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三项双盲安慰剂对照试验表明,4种百日咳无细胞菌苗在接种3剂后18个月可诱导对百日咳的高度防御作用.其中一项试验表明,全细胞菌苗原先产生的高度保护作用在观察期间下降.作者根据这些试验中的一项试验资料,对单组分百日咳类毒素菌苗效果作了延长6个月的观察.3450名婴儿于3、5、12月龄随机接种DT或 DT加百日咳类毒素(DTP类毒素).至1994年7月24日共随访18.5个月.本文报道从1994年7月25日到1995年1月31日对1530名接种DTP类毒素的婴儿和1389名接种DT的婴儿再随访6个月.有19名婴儿失访,其中接种DTP 13名,接种 DT6名.试验采用双盲法,护士对婴儿家长每月随访一次.如咳嗽≥7天,采集鼻咽部标本作细菌培养和聚合酶链反应(PCR)检测,采集血清标本作抗体检测.4周后采恢复期血清.
Three double-blind, placebo-controlled trials showed that four of the B. pertussis cell-free bacterins could induce a high degree of defensive effects on whooping cough 18 months after the three doses 3. One of the tests showed that the original protective effect of the whole cell vaccine Decreased during the observation period.According to one of these trials, the author observed a 6-month prolongation of the efficacy of the one-component pertussis toxoid vaccine.3,450 infants were randomized to DT at 3, 5, 12 months DT plus pertussis toxoid (DTP toxoid) for a total of 18.5 months until July 24, 1994. It is reported here that from 15 July 1994 to 1530 infants immunized with DTP toxoid and from July 25, 1994 to January 31, 1995, 1389 infants inoculated with DT were followed up for another 6 months, 19 infants were lost to follow-up, of which 13 were inoculated with DTP and DT6 were inoculated.The nurses performed monthly follow-up visits to infants’ parents, such as coughing for more than 7 days, Nasopharyngeal specimens were collected for bacterial culture and polymerase chain reaction (PCR) detection, and serum samples were collected for antibody detection. After 4 weeks, recovery sera were collected.