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首页> 外文期刊>Journal of nursing and healthcare of chronic illness >Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial
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Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial

机译：皮下注射与皮内注射卡介苗在南非婴儿预防结核病中的疗效：随机试验

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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 byweek 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.
机译：目的比较皮内注射卡介苗或经皮卡介苗的婴儿出生后两年的结核病发病率。设计随机试验。设置南非。参与者11680名新生儿。干预措施婴儿按出生周随机分配，以在出生后24小时内通过经皮途径（n = 5775）或皮内途径（n = 5905）接受Tokyo 172 BCG疫苗，并随访两年。主要结局指标主要结局指标是结核分枝杆菌感染或结核病的放射学和临床证据。次要结果指标是不良事件发生率，所有原因和特定于医院的肺结核入院率以及死亡率。结果根据基于微生物学，放射学和临床发现的研究定义，皮内组和经皮组之间确定的，可能的和可能的结核病的累积发生率差异为-0.36％（95.5％置信区间为-1.27％）至0.54％）。使用“ 25％以内”的当量范围，在结核病累积发病率的途径之间没有发现显着差异。此外，两种途径之间在不良事件的累积发生率（风险比0.98，95％置信区间0.91至1.06），包括死亡（1.19，0.89至1.58）之间没有发现显着差异。结论南非出生婴儿和随访了两年的婴儿中，皮内注射卡介苗和皮下注射卡介苗在结核病的发生率上是一致的。世界卫生组织应考虑修改其优先进行皮内接种的政策，以允许国家免疫计划选择更为可行的经皮疫苗。试用注册ClinicalTrials.gov NCT00242047。

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