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无细胞百日咳疫苗。迈向更优的安全性概况。

Acellular pertussis vaccines. Towards an improved safety profile.

作者信息

Pichichero M E

机构信息

University of Rochester Medical Center, New York, USA.

出版信息

Drug Saf. 1996 Nov;15(5):311-24. doi: 10.2165/00002018-199615050-00002.

DOI:10.2165/00002018-199615050-00002
PMID:8941493
Abstract

The common adverse reactions associated with diphtheria, tetanus and pertussis (DTP) vaccination are less frequent and less severe with acellular DTP (DTaP) vaccines than with whole cell DTP (DTwP) vaccines. Five key parameters have been identified whose prevalence through the first 48 hours following vaccination accurately characterise the common manifestations of DTaP and DTwP reactogenicity: fever > 37.8 degrees C, moderate or severe fussiness, injection site redness, injection site swelling, and moderate or severe injection site pain. For every DTaP vaccine evaluated, significantly less reactogenicity has been observed in comparison to DTwP vaccines. Although there are differences among the acellular DTaP vaccines in the frequency and severity of some of the adverse reactions, these differences are minor in degree and nature. For both DTaP and DTwP vaccines, local reactions increase in prevalence and severity with successive inoculations. The safety of DTaP vaccines has now been established in infants receiving inoculations at 2,4 and 6 months of age and in other 2 and 3 inoculation sequences below 1 year of age, as well as in toddlers (1 to 3 year olds), preschool children (4 to 6 year olds) and in adults. The increased purity of DTaP vaccines should lead to a reduction in the rare, serious adverse reactions associated with pertussis vaccination.

摘要

与白喉、破伤风和百日咳(DTP)疫苗接种相关的常见不良反应,无细胞DTP(DTaP)疫苗比全细胞DTP(DTwP)疫苗出现得更不频繁且更不严重。已确定五个关键参数,其在接种后最初48小时内的发生率准确地描述了DTaP和DTwP反应原性的常见表现:体温>37.8摄氏度、中度或重度烦躁、注射部位发红、注射部位肿胀以及中度或重度注射部位疼痛。对于每一种评估的DTaP疫苗,与DTwP疫苗相比,观察到的反应原性明显更低。尽管无细胞DTaP疫苗在某些不良反应的频率和严重程度上存在差异,但这些差异在程度和性质上都很小。对于DTaP和DTwP疫苗,局部反应的发生率和严重程度都会随着连续接种而增加。DTaP疫苗的安全性现已在2、4和6月龄接种疫苗的婴儿以及1岁以下其他2剂和3剂接种程序的婴儿中得到证实,同时也在幼儿(1至3岁)、学龄前儿童(4至6岁)和成人中得到证实。DTaP疫苗纯度的提高应会减少与百日咳疫苗接种相关的罕见严重不良反应。

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本文引用的文献

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Reactogenicity and immunogenicity of a three-component acellular pertussis vaccine administered as the primary series to 2, 4 and 6 month old infants in the United States.在美国,对2、4和6月龄婴儿进行三组分无细胞百日咳疫苗基础免疫接种的反应原性和免疫原性。
Vaccine. 1995 Dec;13(17):1631-5. doi: 10.1016/0264-410x(95)00137-p.
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A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine.一项关于双组分无细胞、五组分无细胞和全细胞百日咳疫苗的对照试验。
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Paediatr Drugs. 2000 Mar-Apr;2(2):139-59. doi: 10.2165/00148581-200002020-00007.
两种无细胞百日咳疫苗和一种全细胞百日咳疫苗的对照试验。百日咳项目工作组。
N Engl J Med. 1996 Feb 8;334(6):341-8. doi: 10.1056/NEJM199602083340601.
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Pediatr Infect Dis J. 1993 Feb;12(2):131-5. doi: 10.1097/00006454-199302000-00005.
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Acellular pertussis diphtheria-tetanus-pertussis vaccine containing separately purified pertussis toxoid, filamentous haemagglutinin and 69 kDa outer membrane protein as a booster in children.含分别纯化的百日咳类毒素、丝状血凝素和69kDa外膜蛋白的无细胞百日咳白喉破伤风联合疫苗,用于儿童加强免疫。
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