摘要

BACKGROUND:Although uncomplicated urinary tract infections (UTIs) are often self-limiting, most patients will be prescribed antibiotic treatment. We assessed whether treatment with ibuprofen was non-inferior to pivmecillinam in achieving symptomatic resolution by day 4, with a non-inferiority margin of 10%. METHODS AND FINDINGS:This was a randomized, controlled, double-blind non-inferiority trial. We recruited patients from 16 sites in a general practice setting in Norway, Sweden, and Denmark. Non-pregnant women aged 18-60 years presenting with symptoms of uncomplicated UTI were screened for eligibility from 11 April 2013 to 22 April 2016. Patients with informed consent were randomized (1:1 ratio) to treatment with either 600 mg ibuprofen or 200 mg pivmecillinam 3 times a day for 3 days. The patient, treating physician, and study personnel were blinded to treatment allocation. The primary outcome was the proportion of patients who felt cured by day 4, as assessed from a patient diary. Secondary outcomes included the proportion of patients in need of secondary treatment with antibiotics and cases of pyelonephritis. A total of 383 women were randomly assigned to treatment with either ibuprofen (n = 194, 181 analyzed) or pivmecillinam (n = 189, 178 analyzed). By day 4, 38.7% of the patients in the ibuprofen group felt cured versus 73.6% in the pivmecillinam group. The adjusted risk difference with 90% confidence interval was 35% (27% to 43%) in favor of pivmecillinam, which crossed the prespecified non-inferiority margin. Secondary endpoints were generally in favor of pivmecillinam. After 4 weeks' follow-up, 53% of patients in the ibuprofen group recovered without antibiotic treatment. Seven cases of pyelonephritis occurred, all in the ibuprofen group, giving a number needed to harm of 26 (95% CI 13 to 103). Five of these patients were hospitalized and classified as having serious adverse events; 2 recovered as outpatients. A limitation of the study was the extensive list of exclusion criteria, eliminating almost half of the patients screened. We did not register symptoms in the screening process; hence, we do not know the symptom burden for those who declined to participate. This might make our results less generalizable. CONCLUSIONS:Ibuprofen was inferior to pivmecillinam for treating uncomplicated UTIs. More than half of the women in the ibuprofen group recovered without antibiotics. However, pyelonephritis occurred in 7 out of 181 women using ibuprofen. Until we can identify those women who will develop complications, we cannot recommend ibuprofen alone as initial treatment to women with uncomplicated UTIs. TRIAL REGISTRATION:ClinicalTrials.gov NCT01849926 EU Clinical Trials Register (EU-CTR), EudraCT Number 2012-002776-14.

译文

背景: 虽然简单的尿路感染 (UTIs) 通常是自限性的,但大多数患者会接受抗生素治疗。我们评估了布洛芬治疗是否在第 4 天达到症状缓解方面不亚于 pivmecilinam,非劣效差为 10%。方法和结果: 这是一项随机、对照、双盲非劣效性试验。我们在挪威、瑞典和丹麦的一个普通实践环境中招募了来自 16 个站点的患者。从 2013年4月11日到 2016年4月22日,对年龄在 18-60 岁之间出现无并发症 UTI 症状的非孕妇进行资格筛选。知情同意的患者随机 (1:1 比例) 接受 600 mg 布洛芬或 200 mg pivmecilinam 的治疗,每天 3 次,持续 3 天。患者、治疗医生和研究人员对治疗分配视而不见。主要结果是从患者日记中评估到天感觉治愈的患者比例。次要结果包括需要抗生素二次治疗的患者比例和肾盂肾炎病例。共有 383 名妇女被随机分配到布洛芬 (n = 194,181 分析) 或 pivmecilinam (n = 189,178 分析) 治疗。到第四天,布洛芬组 38.7% 的患者感觉治愈了,而 pivmecilinam 组为 73.6%。90% 置信区间的调整风险差异为 35% (27%-43%),有利于 pivmecilinam,它超过了预先指定的非劣效界限。次要终点通常支持 pivmecilinam。经过 4 周的随访,布洛芬组 53% 的患者在没有抗生素治疗的情况下康复。发生了 7 例肾盂肾炎,全部在布洛芬组,给出了需要伤害的 26 个数字 (95% CI 13 到 103)。其中 5 名患者住院并被归类为严重不良事件; 2 名康复为门诊患者。这项研究的一个限制是广泛的排除标准列表,排除了几乎一半的筛选患者。我们没有在筛选过程中记录症状; 因此,我们不知道那些拒绝参与的人的症状负担。这可能会使我们的结果不那么普遍。结论: 布洛芬在治疗非复杂性尿路感染方面优于 pivmecilinam。布洛芬组一半以上的妇女在没有抗生素的情况下康复。然而,在使用布洛芬的 181 名妇女中,有 7 名发生了肾盂肾炎。在我们确定那些会出现并发症的女性之前,我们不能推荐布洛芬单独作为无并发症尿路感染女性的初始治疗。试验注册: ClinicalTrials.gov NCT01849926 欧盟临床试验注册 (EU-CTR),编号 2012-002776-14。

Urinary tract infection (UTI)

肾内泌尿 病原体感染 疾病
概述  :  

疾病概述尿路感染(Urinary tract infection,UTI)是病原体在尿路中生长、繁殖而引起的感染性疾病。多由细菌、病毒、真菌或多种寄生虫引起,女性患者较多。尿路感染是仅次于呼吸道感染的第二大感染性疾病,致休克而死亡者在所有感染致死中居第3位。 病理机制1. 感染途径 (1)上行感染:是指病原菌由尿道、膀胱、输尿管上行至肾盂引起感染性炎症,占尿路感染的95%。多发生于尿道插管、尿路器械检查及性生活后,全身抵抗力低下及尿流不畅者更易发生。 (2)血行感染:继发于全

Urinary   英/ˈjʊərɪnəri/   美/ˈjʊrɪneri/

释    义   adj. 尿的;泌尿的

               n. 尿壶;小便池(等于urinal)

同根词   urinal n. 尿壶;小便处

例    句   If you have urinary incontinence, you should avoid eating foods that make your condition worse. 如果你有尿失禁,你应该避免吃使你病情恶化的食物。

 

Tract   英 /trækt/   美 /trækt/

释    义   n. 束;大片土地,地带;小册子

               n. (Tract)人名;(英)特拉克特

例    句   She had hardly ever visited the place, only a small tract even of the Vale and its environs being known to her by close inspection. 她从来没有去过那个地方,只有一小块地方,甚至连山谷及附近的地带,她都是通过仔细观察才知道的。

 

Infection   英 /ɪnˈfekʃəs/   美 /ɪnˈfekʃəs/

释    义   n. 感染;传染;影响;传染病

同根词   infectious adj. 传染的;传染性的;易传染的

               infected adj. 被感染的

               infect vt. 感染,传染

例    句   But those antibodies do not totally prevent infection.   但是,那些抗体并不能完全预防感染。

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