早期卡介苗接种、住院和住院死亡：来自几内亚比绍的 3 项随机试验的次要结局分析。

Early BCG Vaccination, Hospitalizations, and Hospital Deaths: Analysis of a Secondary Outcome in 3 Randomized Trials from Guinea-Bissau.

机构信息

Bandim Health Project, Indepth Network, Bissau, Guinea-Bissau.

Research Center for Vitamins and Vaccines, Statens Serum Institut, Copenhagen, Denmark.

出版信息

J Infect Dis. 2019 Jan 29;219(4):624-632. doi: 10.1093/infdis/jiy544.

DOI:10.1093/infdis/jiy544

PMID:30239767

Abstract

BACKGROUND

This study was performed to examine the effects of early BCG vaccination on the risk, cause, and severity of infant hospitalizations. The analysis included 3 trials randomizing low-weight neonates to early BCG vaccination (intervention) versus no BCG vaccination (usual practice in low-weight neonates, control), with hospitalizations as secondary outcome.

METHODS

Hospitalization data were collected at the pediatric ward of the National Hospital. Effects of BCG vaccination on hospitalization risk were assessed in Cox models providing overall and major disease-group incidence rate ratios (IRRs). Severity was assessed by means of in-hospital case-fatality rates and compared by group as cohort study risk ratios (RRs).

RESULTS

Among 6583 infants (3297 in BCG group, 3286 controls), there were 908 infant hospitalizations (450 BCG, 458 controls) and 135 in-hospital deaths (56 BCG, 79 controls). The neonatal (28 days), 6-week, and infant (1-year) BCG versus control hospitalization IRRs were 0.97 (95% confidence interval [CI], .72-1.31), 0.95 (.73-1.24), and 0.96 (.84-1.10). Corresponding BCG versus control case-fatality rate RRs were 0.58 (95% CI, .35-.94), 0.56 (.35-.90), and 0.72 (.53-.99). BCG vaccination tended to reduce neonatal and infant sepsis hospitalization rates (IRR, 0.75 [95% CI, .50-1.13] and 0.78 [.55-1.11], respectively), and it reduced the neonatal in-hospital sepsis mortality rate (RR, 0.46; 95% CI, .22-.98). There were no confirmed hospitalizations for tuberculosis.

CONCLUSIONS

BCG vaccination did not affect hospitalization rates but reduced in-hospital mortality rates significantly, primarily by preventing fatal cases of sepsis. The observed beneficial effects of BCG on the in-hospital mortality rate were entirely nonspecific.

CLINICAL TRIALS REGISTRATION

NCT00146302, NCT00168610, and NCT00625482.

摘要

背景

本研究旨在探讨早期卡介苗（BCG）接种对婴儿住院风险、病因和严重程度的影响。该分析纳入了 3 项随机分配低体重新生儿进行早期 BCG 接种（干预组）与不接种 BCG（低体重新生儿的常规做法，对照组）的试验，以住院为次要结局。

方法

住院数据由国家医院儿科病房收集。使用 Cox 模型评估 BCG 接种对住院风险的影响，提供总体和主要疾病组发病率比（IRR）。通过住院病死率进行严重程度评估，并通过群组作为队列研究风险比（RR）进行比较。

结果

在 6583 名婴儿（BCG 组 3297 名，对照组 3286 名）中，有 908 名婴儿住院（BCG 组 450 名，对照组 458 名），135 名婴儿死亡（BCG 组 56 名，对照组 79 名）。新生儿（28 天）、6 周和婴儿（1 岁）BCG 与对照组的住院 IRR 分别为 0.97（95%置信区间[CI]，0.72-1.31）、0.95（0.73-1.24）和 0.96（0.84-1.10）。相应的 BCG 与对照组病死率 RR 分别为 0.58（95%CI，0.35-0.94）、0.56（0.35-0.90）和 0.72（0.53-0.99）。BCG 接种可降低新生儿和婴儿败血症住院率（IRR 分别为 0.75[95%CI，0.50-1.13]和 0.78[0.55-1.11]），降低新生儿院内败血症病死率（RR，0.46；95%CI，0.22-0.98）。未发现确诊的结核病住院病例。