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北加利福尼亚州凯撒医疗集团使用七价肺炎球菌结合疫苗后肺炎球菌侵袭性疾病的上市后监测

Postlicensure surveillance for pneumococcal invasive disease after use of heptavalent pneumococcal conjugate vaccine in Northern California Kaiser Permanente.

作者信息

Black Steven, Shinefield Henry, Baxter Roger, Austrian Robert, Bracken Laura, Hansen John, Lewis Edwin, Fireman Bruce

机构信息

Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA.

出版信息

Pediatr Infect Dis J. 2004 Jun;23(6):485-9. doi: 10.1097/01.inf.0000129685.04847.94.

Abstract

OBJECTIVE

To assess the direct and indirect effects of the introduction of routine use of pneumococcal conjugate vaccine in infants and toddlers at risk for invasive disease caused by vaccine serotypes and nonvaccine serotypes in vaccinated children and unvaccinated children of the same age. Secondary objectives included determination of the risk of pneumococcal infections in unvaccinated older children and adults in the same population and the impact of vaccine introduction on patterns of antimicrobial resistance.

METHODS

Northern California Kaiser Permanente provides integrated comprehensive care to 3.1 million people and has an annual birth cohort of 38,000 infants. Microbiology services use a regional laboratory. Automated laboratory results, immunization records as well as diagnoses for inpatient and outpatient utilization are available from clinical data bases. Beginning in April 2000, the heptavalent pneumococcal conjugate (PNCV7) vaccine was introduced into routine use in the Northern California Kaiser Permanente population. Cases of invasive pneumococcal disease were identified from the automated hospital diagnosis as well as laboratory databases for all individuals, vaccinees and nonvaccinees, inpatient and outpatient. For the purpose of these analyses, pneumococcal invasive disease was defined as a positive culture from a normally sterile site.

RESULTS

As of March 2003, 157,471 children had received 1 dose or more of PNCV7, but only 24% of those <2 years of age received all 4 doses as a result of shortages of vaccine. During the last year of observation, no cases of vaccine serotype disease were seen in children <1 year of age compared with an incidence ranging between 51.5 and 98.2 cases per 100,000 person-years (16-34 cases per year) in the years before vaccine introduction. Similar reductions were seen in children <5 years of age. There was no evidence of any concomitant increase in pneumococcal disease caused by nonvaccine serotypes. High level resistance of pneumococci to penicillin fell from a peak of 15% in 2000 to 5% in the first half of 2003. Similar trends were seen for other antibiotics.

CONCLUSION

The PNCV7 vaccine is highly effective in reducing the burden of pneumococcal disease in children <5 years of age, and there is evidence of a herd effect as well as a decrease in the antibiotic resistant in strains causing disease. For invasive disease, there is no current evidence of serotype replacement.

摘要

目的

评估在患有由疫苗血清型和非疫苗血清型引起的侵袭性疾病风险的婴幼儿中常规使用肺炎球菌结合疫苗,对已接种疫苗儿童和同年龄未接种疫苗儿童产生的直接和间接影响。次要目标包括确定同一人群中未接种疫苗的大龄儿童和成人发生肺炎球菌感染的风险,以及引入疫苗对抗菌素耐药模式的影响。

方法

北加利福尼亚凯撒医疗集团为310万人提供综合全面的医疗服务,每年有38,000名婴儿出生队列。微生物学服务使用一个区域实验室。可从临床数据库获取自动化实验室结果、免疫接种记录以及住院和门诊使用的诊断信息。从2000年4月开始,七价肺炎球菌结合疫苗(PNCV7)在北加利福尼亚凯撒医疗集团人群中开始常规使用。通过自动化医院诊断以及所有个体(包括接种疫苗者和未接种疫苗者、住院患者和门诊患者)的实验室数据库,识别侵袭性肺炎球菌病病例。为了这些分析的目的,肺炎球菌侵袭性疾病被定义为来自正常无菌部位的阳性培养物。

结果

截至2003年3月,157,471名儿童接种了1剂或更多剂PNCV7,但由于疫苗短缺,2岁以下儿童中只有24%接种了全部4剂。在观察的最后一年,1岁以下儿童未出现疫苗血清型疾病病例,而在引入疫苗前的几年中,发病率为每10万人年51.5至98.2例(每年16 - 34例)。5岁以下儿童也出现了类似的下降。没有证据表明由非疫苗血清型引起的肺炎球菌疾病有任何相应增加。肺炎球菌对青霉素的高水平耐药率从2000年的峰值15%降至2003年上半年的5%。其他抗生素也出现了类似趋势。

结论

PNCV7疫苗在降低5岁以下儿童肺炎球菌疾病负担方面非常有效,有证据表明存在群体效应以及引起疾病的菌株对抗生素的耐药性有所下降。对于侵袭性疾病,目前没有血清型替换的证据。

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