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破伤风类毒素用于预防新生儿破伤风。双盲对照现场试验的最终报告。

The use of toxoid for the prevention of tetanus neonatorum. Final report of a double-blind controlled field trial.

作者信息

Newell K W, Dueñas Lehmann A, LeBlanc D R, Garces Osorio N

出版信息

Bull World Health Organ. 1966;35(6):863-71.

Abstract

With a view to determining the effectiveness of a method for the control of tetanus neonatorum which would be independent of medical examination or care, a double-blind field trial covering 1618 women was conducted between 1961 and 1966 in a rural area of Colombia with an estimated existing tetanus neonatorum death rate of 11.6 per 100 births. The study group was given 1-3 injections of 1 ml of an aluminium-phosphate-adsorbed tetanus toxoid more than 6 weeks apart, and the control group a similar number of injections of an influenza-virus vaccine.There was no statistically significant difference between those in the two groups given one injection. Those in the control group given 2 or 3 injections had a tetanus neonatorum death rate of 7.8 deaths per 100 births, and the corresponding subjects in the study group had none. This difference is unlikely to have occurred by chance.

摘要

为了确定一种独立于医学检查或护理的新生儿破伤风控制方法的有效性,1961年至1966年期间,在哥伦比亚的一个农村地区对1618名妇女进行了一项双盲现场试验,该地区估计现有的新生儿破伤风死亡率为每100例出生中有11.6例死亡。研究组每隔6周以上注射1-3次1毫升磷酸铝吸附破伤风类毒素,对照组注射相同次数的流感病毒疫苗。接受一次注射的两组之间没有统计学上的显著差异。对照组中接受2次或3次注射的新生儿破伤风死亡率为每100例出生中有7.8例死亡,而研究组中的相应受试者无一例死亡。这种差异不太可能是偶然发生的。

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