塞来昔布在治疗压力性尿失禁中的疗效及安全性

The Effectiveness and Safety of Celecoxib in Treatment of Female Stress Urinary Incontinence

目的评价塞来昔布胶囊(西乐葆)治疗压力性尿失禁的疗效、安全性及并探讨可能机制.方法2014年1月至2015年12月昆明医科大学第二附属医院门诊单纯性女性压力性尿失禁患者80例作为实验组:口服塞来昔布胶囊200 mg,Bid,共3月;另80例单纯性女性压力性尿失禁患者为对照组:服用安慰剂(医用淀粉)1粒/次,2次/d,共3月.2组均辅以行为治疗、盆底功能锻炼.治疗3月后随访,以尿垫实验及生活质量量表评估疗效.结果实验组与对照组在年龄、病程上差异无统计学意义(P>0.05);实验组疗效优于对照组,在尿垫实验方面,实验组漏尿量明显少于对照组,在生活质量评分量表(QOL-36-SF)方面,不论是生理维度还是心理维度的得分,实验组明显高于对照组(P<0.05).总的效果,实验组显效21例(26.3%),有效56例(70%),无效3例(3.8%),有效率为96.3%.对照组显效15例(18.8%),有效56例(70%),无效9例(11.2%),有效率为88.6%,2组疗效比较,差异有统计学意义(P<0.05);实验组及对照组均无明显不良反应,亦无自行停药者.结论服用塞来昔布胶囊可改善压力性尿失禁症状,药物具有较好安全性和耐受性.

Objective To explore the effectiveness, safety and the possible mechanism of Celecoxib Capsules （Celebrex） in treatment of female stress urinary incontinence. Methods From January 2014 to December 2015, 80 female patients with stress urinary incontinence, from the outpatient department of our hospital, were selected in experimental group, who took celecoxib orally 200 rag, Bid for 3 months. The other 80 female patients with stress urinary incontinence were selected in control group, who took placebo （medical starch） orally 1 piece, Bid for 3 months. The two groups of patients were treated with behavioral therapy and functional exercise of pelvic floor. Both groups of patients were assessed with the urine pad test and quality of life scale 3 months later. The study was approved by the Institutional Review Board of the second Hospital of Kunming Medical University and followed the principles expressed in the Declaration of Helsinki. The written informed consent was obtained from every patient. Results The difference between the experimental group and the control group in the age, the course of disease had no statistical significance （P〉0.05）. The effectiveness of experimental goup was better than the controlled group. The urine volume in experimental group is less than that in control group in urine pad test. And the score of experimental goup in QOL-36-SF was higher than that of control group both in physical dimension and the psychological dimension. The overall effective rate was 96.3% in experimental group [ 21（26.3%） cases were improved markedly, 56 （70%） patients improved, 3 （3.8%） patients was failed] and 88.6% in control group [15 （18.8%） cases were improved markedly, 56 （70%） patients improved, 3 （3.8%） patients was failed]. Tthe difference has statistical significance （P〈0.05）. No obvious side effects were observed in both groups and no one stooped the treatment by herself. Conclusion Celecoxib can attenuate the symptoms of female stress urinary incontinence, and has the good safety and tolerability.