Gágyor Ildikó, Bleidorn Jutta, Kochen Michael M, Schmiemann Guido, Wegscheider Karl, Hummers-Pradier Eva
Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073 Göttingen, Germany
Institute of General Practice, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany.
BMJ. 2015 Dec 23;351:h6544. doi: 10.1136/bmj.h6544.
Can treatment of the symptoms of uncomplicated urinary tract infection (UTI) with ibuprofen reduce the rate of antibiotic prescriptions without a significant increase in symptoms, recurrences, or complications?
Women aged 18-65 with typical symptoms of UTI and without risk factors or complications were recruited in 42 German general practices and randomly assigned to treatment with a single dose of fosfomycin 3 g (n=246; 243 analysed) or ibuprofen 3 × 400 mg (n=248; 241 analysed) for three days (and the respective placebo dummies in both groups). In both groups additional antibiotic treatment was subsequently prescribed as necessary for persistent, worsening, or recurrent symptoms. The primary endpoints were the number of all courses of antibiotic treatment on days 0-28 (for UTI or other conditions) and burden of symptoms on days 0-7. The symptom score included dysuria, frequency/urgency, and low abdominal pain.
The 248 women in the ibuprofen group received significantly fewer course of antibiotics, had a significantly higher total burden of symptoms, and more had pyelonephritis. Four serious adverse events occurred that lead to hospital referrals; one of these was potentially related to the trial drug. Results have to be interpreted carefully as they might apply to women with mild to moderate symptoms rather than to all those with an uncomplicated UTI.
Two thirds of women with uncomplicated UTI treated symptomatically with ibuprofen recovered without any antibiotics. Initial symptomatic treatment is a possible approach to be discussed with women willing to avoid immediate antibiotics and to accept a somewhat higher burden of symptoms.
FUNDING, COMPETING INTERESTS, DATA SHARING: German Federal Ministry of Education and Research (BMBF) No 01KG1105. Patient level data are available from the corresponding author. Patient consent was not obtained but the data are anonymised and risk of identification is low.Trial registration No ClinicalTrialGov Identifier NCT01488955.
使用布洛芬治疗单纯性尿路感染(UTI)的症状能否降低抗生素处方率,同时不会显著增加症状、复发率或并发症?
在德国42家普通诊所招募了年龄在18至65岁、有典型UTI症状且无危险因素或并发症的女性,随机分配她们接受单剂量3克磷霉素治疗(n = 246;分析了243例)或布洛芬3×400毫克治疗(n = 248;分析了241例),持续三天(两组均有相应的安慰剂对照)。两组随后都根据持续、恶化或复发症状的需要额外开具抗生素治疗。主要终点是第0至28天(针对UTI或其他病症)所有抗生素治疗疗程数以及第0至7天的症状负担。症状评分包括尿痛、尿频/尿急和下腹部疼痛。
布洛芬组的248名女性接受抗生素治疗的疗程显著减少,症状总负担显著更高,肾盂肾炎患者更多。发生了4起导致住院转诊的严重不良事件;其中1起可能与试验药物有关。结果必须谨慎解读,因为它们可能适用于症状轻至中度的女性,而非所有单纯性UTI患者。
三分之二有单纯性UTI症状的女性使用布洛芬进行对症治疗后未使用任何抗生素即康复。初始对症治疗是一种可行的方法,可与愿意避免立即使用抗生素并接受稍高症状负担的女性进行讨论。
资金、利益冲突、数据共享:德国联邦教育与研究部(BMBF),编号01KG1105。患者层面的数据可从通讯作者处获取。未获得患者同意,但数据已匿名化且识别风险较低。试验注册号:ClinicalTrialGov标识符NCT01488955