摘要
简介:咳嗽是结核病(TB)的一个重要症状,也是传播结核的主要原因。然而,最近的文献综述发现,在结核病患者身上,咳嗽频率(每小时咳嗽次数)只在1969年进行过一次研究。本研究的主要目的是描述在结核病治疗开始前和之后的咳嗽频率模式,并确定影响咳嗽频率的基线因素。其次,我们将评估咳嗽频率和TB微生物之间的关系。
方法:本研究将选取秘鲁利马市2家三级医院通过培养确诊的结核患者为研究对象。我们估计,107例患者的样本量对研究咳嗽频率的临床显著变化是足够的。将对受试者通过问卷调查、放射学、显微镜观察药物敏感性、肺结核杆菌肉汤培养、槐黄涂片镜检和咳嗽录音等进行初步评估。我们会在抗结核治疗后的前60天对该队列进行随访,并在整个研究中采集微生物样本和24小时的咳嗽录音。我们将描述咳嗽发作的变异性,并确定其与肺结核的基准实验室参数的关联。此外,我们将分析咳嗽频率降低在预测结核治疗中的作用,调整潜在的混杂因素。
伦理与传播:已从各个参加医院的伦理协会获得了伦理批准:秘鲁的利马、秘鲁利马的Asociación Benéfica PRISMA、秘鲁利马的Universidad Peruana Cayetano Heredia、美国巴尔的摩约翰霍普金斯大学。我们的目标是在本领域前沿期刊发表和宣传我们的研究成果。我们也希望创造和保持在线信息库结核病患者咳嗽的声音以及统计分析。
(苏欣 审校)
BMJ Open. 2016 Apr 22;6(4):e010365. doi: 10.1136/bmjopen-2015-010365.
Protocol for studying cough frequency in people with pulmonary tuberculosis.
Proaño A1, Bravard MA2, Tracey BH3, López JW4, Comina G5, Zimic M6, Coronel J7, O'Neill Lee G8, Caviedes L7, Luis Cabrera J9, Salas A10, Ticona E11,Kirwan DE12, Friedland JS13, Evans CA14, Moore DA15, Gilman RH16; Tuberculosis Working Group in Peru.
Collaborators (18)
Author information
Erratum in
• Correction. [BMJ Open. 2016]
Abstract
INTRODUCTION:Cough is a key symptom of tuberculosis (TB) as well as the main cause of transmission. However, a recent literature review found that cough frequency (number of coughs per hour) in patients with TB has only been studied once, in 1969. The main aim of this study is to describe cough frequency patterns before and after the start of TB treatment and to determine baseline factors that affect cough frequency in these patients. Secondarily, we will evaluate the correlation between cough frequency and TB microbiological resolution.
METHODS:This study will select participants with culture confirmed TB from 2 tertiary hospitals in Lima, Peru. We estimated that a sample size of 107 patients was sufficient to detect clinically significant changes in cough frequency. Participants will initially be evaluated through questionnaires, radiology, microscopic observation drug susceptibility broth TB-culture, auramine smear microscopy and cough recordings. This cohort will be followed for the initial 60 days of anti-TB treatment, and throughout the study several microbiological samples as well as 24 h recordings will be collected. We will describe the variability of cough episodes and determine its association with baseline laboratory parameters of pulmonary TB. In addition, we will analyse the reduction of cough frequency in predicting TB cure, adjusted for potential confounders.
ETHICS AND DISSEMINATION:Ethical approval has been obtained from the ethics committees at each participating hospital in Lima, Peru, Asociación Benéfica PRISMA in Lima, Peru, the Universidad Peruana Cayetano Heredia in Lima, Peru and Johns Hopkins University in Baltimore, USA. We aim to publish and disseminate our findings in peer-reviewed journals. We also expect to create and maintain an online repository for TBcough sounds as well as the statistical analysis employed.
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KEYWORDS: Cough; Monitoring
BMJ Open. 2016 Apr 22;6(4):e010365. doi: 10.1136/bmjopen-2015-010365.