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基于哨点儿科医院的儿童肠套叠回顾性医院监测:在轮状病毒疫苗上市后监测中应用的优缺点。

Retrospective hospital based surveillance of intussusception in children in a sentinel paediatric hospital: benefits and pitfalls for use in post-marketing surveillance of rotavirus vaccines.

机构信息

Rotavirus Group, Murdoch Childrens Research Institute, Melbourne, Australia.

出版信息

Vaccine. 2012 Apr 27;30 Suppl 1:A190-5. doi: 10.1016/j.vaccine.2011.11.015.

DOI:10.1016/j.vaccine.2011.11.015
PMID:22520131
Abstract

UNLABELLED

Evaluation of the safety of rotavirus vaccines, particularly with respect to the risk of intussusception, is recommended for countries planning to introduce rotavirus vaccines into the National Immunisation Program. However, as prospective studies are costly, require time to conduct and may be difficult to perform in some settings, retrospective hospital based surveillance at sentinel sites has been suggested as an option for surveillance for intussusception following introduction of rotavirus vaccines.

OBJECTIVE

To assess the value of retrospective hospital based surveillance to describe clinical and epidemiological features of intussusception in children aged <24 months and to investigate any temporal association between receipt of a rotavirus vaccine and intussusception.

METHODS

A retrospective chart review of all patients diagnosed with intussusception at Royal Children's Hospital, Melbourne, Australia over an 8-year period including before and after rotavirus vaccine introduction into the National Immunisation Program, was conducted using patients identified by a medical record database (ICD-10-CM 56.1). Patient profile, clinical presentation, treatment and outcome were analysed along with records of immunisation status obtained using the Australian Childhood Immunisation Register.

RESULTS

A 9% misclassification rate of discharge diagnosis of intussusception was identified on critical chart review. The incidence rate of intussusception at the Royal Children's Hospital over the study period was 1.91 per 10,000 infants <24 months (95% CI 1.65-2.20). Intestinal resection was required in 6.5% of infants (95% CI 3.6%, 11.0%). Intussusception occurred within 30 days after vaccination in 2 of 27 patients who had received at least 1 dose of a rotavirus vaccine.

CONCLUSIONS

Valuable data on the incidence, clinical presentation and treatment outcomes of intussusception can be obtained from data retrieved from hospital medical records in a sentinel paediatric hospital using standardised methodology. However, there are methodological limitations and the quality of the data is highly dependent on the accuracy and completeness of the patient information recorded, the system of coding and record retrieval.

摘要

目的

评估基于医院的回顾性监测在描述 24 个月以下儿童肠套叠的临床和流行病学特征中的价值,并调查轮状病毒疫苗接种后肠套叠与疫苗接种之间是否存在任何时间关联。

方法

对在澳大利亚墨尔本皇家儿童医院接受肠套叠诊断的所有患者进行了 8 年的回顾性图表审查,包括在国家免疫计划中引入轮状病毒疫苗之前和之后。使用病历数据库(ICD-10-CM 56.1)识别患者。分析了患者特征、临床表现、治疗和结局,以及使用澳大利亚儿童免疫登记处获得的免疫状况记录。

结果

在关键图表审查中发现,肠套叠出院诊断的误诊率为 9%。在研究期间,皇家儿童医院的肠套叠发病率为每 10000 名<24 个月的婴儿 1.91 例(95%可信区间 1.65-2.20)。6.5%的婴儿需要肠切除术(95%可信区间 3.6%,11.0%)。在至少接受过 1 剂轮状病毒疫苗的 27 名患者中,有 2 名患者在接种疫苗后 30 天内发生肠套叠。

结论

使用标准化方法从选定儿科医院的医院病历中可以获得有关肠套叠发生率、临床表现和治疗结局的有价值数据。然而,存在方法学限制,数据的质量高度依赖于记录的患者信息的准确性和完整性、编码系统和记录检索。

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