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血清降钙素原检测与病毒检测指导住院成人呼吸道感染抗生素使用的随机对照试验

Serum Procalcitonin Measurement and Viral Testing to Guide Antibiotic Use for Respiratory Infections in Hospitalized Adults: A Randomized Controlled Trial.

作者信息

Branche Angela R, Walsh Edward E, Vargas Roberto, Hulbert Barbara, Formica Maria A, Baran Andrea, Peterson Derick R, Falsey Ann R

机构信息

Department of Medicine, University of Rochester.

Department of Medicine, University of Rochester Department of Medicine, Rochester General Hospital, New York.

出版信息

J Infect Dis. 2015 Dec 1;212(11):1692-700. doi: 10.1093/infdis/jiv252. Epub 2015 Apr 24.

Abstract

BACKGROUND

Viral lower respiratory tract illness (LRTI) frequently causes adult hospitalization and is linked to antibiotic overuse. European studies suggest that the serum procalcitonin (PCT) level may be used to guide antibiotic therapy. We conducted a trial assessing the feasibility of using PCT algorithms with viral testing to guide antibiotic use in a US hospital.

METHODS

Three hundred patients hospitalized with nonpneumonic LRTI during October 2013-April 2014 were randomly assigned at a ratio of 1:1 to receive standard care or PCT-guided care and viral PCR testing. The primary outcome was antibiotic exposure, and safety was assessed at 1 and 3 months.

RESULTS

Among the 151 patients in the intervention group, viruses were identified in 42% (63), and 83% (126) had PCT values of <0.25 µg/mL. There were no significant differences in antibiotic use or adverse events between intervention patients and those in the nonintervention group. Subgroup analyses revealed fewer subjects with positive results of viral testing and low PCT values who were discharged receiving antibiotics (20% vs 45%; P = .002) and shorter antibiotic durations among algorithm-adherent intervention patients versus nonintervention patients (2.0 vs 4.0 days; P = .004). Compared with historical controls (from 2008-2011), antibiotic duration in nonintervention patients decreased by 2 days (6.0 vs 4.0 days; P < .001), suggesting a study effect.

CONCLUSIONS

Although antibiotic use was similar in the 2 arms, subgroup analyses of intervention patients suggest that physicians responded to viral and biomarker data. These data can inform the design of future US studies.

CLINICAL TRIALS REGISTRATION

NCT01907659.

摘要

背景

病毒性下呼吸道感染(LRTI)常导致成人住院,且与抗生素过度使用有关。欧洲的研究表明,血清降钙素原(PCT)水平可用于指导抗生素治疗。我们进行了一项试验,评估在美国一家医院使用PCT算法结合病毒检测来指导抗生素使用的可行性。

方法

2013年10月至2014年4月期间,300例因非肺炎性LRTI住院的患者按1:1的比例随机分组,分别接受标准治疗或PCT指导治疗及病毒PCR检测。主要结局是抗生素暴露情况,并在1个月和3个月时评估安全性。

结果

干预组的151例患者中,42%(63例)检测出病毒,83%(126例)的PCT值<0.25μg/mL。干预组患者与非干预组患者在抗生素使用或不良事件方面无显著差异。亚组分析显示,病毒检测结果为阳性且PCT值低的患者出院时接受抗生素治疗的比例较低(20%对45%;P = 0.002),与非干预患者相比,遵循算法的干预患者的抗生素使用疗程更短(2.0天对4.0天;P = 0.004)。与历史对照(2008 - 2011年)相比,非干预患者的抗生素使用疗程减少了2天(6.0天对4.0天;P < 0.001),提示存在研究效应。

结论

尽管两组的抗生素使用情况相似,但对干预组患者的亚组分析表明,医生对病毒和生物标志物数据做出了反应。这些数据可为美国未来的研究设计提供参考。

临床试验注册

NCT01907659。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3f1a/4633755/ba7bb1627e6c/jiv25201.jpg

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