布洛芬与美西林治疗单纯性膀胱炎的随机对照试验研究方案
Ibuprofen versus mecillinam for uncomplicated cystitis--a randomized controlled trial study protocol.
作者信息
Vik Ingvild, Bollestad Marianne, Grude Nils, Bærheim Anders, Mölstad Sigvard, Bjerrum Lars, Lindbæk Morten
机构信息
Antibiotic Centre of Primary Care, Department of General Practice, Institute of Health and Society, University of Oslo, Pb 1130, Blindern, 0318, Oslo, Norway.
Department of General Practice, Oslo Accident and Emergency Out Patient Clinic, Storgata 40, 0182, Oslo, Norway.
出版信息
BMC Infect Dis. 2014 Dec 17;14:693. doi: 10.1186/s12879-014-0693-y.
BACKGROUND
Although uncomplicated cystitis is often self-limiting, most such patients will be prescribed antibiotic treatment. We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution.
METHODS/DESIGN: This is a randomized, controlled, double blind trial following the principles of Good Clinical Practice. Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility. 500 women from four sites in Norway, Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three times a day or 200 mg mecillinam three times a day for three days. Allocation is conducted using block randomization. The primary outcome is the number of patients who feel cured by day four as recorded in a diary. Adverse events will be handled and reported in accordance with Good Clinical Practice.
DISCUSSION
If treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief, we can potentially reduce the use of antibiotics on a global scale.
TRIAL REGISTRATION
EudraCTnr: 2012-002776-14. ClinicalTrials.gov: NCT01849926.
背景
尽管单纯性膀胱炎通常具有自限性，但大多数此类患者仍会接受抗生素治疗。我们正在研究使用非甾体抗炎药治疗膀胱炎在实现症状缓解方面是否与抗生素同样有效。
方法/设计：这是一项遵循良好临床实践原则的随机、对照、双盲试验。对年龄在18至60岁之间出现单纯性膀胱炎症状的女性进行资格筛查。来自挪威、瑞典和丹麦四个地点的500名女性被分配接受每日三次、每次600毫克布洛芬或每日三次、每次200毫克美西林的治疗，为期三天。采用区组随机化进行分配。主要结局是日记中记录的到第四天感觉治愈的患者数量。不良事件将按照良好临床实践进行处理和报告。
讨论
如果用布洛芬治疗单纯性膀胱炎在缓解症状方面与美西林同样有效，我们有可能在全球范围内减少抗生素的使用。
试验注册
欧洲药品管理局临床试验编号：2012 - 002776 - 14。美国国立医学图书馆临床试验注册中心编号：NCT01849926。
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