摘要目的 评价长期服用盐酸坦索罗辛治疗伴有下尿路症状(LUTS)的BPH的有效性和安全性.方法 2005-2007年LUTS/BPH患者113例,经4周安慰剂导入期,进入60周开放性研究,每天早餐前口服盐酸坦索罗辛0.2 mg.Ⅰ期治疗(0～12周)结束时对盐酸坦索罗辛的有效性和安全性进行评价,IPSS改善≥25%者行Ⅱ期(13～60周)治疗;IPSS改善＜25%者Ⅱ期联合使用非那雄胺治疗.Ⅱ期治疗结束时行有效性和安全性评价.受试者随访期间监测症状、体征、实验室检查和不良事件.IPSS和Qmax为主要有效性评价参数.结果 113例患者完成Ⅰ期治疗111例,IPSS由治疗前19.5降为15.4,平均改善率21.2%;平均Qmax由治疗前11.2 ml/s提高1.7 ml/s,平均改善率16.5%,治疗前后比较差异均有统计学意义(P＜0.05).完成Ⅱ期治疗95例,其中联合使用非那雄胺25例、未联合使用非那雄胺者70例(P＞0.05),IPSS由治疗前19.0±4.7降为12.6±3.2,改善率30.3%; Qmax由治疗前(11.6±2.3)ml/s提高3.0 ml/s;生活质量评分(QOL)由4.3±0.8降为2.6±0.7,治疗前后比较差异均有统计学意义(P＜0.05).治疗前后IIEF-5评分、前列腺体积和血压差异无统计学意义(P＞0.05).治疗期间共发生13例24次不良事件,其中头晕5例8次、腹泻2例2次、乏力2例5次、口干1例6次,头痛、恶心及皮肤瘙痒各1例1次.无严重不良事件.结果 盐酸坦索罗辛治疗伴有LUTS的BPH患者安全有效,疗效持久,耐受性好,可以作为有效的常规治疗药物.

abstractsObjective To evaluate the efficacy and safety of long-term administration of tamsulosin hydrochloride 0.2 mg once daily in patients with LUTS of BPH. Methods Patients with LUTS of BPH enrolled in a 4-week placebo run-in period, then 60-week open-label study. Tamsulosin hydrochloride 0.2 mg was administered before breakfast every day during the period of the study. The efficacy and safety parameters were evaluated at the end of treatment period Ⅰ (0-12 weeks). If IPSS was improved by 25% or more, the administration of tamsulosin hydrochloride was continued during treatment period Ⅱ (13-60 weeks). If the improvement rate less than 25%, the patients received concomitant medication of finasteride 5 mg once daily during treatment period Ⅱ. The primary parameters assessed to determine efficacy were the International Prostate Symptom Score(IPSS) and maximum urinary flow rate(Qmax). Results A total of 113 patients were recruited in the study, and 111 patients completed treatment period Ⅰ , and 95 patients completed treatment period Ⅱ. After treatment period Ⅰ , average IPSS was decreased by 4.1 and average Qmax was increased by 1.7 ml/s(P＜0.05). Tamsulosin hydrochloride produced a great improvement in average Qmax (3.0 ml/s, 27.7%)and a significant decrease in average IPSS (6.4,30.3%) after 60-week treatment. Significant improvements were also produced in average urinary flow rate and average residual urine volume. There was no significant difference in changes in IIEF-5 score and the prostate volume after treatment with tamsulosin hydrochloride. During the study period, 13 patients experienced 24 adverse events, and the incidence of adverse event was 11.5%. No serious adverse event and significant changes of the data of laboratory examination were recorded during the study. Conclusions Long-term tamsulosin hydrochloride therapy is a safe, effective and well-tolerated method in improving symptoms and quality of life in patients with LUTS of BPH. Tamsulosin hydrochloride can be used as the conventional drug in the patients with LUTS suggestive of BPH.