目的 观察坦索罗辛胶囊和多沙唑嗪片分别联合酒石酸托特罗定缓释片治疗良性前列腺增生伴下尿路症状患者的临床疗效和安全性.方法 将120例患者随机分为对照组60例和试验组60例.对照组予以口服多沙唑嗪4 mg qn和酒石酸托特罗定4 mg qn,4周为1疗程,共治疗3个疗程;试验组予以口服坦索罗辛0.2 mg qn和酒石酸托特罗定4mg qn,4周为1疗程,共治疗3个疗程.比较2组患者的临床疗效、国际前列腺症状(IPSS)评分、刺激症状评分、最大尿流速(Qmax)、生活质量评分(QOL)、膀胱过度活动症评分(OABSS)、膀胱过度活动症状以及药物不良反应发生率.结果 治疗后,试验组和对照组的总有效率分别为96.67％(58例/60例)和83.33％(50例/60例),差异有统计学意义(P＜0.05).治疗后,试验组和对照组的IPSS评分分别为(14.08 ±4.52),(17.15 ±4.34)分,刺激症状评分分别为(4.47±1.11),(5.77±1.10)分,Qmax分别为(14.15 ±1.72),(13.21 ±2.16)mL·s-1,QOL评分分别为(1.38±0.99),(3.27±1.39)分,OABSS评分分别为(8.08±2.12),(13.83±4.37)分,日间排尿次数分别为(7.52±2.21),(8.68±2.00)次,夜尿次数分别为(1.40±0.76),(2.48±1.48)次,急迫性尿失禁次数分别为(1.00±0.55),(1.90±0.35)次,尿急次数分别为(2.58±1.08),(4.53±0.98)次,差异均有统计学意义(均P＜0.05).试验组和对照组药物不良反应发生率分别为5.00％(3例/60例)和5.00％(3例/60例),差异无统计学意义(P＞0.05).结论 坦索罗辛联合酒石酸托特罗定治疗良性前列腺增生伴下尿路症状患者的临床疗效优于多沙唑嗪联合酒石酸托特罗定方案,安全性高.“,”Objective To observe the clinical efficacy and safety profile of tamsulosin in combination with tolterodine tartrate versus doxazosin plus tolterodine tartrate for the treatment of patients with benign prostatic hyperplasia and lower urinary tract symptoms.Methods A total of 120 patients were randomly divided into control group(n =60) and treatment group(n =60).The control group was given oral doxazosin 4 mg qn and tolterodine tartrate 4 mg qn.The treatment group was given oral administration of tansulosin 0.2 mg qn and tolterodine tartrate 4 mg qn.Both groups were treated for 3 cycles (1 cycle =3 weeks).The clinical efficacy,the international prostate symptom score (IPSS),the irritation score,maximum urinary flow rate (Qmax),quality of life index (QOL),overactive bladder score (OABSS),overactive bladder symptoms and the incidence of adverse drug reactions were compared between the 2 groups.Results After treatment,the total effective rates of the treatment group and the control group were 96.67％ (58 cases/60 cases) and 83.33％ (50 cases/60 cases),respectively,and the difference was statistically significant (P ＜ 0.05).After treatment,the IPSS scores of the treatment group and the control group were (14.08 ± 4.52) and (17.15 ± 4.34)point,the scores of irritation symptoms were (4.47 ± 1.11) and (5.77 ± 1.10) point,the values of Qmax were (14.15 ± 1.72),(13.21 ± 2.16) mL· s-1,QOL scores were (1.38 ±0.99) and (3.27 ± 1.39)point,the OABSS were (8.08 ±2.12) and (13.83 ± 4.37) point,the urination frequencies during the day were (7.52 ± 2.21),(8.68 ± 2.00) times,the nocturnal urination frequencies were (1.40 ± 0.76) and (2.48 ± 1.48) times,and the frequencies of urinary incontinence were (1.00 ± 0.55),(1.90 ± 0.35) times,and the frequencies of urinary urgency were (2.58 ± 1.08),(4.53 ± 0.98) times.There were statistical differences in all the above parameters between the two groups (P ＜0.05).The incidences of adverse reactions in the treatment group and the control group were 5％ (3 cases/60 cases) and 5％ (3 cases/60 cases),respectively,and no significant difference was found between the two groups (P ＞ 0.05).Conclusion Tamsulosin combined with tolterodine tartrate exerted higher efficacy and safety profile compared with doxazosin combined with tolterodine tartrate in treatment of benign prostatic hyperplasia with lower urinary tract symptoms.