CHEST:新一代宏基因组测序对ICU重症社区获得性肺炎患者临床结局的影响:一项多中心随机对照试验

Abstract

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).宏基因组下一代测序（mNGS）先前已被建立为一种可以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 BALF in ICU patients with SCAP?在ICU中对SCAP患者进行支气管肺泡灌洗液（BALF）的mNGS对临床结果有何影响？

Study design and methods: A multicenter, randomized, open-label clinical trial was conducted in 10 ICUs. Patients were randomized in a 1:1 ratio to undergo BALF with the conventional microbiological tests (CMTs) only (CMT group) or both BALF with mNGS and CMTs (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ICU中进行了一项多中心、随机、开放标签的临床试验。患者以1:1的比例随机分配，仅接受传统微生物学检测（CMTs）的BALF（CMT组）或同时接受BALF的mNGS和CMTs（mNGS组）。主要结果是临床改善时间，定义为从随机化到在六类有序量表上改善两个点或从ICU出院的时间，以先发生的为准。

Results: A total of 349 patients were randomized between January 1, 2021, to November 18, 2022, of whom 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 that in the CMT group (10 d vs. 13 d, difference: -2.0 [95% CI = -3.0 to 0.0]). Similar results were obtained in the per-protocol analysis. The proportion of patients with clinical improvement within 14 d was significantly higher in the mNGS group (62.0%) than that in the CMT group (46.5%). There was no significant difference in other secondary outcomes.从2021年1月1日到2022年11月18日，共有349名患者被随机分配，其中170名被分配到CMT组，179名被分配到mNGS组。在意向治疗分析中，mNGS组的临床改善时间比CMT组更好（10天 vs. 13天，差异：-2.0 [95% CI = -3.0到0.0]）。在按协议分析中获得了相似的结果。在14天内临床改善的患者比例在mNGS组（62.0%）显著高于CMT组（46.5%）。其他次要结果没有显著差异。

Conclusion: MNGS combined with CMTs reduced the time to clinical improvement for patients with SCAP, compared to the use of CMTs alone. 与单独使用CMTs相比，mNGS结合CMTs减少了SCAP患者的临床改善时间。