Study on efficacy and improvement of diphtheria and tetanus toxoids and pertussis (DPT) vaccine

纯化成分（无细胞）百日咳（aP）疫苗首先在日本开发。20年前，它们被紧急引入全国，这使得前瞻性双盲疗效试验变得困难。为了获得关于其有效性的可靠国内数据，我们在北九州市使用世卫组织百日咳病例定义进行了一项病例对照研究，北九州市自1991年以来一直专门使用双组份角破联合白喉和破伤风类毒素（DTaP）疫苗。调查期间登记的116例中，符合定义的有16例。根据确诊病例及其年龄匹配对照的数据，估计Kaketsuken aP疫苗的有效性为87.4%，并与欧洲国家获得的日本aP疫苗的数据进行了比较。接种少于两剂DTaP疫苗的儿童患百日咳的风险是接种两剂或两剂以上儿童的7.39倍。共有186名青少年和成人注射了DTaP疫苗，以评估其对这些年龄组的安全性，其中44人为10-19岁（a组），142人为20岁及以上（B组）。两组均出现注射部位周围直径大于5cm的肿胀。A组1例，B组3例，肿胀直径1 ~ 5cm。未观察到全身不良反应。

Purified component (acellular) Bordetella pertussis (aP) vaccines were first developed in Japan. Their emergency introduction to the nation 20 years ago made prospective double blind efficacy trial difficult. In order to obtain reliable domestic data on their efficacy, we conducted a case control study using WHO's case definition of pertussis in the City of Kitakyushu where the two-component Kaketsuken aP vaccine combined with diphtheria and tetanus toxoids (DTaP) has been exclusively used since 1991.Among 116 cases registered during the investigation period, 16 fulfilled the definition. Based on the data of the confirmed cases and their age-matched controls, the efficacy of Kaketsuken aP vaccine was estimated to be 87.4 % and comparative to the data of Japanese aP vaccines obtained in European countries. The risk of pertussis in children who had received less than two doses of DTaP vaccine was 7.39 times higher than that of children who had two or more doses.DTaP vaccine was injected to a total of 186 adolescents and adults to evaluate its safety for these age groups, Forty-four persons were 10-19 years of age (Group A) and 142 persons were 20 years of age or older (Group B). Each one case in both groups showed swelling of more than 5 cm in diameter around the injection site. One case in Group A and 3 cases in group B had swelling of 1-5 cm in diameter. Systemic adverse reactions were not observed.