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多重聚合酶链反应即时检测与常规实验室检测在成人呼吸道感染治疗中的比较:一项评估对住院时间和抗菌药物使用影响的半随机研究

Multiplex PCR point of care testing versus routine, laboratory-based testing in the treatment of adults with respiratory tract infections: a quasi-randomised study assessing impact on length of stay and antimicrobial use.

作者信息

Andrews Denise, Chetty Yumela, Cooper Ben S, Virk Manjinder, Glass Stephen K, Letters Andrew, Kelly Philip A, Sudhanva Malur, Jeyaratnam Dakshika

机构信息

Division of Acute Medicine, King's College Hospital NHS Foundation Trust, London, SE5 9RS, UK.

Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand.

出版信息

BMC Infect Dis. 2017 Oct 10;17(1):671. doi: 10.1186/s12879-017-2784-z.

Abstract

BACKGROUND

Laboratory-based respiratory pathogen (RP) results are often available too late to influence clinical decisions such as hospitalisation or antibiotic treatment due to time delay in transport of specimens and testing schedules. Ward-based i.e. point of care (POC) testing providing rapid results may alter the clinical management pathway.

METHODS

FilmArray® RP polymerase chain reaction (PCR) systems were placed in three in-patient and out-patient medical areas. Patients presenting with influenza-like illness /upper respiratory tract infection +/- lower RTI were recruited between January-July 2015. FilmArray® POC testing occurred on even days of the month (intervention) or routine, laboratory-based RP PCR testing +/- atypical serology on odd days (control). The primary outcome was length of hospital stay. The secondary outcomes were impact on the use of antimicrobials, readmissions, all-cause mortality, length of ward stay and turn-around time (TAT) (time to result from admission).

RESULTS

Of 606 eligible patients, 545 (89.9%) were included; 211 in the control arm and 334 in the intervention arm. 20% of control arm patients and 24% of intervention arm patients had an RP detected. POC testing was not associated with the primary outcome measure, length of stay, but reduced the TAT from 39.5 h to 19.0 h, p < 0.001. Only the prescribing decision differed between study arms, p < 0.001. When antivirals were given, the intervention was associated with a reduction in the median time to the first dose of 36 h and allowed appropriate treatment of mycoplasma infection.

CONCLUSIONS

We found no association between respiratory PCR POC testing and length of stay or most of the secondary outcomes except the antimicrobial prescribing decision. This was probably due to a delay in initiating FilmArray® testing. Despite this, POC testing allowed time-critical antivirals to be given significantly faster, appropriate mycoplasma treatment and results were available considerably faster than routine, laboratory-based testing. Ward-staff of all grades performed POC testing without difficulty suggesting potential use across many divergent healthcare settings. Further studies evaluating the implementation of rapid respiratory PCR POC testing and the effect on length of stay and antimicrobial use are required.

TRIAL REGISTRATION

ISRCTN10470967 , Retrospectively Registered, 30/6/2015.

摘要

背景

基于实验室的呼吸道病原体(RP)检测结果往往因标本运输时间延迟和检测计划而来得太晚,无法影响诸如住院或抗生素治疗等临床决策。基于病房即即时检测(POC)能提供快速结果,可能会改变临床管理路径。

方法

FilmArray® RP聚合酶链反应(PCR)系统被放置在三个住院和门诊医疗区域。2015年1月至7月期间,招募出现流感样疾病/上呼吸道感染+/-下呼吸道感染的患者。FilmArray® POC检测在每月偶数日进行(干预组),奇数日进行常规的基于实验室的RP PCR检测+/-非典型血清学检测(对照组)。主要结局是住院时间。次要结局包括对抗生素使用、再入院、全因死亡率、病房停留时间和周转时间(TAT,从入院到出结果的时间)的影响。

结果

在606名符合条件的患者中,545名(89.9%)被纳入研究;对照组211名,干预组334名。对照组20%的患者和干预组24%的患者检测出RP。POC检测与主要结局指标住院时间无关,但将TAT从39.5小时缩短至19.0小时,p < 0.001。仅研究组之间的用药决策存在差异,p < 0.001。给予抗病毒药物时,干预组与首剂用药的中位时间减少了36小时相关,并允许对支原体感染进行适当治疗。

结论

我们发现呼吸道PCR POC检测与住院时间或除抗生素用药决策外的大多数次要结局之间无关联。这可能是由于启动FilmArray®检测存在延迟。尽管如此,POC检测使时间紧迫的抗病毒药物给药速度显著加快,实现了对支原体的适当治疗,且结果比常规的基于实验室的检测快得多。各级病房工作人员进行POC检测均无困难,表明其在许多不同医疗环境中具有潜在用途。需要进一步研究评估快速呼吸道PCR POC检测的实施情况及其对住院时间和抗生素使用的影响。

试验注册

ISRCTN10470967,追溯注册,2015年6月30日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d61/5635493/f47d5f3f74d2/12879_2017_2784_Fig1_HTML.jpg

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