Selective Decontamination of the Digestive Tract during Ventilation in the ICU.

In an earlier analysis of data from Australia, SDD did not result in a lower incidenceof in-hospital death than standard care, but data from the full international trial are needed.

在对澳大利亚数据的早期分析中，SDD并未比标准治疗导致更低的院内死亡发生率，但需要来自完整国际试验的数据。

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.

我们在澳大利亚和加拿大的重症监护病房(ICU)中随机分配了接受机械通气的患者，在两个为期12个月的周期内使用选择性消化道去污染(SDD)方案或继续标准护理。

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.

SDD组的患者在整个通气期间接受了特定的口服和胃部抗菌干预，并在入组后的前4天接受了静脉注射抗生素治疗。

All other patients in the ICU were included in an observational ecologic assessment.

所有其他在重症监护病房的患者都被纳入了一项观察性的生态评估。

Previously reported data from Australia are now combined with data from Canada.

现在将之前澳大利亚报告的数据与来自加拿大的数据结合起来。

The primary outcome was in-hospital death from any cause at 90 days.

主要结果是90天内因任何原因导致的院内死亡。

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.

次要临床结果，评估于90天，包括ICU内的死亡、无需机械通气的存活天数、ICU入院和住院的天数。

Microbiologic secondary outcomes included new positive cultures for bloodstream infections and antibiotic-resistant organisms.

微生物学次要结果包括血流感染和耐药菌株新阳性培养的出现。

For the ecologic assessment, the microbiologic outcomes were tested for noninferiority (noninferiority margin, 2 percentage points).

在生态评估中，微生物学结果被测试以确定非劣效性（非劣效性边界，2个百分点）。

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.

在这项涉及26个ICU的20000名患者的研究中，9289名患者被纳入随机试验，10711名患者被纳入生态评估。

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, 0.94; 95% confidence interval[CI], 0.84 to 1.05; P = 0.27).

在90天时，4215名患者中有1175名（27.9%）在选择性消化道去污染（SDD）组死亡，而在5065名患者中有1494名（29.5%）在标准护理组死亡（比值比，0.94；95%置信区间[CI]，0.84至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).

在选择性消化道去污染（SDD）组中，4.9%的患者出现了新的血流感染，在标准护理组中这一比例为6.8%（调整后的平均差异为-1.30个百分点；95%置信区间为-2.55至-0.05）；分别有16.8%和26.8%的患者培养出了抗生素耐药菌（调整后的平均差异为-9.60个百分点；95%置信区间为-12.40至-6.80）。

In the ecologic assessment, noninferiority of SDD was not confirmed for the development of new antibiotic-resistant organisms.

在生态评估中，SDD对于新抗生素耐药菌的产生非劣效性未得到确认。

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.

在接受SDD治疗的患者中，有12名（0.3%）报告了与SDD或标准护理相关的不良事件，而在接受标准护理的患者中，没有患者报告此类事件。

Serious adverse events occurred in 47 patients (1.1%) and 59 patients (1.2%), respectively.

严重不良事件分别发生在47名患者（1.1%）和59名患者（1.2%）中。

Conclusions

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

在接受机械通气的危重病患者中，选择性消化道去污（SDD）并未导致住院死亡率低于标准护理。

(Funded by the National Health and Medical Research Council of Australia and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT02389036.).

(由澳大利亚国家卫生与医学研究委员会和加拿大健康研究院资助；ClinicalTrials.gov编号，NCT02389036。)