临床试验中抗生素治疗儿童肺炎的试验参与者和非试验参与者的可比结局：一项回顾性队列研究。

Comparable outcomes among trial and nontrial participants in a clinical trial of antibiotics for childhood pneumonia: a retrospective cohort study.

机构信息

Department of Public Health Research, Health Services Unit, KEMRI-Wellcome Trust Research Programme, P.O. Box 43640, 00100 Nairobi, Kenya.

出版信息

J Clin Epidemiol. 2018 Feb;94:1-7. doi: 10.1016/j.jclinepi.2017.10.016. Epub 2017 Oct 31.

DOI:10.1016/j.jclinepi.2017.10.016

PMID:29097339

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5808926/

Abstract

OBJECTIVES

We compared characteristics and outcomes of children enrolled in a randomized controlled trial (RCT) comparing oral amoxicillin and benzyl penicillin for the treatment of chest indrawing pneumonia vs. children who received routine care to determine the external validity of the trial results.

STUDY DESIGN AND SETTING

A retrospective cohort study was conducted among children aged 2-59 months admitted in six Kenyan hospitals. Data for nontrial participants were extracted from inpatient records upon conclusion of the RCT. Mortality among trial vs. nontrial participants was compared in multivariate models.

RESULTS

A total of 1,709 children were included, of whom 527 were enrolled in the RCT and 1,182 received routine care. History of a wheeze was more common among trial participants (35.4% vs. 11.2%; P < 0.01), while dehydration was more common among nontrial participants (8.6% vs. 5.9%; P = 0.05). Other patient characteristics were balanced between the two groups. Among those with available outcome data, 14/1,140 (1.2%) nontrial participants died compared to 4/527 (0.8%) enrolled in the trial (adjusted odds ratio, 0.7; 95% confidence interval: 0.2-2.1).

CONCLUSION

Patient characteristics were similar, and mortality was low among trial and nontrial participants. These findings support the revised World Health Organization treatment recommendations for chest indrawing pneumonia.

摘要

目的

我们比较了入组一项随机对照试验（RCT）的儿童与接受常规治疗的儿童的特征和结局，该 RCT 比较了口服阿莫西林和苄星青霉素治疗胸凹陷性肺炎的效果，以确定试验结果的外部有效性。

研究设计和地点

一项回顾性队列研究在肯尼亚的六家医院进行，纳入年龄在 2-59 个月的儿童。非试验参与者的数据是在 RCT 结束后从住院记录中提取的。在多变量模型中比较了试验组和非试验组的死亡率。

结果

共纳入 1709 名儿童，其中 527 名入组 RCT，1182 名接受常规治疗。试验组有喘息史的比例更高（35.4% vs. 11.2%；P<0.01），而非试验组脱水的比例更高（8.6% vs. 5.9%；P=0.05）。两组间其他患者特征平衡。在有结局数据的儿童中，1140 名非试验参与者中有 14 例（1.2%）死亡，527 名试验参与者中有 4 例（0.8%）死亡（校正比值比，0.7；95%置信区间：0.2-2.1）。