Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial.
Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial.
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DOI：
10.1136/bmj.a2052
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发表时间：
2008-11-13
影响因子：
105.7
通讯作者：
Hussey, Greg
中科院分区：
文献类型：
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作者：
Hawkridge, Anthony;Hatherill, Mark;Little, Francesca;Goetz, Margaret Ann;Barker, Lew;Mahomed, Hassan;Sadoff, Jerald;Hanekom, Willem;Geiter, Larry;Hussey, Greg
目的比较出生时皮内接种卡介苗和经皮接种卡介苗的婴儿两年内结核病发病率。设计随机试验。背景是南非。研究对象为11名 680名新生儿。干预措施按出生周数随机选择出生后24小时内经皮途径(n=5775)或皮内途径(n=5905)接种东京172卡介苗的婴儿，并进行两年的随访。主要结果指标主要结果指标是记录的结核分枝杆菌感染或结核疾病的放射学和临床证据。次要结果指标是不良事件发生率、所有原因和特定于结核病的入院人数和死亡率。结果皮内给药组和经皮给药组根据微生物学、放射学和临床结果的研究定义，确定的、可能的和可能的结核病累积发病率差异为−0.36%(95.5%可信区间−1.27%到0.54%)。在“25%以内”的等值范围内，两种方法在结核病累积发病率方面没有发现显著差异。此外，在不良事件(风险比0.98，95%可信区间0.91至1.06)，包括死亡(1.19，0.89至1.58)方面，两种路线之间没有发现显著差异。结论皮内卡介苗和经皮卡介苗对南非婴儿出生时接种卡介苗后2年的结核病发病率相当。世界卫生组织应考虑修订其优先皮内接种政策，允许国家免疫规划选择经皮接种，如果这更实际的话。试验注册诊所Trials.gov NCT00242047。
Objective To compare the incidence of tuberculosis over two years in infants vaccinated at birth with intradermal BCG or with percutaneous BCG. Design Randomised trial. Setting South Africa. Participants 11 680 newborn infants. Interventions Infants were randomised by week of birth to receive Tokyo 172 BCG vaccine through the percutaneous route (n=5775) or intradermal route (n=5905) within 24 hours of birth and followed up for two years. Main outcome measures The primary outcome measure was documented Mycobacterium tuberculosis infection or radiological and clinical evidence of tuberculosis disease. Secondary outcome measures were rates of adverse events, all cause and tuberculosis specific admissions to hospital, and mortality. Results The difference in the cumulative incidence of definite, probable, and possible tuberculosis between the intradermal group and the percutaneous group, as defined using study definitions based on microbiological, radiological, and clinical findings was −0.36% (95.5% confidence interval −1.27% to 0.54%). No significant differences were found between the routes in the cumulative incidence of tuberculosis using a range of equivalence of “within 25%.” Additionally, no significant differences were found between the routes in the cumulative incidence of adverse events (risk ratio 0.98, 95% confidence interval 0.91 to 1.06), including deaths (1.19, 0.89 to 1.58). Conclusion Equivalence was found between intradermal BCG vaccine and percutaneous BCG in the incidence of tuberculosis in South African infants vaccinated at birth and followed up for two years. The World Health Organization should consider revising its policy of preferential intradermal vaccination to allow national immunisation programmes to choose percutaneous vaccination if that is more practical. Trial registration ClinicalTrials.gov NCT00242047.
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影响因子：
1.9
作者：
OBRIEN, PC;FLEMING, TR
通讯作者：
FLEMING, TR
影响因子：
--
作者：
HART, PD
通讯作者：
HART, PD
影响因子：
3.3
作者：
Bricks, Lucia F.
通讯作者：
Bricks, Lucia F.
影响因子：
--
作者：
Davids, Virginia;Hanekom, Willem;Kaplan, Gilla
通讯作者：
Kaplan, Gilla
DOI：
10.1016/s0962-8479(96)90012-x
发表时间：
1996-06-01
期刊：
TUBERCLE AND LUNG DISEASE
影响因子：
--
作者：
Mori, T;Yamauchi, Y;Shiozawa, K
通讯作者：
Shiozawa, K