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吸附无细胞百、白、破混合制剂(DTacP)于1995年6月至1997年9月在广东省4个市和陕西省大荔县进行了Ⅲ期临床人体接种反应和血清学效果观察,全程基础免疫婴幼儿64961例,加强注射38860例,总计为103821例,接种反应轻微,未发现有严重异常反应者。DTacP在基免后1年和加强注射前抗PT和抗FHA的抗体水平分别为101EU/ml和513EU/ml;加强注射后1个月,抗PT和抗FHA的抗体水平显著增长,分别为2434EU/ml和3113EU/ml;加强免疫后1年,抗PT和抗FHA的抗体水平均能维持在较高的抗感染水平,分别为201EU/ml和586EU/ml;DTacP抗白喉和抗破伤风的抗体水平,不论是在基免后还是在加强注射后1个月或1年,其≥001HAU/ml的例数均为100%,均显著超过儿童抗白喉和抗破伤风感染要求的保护水平(001HAU/ml)。
Adsorption of cell-free, white and broken mixed preparation (DTacP) in June 1995 to September 1997 in four cities in Guangdong Province and Dali County, Shaanxi Province conducted a phase III clinical inoculation and serological effects observed, the whole process Basic immunization of infants 64,961 cases, to strengthen the injection 38,860 cases, a total of 103,821 cases, vaccination minor, no serious abnormalities were found. Anti-PT and anti-FHA antibody levels were 10 1EU / ml and 51 3EU / ml respectively for 1 year after DTacP and 1 and 2 months after injection. Anti-PT and anti-FHA antibody levels increased significantly , Respectively, 243 4EU / ml and 311 3EU / ml; 1 year after booster immunization, anti-PT and anti-FHA antibody levels can be maintained at a higher level of anti-infective, were 20 1EU / ml and 58 6EU / ml; DTacP anti-diphtheria and anti-tetanus antibody levels, either in the base-based or 1 month after the booster injection or 1 year, the number of cases ≥0 01HAU / ml were 100%, were significant Exceeds the level of protection required for children against diphtheria and tetanus infections (0 01 HAU / ml).