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在家中使用帕利珠单抗的治疗效果改善:2000 - 2004年帕利珠单抗疗效登记研究结果

Improved outcomes with home-based administration of palivizumab: results from the 2000-2004 Palivizumab Outcomes Registry.

作者信息

Frogel Michael, Nerwen Cliff, Boron Marnie, Cohen Alan, VanVeldhuisen Paul, Harrington Molly, Groothuis Jessie

机构信息

Schneider Children's Hospital, New Hyde Park, NY 11042, USA.

出版信息

Pediatr Infect Dis J. 2008 Oct;27(10):870-3. doi: 10.1097/INF.0b013e318174e0c4.

Abstract

BACKGROUND

Palivizumab Outcomes Registry data collected during 4 years were examined to assess compliance and respiratory syncytial virus (RSV) hospitalization rates in high-risk children receiving palivizumab prophylaxis at home compared with an outpatient setting.

METHODS

Prospective observational registry enrolling high-risk infants who received > or = 1 dose of palivizumab throughout the 2000-2001 to 2003-2004 RSV seasons at participating U.S. pediatric sites.

RESULTS

Registry data were analyzed for compliance and RSV hospitalization outcomes in 19,548 infants receiving doses at home versus an outpatient setting. Compliance with the injection regimen was determined by comparing the number of palivizumab injections received versus the projected number of anticipated doses and by comparing infants receiving all injections within a 35-day interval. Compliance was significantly greater for infants who received palivizumab at home (n = 1226) as compared with those who received palivizumab in a clinic or office (n = 17,641), whether measured by the number of doses received (88% versus 81%, P < 0.0001) or by the timing of doses (73% versus 66%, P < 0.0001). Infants who received palivizumab at home also had fewer RSV-associated hospitalizations compared with those who received palivizumab in a clinic or office [0.4% (5/1226) versus 1.2% (207/17,641), P = 0.0139].

CONCLUSIONS

Home administration of palivizumab was associated with a significantly higher rate of compliance and lower hospitalization rate for RSV illness in high-risk infants.

摘要

背景

对4年期间收集的帕利珠单抗疗效登记数据进行分析,以评估在家接受帕利珠单抗预防的高危儿童与门诊环境下的高危儿童相比的依从性和呼吸道合胞病毒(RSV)住院率。

方法

一项前瞻性观察性登记研究,纳入在2000 - 2001年至2003 - 2004年RSV流行季节期间在美国参与研究的儿科机构接受≥1剂帕利珠单抗的高危婴儿。

结果

分析了19548名在家与门诊接受帕利珠单抗剂量的婴儿的依从性和RSV住院结局数据。通过比较接受的帕利珠单抗注射次数与预期剂量数,并比较在35天间隔内接受所有注射的婴儿,来确定注射方案的依从性。在家接受帕利珠单抗的婴儿(n = 1226)的依从性显著高于在诊所或办公室接受帕利珠单抗的婴儿(n = 17641),无论是按接受的剂量数衡量(88%对81%,P < 0.0001)还是按剂量时间衡量(73%对66%,P < 0.0001)。与在诊所或办公室接受帕利珠单抗的婴儿相比,在家接受帕利珠单抗的婴儿RSV相关住院也更少[0.4%(5/1226)对1.2%(207/17641),P = 0.0139]。

结论

在家给予帕利珠单抗与高危婴儿中显著更高的依从率和更低的RSV疾病住院率相关。

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