A CONTROLLED TRIAL IN INTENSIVE-CARE UNITS OF SELECTIVE DECONTAMINATION OF THE DIGESTIVE-TRACT WITH NONABSORBABLE ANTIBIOTICS
A CONTROLLED TRIAL IN INTENSIVE-CARE UNITS OF SELECTIVE DECONTAMINATION OF THE DIGESTIVE-TRACT WITH NONABSORBABLE ANTIBIOTICS
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DOI：
10.1056/nejm199202273260903
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发表时间：
1992-02-27
影响因子：
158.5
通讯作者：
CHEVRET, S
中科院分区：
文献类型：
--
作者：
GASTINNE, H;WOLFF, M;CHEVRET, S
背景 据报道，局部使用非吸收性抗生素对消化道进行选择性去污可预防接受机械通气的患者的医院感染，该程序在欧洲广泛使用。然而，目前还不清楚选择性去污是否能提高生存率。 我们进行了一项随机、双盲、多中心研究，其中445例在15个重症监护病房接受机械通气的患者接受预防性非吸收性抗生素（n = 220）或安慰剂（n = 225）。通过鼻胃管给予局部抗生素（妥布霉素、硫酸粘杆菌素和阿替霉素B）或安慰剂，并在整个通气期间应用于口咽部。主要终点为重症监护病房的死亡率和随机分组后60天内的死亡率。 共有142名患者在重症监护室死亡：治疗组75名（34%），安慰剂组67名（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），即使调整了两组中不平衡或单独预测生存的因素（P = 0.70）。在研究入组后30天内，重症监护病房的59名患者（13%）发生了肺炎（安慰剂组33名，治疗组26名，P = 0.42）。治疗组重症监护室获得性肺炎和革兰氏阴性杆菌肺炎的发生率低于安慰剂组（P = 0.01）。治疗组抗生素总费用是对照组的2.2倍。 选择性消化道净化并不能提高重症监护室接受机械通气的患者的生存率，尽管它大大增加了他们的护理成本。
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 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 the mortality rate 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.