[1929年以来匈牙利卡介苗接种的结果：预防和免疫治疗效果评估]

Országos Közegészségügyi Intézet, Budapest.

Orv Hetil. 1998 Jun 28;139(26):1563-70.

BACKGROUND

The BCG (Bacille Calmette-Guérin), a living attenuated bacterial vaccine with a characteristic residual virulence, has been used to prevent tuberculosis since 1921 (in Hungary non-systematically since 1929) and applied for immunostimulation in neoplasia since the 1960s.

MEASURES

Considering the grave tuberculosis epidemiological situation in Hungary, the BCG revaccination became compulsory up to 20 years old tuberculin negatives since 1959. The Pasteur P1173P2 BCG strain has been used for vaccine manufacturing with improved quality control methods according to the requirements of the WHO. With in systematic BCG primo and revaccination policy 8.1 million BCG vaccination from 1959 to 1983 then further 3.1 million between 1984 and 1996 have been performed.

RESULTS

Linear regression analysis demonstrates that the decrease of the TB incidence in children was 3-5 times more rapid (annual average decrease was 25.5%) than in adult since 1959. Multiple regression analysis indicates that the BCG is the strongest explanatory variable decreasing children TB incidence among other antituberculosis measures. The BCG vaccination efficacy ins demonstrated by 2 x 2 table analysis. The systematic BCG vaccination, the living and persisting BCG in the macrophages, confers acquired resistance against virulent TB infections. The immunostimulation in neoplasia has been applied with concentrated BCG developed in Hungary since 1979. The adverse reactions are at accepted frequency. The number of BCG vaccinated subjects was estimated at 1.5 billion from 1948 to 1974 in the world. The yearly number of BCG vaccination in the WHOI-EPI System is estimated 50-100 million.

CONCLUSION

The efficacy of the BCG vaccination can only be ensured if the vaccine is manufactured and controlled with standardized methods, and applied in a systematic vaccination programme. The effectiveness has to be evaluated in statistically valid biostatistical models.

背景

卡介苗（BCG）是一种具有残留毒力特征的减毒活细菌疫苗，自1921年起用于预防结核病（匈牙利自1929年起非系统性使用），自20世纪60年代起用于肿瘤的免疫刺激。

措施

鉴于匈牙利严峻的结核病流行形势，自1959年起，对20岁以下结核菌素阴性者强制进行卡介苗复种。根据世界卫生组织的要求，已采用巴斯德P1173P2卡介苗菌株并改进了质量控制方法来生产疫苗。在系统性的卡介苗初种和复种政策下，1959年至1983年共进行了810万次卡介苗接种，1984年至1996年又进行了310万次接种。

结果

线性回归分析表明，自1959年以来，儿童结核病发病率的下降速度比成人快3至5倍（年平均下降25.5%）。多元回归分析表明，在其他抗结核措施中，卡介苗是降低儿童结核病发病率的最强解释变量。通过2×2表分析证明了卡介苗接种的效果。系统性的卡介苗接种，即巨噬细胞中存活并持续存在的卡介苗，赋予了对毒性结核感染的获得性抵抗力。自1979年起，匈牙利已采用浓缩卡介苗对肿瘤进行免疫刺激。不良反应发生率在可接受范围内。1948年至1974年全球估计有15亿人接种了卡介苗。世界卫生组织扩大免疫规划系统中每年卡介苗接种估计为5000万至1亿剂次。