坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症的临床观察

目的 探讨坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症的有效性及安全性。 方法 本组良性前列腺增生伴膀胱过度活动症患者82例。年龄50～75岁，平均57岁。入选标准：平均每天排尿次数≥8次，夜间≥2次，每次尿量＜200 ml;膀胱过度活动症症状评分(OABSS)：第3项评分＞2分，总分＞3分。采用随机对照方法，分为对照组（38例）和实验组(44例)。2组临床指标比较差异无统计学意义(P＞0.05)。对照组口服坦索罗辛0.2 mg，每日1次，共12周；实验组口服坦索罗辛0.2 mg，每日1次，索利那新5 mg，每日1次，共12周。比较2组治疗前后国际前列腺症状评分(IPSS)、排尿期症状评分、储尿期症状评分、最大尿流率(Qmax)、残余尿量、OABSS、尿常规检查、不良事件登记等。 结果 ①对照组治疗前后IPSS评分(19.5±2.2 vs 15.6±2.4)、排尿期症状评分(15.6±2.4 vs3.4±1.7)、Qmax(13.7±3.8 vs16.6±4.1)，治疗前后比较差异有统计学意义（P值均＜0.05）。②实验组治疗前后IPSS评分(19.7±2.3 vs9.7±3.0)、储尿期症状评分（13.8±1.9 vs5.6±1.6）、OABSS( 10.3±1.8 vs5.3±1.3)、Qmax(14.1±4.1 vs 17.2±3.5)，治疗前后比较差异有统计学意义（P值均＜0.05）。③治疗后实验组与对照组IPSS评分(9.7±3.0 vs15.6±2.4)、储尿期症状评分(5.6±1.6 vs 12.0±1.6，)、OABSS(5.3±1.3 vs9.7±2.7)比较差异有统计学意义（P值均＜0.05）。实验组与对照组排尿期症状评分(3.4±1.1 vs3.4±1.7)、Qmax (17.2±3.5 vs 16.6±4.1)、残余尿量(36.7±17.1 vs 35.7±12.5)比较差异无统计学意义(P值均＞0.05)。2组均无急性尿潴留发生，对照组总体不良反应发生率为7.9％( 3/38)，实验组总体不良反应发生率为20.5％ (9/44)。 结论 坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症有效、安全，疗效优于单用坦索罗辛。

Clinical study of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia with overactive bladder

Objective To evaluate the efficacy and safety of combination therapy of tamsulosin and solifenacin for benign prostatic hyperplasia ( BPH ) with overactive bladder ( OAB ).Methods 82 patients with OAB and coexisting BPH were randomly divided into tamsulosin group ( n = 38 ) and combination group ( n = 44). The ages were from 50 to 75 y ( averaged, 56.8 ± 8.6). Inclusion criteria: the mean frequency of micturition ≥8 times per day, the frequency of nocturia ≥2 times per day, voiding volume ＜200 ml each time; for the overactive bladder symptom score ( OA BSS), the 3 rd score ＞ 2, total score ＞ 3. The tamsulosin group accepted tamsulosin 0.2 mg once daily, the combination group accepted tansulouxin 0.2 mg and solifenacin 0.2 mg once daily. Both groups were maintained the corresponding therapy for 12 weeks.The international prostate symptom score (IPSS), Qmax, residual urine volume, OAB score and adverse reactions were recorded.Results The values of IPSS ( 19.5 ±2.2 vs 15.6 ±2.4, P =0.027), the voiding symptom score ( 15.6 ± 2.4 vs 3.4 ± 1. 7, P = 0. 022) and Qmax ( 13.7 ± 3.8 vs 16.6 ± 4.1, P = 0. 034 )improved significantly after treatment in tamsulosin group ( P ＜ 0. 05 ). The values of IPSS ( 19.7 ± 2.3 vs 9.7 ± 3.0, P ＜0. 001), the storage symptom score (13.8 ± 1.9 vs 5.6 ± 1.6, P ＜0. 001 ), OABSS (10.3 ±1.8 vs 5.3 ±1.3, P ＜0.001) and Qmax(14.1 ±4.1 vs 17.2 ±3.5, P=0.027) also improved significantly after treatment in combination group ( P ＜ 0. 05 ). The values of IPSS ( 9.7 ± 3.0 vs 15.6 ±2.4, P ＜ 0.001 ), the storage symptom score (5.6 ± 1.6 vs 12.0 ± 1.6, P ＜ 0.001 ) and OABSS ( 5.3 ±1.3 vs 9.7 ± 2.7, P ＜ 0. 001 ) improved significantly in combination group than those in tamsulosin group ( P ＜0.001 ). There were no difference between two groups in values of the voiding symptom score, Qmax and residual urine volume ( P ＞ 0.05 ). The incidences of adverse reactions in tamsulosin group and combination group were 7.9％ (3/38) and 20.5％ (9/44) without significant difference. There was no acute urinary retention in both groups.Conclusions It is effective and safe for patients with BPH and OAB to accept combination therapy of tamsulosin and solifenacin.