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儿童静脉注射甲基纳曲酮的临床结局:一项单臂回顾性队列研究

Clinical Outcomes of Intravenous Methylnaltrexone in Children: A Single-Arm Retrospective Cohort Study.

作者信息

Raschka Michael, Gahr Kayla, Watson Dave, Lu Melisa

机构信息

Department of Pharmacy (MR, KG, ML), Children's Minnesota, Minneapolis, MN.

Research Institute (DW) Children's Minnesota, Minneapolis, MN.

出版信息

J Pediatr Pharmacol Ther. 2024 Jun;29(3):292-298. doi: 10.5863/1551-6776-29.3.292. Epub 2024 Jun 10.

Abstract

OBJECTIVES

Constipation is a common adverse event of opioid use that is often difficult to treat. Methylnaltrexone is a therapeutic option for opioid-induced constipation (OIC) approved for oral and subcutaneous use in adults. These administration routes are not always feasible in the pediatric population. The primary objective of this research was to quantify the response rate of methylnaltrexone in pediatric patients when it was administered via the intravenous (IV) route.

METHODS

This retrospective study evaluated patients ages <18 years who received IV methylnaltrexone between January 1, 2013, and June 30, 2020, for OIC. Efficacy was evaluated through documentation of bowel evacuation within 4 hours of methylnaltrexone administration. Adverse events observed within 24 hours of administration were attributed to methylnaltrexone.

RESULTS

Methylnaltrexone was administered to 134 unique patients during the study period. Of these, 46 met exclusion criteria, resulting in 88 patients being included in the study. Patients with an underlying hematology/oncology diagnosis consisted of 77% of the study population, and 23% of patients had an -underlying medical/surgical diagnosis. The response rate to IV methylnaltrexone was 25% (CI, 16-34).

CONCLUSIONS

The results of this retrospective chart review demonstrate the potential role of IV methylnaltrexone in the pediatric population. Despite the overall lower response rate relative to that reported in adults, IV methylnaltrexone possesses a unique mechanism of action that may serve as an alternative treatment option for patients unable to use the oral and subcutaneous administration routes. There were no significant adverse events seen in the study.

摘要

目的

便秘是阿片类药物使用常见的不良事件,往往难以治疗。甲基纳曲酮是一种用于治疗阿片类药物引起的便秘(OIC)的治疗选择,已获批用于成人口服和皮下给药。这些给药途径在儿科人群中并不总是可行的。本研究的主要目的是量化甲基纳曲酮经静脉(IV)途径给药时在儿科患者中的反应率。

方法

这项回顾性研究评估了2013年1月1日至2020年6月30日期间因OIC接受静脉注射甲基纳曲酮的18岁以下患者。通过记录甲基纳曲酮给药后4小时内的排便情况来评估疗效。给药后24小时内观察到的不良事件归因于甲基纳曲酮。

结果

在研究期间,134例不同患者接受了甲基纳曲酮治疗。其中,46例符合排除标准,最终88例患者纳入研究。潜在血液学/肿瘤学诊断的患者占研究人群的77%,23%的患者有潜在内科/外科诊断。静脉注射甲基纳曲酮的反应率为25%(CI,16 - 34)。

结论

这项回顾性图表审查的结果证明了静脉注射甲基纳曲酮在儿科人群中的潜在作用。尽管总体反应率低于成人报告的水平,但静脉注射甲基纳曲酮具有独特的作用机制,可能为无法采用口服和皮下给药途径的患者提供替代治疗选择。本研究中未观察到显著不良事件。

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