膀胱三角区联合逼尿肌注射A型肉毒毒素治疗神经源性逼尿肌过度活动伴尿失禁的疗效和安全性：前瞻性、多中心、单盲、随机对照试验  

Effect and safety of trigone-including intradetrusor injection of botulinum toxin A in patients with neurogenic detrusor overactivity and incontinence： a prospective, multicenter, single-blind and randomized controlled trial

作　　者：谢克基[1] 陈晖[2] 蒋重和 汤平[1] 欧汝彪[1] 曾健文[3] 邓向荣[1] 周理林[3] 黄马平[2] 李青青[2] 刘秋玲[2] 黄杰滨 

机构地区：[1]广州医科大学附属广州市第一人民医院泌尿外科,510180 [2]广东省工伤康复中心泌尿外科 [3]暨南大学附属广东省清远市人民医院泌尿外科

出　　处：《中华泌尿外科杂志》2015年第2期95-99,共5页Chinese Journal of Urology

基　　金：广东省科技计划项目（2012B031800007）;广东省医学科研基金项目（A2013477）

摘　　要：目的 探讨膀胱三角区联合逼尿肌注射A型肉毒毒素治疗神经源性逼尿肌过度活动（neurogenic detrusor overactivity,NDO）伴尿失禁的疗效和安全性. 方法 采用前瞻性、多中心、单盲、随机对照的试验方法,2011年6月至2014年6月按1：1的比例将脊髓损伤NDO伴尿失禁患者分为实验组和对照组.实验组患者行膀胱镜下逼尿肌A型肉毒毒素160 U注射,膀胱三角区40 U注射;对照组行膀胱镜下逼尿肌A型肉毒毒素200 U注射术（不包括膀胱三角区）.记录治疗前和治疗后4、12周两组患者尿失禁生命质量评分、平均每日尿失禁次数、尿失禁患者、平均每次排尿量（导尿＋自然排尿）.记录治疗前及治疗后12周的储尿期膀胱逼尿肌最大压力、首次出现逼尿肌过度活动时膀胱容量和膀胱输尿管反流.记录治疗后不良事件.采用SPSS 13.0软件对计量资料采用t检验,计数资料采用x2检验法. 结果 96例患者入选,91例完成试验,其中实验组47例、对照组44例.两组间各基线数据比较差异均无统计学意义（P＞0.05）.术后两组内各指标与基线比较差异均有统计学意义（P＜0.05）.术后12周,两组尿失禁生命质量评分较基线分别增加65.84％、55.81％ （P=0.01）,平均每日尿失禁次数分别减少71.95％、65.80％ （P=0.02）,尿失禁患者分别减少29.79％、11.36％ （P=0.03）,平均每次排尿量分别增加79.47％、69.76％（P=0.02）,储尿期膀胱逼尿肌最大压力分别减少48.76％、40.68％（P=0.04）,首次出现逼尿肌过度活动时膀胱容量分别增加64.56％、57.23％（P=0.02）,组间比较差异均有统计学意义.实验组和对照组患者均未发生膀胱输尿管反流.术后3例出现尿路感染,其中实验组1例、对照组2例. 结论 膀胱三角区联合逼尿肌注射A型肉毒毒素治疗NDO伴尿失禁的疗效优于单独逼尿肌注射,且不会引起膀胱输尿管反流.Objective To evaluate the effect and safety of trigone-including intradetrusor injection of botulinum toxin A （BTX-A） for patients with neurogenic detrusor overactivity （NDO） and incontinence.Methods A prospective,multicenter,single-blind and randomized controlled trial was conducted between June 2011 and June 2014.Patients with NDO and incontinence who suffered from spinal cord injury were recruited.At a 1：1 ratio patients randomly received 200 U BTX-A intradetrusor injections excluding the trigone （control group） or 160 U intradetrusor plus 40 U intratrigonal injections （experimental group）.Patients were evaluated at baseline,4 and 12 weeks after injection.The primary outcomes included incontinence specific quality of life （I-QOL）,mean voiding volume,mean incontinence episodes,complete dryness,maximum detrusor pressure （Pdetmax） during filling,volume at first involuntary detrusor contraction （VFIDC）.Vesicoureteral reflux （VUR） and other adverse events were recorded.Results Ninety-six patients were recruited and 91 of them completed the trial.Among the 91 patients,47 were randomized to experimental group,44 to control group.There were no significant differences in baseline evaluation items between the 2 groups.All outcomes after treatment improved significantly as compared to the baseline in each group （P〈 0.05）.Twelve weeks after treatment,the improvement percentage of I-QOL （65.84%）,mean incontinence episodes （71.95%）,complete dryness （29.79%）,mean voiding volume （79.47%）,P detmax （48.76%）,VFIDC（64.56%） in experimental group had significant difference as compared to those in control group （55.81%,65.80%,11.36%,69.76%,40.68%,57.23%） （P=0.01,0.02,0.03,0.02,0.04,0.02）,respectively.In both groups,no patients developed VUR.Three cases （1 in experimental group,2 in control group） developed urinary tract infection.Conclusions Trigone-including intradetrusor injection of BTX-A is more effective than intradetrusor injection excluding the trigon

关 键 词：膀胱 过度活动性 膀胱 神经源性 肉毒杆菌毒素 A型 膀胱三角区 治疗结果 

分 类 号：R694.5[医药卫生—泌尿科学]