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29-36 孕周婴儿帕利珠单抗的有效性观察。

Observed Effectiveness of Palivizumab for 29-36-Week Gestation Infants.

机构信息

Baylor College of Medicine, Texas Children's Hospital, and Texas Children's Health Plan, Houston, Texas;

Community Health Choice, Houston, Texas;

出版信息

Pediatrics. 2016 Aug;138(2). doi: 10.1542/peds.2016-0627. Epub 2016 Jul 18.

Abstract

BACKGROUND

Respiratory syncytial virus (RSV) is a common reason for hospitalization of infants. In clinical trials, palivizumab reduced RSV hospitalization rates for premature infants. The 2014 American Academy of Pediatrics clinical practice guideline advised against use of palivizumab for otherwise healthy infants ≥29 weeks' gestation. The aim of this study was to determine the effect of palivizumab administration on hospitalization rates for RSV and bronchiolitis without RSV diagnosis among infants 29 to 36 weeks' gestation who do not have chronic illness.

METHODS

Claims data were extracted from databases of 9 Texas Medicaid managed care programs. Eligible infants were 29 to 36 weeks' gestation, without claims suggesting chronic illness, and who were born between April 1 and December 31 of 2012, 2013, and 2014.

RESULTS

A total of 2031 eligible infants of 29 to 32 weeks' gestation and 12 066 infants of 33 to 36 weeks' gestation were identified; 41.5% of the infants 29 to 32 weeks' gestation and 3.7% of the infants 33 to 36 weeks' gestation had paid claims for dispensing of ≥1 palivizumab doses. Among the infants of 29 to 32 weeks' gestation, palivizumab dispensing was associated with reduced RSV hospitalization rates (3.1% vs 5.0%, P = .04) but increased hospitalizations for bronchiolitis without RSV diagnosis (3.3% vs 1.9%, P = .05). There were no significant differences by palivizumab administration status for the infants of 33 to 36 weeks' gestation.

CONCLUSIONS

Among infants 29 to 32 weeks' gestation without chronic illness, palivizumab use was associated with reduced RSV hospitalizations but increased hospitalizations for bronchiolitis without RSV diagnosis.

摘要

背景

呼吸道合胞病毒(RSV)是导致婴儿住院的常见原因。在临床试验中,帕利珠单抗降低了早产儿因 RSV 住院的比例。2014 年美国儿科学会临床实践指南建议,对于胎龄≥29 周、无其他慢性疾病的健康婴儿,不使用帕利珠单抗。本研究旨在确定帕利珠单抗对无 RSV 诊断的 RSV 和毛细支气管炎住院率的影响,研究对象为胎龄 29 至 36 周、无慢性疾病的婴儿。

方法

从德克萨斯州 9 个医疗补助管理式医疗计划的数据库中提取了索赔数据。符合条件的婴儿胎龄为 29 至 36 周,没有表明患有慢性疾病的索赔记录,且于 2012 年 4 月 1 日至 12 月 31 日、2013 年和 2014 年期间出生。

结果

共确定了 2031 名胎龄 29 至 32 周的合格婴儿和 12066 名胎龄 33 至 36 周的婴儿;29 至 32 周的婴儿中有 41.5%、33 至 36 周的婴儿中有 3.7%有支付 1 次以上帕利珠单抗剂量的记录。在胎龄 29 至 32 周的婴儿中,帕利珠单抗的使用与 RSV 住院率的降低相关(3.1%对 5.0%,P=0.04),但与无 RSV 诊断的毛细支气管炎住院率的增加相关(3.3%对 1.9%,P=0.05)。胎龄 33 至 36 周的婴儿中,帕利珠单抗使用与使用状况之间无显著差异。

结论

在无慢性疾病的胎龄 29 至 32 周的婴儿中,帕利珠单抗的使用与 RSV 住院率降低有关,但与无 RSV 诊断的毛细支气管炎住院率增加有关。

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