Turnbull F M, McIntyre P B, Achat H M, Wang H, Stapledon R, Gold M, Burgess M A
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Royal Alexandra Hospital for Children and the University of Sydney, Sydney, Australia.
Clin Infect Dis. 2002 Feb 15;34(4):447-53. doi: 10.1086/338462. Epub 2002 Jan 4.
Few large prospective studies of adverse reactions after bacille Calmette-Guérin (BCG) vaccination are available. In a prospective national study of such adverse reactions among 918 subjects (aged 1 day to 54 years) over a 14-month period, 45 vaccinees (5%) reported 53 adverse reactions (23 injection-site abscesses, 14 severe local reactions, 10 cases of lymphadenitis, and 6 other reactions). Only 1% of vaccinees required medical attention. Reactions, particularly lymphadenitis, were significantly less common in infants <6 months old (but not in subjects aged > or =6 months) vaccinated by trained (vs. untrained) providers (relative risk [RR], 0.24; 95% confidence interval [CI], 0.09-0.68). Injection-site abscesses (RR, 2.96; 95% CI, 1.11-7.90) and severe local reactions (RR, 4.93; 95% CI, 1.11-21.90) were significantly more common in older vaccinees. Local reactions were more frequently reported by adult females than by adult males (RR, 7.18; 95% CI, 1.59-32.45). Adverse reactions were not significantly associated with any currently available vaccine batch, previous receipt of BCG vaccine, or concomitant administration of other vaccines.
关于卡介苗（BCG）接种后不良反应的大型前瞻性研究较少。在一项为期14个月的针对918名受试者（年龄从1天至54岁）的此类不良反应的全国性前瞻性研究中，45名接种者（5%）报告了53例不良反应（23例注射部位脓肿、14例严重局部反应、10例淋巴结炎和6例其他反应）。只有1%的接种者需要医疗护理。在由经过培训（与未经过培训相对）的医护人员为6个月以下婴儿（但6个月及以上受试者并非如此）接种疫苗时，不良反应，尤其是淋巴结炎，明显较少见（相对风险[RR]为0.24；95%置信区间[CI]为0.09 - 0.68）。注射部位脓肿（RR为2.96；95% CI为1.11 - 7.90）和严重局部反应（RR为4.93；95% CI为1.11 - 21.90）在年龄较大的接种者中明显更常见。成年女性比成年男性更频繁地报告局部反应（RR为7.18；95% CI为1.59 - 32.45）。不良反应与任何现有的疫苗批次、既往接种卡介苗或同时接种其他疫苗均无显著关联。
