Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial
Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial
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使用宏基因组分析评估口腔健康促进干预措施在降低急性期中风患者肺炎风险方面的有效性：随机对照试验的研究方案
DOI：
10.1186/s13063-020-04528-3
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发表时间：
2020-05
期刊：
影响因子：
2.5
通讯作者：
Dai Ruoxi
中科院分区：
文献类型：
--
作者：
Wu Juncang;Dai Yuanchang;Lo Edward C. M.;Qi Yinliang;Zhang Ya;Li Quan-li;Dai Ruoxi
研究背景脑卒中急性期并发肺炎的发生率高，预后差，死亡风险高。据报道，口腔条件致病菌与健康受损人群的肺炎有关。口腔健康促进可有效减少中风患者的牙菌斑，牙菌斑被认为是口腔条件致病菌的储存库。本研究评估口腔健康促进的有效性，通过其对口腔条件致病菌的组成和相对丰度的影响，在减少肺炎的患病率。方法/设计本研究是一项随机，单盲，平行试验6个月的持续时间。该研究正在中国合肥最大的医学教学医院之一进行。将招募总共166名患有卒中且无任何卒中后并发症的患者。入组后，患者将被随机分配至以下组之一：（1）口腔卫生指导（OHI）或（2）OHI，使用电动牙刷6个月，以及0.2%葡萄糖酸氯己定漱口水（10 ml，每日两次）。主要结局是卒中并发肺炎的患病率。在整个试验期间，将密切监测患者是否发生肺炎。将在基线和多次随访审查（基线后3、5、7天和1、3、6个月）时采集口腔冲洗液样本。下一代测序将用于检测口腔冲洗液样本中微生物的组成和相对丰度。问卷调查和临床口腔检查将在基线和1，3，6个月后baseline.DiscussionThe的研究结果，这项试验将提供证据，口腔健康促进干预是否有效地减少肺炎并发中风通过其对口腔微生物组的影响。16 S rRNA水平的宏基因组学分析为该试验结果的分析提供了支持，该分析更敏感和全面，可以帮助我们检测口腔健康促进发明如何影响口腔微生物组的组成，相对丰度和物种之间的相互作用，这些都可能导致中风并发肺炎的发生。registrationClinicalTrials.gov NCT04095780 .注册日期：2019年9月19日
BackgroundThe prevalence of pneumonia complicating stroke in acute phase has a poor prognosis and higher risk for death. Oral opportunistic pathogens have been reported to be associated with pneumonia among people with compromised health. Oral health promotion is effective in reducing dental plaque among patients with stroke, which is considered as reservoirs for oral opportunistic pathogens. This study evaluates the effectiveness of oral health promotions in reducing the prevalence of pneumonia via its effects on composition and relative abundance of oral opportunistic pathogens.Methods/designThis study is a randomized, single-blind, parallel trial of 6 months duration. The study is being conducted at one of the largest medical teaching hospitals in Hefei, China. A total of 166 patients with stroke and free from any post-stroke complication will be recruited. After enrollment, patients will be randomized to one of the following groups: (1) oral hygiene instruction (OHI) or (2) OHI, 6-month use of powered tooth brushing, and 0.2% chlorhexidine gluconate mouth rinse (10 ml twice daily). The primary outcome is the prevalence of pneumonia complicating stroke. Patients will be monitored closely for any occurrence of pneumonia over the entire period of this trial. Oral rinse samples will be collected at baseline and multiple follow-up reviews (3, 5, 7 days, and 1, 3, 6 months after baseline). Next-generation sequencing will be employed to detect composition and relative abundances of the microorganism in the oral rinse samples. Questionnaire interviews and clinical oral examinations will be conducted at baseline and 1, 3, and 6 months after baseline.DiscussionThe findings of this trial will provide evidence whether oral health promotion intervention is effective in reducing the prevalence of pneumonia complicating stroke via its effect on the oral microbiome. The analysis of the outcomes of this trial is empowered by metagenomic analysis at 16S rRNA level, which is more sensitive and comprehensive to help us detect how oral health promotion inventions affect the oral microbiome in terms of its composition, relative abundance, and interactions between species, which all may contribute to the occurrence of pneumonia complicating stroke.Trial registrationClinicalTrials.gov NCT04095780 . Registered on 19 September 2019
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影响因子：
5.3
作者：
通讯作者：
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影响因子：
2.3
作者：
K. Atchison;T. Dolan
通讯作者：
K. Atchison;T. Dolan
影响因子：
168.9
作者：
Kalra, Lalit;Irshad, Saddif;Rebollo-Mesa, Irene
通讯作者：
Rebollo-Mesa, Irene
DOI：
10.1016/j.apmr.2012.10.024
发表时间：
2013-03-01
影响因子：
4.3
作者：
Lam, Otto L.;McMillan, Anne S.;McGrath, Colman
通讯作者：
McGrath, Colman