在重症监护病房进行的一项关于使用不可吸收抗生素进行消化道选择性去污的对照试验。法国消化道选择性去污研究小组。

A controlled trial in intensive care units of selective decontamination of the digestive tract with nonabsorbable antibiotics. The French Study Group on Selective Decontamination of the Digestive Tract.

作者信息

Gastinne H, Wolff M, Delatour F, Faurisson F, Chevret S

机构信息

Service de Réanimation, Hôpital Universitaire Dupuytren, Limoges, France.

出版信息

N Engl J Med. 1992 Feb 27;326(9):594-9. doi: 10.1056/NEJM199202273260903.

DOI:10.1056/NEJM199202273260903

PMID:1734249

Abstract

BACKGROUND

Selective decontamination of the digestive tract with topical nonabsorbable antibiotics has been reported to prevent nosocomial infections in patients receiving mechanical ventilation, and the procedure is used widely in Europe. However, it is unclear whether selective decontamination improves survival.

METHODS

We conducted a randomized, double-blind multicenter study in which 445 patients receiving mechanical ventilation in 15 intensive care units were given either prophylactic nonabsorbable antibiotics (n = 220) or a placebo (n = 225). Topical antibiotics (tobramycin, colistin sulfate, and amphotericin B) or a placebo was administered through a nasogastric tube and applied to the oropharynx throughout the period of ventilation. The main end points were the mortality rate in the intensive care unit and within 60 days of randomization.

RESULTS

A total of 142 patients died in the intensive care unit; 75 (34 percent) in the treatment group and 67 (30 percent) in the placebo group (P = 0.37). Mortality within 60 days of randomization was similar in the two groups (P = 0.40), even after adjustment for factors that were either unbalanced or individually predictive of survival in the two groups (P = 0.70). Pneumonia developed in 59 patients (13 percent) in the intensive care unit within 30 days of enrollment in the study (33 in the placebo group and 26 in the treatment group, P = 0.42). Pneumonia acquired in the intensive care unit and due to gram-negative bacilli was less frequent (P = 0.01) in the treatment group than in the placebo group. The total charges for antibiotics were 2.2 times higher in the treatment group.

CONCLUSIONS

Selective decontamination of the digestive tract does not improve survival among patients receiving mechanical ventilation in the intensive care unit, although it substantially increases the cost of their care.

摘要

背景

据报道，使用局部不可吸收抗生素进行消化道选择性去污可预防接受机械通气患者的医院感染，该方法在欧洲被广泛应用。然而，选择性去污是否能提高生存率尚不清楚。

方法

我们进行了一项随机、双盲多中心研究，15个重症监护病房中445例接受机械通气的患者被给予预防性不可吸收抗生素（n = 220）或安慰剂（n = 225）。通过鼻胃管给予局部抗生素（妥布霉素、硫酸多粘菌素和两性霉素B）或安慰剂，并在整个通气期间应用于口咽。主要终点是重症监护病房内及随机分组后60天内的死亡率。

结果

共有142例患者在重症监护病房死亡；治疗组75例（34%），安慰剂组67例（30%）（P = 0.37）。随机分组后60天内的死亡率在两组中相似（P = 0.40），即使在对两组中不平衡或单独预测生存的因素进行调整后也是如此（P = 0.70）。在研究入组后30天内，59例（13%）重症监护病房患者发生肺炎（安慰剂组33例，治疗组26例，P = 0.42）。在重症监护病房获得的、由革兰氏阴性杆菌引起的肺炎在治疗组中的发生率低于安慰剂组（P = 0.01）。治疗组抗生素总费用高出2.2倍。