治疗莱姆病后持续性症状的患病率及其决定因素：一项观察性、前瞻性队列研究（LymeProspect）的研究方案。
Prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis: study protocol for an observational, prospective cohort study (LymeProspect).
机构信息
Department of Internal Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands.
National Institute for Public Health and Environment (RIVM), Center for Infectious Disease Control, P.O. Box 1, 3720, BA, Bilthoven, the Netherlands.
出版信息
BMC Infect Dis. 2019 Apr 15;19(1):324. doi: 10.1186/s12879-019-3949-8.
BACKGROUND
After antibiotic treatment of Lyme borreliosis, a subset of patients report persistent symptoms, also referred to as post-treatment Lyme disease syndrome. The reported prevalence of persistent symptoms varies considerably, and its pathophysiology is under debate. The LymeProspect study has been designed to investigate the prevalence, severity, and a wide range of hypotheses on the etiology of persistent symptoms among patients treated for Lyme borreliosis in the Netherlands.
METHODS
LymeProspect is a prospective, observational cohort study among adults with proven or probable Lyme borreliosis, either erythema migrans or disseminated manifestations, included at the start of antibiotic treatment. During one year of follow-up, participants are subjected to questionnaires every three months and blood is collected repeatedly during the first three months. The primary outcome is the prevalence of persistent symptoms after treatment, assessed by questionnaires online focusing on fatigue (CIS, subscale fatigue severity), pain (SF-36, subscale pain) and neurocognitive dysfunction (CFQ). Potential microbiological, immunological, genetic, epidemiological and cognitive-behavioral determinants for persistent symptoms are secondary outcome measures. Control cohorts include patients with long-lasting symptoms and unconfirmed Lyme disease, population controls, and subjects having reported a tick bite not followed by Lyme borreliosis.
DISCUSSION
This article describes the background and design of the LymeProspect study protocol. This study is characterized by a prospective, explorative and multifaceted design. The results of this study will provide insights into the prevalence and determinants of persistent symptoms after treatment for Lyme borreliosis, and may provide a rationale for preventive and treatment recommendations.
TRIAL REGISTRATION
NTR4998 (Netherlands Trial Register). Date of registration: 13 February 2015.
背景
在莱姆病的抗生素治疗后，一部分患者会出现持续的症状，也被称为治疗后莱姆病综合征。持续症状的报告患病率差异很大，其病理生理学仍存在争议。LymeProspect 研究旨在调查在荷兰接受莱姆病治疗的患者中，持续症状的患病率、严重程度以及广泛的病因假说。
方法
LymeProspect 是一项针对已确诊或可能患有莱姆病的成年人的前瞻性、观察性队列研究，包括出现游走性红斑或播散性表现的患者，在开始抗生素治疗时纳入研究。在为期一年的随访中，参与者每三个月接受一次问卷调查，并在头三个月内多次采集血液样本。主要结局是治疗后持续症状的患病率，通过在线问卷评估疲劳（CIS，疲劳严重程度子量表）、疼痛（SF-36，疼痛子量表）和神经认知功能障碍（CFQ）。持续症状的潜在微生物学、免疫学、遗传学、流行病学和认知行为决定因素是次要结局测量指标。对照组包括持续症状和未经证实的莱姆病患者、普通人群对照以及报告被蜱叮咬但未感染莱姆病的人群。
讨论
本文描述了 LymeProspect 研究方案的背景和设计。该研究的特点是前瞻性、探索性和多方面的设计。该研究的结果将提供关于莱姆病治疗后持续症状的患病率和决定因素的见解，并可能为预防和治疗建议提供依据。
试验注册
NTR4998（荷兰试验注册）。注册日期：2015 年 2 月 13 日。
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