Jansåker Filip, Thønnings Sara, Hertz Frederik Boëtius, Kallemose Thomas, Værnet Jan, Bjerrum Lars, Benfield Thomas, Frimodt-Møller Niels, Knudsen Jenny Dahl
Department of Clinical Microbiology, Hvidovre Hospital, Copenhagen University Hospital, Kettegård Allé 30, 2650 Hvidovre, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark.
EClinicalMedicine. 2019 Jul 20;12:62-69. doi: 10.1016/j.eclinm.2019.06.009. eCollection 2019 Jul.
To investigate if a 5-day course pivmecillinam (amdinocillin pivoxil) 400 mg three times daily is superior to a 3-day course in women with uncomplicated urinary tract infection (UTI).
A randomised, double-blind, placebo-controlled trial conducted at nine primary care centres in Denmark. 368 women (18-70 years) with symptoms compatible with UTI were randomised to blinded therapy of 5 days [5d] or 3 days followed by 2 days of placebo [3d] from May 2015 to November 2017. Clinical data were assessed using a validated questionnaire at inclusion (day-0), daily the following 7 days and once again within the 2nd to 6th week after intervention. Bacteriological data were collected prior to intervention and twice between day 7 and 42. Main clinical endpoints were days to symptom resolution within 7 days after inclusion and proportions with clinical success at the end of intervention. Main bacteriological endpoint was proportion of participants with significant reduction of bacteriuria (≥ 10 CFU/mL) in 1st control urine sample. ClinicalTrialsRegister.eu: 2014-001321-32.
180 (5d) and 188 (3d) participants were included in the study (mean age: 35.4 [5d] and 34.9 [3d]). Of these, 125 (70% [5d]) and 122 (66% [3d]) had a positive baseline urine culture. Forty-four participants were lost to follow-up, leaving 161 [5d] and 163 [3d] participants for analysis, respectively. Mean time to symptom resolution was 2.91 (SD 1.46; [5d]) days and 2.94 (SD 1.42; [3d]) days (P = .894). Clinical success at the end of treatment occurred for 117 of 153 (76%) receiving the 5d-course and for 115 of 157 (73%) receiving the 3d course (difference 3.2% [95% CI -7.1% - 13.5%]; P = .601). Bacteriological success was seen in 92 of 104 (88%) participants given the 5d course and in 86 of 99 (87%) given the 3d course (difference 1.6% [95% CI -8.4%-11.6%]; P = .895).
A 5-day course of pivmecillinam was not superior to a 3-day course in clinical or bacteriological outcomes for UTI.
The Danish Regions [no. 14/217].
探讨对于患有单纯性尿路感染（UTI）的女性，每日三次服用400毫克匹美西林（氨比西林匹酯），疗程为5天是否优于疗程为3天的治疗方案。
在丹麦的九个初级保健中心进行了一项随机、双盲、安慰剂对照试验。2015年5月至2017年11月，368名（年龄在18 - 70岁之间）有UTI相关症状的女性被随机分配接受5天[5d]或3天加2天安慰剂[3d]的盲法治疗。在纳入研究时（第0天）使用经过验证的问卷评估临床数据，在接下来的7天内每天评估一次，并在干预后的第2至6周再次评估。在干预前以及第7天至42天之间收集两次细菌学数据。主要临床终点是纳入研究后7天内症状缓解的天数以及干预结束时临床成功的比例。主要细菌学终点是第一次对照尿液样本中细菌尿显著减少（≥10 CFU/mL）的参与者比例。ClinicalTrialsRegister.eu：2014 - 001321 - 32。
180名（5d组）和188名（3d组）参与者纳入研究（平均年龄：35.4岁[5d组]和34.9岁[3d组]）。其中，125名（70%[5d组]）和122名（66%[3d组]）基线尿培养呈阳性。44名参与者失访，分别留下161名[5d组]和163名[3d组]参与者进行分析。症状缓解的平均时间为2.91（标准差1.46；[5d组]）天和2.94（标准差1.42；[3d组]）天（P = 0.894）。接受5天疗程的153名参与者中有117名（76%）在治疗结束时临床成功，接受3天疗程的157名参与者中有115名（73%）临床成功（差异3.2%[95%置信区间 -7.1% - 13.5%]；P = 0.601）。接受5天疗程的104名参与者中有92名（88%）细菌学成功，接受3天疗程的99名参与者中有86名（87%）细菌学成功（差异1.6%[95%置信区间 -8.4% - 11.6%]；P = 0.895）。
对于UTI，5天疗程的匹美西林在临床或细菌学结局方面并不优于3天疗程。
丹麦地区[编号14/217]。
