Decontamination of the Digestive Tract and Oropharynx in ICU Patients
Decontamination of the Digestive Tract and Oropharynx in ICU Patients
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DOI：
10.1056/nejmoa0800394
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发表时间：
2009-01-01
影响因子：
158.5
通讯作者：
Bonten, M. J. M.
中科院分区：
文献类型：
--
作者：
de Smet, A. M. G. A.;Kluytmans, J. A. J. W.;Bonten, M. J. M.
背景 选择性消化道去污 (SDD) 和选择性口咽去污 (SOD) 是治疗某些重症监护患者时使用的感染预防措施，但报告的对患者预后的影响是相互矛盾的。方法我们在荷兰 13 个重症监护病房 (ICU) 中使用整群随机化的交叉研究评估了 SDD 和 SOD 的有效性。预计插管时间超过 48 小时或预计 ICU 住院时间超过 72 小时的患者符合资格。在每个 ICU 中，在 6 个月的时间内以随机顺序应用三种治疗方案（SDD、SOD 和标准护理）。第 28 天的死亡率是主要终点。 SDD 包括 4 天静脉注射头孢噻肟以及在口咽部和胃部局部使用妥布霉素、粘菌素和两性霉素 B。 SOD 包括仅在口咽部施用相同的抗生素。每月进行点患病率研究来分析抗生素耐药性。 结果 共有 5939 名患者参与研究，其中 1990 名患者被分配到标准护理组，1904 名患者被分配到 SOD，2045 名患者被分配到 SDD；第 28 天时各组的粗死亡率分别为 27.5%、26.6% 和 26.9%。在以年龄、性别、急性生理学和慢性健康评估 (APACHE II) 评分、插管状态和医学专业作为协变量的随机效应逻辑回归模型中，与标准治疗组相比，SOD 和 SDD 组第 28 天死亡的比值比分别为 0.86（95% 置信区间 [CI]，0.74 至 0.99）和 0.83（95%）。 CI 分别为 0.72 至 0.97）。 结论 在第 28 天标准护理相关死亡率为 27.5% 的 ICU 人群中，SDD 死亡率估计降低了 3.5 个百分点，SOD 死亡率降低了 2.9 个百分点。 （对照临床试验编号，ISRCTN35176830。）。
Background Selective digestive tract decontamination ( SDD) and selective oropharyngeal decontamination ( SOD) are infection- prevention measures used in the treatment of some patients in intensive care, but reported effects on patient outcome are conflicting.Methods We evaluated the effectiveness of SDD and SOD in a crossover study using cluster randomization in 13 intensive care units ( ICUs), all in the Netherlands. Patients with an expected duration of intubation of more than 48 hours or an expected ICU stay of more than 72 hours were eligible. In each ICU, three regimens ( SDD, SOD, and standard care) were applied in random order over the course of 6 months. Mortality at day 28 was the primary end point. SDD consisted of 4 days of intravenous cefotaxime and topical application of tobramycin, colistin, and amphotericin B in the oropharynx and stomach. SOD consisted of oropharyngeal application only of the same antibiotics. Monthly point- prevalence studies were performed to analyze antibiotic resistance.Results A total of 5939 patients were enrolled in the study, with 1990 assigned to standard care, 1904 to SOD, and 2045 to SDD; crude mortality in the groups at day 28 was 27.5%, 26.6%, and 26.9%, respectively. In a random- effects logistic- regression model with age, sex, Acute Physiology and Chronic Health Evaluation (APACHE II) score, intubation status, and medical specialty used as covariates, odds ratios for death at day 28 in the SOD and SDD groups, as compared with the standard- care group, were 0.86 ( 95% confidence interval [CI], 0.74 to 0.99) and 0.83 ( 95% CI, 0.72 to 0.97), respectively.Conclusions In an ICU population in which the mortality rate associated with standard care was 27.5% at day 28, the rate was reduced by an estimated 3.5 percentage points with SDD and by 2.9 percentage points with SOD. (Controlled Clinical Trials number, ISRCTN35176830.).