重症监护室的精准处方：评估BioFire®FilmArray®肺炎专家组和呼吸机相关性肺炎的标准培养引导治疗

摘要(中文译文)

呼吸机相关性肺炎（VAP）是重症监护病房（ICU）中发病和死亡的主要原因之一。及时识别病原体对于启动目标性抗菌治疗至关重要。本研究评估了BioFire® FilmArray®肺炎检测板（BFPP；BioFire Diagnostics，LLC，美国犹他州盐湖城）——一种基于多重PCR的快速检测——与常规培养及药敏试验相比，在VAP患者中的临床和诊断影响。本研究在印度北部一所三级医疗医学院开展了一项前瞻性观察性纵向研究。共纳入106例依据国家医疗安全网络（NHSN）感染相关呼吸机相关性并发症（IVAC）标准诊断的VAP患者，均等分为两组。A组同时接受BFPP和培养检测；B组仅采用基于培养的诊断方法进行评估。记录并分析人口学数据、急性生理与慢性健康评估II（APACHE II）评分、ICU住院时间、通气时长、拔管时机、抗生素使用及28天死亡率。培养组平均APACHE II评分（30.7 ± 6.2）高于BFPP组（29.5 ± 7.1；p = 0.20），但差异无统计学意义。BFPP阳性患者的ICU住院时间（中位数9天）显著短于培养阳性患者（中位数13天；p = 0.021）。BFPP组7天内早期拔管更为常见（73.7%），高于培养组（52.9%；p = 0.047）。虽然BFPP组总体28天死亡率（55.8%）低于培养组（62.3%），但差异无统计学意义（p = 0.21）。然而，按性别分层分析显示，BFPP组男性和女性死亡率均显著降低（p = 0.037和p = 0.048）。一项值得关注的发现是，BFPP阴性患者死亡率（43.5%）高于培养阴性病例（38.5%；p = 0.042）。将BFPP整合至VAP诊断流程中，可改善中间临床结局，包括缩短ICU住院时间、提前拔管及缩短通气时长。虽然总体死亡率获益无统计学意义，但亚组分析提示BFPP指导的管理可能具有生存优势，尤其在病原体阳性病例中。然而，在缺乏临床相关性时解读阴性分子检测结果需谨慎，因其可能导致治疗延迟或不当。本研究支持将分子诊断作为常规培养的补充工具用于VAP管理，尤其在与可靠的临床判断和抗菌药物管理相结合时。

Abstract

Ventilator-associated pneumonia (VAP) is a leading cause of morbidity and mortality in ICUs. Timely identification of pathogens is critical to initiating targeted antimicrobial therapy. This study evaluated the clinical and diagnostic impact of the BioFire® FilmArray® Pneumonia Panel (BFPP; BioFire Diagnostics, LLC, Salt Lake City, UT, USA), a rapid multiplex PCR-based test, compared to conventional culture and sensitivity testing in patients with VAP. A prospective observational longitudinal study was conducted in a North Indian tertiary care medical college. A total of 106 patients with VAP, diagnosed based on the National Healthcare Safety Network (NHSN) infection-related ventilator-associated complication (IVAC) criteria, were equally divided into two groups. Group A underwent both BFPP and culture testing; Group B was assessed using culture-based diagnostics alone. Demographic data, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, ICU stay, ventilation duration, extubation timing, antibiotic usage, and 28-day mortality were recorded and analyzed. The mean APACHE II score was higher in the culture group (30.7 ± 6.2) than in the BFPP group (29.5 ± 7.1; p = 0.20), but was not statistically significant. ICU stay was significantly shorter in BFPP-positive patients (median nine days) than in culture-positive patients (median 13 days; p = 0.021). Early extubation within seven days was more frequent in the BFPP group (73.7%) compared to the culture group (52.9%; p = 0.047). While overall 28-day mortality was lower in the BFPP group (55.8%) compared to the culture group (62.3%), the difference was not statistically significant (p = 0.21). However, sex-stratified analysis showed significantly lower mortality among both males (p = 0.037) and females (p = 0.048) in the BFPP group. A concerning finding was the higher mortality rate in BFPP-negative patients (43.5%) compared to culture-negative cases (38.5%; p = 0.042). The integration of the BFPP into the diagnostic workflow for VAP demonstrated improved intermediate clinical outcomes, including reduced ICU stay, earlier extubation, and shortened ventilation duration. While overall mortality benefits were not statistically significant, subgroup analyses indicated a potential survival advantage with BFPP-guided management, particularly in pathogen-positive cases. However, caution is warranted in interpreting negative molecular results without clinical correlation, as these may lead to delayed or inappropriate therapy. This study supports the adoption of molecular diagnostics as a complementary tool to conventional cultures in managing VAP, especially when paired with robust clinical judgment and antimicrobial stewardship.

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