anticholinergics is an effective and safe treatment for LUT/BPH patients with relatively small prostate volume, moderate impaired Q(max) and dominant storage symptoms.