文献简介

出版社:BioMed Central

作  者:Michael Quirke, Abel Wakai, Peadar Gilligan and Ronan O’Sullivan

编  号:

关键字:

年  份:2013   点击量:778

文献摘要

Abstract

概要

Background.

Oral flucloxacillin, either alone or in combination with phenoxymethylpenicillin, is a commonly prescribed antibiotic for the treatment of cellulitis, particularly in Ireland and the United Kingdom. This study aims to establish the non-inferiority of oral monotherapy (flucloxacillin alone) to dual therapy (flucloxacillin and phenoxymethylpenicillin) for the outpatient treatment of cellulitis in adults.

背景:

    口服氟氯西林,无论是单独服用或与青霉素联合使用,都是治疗蜂窝织炎常用的抗生素处方,尤其是在爱尔兰和英国。本文旨在对门诊处治疗的成人蜂窝组织炎患者,建立口服单药治疗(单独服用氟氯西林)与联合疗法(氟氯西林和青霉素)之间的非劣效性研究。

Methods/design.

This study is a multicentre, randomised, double-blind, placebo-controlled trial of adults who present to the emergency department (ED) with cellulitis that is deemed treatable on an outpatient basis with oral antibiotics. After fulfilling specified inclusion and exclusion criteria, informed consent will be taken. Patients will be given a treatment pack containing 7 days of treatment with flucloxacillin 500 mg four times daily and placebo or flucloxacillin 500 mg four times daily and phenoxymethylpenicillin 500 mg four times daily. The primary outcome measure under study is the proportion of patients in each group in which there is greater than or equal to a 50% reduction in the area of diameter of infection from the area measured at enrolment at the end-of-treatment visit (7 to 10 days). Secondary endpoints include a health-related quality of life measurement as rated by the SF-36 score and the Extremity Soft Tissue Infection Score (not validated), compliance and adverse events. Patients will be followed up by telephone call at 3 days, end-of-treatment visit (EOT) at 7 to 10 days and test-of-cure (TOC) visit at 30 days. To achieve 90% power, a sample size of 172 patients per treatment arm is needed. This assumes a treatment success rate of 85% with oral flucloxacillin and phenoxymethylpenicillin, an equivalence threshold Δ = 12.5% and an

α = 0.025. Non-inferiority will be assessed using a one-sided confidence interval on the difference of proportions between the two groups. Standard analysis including per-protocol and intention-to-treat will be performed.

方法/设计:

本文对曾经在门诊处口服抗生素治疗现转诊到急诊处的蜂窝织炎成年患者进行了一项多中心、随机的、双盲对照试验。在完成规定的入选和排除标准后,发放患者知情同意书。患者将被给予氟氯西林(500mg/次,4次/天,共7天),安慰剂或氟氯西林(500mg/次,4次/天),和青霉素(500mg/次,4次/天)进行治疗。主要研究结果依据各组患者的比例哪一组大于或等于在感染区域上减少了50%(观察治疗结束时登记人数的测量区域)。次要结果包括通过SF-36得分评定的健康相关的生活质量、下肢软组织感染评分(未经验证)、合规性以及不良反应。患者将在第3天进行电话随访,在治疗结束后(EOT)第7〜10天随访,第30天进行治愈测试的(TOC)随访。为了获得90%的治愈率,需要对172名治疗组样本进行研究。综上所述,我们可以近似得出:口服氟氯西林和青霉素联合治疗的成功率是85%,等值的阈值是Δ=12.5%和α=0.025。非劣效性的评估将采用(在两组之间比例差异基础上的)单侧置信区间的方法。使用两组之间比例差异的单侧置信区间评估非劣效性。将要进行标准分析包括合方案集和意向性治疗。

Discussion.

This trial aims to establish the non-inferiority of flucloxacillin monotherapy to dual therapy in the treatment of uncomplicated cellulitis among ED patients. In doing so, this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines.

讨论:

    本试验旨在对急诊科处治疗的简单蜂窝组织炎患者,建立氟氯西林单药治疗与联合疗法之间的非劣效性研究。。与此同时,该试验将弥补深入研究与常见疾病相关知识方面的缺口,并与一些不同学科的临床医生有关。