PDF(Pubmed)
Abstract：
OBJECTIVE: 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.
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的常见不良事件，通常难以治疗。甲基纳曲酮是阿片类药物引起的便秘（OIC）的治疗选择，已批准用于成人口服和皮下使用。这些给药途径在儿科人群中并不总是可行的。这项研究的主要目的是量化通过静脉（IV）途径给药的甲基纳曲酮在儿科患者中的反应率。
方法：这项回顾性研究评估了在2013年1月1日至2020年6月30日期间接受静脉注射甲基纳曲酮治疗OIC的年龄<18岁的患者。通过记录甲基纳曲酮给药4小时内肠排空来评价功效。在给药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，对134例患者给予了甲基纳曲酮。其中,46符合排除标准，导致88名患者被纳入研究。基础血液学/肿瘤学诊断的患者占研究人群的77％，23%的患者有潜在的内科/外科诊断。对IV甲基纳曲酮的应答率为25%(CI,16-34)。
结论：本回顾性图表综述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。尽管总体响应率相对于成人报告的响应率较低，IV甲基纳曲酮具有独特的作用机制,其可以作为不能使用口服和皮下给药途径的患者的替代治疗选择。在研究中没有观察到显著的不良事件。
方法：这项回顾性研究评估了在2013年1月1日至2020年6月30日期间接受静脉注射甲基纳曲酮治疗OIC的年龄<18岁的患者。通过记录甲基纳曲酮给药4小时内肠排空来评价功效。在给药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，对134例患者给予了甲基纳曲酮。其中,46符合排除标准，导致88名患者被纳入研究。基础血液学/肿瘤学诊断的患者占研究人群的77％，23%的患者有潜在的内科/外科诊断。对IV甲基纳曲酮的应答率为25%(CI,16-34)。
结论：本回顾性图表综述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。尽管总体响应率相对于成人报告的响应率较低，IV甲基纳曲酮具有独特的作用机制,其可以作为不能使用口服和皮下给药途径的患者的替代治疗选择。在研究中没有观察到显著的不良事件。
