索利那新联合坦索罗辛治疗前列腺增生合并膀胱出口梗阻

Tamsulosin combined with solifenacin for benign prostatic hyperplasia complicated with overactive bladder

目的:探讨索利那新联合坦索罗辛治疗良性前列腺增生(benign prostatic hyperplasia,BPH)合并膀胱出口梗阻(bladder outlet obstruction,BOO)的有效性及安全性。方法:选择未经治疗且无严重BOO的BPH患者105例进行为期12周的治疗;随机分成Ⅰ、Ⅱ两组,Ⅰ组(n=50)单用坦索罗辛(0.2 mg,每晚),Ⅱ组(n=55)联合服用坦索罗辛(0.2 mg,每晚)和索利那新(5 mg,1次/d)。两组分别在治疗前后以国际前列腺症状评分(international prostate symptoms score,IPSS)、生活质量评估(quality of life,QOL)、膀胱过度活动症评分(overactive bladder sypmtom score,OABSS)、最大尿流率(maximum flow rate,Qmax)以及24 h排尿次数、尿急次数、急迫性尿失禁次数和尿潴留次数为评估指标,观察其有效性及安全性。结果:服药12周后,可评价病例97例;两组治疗前后IPSS、QOL、Qmax及24 h排尿次数均得到显著改善(P<0.05);Ⅱ组治疗后OABSS评分以及储尿期症状(尿急、尿频、急迫性尿失禁)明显优于Ⅰ组[(4.82±1.15 vs.9.27±2.10)、(3.31±0.18 vs.6.82±2.15)、(8.02±2.15 vs.10.13±2.07)、(0.50±0.13 vs.2.03±0.87),P<0.05],而Qmax两组治疗后比较差异无统计学意义(15.81±2.56 vs.16.04±3.26,P>0.05);两组均未发生尿潴留,不良事件发生率Ⅰ组为4.3%、Ⅱ组为8.0%。结论:索利那新联合坦索罗辛能有效并安全地缓解BPH所合并的OAB症状,极大地改善了患者的生活质量。

Objective： To evaluate the efficacy and safety of combined use of solifenacin and tamsulosin in the treatment of benign prostatic hyperplasia（BPH） accompanied by overactive bladder（OAB）. Methods：Totally 105 cases of clinically diagnosed BPH without serious obstruction of urinary tract were selected and were randomly assigned to I group（n=50） to receive 0.2 mg of tamsulosin once a day and Ⅱ group（n=55） to be treated with 0.2 mg of tamsulosin once a day plus 5 mg of solifenacin once a day at night,both for 12 weeks. Before and after the treatment,international prostate symptom score （IPSS）, quality of life （QOL） score, overactive bladder symptom score（OABSS）, maximum urinary flow rate（Qmax）, 24 h micturition frequency, 24 h urinary urgency frequency, 24 h uroclepsia frequency and urinary retention times of patients were recorded and used to do evaluation. Results ：After 12 weeks medication,the assessable cases were 97 ;vales of IPSS, QOL,Qmax and 24 h micturition frequency were improved significantly in both groups（P〈 0.05）. Besides, OABSS, frequent micturition, urinary frequency and uroclepsia in group Ⅱ were respectively better than those in group I （（4.82 ± 1.15 vs. 9.27 ＋2.10）, （3.31±0.18 vs. 6.82 ±2.15）, （8.02 ±2.15 vs. 10.13 ±2.07）, （0.50 ±0.13 vs. 2.03 ±0.87）,P〈 0.05）. No significant difference was found between two groups in Qmax（ 15.81 ±2.56 vs. 16.04 ± 3.26, P〉0.05）. No case of acute urinary retention occurred in either group. Incidences of adverse reactions in both groups were 4.3% and 8.0% respectively without significant differences. Conclusions：Combination therapy with tamsulosin and solifenacin is effective and safe in relieving the symptoms of patients with BPH and OAB and improving patient＇ s quality of life greatly.