通过使用熊果酸（REGATTA）治疗减少普通实践中非复杂性尿路感染中的抗生素使用 - 一项双盲、随机、对照的比较有效性试验。
Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA) - a double-blind, randomized, controlled comparative effectiveness trial.
机构信息
Institute for General Practice, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073, Göttingen, Germany.
出版信息
BMC Complement Altern Med. 2018 Jul 3;18(1):203. doi: 10.1186/s12906-018-2266-x.
BACKGROUND
Uncomplicated urinary tract infections (UTI) are common in general practice and usually treated with antibiotics. This contributes to increasing resistance rates of uropathogenic bacteria. A previous trial showed a reduction of antibiotic use in women with UTI by initial symptomatic treatment with ibuprofen. However, this treatment strategy is not suitable for all women equally. Arctostaphylos uva-ursi (UU, bearberry extract arbutin) is a potential alternative treatment. This study aims at investigating whether an initial treatment with UU in women with UTI can reduce antibiotic use without significantly increasing the symptom burden or rate of complications.
METHODS
This is a double-blind, randomized, and controlled comparative effectiveness trial. Women between 18 and 75 years with suspected UTI and at least two of the symptoms dysuria, urgency, frequency or lower abdominal pain will be assessed for eligibility in general practice and enrolled into the trial. Participants will receive either a defined daily dose of 3 × 2 arbutin 105 mg for 5 days (intervention) or fosfomycin 3 g once (control). Antibiotic therapy will be provided in the intervention group only if needed, i.e. for women with worsening or persistent symptoms. Two co-primary outcomes are the number of all antibiotic courses regardless of the medical indication from day 0-28, and the symptom burden, defined as a weighted sum of the daily total symptom scores from day 0-7. The trial result is considered positive if superiority of initial treatment with UU is demonstrated with reference to the co-primary outcome number of antibiotic courses and non-inferiority of initial treatment with UU with reference to the co-primary outcome symptom burden.
DISCUSSION
The trial's aim is to investigate whether initial treatment with UU is a safe and effective alternative treatment strategy in women with UTI. In that case, the results might change the existing treatment strategy in general practice by promoting delayed prescription of antibiotics and a reduction of antibiotic use in primary care.
TRIAL REGISTRATION
EudraCT: 2016-000477-21 . Clinical trials.gov: NCT03151603 (registered: 10 May 2017).
背景
单纯性尿路感染（UTI）在全科医学中较为常见，通常采用抗生素治疗。这导致尿路病原体的耐药率不断上升。先前的一项试验表明，对于 UTI 女性，采用布洛芬进行初始症状治疗可减少抗生素的使用。然而，这种治疗策略并非对所有女性都同样适用。熊果（UU，熊果苷提取物）是一种潜在的替代治疗方法。本研究旨在研究对于 UTI 女性，采用 UU 进行初始治疗是否可以在不显著增加症状负担或并发症发生率的情况下减少抗生素的使用。
方法
这是一项双盲、随机、对照的有效性比较试验。在全科医学中对疑似患有 UTI 且至少有尿痛、尿急、尿频或下腹痛等两种症状的 18 至 75 岁女性进行评估，以确定其是否符合纳入标准并将其纳入试验。参与者将接受 3×2 剂量的 105mg 熊果苷 5 天（干预组）或 3g 磷霉素一次（对照组）。仅在女性症状恶化或持续存在时，干预组才会给予抗生素治疗。两个主要次要结局为 0-28 天内所有抗生素疗程的数量，以及症状负担，定义为 0-7 天内每日总症状评分的加权总和。如果与主要次要结局抗生素疗程相比，UU 初始治疗具有优越性，且与主要次要结局症状负担相比，UU 初始治疗具有非劣效性，则认为试验结果为阳性。
讨论
本试验旨在研究对于 UTI 女性，UU 初始治疗是否为一种安全有效的替代治疗策略。如果是这样，那么结果可能会改变全科医学中的现有治疗策略，促进抗生素的延迟处方和初级保健中抗生素的使用减少。
试验注册
EudraCT：2016-000477-21；Clinicaltrials.gov：NCT03151603（于 2017 年 5 月 10 日注册）。
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