索利那新联合多沙唑嗪治疗中青年女性重度膀胱过度活动症伴性功能障碍的疗效观察

Comparison of Solifenacin monotherapy with Solifenacin and Doxazosin combination therapy for the treatment of severe overactive bladder with sexual dysfunction among youthful and middle-aged females

目的：探讨索利那新联合多沙唑嗪治疗中青年女性重度膀胱过度活动症（OAB）伴性功能障碍（FSD）的疗效。方法2010年10月至2013年9月，门诊收治女性重度OAB伴FSD患者93例，年龄25~40岁，平均年龄33岁。入选标准：平均每日排尿次数≥8次，夜间≥2次，每次尿量＜200ml；膀胱过度活动症状评分（OABSS）≥12分且尿急评分≥2分，残余尿＜50ml，女性性功能指数（FSFI）＜25分，病程≥3个月。采用随机对照方法，分为单药组（44例）和联合组（49例）。单药组口服索利那新5mg/d，共4周；联合组口服索利那新5mg/d，多沙唑嗪4mg/d，用药时间为4周，观察指标为：感知膀胱症状量表（PPBC），OABSS（包括白天排尿次数，夜尿次数，尿急次数，急迫性尿失禁次数），FSFI（包括性欲、性唤起、阴道润滑、性高潮、性交疼痛、性满意评分），膀胱顺应性（BC），初始尿意容量（VFD），最大膀胱容量（MC），最大尿流率时逼尿肌压力（PdetQmax），最大尿道压（MUP），最大尿流率（Qmax），PVR，并登记不良事件。结果两组间基础资料比较无统计学意义（P＞0.05）。与基线值比较，联合组用药4周后PPBC、OABSS、MUP、PdetQmax、BC、VFD、MC、Qmax、FSFI有显著统计学差异（P=0.00）；单药组用药4周后PPBC、OABSS、VFD、MC、FSFI比较亦有统计学意义（P=0.00），而MUP、PdetQmax、BC、Qmax治疗前后无统计学差异（P＞0.05）。两组间比较：联合组PPBC、OABSS、MUP、PdetQmax、BC、VFD、MC、Qmax改善优于单药组（P＜0.01），尤其在性欲、性唤起、性交疼痛、性满意评分较单药治疗后改善显著（P=0.00），而阴道润滑度（3.87＆#177;0.79 vs 4.08＆#177;0.73）、性高潮（3.42＆#177;0.74 vs 3.40＆#177;0.64）评分改善无明显差异（P＞0.05）。治疗过程中，未见急性尿潴留及其他严重不良反应发生。两组治疗前后血清C-反应蛋白（CRP）及残余尿量（PVR）改变无统计学差异（P＞0.05）。结论索利那新单用或索利那新联合多沙唑嗪均能改善中青年女性重度OAB症状，能有效提高性生活满意度。索利那新联合多沙唑嗪疗效更佳。两组均未见严重不良反应及急性尿潴留出现。

Objective To evaluate the effectiveness and safety of the combination therapy of Solifenacin and Doxazosin for severe overactive bladder with sexual dysfunction among youthful and middle-aged females. Methods The OAB female patients with FSD who suffered from OAB and FSD sympotoms for at least 3 months were enrolled in a prospective study from October 2010 to September 2013. The inclusion criteria included ages among 25~40y, the mean frequency of micturition≥8 times per day, the frequency of nocturia≥2 times per day,voiding volume 〈200ml each time, OABSS≥12, Urgency Score≥2,Postvoid residual volume 〈50ml, and female sexual function index（FSFI） 〈25. All 93 patients were devided randomly into two groups：monotherapy group （n=44） in which patients were treated with Solifenacin 5mg once daily for 4 weeks,and combination group （n=49） in which patients were treated with Solifenacin 5mg once daily and Doxazosin 4mg once daily for 4 weeks. Results There was no significant differences in baseline between two groups（P〉0.05）. There were significant statistical differences between the pre-treatment and post-treatment in the indicators of Patient＆#39;s perception of bladder condition （PPBC）, OABSS,maximum urethral pressur,detrusor pressure at maximal flow rate, bladder compliance, volume at first desire, maximal capacity, Qmax and FSFI （P=0.00）, compared with baseline values. The values of PPBC, OABSS, volume at first desire, maximal capacity and FSFI were also significantly improved after treatment in single therapy （P=0.00）, but maximum urethral pressure,detrusor pressure at maximal flow rate,bladder compliance and Qmax had no obvious differences between pre-treatment and post-treatment （P〉0.05）.The improvements of PPBC, OABSS,maximum urethral pressure, detrusor pressure at maximal flow rate, volume at first desire, maximal capacity and Qmax in combination group were expressively greater than that in monotherapy group （P〈0.01）. The scores of sexual desire,sexual arousal, sexual pain, sexual satisfaction, particularly, exhibited dominant position in combination group （P=0.00）. The changes of vaginal lubrication and Orgasm, however, showed no changes in post-treatment of two groups（P〉0.05）. There were no differences between the two groups in post-voiding residual and serum C-reactive protein （P〉0.05）. No acute urinary retention was found. Conclusion Both Solifenacin monotherapy and Solifenacin with Doxazosin combination therapy can ameliorate severe OAB and FSD symptoms among youthful and middle-aged females. The effects of Solifenacin with Doxazosin are superior to that of single use of Solifenacin.