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消化道选择性去污随机对照试验的荟萃分析。消化道选择性去污试验协作组

Meta-analysis of randomised controlled trials of selective decontamination of the digestive tract. Selective Decontamination of the Digestive Tract Trialists' Collaborative Group.

出版信息

BMJ. 1993 Aug 28;307(6903):525-32. doi: 10.1136/bmj.307.6903.525.

Abstract

OBJECTIVE

To determine the clinical benefits of selective decontamination of the digestive tract in patients treated in intensive care units.

DESIGN

Meta-analysis of 22 randomised trials that compared different combinations of oral non-absorbable antibiotics, with or without a systemic component, with no treatment in controls.

SUBJECTS

4142 patients seen in general and specialised intensive care units around the world. 2047 received some form of antibiotic treatment, the remainder no prophylaxis.

DATA ANALYSIS

Each trial was reviewed through direct contact with study investigators. Data collected were: the randomisation procedure, number of patients, number excluded from the analysis, and numbers of respiratory tract infections and deaths. Data were combined according to an intention to treat analysis with the Mantel-Haenszel-Peto method.

MAIN OUTCOME MEASURES

Respiratory tract infections and total mortality.

RESULTS

Selective decontamination of the digestive tract significantly reduced respiratory tract infections (odds ratio 0.37; 95% confidence interval 0.31 to 0.43). The value of the common odds ratio for total mortality (0.90; 0.79 to 1.04) suggested at best a moderate treatment effect, reaching statistical significance only when the subgroup of trials of topical and systemic treatment combined was considered separately (odds ratio 0.80; 0.67 to 0.97). No firm conclusions could be drawn owing to large variations in patient mix and severity within and between trials.

CONCLUSIONS

The findings strongly indicate that selective decontamination significantly reduces infection related morbidity in patients receiving intensive care. They also highlight why definite conclusions about the effect of prophylaxis on mortality cannot be drawn despite the large number of trials available. Based on the most favourable results obtained by pooling data from trials in which combined topical and systemic treatment was used it may be estimated that 6 (range 5-9) and 23 (13-139) patients would need to be treated to prevent one respiratory tract infection and one death respectively.

摘要

目的

确定在重症监护病房接受治疗的患者中进行消化道选择性去污的临床益处。

设计

对22项随机试验进行荟萃分析,这些试验比较了口服不可吸收抗生素的不同组合(有或没有全身用药成分)与对照组不进行治疗的情况。

研究对象

全球普通及专科重症监护病房的4142例患者。2047例接受了某种形式的抗生素治疗,其余未进行预防。

数据分析

通过与研究调查人员直接联系对每项试验进行审查。收集的数据包括:随机化程序、患者数量、排除在分析之外的数量以及呼吸道感染和死亡人数。根据意向性分析,采用Mantel-Haenszel-Peto方法合并数据。

主要观察指标

呼吸道感染和总死亡率。

结果

消化道选择性去污显著降低了呼吸道感染(比值比0.37;95%置信区间0.31至0.43)。总死亡率的共同比值比(0.90;0.79至1.04)表明治疗效果充其量为中等,仅在单独考虑局部和全身联合治疗试验亚组时才达到统计学显著性(比值比0.80;0.67至0.97)。由于各试验内部和之间患者构成及严重程度差异很大,无法得出确凿结论。

结论

研究结果有力地表明,选择性去污显著降低了接受重症监护患者的感染相关发病率。它们还突出了尽管有大量试验,但仍无法就预防对死亡率的影响得出明确结论的原因。根据汇总使用局部和全身联合治疗试验数据获得的最有利结果,估计分别需要治疗6例(范围5 - 9例)和23例(13 - 139例)患者以预防一例呼吸道感染和一例死亡。

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