在普通实践中比较苯氧甲基青霉素、阿莫西林和强力霉素治疗游走性红斑的疗效。一项为期 1 年随访的随机对照试验。

Comparison of phenoxymethylpenicillin, amoxicillin, and doxycycline for erythema migrans in general practice. A randomized controlled trial with a 1-year follow-up.

机构信息

General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.

出版信息

Clin Microbiol Infect. 2018 Dec;24(12):1290-1296. doi: 10.1016/j.cmi.2018.02.028. Epub 2018 Mar 2.

DOI:10.1016/j.cmi.2018.02.028

PMID:29505880

Abstract

OBJECTIVES

To compare the three most commonly used antibiotics for erythema migrans (EM) in Norwegian primary care.

METHODS

A randomized, parallel, controlled trial was carried out. Treatments were open to the patients, but blinded for the GPs and investigators. Patients eligible for inclusion were aged ≥18 years and clinically diagnosed with EM. Block randomization was processed in blocks of six. Patients were assigned to receive one of three antibiotic treatments for 14 days: phenoxymethylpenicillin (PCV), amoxicillin, or doxycycline. The primary outcome was the duration of EM in days in the three treatment groups. Patients kept a diary for the 14 days of treatment, in which they registered concomitant symptoms and side effects. The patients consulted their GP after 14 days of treatment and had a 1-year follow-up to monitor any development of disseminated Lyme borreliosis (LB). EMs with a duration of more than 14 days were followed until resolution. ClinicalTrials.govNCT01368341 and EU Clinical Trials Register 2010-023747-15.

RESULTS

One hundred and eighty eight patients (PCV: n = 56, amoxicillin: n = 64, doxycycline: n = 68) were included by 44 Norwegian general practitioners (GPs) from June 2011 to November 2013. Follow-up was completed by December 2014. The median duration of EM was altogether 14 days (range 3-293). For the PCV group median duration was 14 days (range 5-91), for amoxicillin 13 days (range 4-179) and for doxycycline 14 days (range 3-293). The duration of EM did not differ significantly between the three antibiotic groups (p 0.277). None of the patients developed disseminated LB within the 1-year follow-up.

CONCLUSIONS

We did not find 14 days of PCV, doxycycline, and amoxicillin treatments to differ in effectiveness or safety in the treatment of clinically diagnosed EM in primary care.

摘要

目的

比较挪威初级保健中三种最常用于游走性红斑（EM）的抗生素。

方法

进行了一项随机、平行、对照试验。治疗方案对患者开放，但全科医生和研究人员对此不知情。符合纳入标准的患者年龄≥18 岁，临床诊断为 EM。采用 6 个为一组的区组随机化。患者被分配接受为期 14 天的三种抗生素治疗之一：苯氧甲基青霉素（PCV）、阿莫西林或强力霉素。主要结局是三组治疗中 EM 的持续时间（以天为单位）。患者在治疗的 14 天内记录了伴随症状和副作用。治疗 14 天后，患者咨询了他们的全科医生，并进行了为期 1 年的随访，以监测是否出现播散性莱姆病（LB）的发展。持续时间超过 14 天的 EM 继续随访直至消退。ClinicalTrials.govNCT01368341 和 EU Clinical Trials Register 2010-023747-15。

结果

2011 年 6 月至 2013 年 11 月，44 名挪威全科医生（GP）纳入了 188 名患者（PCV：n=56，阿莫西林：n=64，强力霉素：n=68）。随访于 2014 年 12 月完成。EM 的中位持续时间均为 14 天（范围 3-293）。PCV 组的中位持续时间为 14 天（范围 5-91），阿莫西林组为 13 天（范围 4-179），强力霉素组为 14 天（范围 3-293）。三组抗生素的 EM 持续时间无显著差异（p 0.277）。在 1 年的随访中，没有患者发展为播散性 LB。