Krilov Leonard R, Masaquel Anthony S, Weiner Leonard B, Smith David M, Wade Sally W, Mahadevia Parthiv J
Children's Medical Center, Winthrop University Hospital, Mineola, NY, USA.
BMC Pediatr. 2014 Oct 13;14:261. doi: 10.1186/1471-2431-14-261.
Infection with respiratory syncytial virus (RSV) is common among young children insured through Medicaid in the United States. Complete and timely dosing with palivizumab is associated with lower risk of RSV-related hospitalizations, but up to 60% of infants who receive palivizumab in Medicaid population do not receive full prophylaxis. The purpose of this study was to evaluate the association of partial palivizumab prophylaxis with the risk of RSV hospitalization among high-risk Medicaid-insured infants.
Claims data from 12 states during 6 RSV seasons (October 1st to April 30th in the first year of life in 2003-2009) were analyzed. Inclusion criteria were birth hospital discharge before October 1st, continuous insurance eligibility from birth through April 30th, ≥ one palivizumab administration from August 1st to end of season, and high-risk status (≤34 weeks gestational age or chronic lung disease of prematurity [CLDP] or hemodynamically significant congenital heart disease [CHD]). Fully prophylaxed infants received the first palivizumab dose by November 30th with no gaps >35 days up to the first RSV-related hospitalization or end of follow-up. All other infants were categorized as partially prophylaxed.
Of the 8,443 high-risk infants evaluated, 67% (5,615) received partial prophylaxis. Partially prophylaxed infants were more likely to have RSV-related hospitalization than fully prophylaxed infants (11.7% versus 7.9%, p< 0.001). RSV-related hospitalization rates ranged from 8.5% to 24.8% in premature, CHD, and CLDP infants with partial prophylaxis. After adjusting for potential confounders, logistic regression showed that partially prophylaxed infants had a 21% greater odds of hospitalization compared with fully prophylaxed infants (odds ratio 1.21, 95% confidence interval 1.09-1.34).
RSV-related hospitalization rates were significantly higher in high-risk Medicaid infants with partial palivizumab prophylaxis compared with fully prophylaxed infants. These findings suggest that reduced and/or delayed dosing is less effective.
在美国，通过医疗补助计划参保的幼儿中，呼吸道合胞病毒（RSV）感染很常见。帕利珠单抗的完整、及时给药与降低RSV相关住院风险相关，但在医疗补助计划人群中，接受帕利珠单抗治疗的婴儿中高达60%未接受全程预防。本研究的目的是评估部分帕利珠单抗预防与高危医疗补助参保婴儿RSV住院风险之间的关联。
分析了6个RSV流行季（2003 - 2009年出生后第一年的10月1日至4月30日）期间12个州的理赔数据。纳入标准为10月1日前出生并出院、从出生到4月30日持续具备保险资格、8月1日至流行季结束接受≥1次帕利珠单抗给药，以及高危状态（胎龄≤34周或早产慢性肺病[CLDP]或血流动力学显著的先天性心脏病[CHD]）。全程预防的婴儿在11月30日前接受首剂帕利珠单抗，直至首次RSV相关住院或随访结束，给药间隔不超过35天。所有其他婴儿被归类为部分预防。
在评估的8443名高危婴儿中，67%（5615名）接受了部分预防。部分预防的婴儿比全程预防的婴儿更有可能因RSV住院（11.7%对7.9%，p<0.001）。部分预防的早产、CHD和CLDP婴儿中，RSV相关住院率在8.5%至24.8%之间。在对潜在混杂因素进行调整后，逻辑回归显示，与全程预防的婴儿相比，部分预防的婴儿住院几率高21%（优势比1.21，95%置信区间1.09 - 1.34）。
与全程预防的婴儿相比，接受部分帕利珠单抗预防的高危医疗补助婴儿中，RSV相关住院率显著更高。这些发现表明，减少和/或延迟给药效果较差。
