CHEST: 二代测序对ICU重症社区获得性肺炎患者临床预后的影响

Background

Metagenomic next-generation sequencing (mNGS) was previously established as a method that can increase the pathogen identification rate in patients with severe community-acquired pneumonia (SCAP).宏基因组二代测序（mNGS）此前已被证实是一种可提高重症社区获得性肺炎（SCAP）患者病原体检出率的方法。

Research Question

What is the impact on clinical outcomes of mNGS of BAL fluid (BALF) in patients with SCAP in the ICU?在重症监护病房（ICU）中，对重症社区获得性肺炎患者的支气管肺泡灌洗液（BALF）进行mNGS检测对临床结局有何影响？

Study Design and Methods

A multicenter, randomized controlled, open-label clinical trial was conducted in 10 ICUs. Patients were randomized in a 1:1 ratio to undergo BALF assessment with conventional microbiological tests (CMTs) only (ie, the CMT group) or BALF assessment with both mNGS and CMTs (ie, the mNGS group). The primary outcome was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a six-category ordinal scale or discharge from the ICU, whichever occurred first.在10个重症监护病房开展了一项多中心、随机对照、开放标签的临床试验。患者按1:1的比例随机分组，分别接受仅采用传统微生物检测（CMTs）的支气管肺泡灌洗液评估（即CMT组）和同时采用mNGS与CMTs的支气管肺泡灌洗液评估（即mNGS组）。主要结局指标为临床改善时间，定义为从随机分组至六类序数量表评分改善两点或从重症监护病房出院的时间，以先发生者为准。

Results

A total of 349 patients were randomized to treatment between January 1, 2021, and November 18, 2022; 170 were assigned to the CMT group and 179 to the mNGS group. In the intention-to-treat analysis, the time to clinical improvement was better in the mNGS group than in the CMT group (10 days vs 13 days; difference, –2.0 days; 95% CI, –3.0 to 0.0 days). Similar results were obtained in the per-protocol analysis. The proportion of patients with clinical improvement within 14 days was significantly higher in the mNGS group (62.0%) than in the CMT group (46.5%). There was no significant difference in other secondary outcomes.2021年1月1日至2022年11月18日期间，共有349例患者被随机分配至相应治疗组；其中170例被分配至CMT组，179例被分配至mNGS组。意向性治疗分析显示，mNGS组的临床改善时间优于CMT组（10天对比13天；差异为 -2.0天；95%置信区间为 -3.0天至0.0天）。符合方案分析也得到了相似的结果。mNGS组患者在14天内临床改善的比例显著高于CMT组（62.0%对比46.5%）。其他次要结局指标两组间无显著差异

Interpretation

Compared with the use of CMTs alone, mNGS combined with CMTs reduced the time to clinical improvement for patients with SCAP.与单独使用传统微生物检测相比，mNGS与传统微生物检测联合使用可缩短重症社区获得性肺炎患者的临床改善时间 。