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日本爱知县无细胞百日咳疫苗有效性和安全性的临床研究。

Clinical studies on efficacy and safety of an acellular pertussis vaccine in Aichi Prefecture, Japan.

作者信息

Isomura S

机构信息

Aichi Prefectural Institute of Public Health, Nagoya, Japan.

出版信息

Dev Biol Stand. 1991;73:37-42.

PMID:1778331
Abstract

Of 342 cases with pertussis notified from 1986 through 1989 in Aichi Prefecture, Japan, 331 (96.8%) were unimmunized children. To confirm the clinical efficacy of the acellular pertussis vaccine combined with diphtheria and tetanus toxoids (ACP-DT i.e.) used in the mass immunization, a prospective household case contact study has been conducted since 1983. Of 56 unimmunized children, 48 developed clinically diagnosed pertussis, and of 80 children who received recommended doses of the vaccine, only four contracted the disease after the household exposure. There were no serious systemic adverse reactions including high fever, encephalopathy, shock or death attributable to the mass immunization with ACP-DT. Severe local reactions occurred in 2.5/100,000 recipients of a third and fourth dose of the vaccine during 1984-1989.

摘要

在日本爱知县1986年至1989年报告的342例百日咳病例中,331例(96.8%)为未接种疫苗的儿童。为了证实大规模免疫中使用的无细胞百日咳疫苗联合白喉和破伤风类毒素(即 ACP-DT)的临床疗效,自1983年以来开展了一项前瞻性家庭病例接触者研究。在56例未接种疫苗的儿童中,48例临床诊断为百日咳;在80例接种了推荐剂量疫苗的儿童中,家庭接触后仅4例感染该病。大规模接种 ACP-DT 未出现包括高热、脑病、休克或死亡在内的严重全身不良反应。1984年至1989年期间,每100,000名接种第三剂和第四剂疫苗的受种者中发生严重局部反应的有2.5例。

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