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评估与第一剂和第二剂麻疹-腮腺炎-风疹疫苗相关的潜在常见不良事件。

Evaluation of potentially common adverse events associated with the first and second doses of measles-mumps-rubella vaccine.

作者信息

LeBaron Charles W, Bi Daoling, Sullivan Bradley J, Beck Carol, Gargiullo Paul

机构信息

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.

出版信息

Pediatrics. 2006 Oct;118(4):1422-30. doi: 10.1542/peds.2006-0678.

Abstract

BACKGROUND/OBJECTIVES: In 1989, the American Academy of Pediatrics and the Advisory Committee on Immunization Practices recommended that school children receive 2 doses of measles-mumps-rubella vaccine. With measles and rubella eliminated from the United States, measles-mumps-rubella vaccine adverse events have come under scrutiny, but no study has compared the reactogenicity of the first (measles-mumps-rubella vaccine dose 1) and second (measles-mumps-rubella vaccine dose 2) doses at the most common ages of administration in the United States.

METHODS

From a health maintenance organization, 3 groups of children were recruited: (1) toddlers aged 12 to 24 months receiving measles-mumps-rubella vaccine dose 1; (2) kindergartners aged 4 to 6 years receiving measles-mumps-rubella vaccine dose 2; and (3) middle schoolers aged 10 to 12 years receiving measles-mumps-rubella vaccine dose 2. From 2 weeks before measles-mumps-rubella vaccine administration until 4 weeks afterward, families recorded in diaries the occurrence of potentially common symptoms. Postvaccination symptom rates were compared with the prevaccination baseline, with significance assessed by testing incidence rate ratios estimated by Poisson regression.

RESULTS

Of 2173 children enrolled, 373 (17%) were lost to attrition, producing a study population of 1800. Compared with the prevaccination baseline, rates of fever, diarrhea, and rash were significantly elevated postvaccination among 535 toddlers receiving measles-mumps-rubella vaccine dose 1. An estimated net 95 (18%) experienced measles-mumps-rubella vaccine-associated events (median onset 5-10 days postvaccination, duration 2-5 days), with high fever (temperature > or = 39.5 degrees C) occurring in 33 (6%). None required medical attention. For 633 kindergartners and 632 middle schoolers, symptom rates were not significantly elevated after measles-mumps-rubella vaccine dose 2 compared with baseline.

CONCLUSIONS

Vaccination-associated adverse events occur in approximately 1 of every 6 toddlers receiving measles-mumps-rubella vaccine dose 1, with high fever occurring in 1 of 20. Adverse events are infrequent for measles-mumps-rubella vaccine dose 2 administered to school-aged children.

摘要

背景/目的:1989年,美国儿科学会和免疫实践咨询委员会建议学龄儿童接种两剂麻疹-腮腺炎-风疹疫苗。随着美国消除了麻疹和风疹,麻疹-腮腺炎-风疹疫苗的不良事件受到了审查,但尚无研究比较美国最常见接种年龄下第一剂(麻疹-腮腺炎-风疹疫苗第1剂)和第二剂(麻疹-腮腺炎-风疹疫苗第2剂)的反应原性。

方法

从一个健康维护组织招募了3组儿童:(1)12至24个月大的幼儿接种麻疹-腮腺炎-风疹疫苗第1剂;(2)4至6岁的幼儿园儿童接种麻疹-腮腺炎-风疹疫苗第2剂;(3)10至12岁的中学生接种麻疹-腮腺炎-风疹疫苗第2剂。从接种麻疹-腮腺炎-风疹疫苗前2周直到接种后4周,家庭通过日记记录可能出现的常见症状。将接种疫苗后的症状发生率与接种前基线进行比较,通过泊松回归估计的发病率比检验评估显著性。

结果

在登记的2173名儿童中,373名(17%)失访,最终研究人群为1800名。与接种前基线相比,535名接种麻疹-腮腺炎-风疹疫苗第1剂的幼儿接种疫苗后发热、腹泻和皮疹的发生率显著升高。估计有95名(18%)经历了与麻疹-腮腺炎-风疹疫苗相关的事件(中位发病时间为接种后5至10天,持续时间为2至5天),其中33名(6%)出现高烧(体温≥39.5摄氏度)。无人需要就医。对于633名幼儿园儿童和632名中学生,接种麻疹-腮腺炎-风疹疫苗第2剂后的症状发生率与基线相比无显著升高。

结论

每6名接种麻疹-腮腺炎-风疹疫苗第1剂的幼儿中约有1人会出现与疫苗接种相关的不良事件,每20人中有1人会出现高烧。对于学龄儿童接种的麻疹-腮腺炎-风疹疫苗第2剂,不良事件很少见。

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