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无细胞百日咳疫苗的疗效和安全性临床研究。

Clinical studies on efficacy and safety of acellular pertussis vaccine.

作者信息

Isomura S

机构信息

Aichi Prefectural Institute of Public Health, Nagoya, Japan.

出版信息

Tokai J Exp Clin Med. 1988;13 Suppl:39-43.

PMID:3078809
Abstract

We conducted a retrospective survey of immunized school children in order to define the incidence of pertussis in relation to the acceptance rate of acellular pertussis vaccine combined with diphtheria and tetanus toxoid (ACP-DT vaccine). The attack rate of the disease was 0.01-0.02% in children with a history of recommended doses of the vaccine. In unimmunized children, 6.43-6.52% had a history of pertussis. To confirm the efficacy of the vaccine, a prospective household contact study based on clinical findings was conducted. Of 37 unimmunized children, 30 developed clinically diagnosed pertussis, and of 39 fully immunized children only two contracted the disease. Because there was no cluster of pertussis cases, a difference in vaccine efficacy between products seemed unlikely. From 1984 to 1987, there were no cases of high fever, encephalopathy, shock or death attributable to mass immunization with the vaccine. Severe erythema and swelling of the inoculated arm to the wrist were observed in 16 children (3.06/100,000 doses) after the third dose or after the booster dose. The vaccines used for these 16 children were from different manufacturers. All cases recovered completely.

摘要

我们对已免疫的学龄儿童进行了一项回顾性调查,以确定百日咳发病率与无细胞百日咳疫苗联合白喉和破伤风类毒素(无细胞百白破疫苗)接种率之间的关系。在有推荐剂量疫苗接种史的儿童中,该病的发病率为0.01%-0.02%。在未免疫儿童中,6.43%-6.52%有百日咳病史。为了确认疫苗的疗效,基于临床发现进行了一项前瞻性家庭接触者研究。在37名未免疫儿童中,30名临床诊断为百日咳,而在39名完全免疫的儿童中,只有两名感染了该病。由于没有百日咳病例聚集现象,不同产品之间的疫苗疗效差异似乎不大。1984年至1987年期间,没有因大规模接种该疫苗而导致的高热、脑病、休克或死亡病例。在第三剂或加强剂接种后,16名儿童(每100,000剂中有3.06例)出现接种手臂至手腕严重红斑和肿胀。这16名儿童使用的疫苗来自不同厂家。所有病例均完全康复。

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Clinical studies on efficacy and safety of acellular pertussis vaccine.无细胞百日咳疫苗的疗效和安全性临床研究。
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