摘要
目的探讨尿道外括约肌注射A型肉毒毒素(BTX-A)治疗男性神经源性逼尿肌活动低下(NDU)的临床疗效和安全性。方法采用前瞻性自身对照研究方法对2012年8月至2017年10月广东省工伤康复医院收治的男性神经损伤患者进行研究。纳入标准:年龄≥18岁;有明确神经系统疾病且病情平稳(3个月内神经损伤症状无进行性进展);排尿困难>6个月且符合NDU诊断标准(尿动力学检查示膀胱逼尿肌收缩力指数<100)。排除标准:急性泌尿系感染、膀胱结石、良性前列腺增生、尿道狭窄、尿道憩室、重症肌无力、胃潴留、严重的溃疡性结肠炎患者及凝血功能障碍患者;对BTX-A或其组成成分过敏者。纳入的患者行尿道膀胱镜下BTX-A尿道外括约肌内注射。将100 U BTX-A溶解于生理盐水4 ml中,经膀胱注射针于尿道外括约肌3、6、9、12点分别注射1 ml。记录患者基线及注射后12周的膀胱残余尿量(PVR)、最大尿流率(Qmax)、排尿期膀胱逼尿肌最大压力(Pdet.max)、最大尿道闭合压(MUCP)、间歇导尿(IC)患者例数、生活质量(QOL)评分和治疗后不良事件。结果本研究共纳入63例患者,58例完成研究,神经系统病变分别为脑瘫2例,脑血管意外19例,脊髓损伤37例。年龄19~42岁,平均28.6岁。体重53~73 kg,平均63.6 kg。病程0.5~21.0年,平均2.2年。所有患者均需行清洁间歇导尿。BTX-A注射术前与术后12周的PVR(280.11 ml与56.68 ml,P<0.001),Qmax(3.28 ml/s与6.74 ml/s,P=0.019),Pdet.max[30.01 cmH2O(1 cmH2O=0.098 kPa)与23.95 cmH2O,P=0.042],MUCP(79.34 cmH2O与48.25 cmH2O,P<0.001),IC患者例数(58例与40例,P<0.001),QOL评分(5.22分与3.63分,P<0.001)比较差异均有统计学意义。术后5例出现会阴区疼痛,口服止痛药3~5 d症状消失;16例尿管内短暂出现肉眼血尿,无需特殊处理1周后血尿消失。结论BTX-A尿道外括约肌注射能有效降低尿道阻力,促进排尿和减少PVR,提高NDU患者生活质量。
Objective To assess clinical effect and safety of botulinum toxin A injection in external urethral sphincter for male patient with neurogenic detrusor underactivity(DU).Methods A prospective and self-controlled trail was conducted from August 2012 to October 2017.Male patients with nerve injury,dysuria more than 6 months,DU(bladder contractility index less than 100)were enrolled in this study.Exclusion criteria included patients with acute urinary tract infection,bladder stone,benign prostate hyperplasia,urethral stricture and urethral diverticulum.100 IU BTX-A was dissolved in 4ml normal saline,and the solution of BTX-A was injected into 4 different points(3-o’clock,6-o’clock,9-o’clock,and 12-o’clock)in external urinary sphincter with each point of 1ml solution.Patients were evaluated at baseline and 12 weeks after injection.The outcomes included post void residual(PVR),maximum flow rate(Qmax),maximum detrusor pressure during voiding phases(Pdet.max),maximum urethral closure pressure(MUCP),the case number of intermittent catheterization(IC)and the score of quality of life(QOL score).Adverse events were also recorded.Results A total of 58 male patients(all from Guangdong provincial work injury rehabilitation hospital)with mean age 28.6 years suffered from cerebral palsy(n=2),cerebrovascular accident(n=19)and spinal cord injury(n=37)were included into the study.Compared to baseline data,significant difference were observed at week 12 in PVR(56.68 ml vs.280.11 ml,P<0.001),Pdet.max(23.95 cmH2O vs.30.01 cmH2O,P=0.019),Qmax(6.74 ml/s vs.3.28 ml/s,P=0.042),MUCP(48.25 cmH2O vs.79.34 cmH2O,P<0.001),the case number of IC(40 vs.58,P<0.001)and QOL score(3.63 vs.5.22,P<0.001)respectively.5 cases developed perineal pain and 16 cases developed mild transient haematuria.These adverse events were disappeared by medical symptomatic treatment during 3-5 days.Conclusions BTX-A externalurethral sphincter injections help reduce urethra resistance and also improve the quality of life for patients with neurogenic detrusor underactivity.
作者
陈晖
谢克基
蒋重和
黄马平
黄天海
汤平
欧汝彪
曾健文
邓向荣
李青青
刘秋玲
杨晓毅
Chen Hui;Xie Keji;Jiang Chonghe;Huang Maping;Huang Tianhai;Tang Ping;Ou Rubiao;Zeng Jianwen;Deng Xiangrong;Li Qingqing;Liu Qiuling;Yang Xiaoyi(Department of Urology,Guangdong Provincial Work Injury Rehabilitation Hospital,Guangzhou 510440,China;Department of Urology,Guangzhou First People’s Hospital,Guangzhou 510180,China;Department of Urology,Qingyuan City People′s Hospital,Qingyuan 511500,China)
出处
《中华泌尿外科杂志》
CAS
CSCD
北大核心
2019年第11期849-852,共4页
Chinese Journal of Urology