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高疫情环境下针对幼儿疫苗试验的结核病病例发现:一项随机试验。

Tuberculosis case finding for vaccine trials in young children in high-incidence settings: a randomised trial.

机构信息

South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine & School of Child and Adolescent Health, University of Cape Town, Cape Town, South Africa.

出版信息

Int J Tuberc Lung Dis. 2012 Feb;16(2):185-91. doi: 10.5588/ijtld.11.0348.

DOI:10.5588/ijtld.11.0348
PMID:22236918
Abstract

SETTING

A high tuberculosis (TB) burden rural area in South Africa.

OBJECTIVE

To compare TB case yield and disease profile among bacille Calmette-Guérin (BCG) vaccinated children using two case-finding strategies from birth until 2 years of age.

DESIGN

BCG-vaccinated infants were enrolled within 2 weeks of birth and randomised to 3-monthly home visits for questionnaire-based TB screening plus record surveillance of TB registers, hospital admission and X-ray lists at health facilities for TB suspects and cases (Group 1), or record surveillance (as above) only (Group 2). Both groups received a close-out visit after 2 years. Participants were evaluated for suspected TB disease using standardised investigations.

RESULTS

A total of 4786 infants were enrolled: 2392 were randomised to Group 1 and 2394 to Group 2. The case-finding rate was significantly greater in Group 1 (2.2/100 py) than in Group 2 (0.8/100 py), with a case-finding rate ratio of 2.6 (95%CI 1.8-4.0, P < 0.001). Although the proportion of cases with bacteriological confirmation was lower in Group 1, this difference did not reach statistical significance. There was also no significant difference in the proportions with TB symptoms and signs.

CONCLUSION

Home visits combined with record surveillance detected significantly more cases than record surveillance with a single study-end visit. The TB case profile did not differ significantly between the two groups.

摘要

背景

南非一个结核病负担较高的农村地区。

目的

比较两种从出生到 2 岁的卡介苗(BCG)接种儿童的结核病病例检出率和疾病特征。

设计

在出生后 2 周内招募 BCG 接种婴儿,并将其随机分配至每 3 个月进行一次家访的组,通过问卷调查进行结核病筛查,并对卫生设施的结核病登记处、住院和 X 射线名单进行结核病疑似病例和病例的记录监测(第 1 组),或仅进行记录监测(第 2 组)。两组在 2 年后均进行结束访问。使用标准化调查评估参与者疑似结核病疾病。

结果

共纳入 4786 名婴儿:2392 名随机分配至第 1 组,2394 名随机分配至第 2 组。第 1 组的病例检出率(2.2/100 人年)显著高于第 2 组(0.8/100 人年),病例检出率比为 2.6(95%CI 1.8-4.0,P < 0.001)。尽管第 1 组中具有细菌学证实的病例比例较低,但差异无统计学意义。两组中具有结核病症状和体征的比例也无显著差异。

结论

家访结合记录监测比单独的研究结束时的记录监测检测到的病例显著更多。两组的结核病病例特征无显著差异。

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