双倍剂量坦索罗辛对良性前列腺增生引起的下尿路症状的临床研究

摘要

Objective To investigate the efficacy of double dose of Tamsulosin in the treatment of lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Methods 64 patients associated with BPH caused by LUTS from June 2010 to June 2012 in Zhumadian Central Hospital were randomly divided into double-dose group (Tamsulosin 0.4 mg) and recommended dose group (Tamsulosin 0.2 mg) accoding to 1:1 ratio, with 32 cases in each group, entered 8 weeks of double-blind drug treatment. The efficacy and the clinical symptoms, international prostate symptom score (IPSS), quality of life (QOL), storage symptom scores (SSS), maximum flow rate (Qmax), residual volume (RV) and prostate volume changes were compared between the two groups after treatment for 8 weeks. Results The im-provement rate of clinical symptoms of the double-dose group was significantly higher than the recommended dose group, the difference was significant (87.5% v s 68.8%, P< 0.05). After treatment, IPSS, QOL, SSS, Qmax, RV of two groups significantly changed than before treatment (P< 0.01 or P< 0.05), but there was no significant difference be-tween two groups. Qmax of double-dose group improved significantly than the recommended dose group, the difference was significant [(13.75±2.47) mL/s v s (10.21±1.65) mL/s] (P< 0.05). There was no significant difference of prostate volume within the group and between two groups before treatment and after treatment (P>0.05). Conclusion Double dose of Tamsulosin can significantly improve subjective symptoms and Qmax of patients with BPH compared with the recommended dose, but it still needs large prospective randomized controlled trials to prove the safety and effectiveness of double dose of Tamsulosin for a long-term medication.%目的：探讨双倍剂量坦索罗辛对良性前列腺增生引起的下尿路症状的疗效。方法将2010年6月~2012年6月河南省驻马店市中心医院确诊的64例良性前列腺增生(BPH)伴下尿路症状(LUTS)患者按1：1的比例完全随机分配到双倍剂量组(坦索罗辛0.4 mg)和推荐剂量组(坦索罗辛0.2 mg)各32例，进入8周的双盲药物治疗期。比较两组治疗8周后临床症状的疗效以及两组治疗前后国际前列腺症状评分(IPSS)、生命质量评分(QOL)、储尿期症状评分(SSS)、最大尿流率(Qmax)、残余尿量(RV)及前列腺体积的变化情况。结果双倍剂量组的临床症状改善率明显高于推荐剂量组(87.5%比68.8%)(P<0.05)。治疗后两组IPSS、QOL、SSS、Qmax、RV均较各组治疗前有显著变化(P<0.01或P<0.05)，但治疗后两组组间比较差异无统计学意义(P跃0.05)，其中双倍剂量组Qmax治疗后较推荐剂量组明显提高[(13.75±2.47)mL/s比(10.21±1.65)mL/s](P<0.05)。两组前列腺体积治疗前后组内及组间比较差异均无统计学意义(P跃0.05)。结论双倍剂量坦索罗辛对BPH患者自觉症状和Qmax较推荐剂量有明显的改善作用，但仍需要大规模的前瞻性的随机对照试验来进一步证实双倍剂量坦索罗辛长期用药的安全性、有效性。