Newell K W, Leblanc D R, Edsall G, Levine L, Christensen H, Montouri M H, Ramirez N
Bull World Health Organ. 1971;45(6):773-85.
To determine the effectiveness of a method for controlling tetanus neonatorum, a double-blind controlled trial involving 1 618 women was conducted between 1961 and 1966. Women in the study were given 1-3 injections (1 ml) of aluminium-phosphate-adsorbed tetanus toxoid or a placebo (influenza vaccine). At the conclusion of the trial, 5-ml samples of blood were obtained from 299 women. Sera were titrated for anti-tetanus antibodies by two methods.A comparison of the clinical and laboratory results showed a close relationship. It is suggested that the level of protection may be lower than is at present accepted. Antitoxin levels were inversely related to age and directly to the interval between injections. Two widely spaced injections (8 months or more) may be about as effective as 3 injections. One injection of specially prepared toxoid with a high immunizing potency might give significant protection.
为确定一种控制新生儿破伤风方法的有效性,于1961年至1966年间开展了一项涉及1618名妇女的双盲对照试验。研究中的妇女接受了1 - 3次注射(1毫升)磷酸铝吸附破伤风类毒素或安慰剂(流感疫苗)。试验结束时,从299名妇女身上采集了5毫升血液样本。血清通过两种方法滴定抗破伤风抗体。临床和实验室结果的比较显示出密切关系。有人认为保护水平可能低于目前公认的水平。抗毒素水平与年龄呈负相关,与注射间隔呈正相关。两次间隔较长时间(8个月或更长)的注射可能与3次注射效果相当。一次注射具有高免疫效力的特制类毒素可能会提供显著的保护。