赛洛多辛和坦索罗辛治疗良性前列腺增生相关下尿路症状的疗效及安全性研究

Efficacy and safety of silodosin and tamsulosin in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia

目的:探讨赛洛多辛和坦索罗辛治疗良性前列腺增生(BPH)相关下尿路症状(LUTS)的有效性及安全性。方法:采用开放、随机、交叉试验,选择2014年2月至2015年3月期间收治的BPH/LUTS患者40例为研究对象,随机分为试验组(A组)和对照组(B组)两组,每组各20例。试验组采用赛洛多辛4 mg,bid,治疗4周,随后坦索罗辛0. 2 mg,qd,治疗4周;对照组采用坦索罗辛0. 2 mg,qd,治疗4周,随后赛洛多辛4 mg,bid,治疗4周。通过国际前列腺症状评分(IPSS)、生活质量评分(QOL)、最大尿流率(Q_(max))及不良反应(AR)等观察指标对试验药物的有效性及安全性进行评价。结果:服药后1周末、4周末,两组IPSS总分与服药前相比均明显下降,具有统计学意义(P <0. 05);服药后1周末、4周末,试验组IPSS储尿期症状评分与服药前相比均明显下降,具有统计学意义(P <0. 05);服药后1周末、4周末,两组QOL评分与服药前相比均明显下降,具有统计学意义(P <0. 05);服药后4周末,两组Q_(max)与服药前相比均明显上升,具有统计学意义(P <0. 05);服药后8周末,试验组患者换用坦索罗辛后Q_(max)下降,而对照组患者换用赛洛多辛后Q_(max)继续上升;两组不良反应无统计学差异(P> 0. 05)。结论:在服药后1周和4周时赛洛多辛均能有效改善BPH患者临床症状及生活质量,交叉换药后,继续使用赛洛多辛能显著改善最大尿流率,且药物不良反应较少,安全性较高。

Objective:To investigate the efficacy and safety of silodosin and tamsulos in the treatment of lower urinary tract symptoms (LUTS)in patients with benign prostatic hyperplasia (BPH).Methods:Forty cases of BPH/LUTS patients admitted from February 2014 to March 2015 were enrolled into this open,random and crossover trial.They were randomly divided into experimental group (group A)and control group (group B),with 20 cases in each group.The subjects in group A received silodosin at 4mg,bid,for 4 weeks,then tamsulosin at 0.2mg, qd,for 4 weeks ;those in group B received tamsulosin at 0.2mg,qd,for 4 weeks,then silodosin at 4mg,bid,for 4 weeks.The efficacy and safety of the test drugs were evaluated using the international prostatic symptom score (IPSS),quality of life score (QOL),maximum urinary flow rate (Qmax)and adverse reaction (AR).Results: One week and 4 week after taking the medicine,the total score of IPSS in group A and B decreased statistically significantly compared with that before taking the medicine (P <0.05),the symptom score of IPSS urine storage period in group A was significantly lower than that before taking the medicine (P <0.05),the QOL scores of group A and B were significantly lower than those before taking the medicine (P <0.05).Four weeks after taking the medicine,the Q of group A and B were significantly higher than before taking the medicine (P <0.05).Eight weeks after taking the medicine,the Qmax decreased after the exchange of tamsulosin in group A.And in group B, the Qmax continued to rise after the replacement of silodosin.There was no significant difference in the adverse reactions between the two groups (P >0.05).Conclusion:The clinical symptoms and quality of life of BPH patients were effectively improved after taking the medicine for 1 and 4 weeks.After cross-over,continued use of silodosin could significantly improve the maximum urine flow rate,and the adverse reactions were less and the safety was higher.