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Lancet infect dis:针对成人反复性尿路感染采用持续低剂量抗生素预防:一项随机,开放标签试验

发布日期:2018-07-01来源:Lancet infect dis发布人:感控雏鹰


【背景】

重复症状性尿路感染(UTI)影响25%使用清洁间歇性自我导尿(CISC)清空膀胱的人。我们的目标是确定连续低剂量抗生素预防CISC成年使用者复发性尿路感染的好处、危害和成本效益。

【方法】

在这个随机的,开放标签的优势试验中,我们招募了来自51个英国国家卫生服务机构的参与者。这些参与者是具有复发性UTI的CISC的社区居民(而不是医院住院患者)。我们随机分配参与者(1:1)接受预防性抗生素预防(预防组)或无预防措施(对照组)12个月,通过使用互联网系统并排列变长块。评估结果的试验和实验室工作人员被掩盖到分配,但参与者知道他们的治疗组。主要终点是12个月内症状性抗生素治疗的UTI的发生率。完成至少6个月随访的参与者被假定为提供UTI发生率的可靠估计值,并被纳入主要结局分析。监测尿和粪便细菌的抗微生物药物耐药性的变化作为次要结果。AnTIC试验注册于ISRCTN,编号67145101; 和EudraCT,编号2013-002556-32。

【结果】

在2013年11月25日和2016年1月29日之间,我们筛选了1743名CISC成年用户的资格,其中404名(23%)参与者于2013年11月26日至2016年1月31日入学。这404名参与者中,203名(50%)被分配用于接受预防,201(50%)被分配接受预防。在随机化之前排除了1339名参与者。主要分析包括分配给预防组的181名(89%)成人和无预防(对照)组的180名(90%)成人。预防组的22名参与者和对照组的21名参与者未被纳入初步分析,因为他们在6个月之前缺失了随访数据。症状性抗生素治疗的UTIs在12个月内的发生率预防组为每人1年3个病例(95%CI 1?1?1?6),而在预防组中为2?6(2?3?2?9)对照组,发病率比率为0?52(0?44-0?61; p <0?0001),表明预防治疗后UTI频率降低48%。使用预防措施的耐受性良好:我们在研究期间记录了预防组中22个轻微不良事件,这些事件与预防性抗生素有关,主要是胃肠道疾病(6人),皮疹(6人)和念珠菌感染(4人)。然而,对抗尿素治疗的抗生素在预防组的尿路分离物中的耐药率要高于对照组的9-12个月时的耐药率(在预防组中51名参与者中呋喃妥因12 [24%])使用预防措施的耐受性良好:我们在研究期间记录了预防组中22个轻微不良事件,这些事件与预防性抗生素有关,主要是胃肠道疾病(6人),皮疹(6人)和念珠菌感染(4人)。然而,对抗尿素治疗的抗生素在预防组的尿路分离物中的耐药率要高于对照组的9-12个月时的耐药率(在预防组中51名参与者中呋喃妥因12 [24%])使用预防措施的耐受性良好:我们在研究期间记录了预防组中22个轻微不良事件,这些事件与预防性抗生素有关,主要是胃肠道疾病(6人),皮疹(6人)和念珠菌感染(4人)。然而,对抗尿素治疗的抗生素在预防组的尿路分离物中的耐药率要高于对照组的9-12个月时的耐药率(在预防组中51名参与者中呋喃妥因12 [24%])VS从与至少一个分离株,对照组64名参与者6 [9%]; p = 0?038),甲氧苄氨嘧啶(51 [67%] 51 比 21 [33%] 64; p = 0?0003)和复方新诺明(26 [53%] 49 比 15 [24%] 62; p = 0.002)。

【结论】

持续的抗生素预防可有效降低复发性UTIs的CISC患者的尿路感染的频率,并且在这些患者中耐受良好。然而,如果开始预防,尿检出细菌抗性的增加是需要监视的问题。

Continuous low-dose antibiotic prophylaxis for adults with repeated urinary tract infections (AnTIC): a randomised, open-label trial

Summary

Background

Repeated symptomatic urinary tract infections (UTIs) affect 25% of people who use clean intermittent self-catheterisation (CISC) to empty their bladder. We aimed to determine the benefits, harms, and cost-effectiveness of continuous low-dose antibiotic prophylaxis for prevention of recurrent UTIs in adult users of CISC.

Methods

In this randomised, open-label, superiority trial, we enrolled participants from 51 UK National Health Service organisations. These participants were community-dwelling (as opposed to hospital inpatient) users of CISC with recurrent UTIs. We randomly allocated participants (1:1) to receive either antibiotic prophylaxis once daily (prophylaxis group) or no prophylaxis (control group) for 12 months by use of an internet-based system with permuted blocks of variable length. Trial and laboratory staff who assessed outcomes were masked to allocation but participants were aware of their treatment group. The primary outcome was the incidence of symptomatic, antibiotic-treated UTIs over 12 months. Participants who completed at least 6 months of follow-up were assumed to provide a reliable estimate of UTI incidence and were included in the analysis of the primary outcome. Change in antimicrobial resistance of urinary and faecal bacteria was monitored as a secondary outcome. The AnTIC trial is registered at ISRCTN, number 67145101; and EudraCT, number 2013-002556-32.

Findings

Between Nov 25, 2013, and Jan 29, 2016, we screened 1743 adult users of CISC for eligibility, of whom 404 (23%) participants were enrolled between Nov 26, 2013, and Jan 31, 2016. Of these 404 participants, 203 (50%) were allocated to receive prophylaxis and 201 (50%) to receive no prophylaxis. 1339 participants were excluded before randomisation. The primary analysis included 181 (89%) adults allocated to the prophylaxis group and 180 (90%) adults in the no prophylaxis (control) group. 22 participants in the prophylaxis group and 21 participants in the control group were not included in the primary analysis because they were missing follow-up data before 6 months. The incidence of symptomatic antibiotic-treated UTIs over 12 months was 1·3 cases per person-year (95% CI 1·1–1·6) in the prophylaxis group and 2·6 (2·3–2·9) in the control group, giving an incidence rate ratio of 0·52 (0·44–0·61; p<0·0001), indicating a 48% reduction in UTI frequency after treatment with prophylaxis. Use of prophylaxis was well tolerated: we recorded 22 minor adverse events in the prophylaxis group related to antibiotic prophylaxis during the study, predominantly gastrointestinal disturbance (six participants), skin rash (six participants), and candidal infection (four participants). However, resistance against the antibiotics used for UTI treatment was more frequent in urinary isolates from the prophylaxis group than in those from the control group at 9–12 months of trial participation (nitrofurantoin 12 [24%] of 51 participants from the prophylaxis group vssix [9%] of 64 participants from the control group with at least one isolate; p=0·038), trimethoprim (34 [67%] of 51 vs 21 [33%] of 64; p=0·0003), and co-trimoxazole (26 [53%] of 49 vs 15 [24%] of 62; p=0·002).

Interpretation

Continuous antibiotic prophylaxis is effective in reducing UTI frequency in CISC users with recurrent UTIs, and it is well tolerated in these individuals. However, increased resistance of urinary bacteria is a concern that requires surveillance if prophylaxis is started.

原文:

Continuous low-dose antibiotic prophylaxis for adults with repeated urinary tract infections (AnTIC) a randomised, open-label trial.pdf

简译人:感控雏鹰