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作者采用随机双盲多中心临床试验,分别给予432名健康婴儿4剂(2、4、6月龄时及17～19月龄间)百日咳无细胞菌苗DTP(APDT)或DTP.观察两组婴儿的局部和全身反应及抗体应答以比较两种菌苗在幼儿中的免疫原性和安全性.结果表明,每剂免疫后的最初48小时,DTP组的局部反应和全身反应(发热、烦躁不安、嗜睡和厌食)发生率明显高于APDT组,但两组的呕吐和腹泻发生率相同.3剂免疫后DTP组的严重局部反应发生率显著高于APDT组.而两组间的严重全身反应发生率则无差异.初免(3剂)后DTP组中度以上
In a randomized, double-blind, multicenter, randomized, double-blind, multicenter trial, we administered 4 doses of acellular pertussis (DTP) or DTP to 432 healthy infants (ages 2-4, 6 and 17-19 months) Local and systemic reactions and antibody responses in infants to compare the immunogenicity and safety of the two vaccines in young children.The results showed that the local and systemic reactions (fever, irritability) in the DTP group during the first 48 hours after each dose of immunization Anxiety, drowsiness and anorexia) were significantly higher than those in the APDT group, but the incidence of vomiting and diarrhea was the same in both groups.The incidence of severe local reactions in DTP group after 3 doses of immunization was significantly higher than that in APDT group There was no difference in the incidence of the reaction. After the initial dose (3 doses), the DTP group was moderately above