铜绿假单胞菌注射液预防女性反复发作尿路感染的多中心、随机对照临床研究  

A multicenter,randomized controlled clinical trial of Pseudomonas aeruginosa injection for prevention of recurrent urinary tract infections

作　　者：杜震[1] 崔亮 高瞻[3] 支轶 崔刚[5] 张鹏[6] 果宏峰[7] 钟山 史本康 李岩[9] 张勇[10] 邢毅飞[11] 陈山[1] 乔庐东[1] Du Zhen;Cui Liang;Gao Zhan;Zhi Yi;Cui Gang;Zhang Peng;Guo Hongfeng;Zhong Shan;Shi Benkang;Li Yan;Zhang Yong;Xing Yifei;Chen Shan;Qiao Ludong(Department of Urology,Bejing Tongren Hospital,Capital Medical University,Bejing 100176,China;Department of Urology,Civil Aviation General Hospital,Beijing 100123,China;Department of Urology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Bejing 100091,China;Department of Urology,The Third Affliated Hospital of Chongqing Medical University,Chongqing 401120,China;Department of Urology,Daxing District People's Hospital,Bejing 102600,China;Department of Urology,Bejing Chaoyang Hospital,Capital Medical University,Bejing 100020,China;Department of Urology,Shougang Hospital,Peking University,Beijing 100144,China;Department of Urology,Huashan Hospital Affiliated to Fudan University,Shanghai 200040,China;Department of Urology,Qilu Hospital,Shandong University,Jinan 250012,China;Department of Urology,Bejing Tiantan Hospital Capital Medical University,Beijing 100071,China;Department of Urology,Union Hospital Affiliated to Tongji Medical College,Huazhong Unversity of Science and Technology,Wuhan 430023,China)

机构地区：[1]首都医科大学附属北京同仁医院泌尿外科,北京100176 [2]民航总医院泌尿外科,北京100123 [3]中国中医科学院西苑医院泌尿外科,北京100091 [4]重庆医科大学附属第三医院泌尿外科,重庆401120 [5]北京市大兴区人民医院泌尿外科,北京102600 [6]首都医科大学附属北京朝阳医院泌尿外科,北京1100020 [7]北京大学首钢医院泌尿外科,北京100144 [8]复旦大学附属华山医院泌尿外科,上海200040 [9]山东大学齐鲁医院泌尿外科,济南250012 [10]首都医科大学附属北京天坛医院泌尿外科,北京100071 [11]华中科技大学同济医学院附属协和医院泌尿外科,武汉430023

出　　处：《中华泌尿外科杂志》2024年第12期925-931,共7页Chinese Journal of Urology

摘　　要：目的探讨铜绿假单胞菌注射液预防女性反复发作尿路感染复发的临床疗效和安全性。方法本研究为多中心、随机、开放、阳性对照非劣效性试验,受试者为就诊于国内11家医疗中心的女性复发性尿路感染(rUTIs)患者。纳入标准:①年龄18~70岁,有可证实的临床资料显示1年内≥3次、6个月内≥2次急性UTIs发作,且经抗菌药物治疗治愈;②入组时患者无明显尿路刺激症状,中段尿尿常规检查白细胞计数正常(在各单位实验室标准正常范围内)或离心镜检≤3HP,白细胞酯酶、亚硝酸盐阴性,尿细菌培养阴性;③泌尿系B超检查无尿路解剖功能异常(如:尿路梗阻、结石或先天性尿路畸形等)且残余尿量≤50ml;④本人或代理人签署知情同意书;⑤意识清晰,能独立回答问题,按试验方案要求自行完成研究问卷。排除标准:①对治疗用药过敏者;②任何复杂的尿路感染或肾盂肾炎迹象(表现为腰痛、体温≥37.3℃、全身症状);③入组前7d内应用影响免疫功能的药物;④有泌尿系统基础疾病,如梗阻、结石、尿路狭窄、膀胱输尿管反流或其他功能异常、尿流改道、留置导尿管或支架管或间歇导尿患者;⑤合并或存在系统性红斑狼疮、艾滋病等可导致全身免疫功能异常的疾病;⑥已知/疑似怀孕、母乳喂养或停药后3个月内计划妊娠的患者;⑦恶性肿瘤患者和精神病患者;⑧筛选前4周内曾接受其他任何试验药物治疗或参加过另一项干预性临床试验者;⑨不能遵守试验方案或其他研究者认为不适合入组的情况。将患者随机分为2组,试验组注射铜绿假单胞菌注射液,共给药5次,首次用药0.5ml,随后4周每周用药1次,每次1ml;对照组采用磷霉素氨丁三醇3g口服,每10天1次,连续给药9次。随访6~8个月,随访期间出现尿路症状,且尿常规检查示白细胞异常升高定义为UTIs复发。于试验组第5次给药当天、对照组第4次用�Objective To investigate the clinical efficacy and safety of Pseudomonas aeruginosa injection in preventing reurrent urinary tract infection in women.Methods This was a multicenter,randomized,open,positive-controlled,non-inferiority trial involving female patients with recurrent urinary tract infections(rUTIs)who were admitted to 11 medical centers in China.Inclusion criteria:①Aged 18-70 years,with verifiable clinical data showing at least 3 episodes of acute UTIs within 1 year and at least 2 episodes within 6 months,and cured by antimicrobial therapy;②At the time of enrollment,the patients had no obvious symptoms of urinary tract irritation,normal white blood cell count in midstream urine routine(within the normal range of laboratory standards of each unit)or≤3HP by centrifuge microscopy,negative leucocyte esterase and nitrite,and negative urine culture;③No abnormal urinary anatomic function(suchas urinary obstruction,calculus or congenital urinary malformation)and residual urine volume≤50 ml were detected by B-ultrasound of urinary system;④Informed consent signed by the person or agent;⑤Clear consciousness,able to answer questions independently,according to the requirements of the test plan to complete the research questionnaire.Exclusion criteria:①Patients allergic to the above drugs;②Any complex signs of urinary tract infection or pyelonephritis(manifested as low back pain,fever≥37.3℃,systemic symptoms);③Drugs affecting immunefunction were used within 7 days before randomization;④Patients with basic diseases of urinary system such as obstruction,calculus,urinary stenosis,vesicoureteral reflux or other functional abnormalities,urine diversion,indwelling catheter or stent tube or intermittent catheterization;⑤Combined with or existing systemic lupus erythematosus,AIDS and other diseases that can lead to systemic immune function abnormalities;⑥Patients who are known or suspected to be pregnant,breastfeeding,or planning a pregnancy within 3 months of stopping the drug;⑦Patients wit

关 键 词：尿路感染 复发 预防 铜绿假单胞菌注射液 

分 类 号：R47[医药卫生—护理学]