索利那新治疗尿急及急迫性尿失禁的有效性和安全性分析

Efficacy and safety of Solifenacin in the treatment of patients with urgency and urge incontinence

目的评价索利那新治疗尿急和急迫性尿失禁的临床有效性和安全性。方法病程≥3个月的尿急和（或）急迫性尿失禁患者246例，经临床确诊为膀胱过度活动症（OAB），并通过排尿日记分析符合入选标准后，采用双盲双模拟多中心临床试验设计方法，随机分2组：①试验组：123例。男17例，女106例。24h尿急次数中位数为4．33次。予索利那新1次／d，5mg／次。②对照组：123例。男26例，女97例。24h尿急次数中位数为4．00次。予托特罗定2次／d，2mg／次。服药8周后再次记录排尿日记，并判断不良反应。采用SAS V8．2统计分析软件对2组患者的疗效和安全性进行分析。结果服药8周后与基线相比，试验组和对照组24h尿急次数中位数均减少3．00次（P〈0．01），24h尿失禁次数中位数分别减少1．00次（P〈0．01）和0．67次（P=0．05），组间比较差异均无统计学意义（P=0．58，P=0．29）。2组24h平均夜尿次数分别减少0．74次（P〈0．01）和0．68次（P〈0．01），组间比较差异无统计学意义（P=0．73）；24h排尿次数分别减少2．79和2．47次，每次尿量分别增加29．53和23．04ml，组间比较差异均无统计学意义（P＝0．54，P＝0．29）。试验组和对照组不良反应总发生率分别为11．7％（14／120）和23．5％（27／115），差异有统计学意义（P〈0．05），其中主要不良反应口干发生率分别为5．8％和10．4％（P〈0．05）。结论索利那新治疗尿急和急迫性尿失禁等OAB症状安全有效。

Objective To evaluate the efficacy and safety of Solifenacin in patients with urinary urgency and urgy incontinence. Methods Two hundred and forty-six patients with urgency and urgy incontinence who had symptoms of overactive bladder（OAB） for ≥3 months were enrolled. A doubleblind double-dummy randomized controlled multicenter clinical trial was conducted. Patients were randomized into 2 groups. One hundred and twenty-three patients （17 males, 106 females） received Solifenacin （5 mg once daily） whose median urgency episodes were 4.33. The other 123 patients （26 males, 97 females） received Tolterodine （2 mg twice daily） whose median urgency episodes were 4.00. After 8 weeks＇ treatment, all patiens recorded the 3-day diary repeatedly and the adverse events as well. The results of the efficacy and safety were analyzed by using SAS V8.2. Results After 8 week treatment, the median decreases of urgency episodes were both 3.00 （P〈0.01）, there was no significant difference between the 2 groups （P=0.58）. The median decreases of urge incontinence episodes were 1.00（P〈0.01） and 0. 67（P=0. 05）, there was no significant difference between the 2 groups （P=0.29）. That of nocturia, the decreases were 0. 74（P〈0. 01） and 0.68 （P〈0.01）, there also was no significant difference between the 2 groups （P= 0.73）. In addition, the mean decreases of number of micturition were 2.79 and 2.47, and the mean increases of volume voids were 29.53 ml and 23.04 ml, there were no significant differences between the 2 groups （P= 0.54, P= 0.29）. The total incidences of treatment-emergent adverse events （AEs） were 11.7% （14/120） in the Solifenacin group and 23.5% （27/115） in the Tolterodine group （P〈0.05）. The most frequently reported AE was dry mouth, the frequency was lower among patients receiving Solifenacin 5.8% compared to those receiving Tolterodine 10.4%（P〈0.05）. Conclusion Solifenacin could be the safer and effective drug in the treatment of OAB patients with main complaints of urinary urgency and urgy incontinence.