英国弗里曼医院Chris Harding团队研究了替代预防性抗生素治疗妇女反复尿路感染的效果。相关论文于2022年3月9日发表在《英国医学杂志》上。
为了评估并比较马尿酸乌洛托品与当前标准的每日低剂量抗生素预防措施预防复发性尿路感染的疗效，2016年6月至2018年6月，研究组在英国的八个中心进行了一项多中心、开放标签、随机、非劣效性试验，招募年龄≥18岁、反复尿路感染、需要预防性治疗的妇女。
将参与者按1：1随机分配，分别接受抗生素预防或马尿酸乌洛托品治疗12个月。治疗分配不掩盖，允许双臂交叉。主要结局为治疗期间症状、抗生素治疗、尿路感染发生率的绝对差异。一个患者和公众参与组预先定义非劣效性界限为每人每年发生一次尿路感染。改良意向治疗人群分析包括至少观察六个月的所有参与者。
将受试者随机分组后，抗生素预防组有120名，马尿酸乌洛托品组有120名。改良意向治疗分析包括205（85%）名参与者，其中抗生素组102名（85%），马尿酸乌洛托品组103名（86%）。
在12个月治疗期间，抗生素组的抗生素治疗尿路感染发生率为0.89次/人年，马尿酸乌洛托品组为1.38次/人年，绝对差异为0.49，符合非劣效性。抗生素组的不良反应报告率为34/142（24%），马尿酸乌洛托品组为35/127（28%），大多数反应都很轻微。
研究结果表明，马尿酸乌洛托品非劣于日常抗生素预防，根据患者偏好和抗生素管理措施，马尿酸乌洛托品非抗生素预防性治疗可能适用于有尿路感染复发史的女性。
附：英文原文
Title: Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial
Author: Chris Harding, Helen Mossop, Tara Homer, Thomas Chadwick, William King, Sonya Carnell, Jan Lecouturier, Alaa Abouhajar, Luke Vale, Gillian Watson, Rebecca Forbes, Stephanie Currer, Robert Pickard, Ian Eardley, Ian Pearce, Nikesh Thiruchelvam, Karen Guerrero, Katherine Walton, Zahid Hussain, Henry Lazarowicz, Ased Ali
Issue&Volume: 2022/03/09
Abstract:
Objective To test and compare the efficacy of methenamine hippurate for prevention of recurrent urinary tract infections with the current standard prophylaxis of daily low dose antibiotics.
Design Multicentre, open label, randomised, non-inferiority trial.
Setting Eight centres in the UK, recruiting from June 2016 to June 2018.
Participants Women aged ≥18 years with recurrent urinary tract infections, requiring prophylactic treatment.
Interventions Random assignment (1:1, using permuted blocks of variable length via a web based system) to receive antibiotic prophylaxis or methenamine hippurate for 12 months. Treatment allocation was not masked and crossover between arms was allowed.
Main outcome measure Absolute difference in incidence of symptomatic, antibiotic treated, urinary tract infections during treatment. A patient and public involvement group predefined the non-inferiority margin as one episode of urinary tract infection per person year. Analyses performed in a modified intention-to-treat population comprised all participants observed for at least six months.
Results Participants were randomly assigned to antibiotic prophylaxis (n=120) or methenamine hippurate (n=120). The modified intention-to-treat analysis comprised 205 (85%) participants (antibiotics, n=102 (85%); methenamine hippurate, n=103 (86%)). Incidence of antibiotic treated urinary tract infections during the 12 month treatment period was 0.89 episodes per person year (95% confidence interval 0.65 to 1.12) in the antibiotics group and 1.38 (1.05 to 1.72) in the methenamine hippurate group, with an absolute difference of 0.49 (90% confidence interval 0.15 to 0.84) confirming non-inferiority. Adverse reactions were reported by 34/142 (24%) in the antibiotic group and 35/127 (28%) in the methenamine group and most reactions were mild.
Conclusion Non-antibiotic prophylactic treatment with methenamine hippurate might be appropriate for women with a history of recurrent episodes of urinary tract infections, informed by patient preferences and antibiotic stewardship initiatives, given the demonstration of non-inferiority to daily antibiotic prophylaxis seen in this trial.
DOI: 10.1136/bmj-2021-0068229
Source: https://www.bmj.com/content/376/bmj-2021-0068229
BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
官方网址：http://www.bmj.com/
投稿链接：https://mc.manuscriptcentral.com/bmj
本期文章：《英国医学杂志》：Online/在线发表
