近日，加拿大Sunnybrook健康科学中心Brian H. Cuthbertson团队研究了ICU患者通气过程中消化道选择性脱污染对患者预后的影响。相关论文于2025年10月29日发表在《新英格兰医学杂志》上。

选择性消化道脱污染（SDD）是否能降低机械通气患者的死亡率，以及它是否会对重症监护病房（ICU）的微生物生态产生不利影响，目前尚不清楚。在对澳大利亚数据的早期分析中，SDD并没有导致比标准治疗更低的住院死亡率，但需要来自完整国际试验的数据。

研究组在澳大利亚和加拿大随机分配ICU，对机械通气患者使用SDD或继续进行两个12个月的标准护理。SDD组患者在通气期间接受特定的口服和胃抗菌干预，并在入组后的前4天接受静脉抗生素治疗。ICU所有其他患者均纳入观察性生态评估。以前报告的来自澳大利亚的数据现在与来自加拿大的数据相结合。主要结局为90天内任何原因导致的院内死亡。在第90天评估的次要临床结果是ICU中的死亡、存活和不使用机械通气的天数、ICU入院和住院。微生物学次要结果包括血液感染和抗生素耐药生物的新阳性培养。对于生态评估，微生物学结果进行了非劣效性测试（非劣效边际，2个百分点）。

该试验涉及26个ICU的20,000例患者，9289例患者纳入随机试验，10,711例患者纳入生态评估。90天时，SDD组4215例患者中有1175例（27.9%）在出院前死亡，标准治疗组5065例患者中有1494例（29.5%）在出院前死亡（优势比0.93；95%可信区间0.84 ~ 1.05；P=0.27）。SDD组新血流感染发生率为4.9%，标准治疗组为6.8%（调整后平均差异为1.30个百分点；95% CI, 2.55 ~ 0.05）；耐药菌培养率分别为16.8%和26.8%（调整后平均差异为9.60个百分点；95% CI为12.40 ~ 6.80）。在生态评价中，未证实SDD对新的耐药菌的发展具有非劣效性。SDD组中有12例（0.3%）患者报告了被认为与SDD或标准治疗相关的不良事件，而标准治疗组中没有患者报告不良事件。严重不良事件分别发生47例（1.1%）和59例（1.2%）。

研究结果表明，在接受机械通气的危重患者中，SDD并未导致院内死亡发生率低于标准护理。

附：英文原文

Title: Selective Decontamination of the Digestive Tract during Ventilation in the ICU

Author: The SuDDICU Investigators for the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group

Issue&Volume: 2025-10-29

Abstract:

BACKGROUND

Whether selective decontamination of the digestive tract (SDD) reduces mortality among patients undergoing mechanical ventilation and whether it adversely affects microbial ecology in the intensive care unit (ICU) remain unclear. In an earlier analysis of data from Australia, SDD did not result in a lower incidence of in-hospital death than standard care, but data from the full international trial are needed.

METHODS

We randomly assigned ICUs in Australia and Canada to use SDD or to continue standard care for two 12-month periods in patients undergoing mechanical ventilation. Patients in the SDD group received specific oral and gastric antimicrobial interventions for the duration of ventilation and an intravenous antibiotic agent for the first 4 days after enrollment. All other patients in the ICU were included in an observational ecologic assessment. Previously reported data from Australia are now combined with data from Canada. The primary outcome was in-hospital death from any cause at 90 days. The secondary clinical outcomes, assessed at 90 days, were death in the ICU and the number of days alive and free of mechanical ventilation, ICU admission, and hospitalization. Microbiologic secondary outcomes included new positive cultures for bloodstream infections and antibiotic-resistant organisms. For the ecologic assessment, the microbiologic outcomes were tested for noninferiority (noninferiority margin, 2 percentage points).

RESULTS

In this trial involving 20,000 patients in 26 ICUs, 9289 patients were enrolled in the randomized trial and 10,711 were included in the ecologic assessment. At 90 days, 1175 of 4215 patients (27.9%) in the SDD group and 1494 of 5065 (29.5%) in the standard-care group had died before hospital discharge (odds ratio, 0.93; 95% confidence interval [CI], 0.84 to 1.05; P=0.27). New bloodstream infections occurred in 4.9% of the patients in the SDD group and in 6.8% of those in the standard-care group (adjusted mean difference, 1.30 percentage points; 95% CI, 2.55 to 0.05); antibiotic-resistant organisms were cultured in 16.8% and 26.8%, respectively (adjusted mean difference, 9.60 percentage points; 95% CI, 12.40 to 6.80). In the ecologic assessment, noninferiority of SDD was not confirmed for the development of new antibiotic-resistant organisms. Adverse events considered to be related to SDD or standard care were reported in 12 patients (0.3%) in the SDD group and in no patients in the standard-care group. Serious adverse events occurred in 47 patients (1.1%) and 59 patients (1.2%), respectively.

CONCLUSIONS

Among critically ill patients undergoing mechanical ventilation, SDD did not result in a lower incidence of in-hospital death than standard care.

DOI: NJ202510290000005

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2506398