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对新生儿戒断综合征进行基于药代动力学模型的美沙酮逐渐减量优化的队列分析。

Cohort Analysis of a Pharmacokinetic-Modeled Methadone Weaning Optimization for Neonatal Abstinence Syndrome.

机构信息

Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

出版信息

J Pediatr. 2015 Dec;167(6):1221-5.e1. doi: 10.1016/j.jpeds.2015.09.038. Epub 2015 Oct 21.

Abstract

OBJECTIVE

To evaluate neonatal abstinence syndrome (NAS) treatment outcomes achieved using an optimized methadone weaning protocol developed using pharmacokinetic (PK) modeling compared with standard methadone weaning.

STUDY DESIGN

This pre-post cohort study evaluated 360 infants who completed pharmacologic treatment for NAS with methadone as inpatients at 1 of 6 nurseries in southwest Ohio between January 2012 and March 2015. Infants were initially treated with a standard methadone weaning protocol (n = 267). Beginning in July 2014, infants were treated with a revised methadone weaning protocol developed using PK modeling (n = 93). Linear mixed models were used to calculate adjusted mean primary outcomes, including total duration of methadone treatment, total administered methadone dosage, and length of inpatient hospital stay, which were compared between weaning protocols. The use of adjunctive therapy for NAS treatment was examined as a secondary outcome.

RESULTS

Infants who received NAS treatment with the revised protocol experienced a shorter duration of methadone treatment (13.1 vs 16.4 days; P < .001) and shorter duration of inpatient treatment (18.3 vs 21.7 days; P < .001) compared with infants receiving standard methadone weaning. No difference was observed in total methadone dosage administered (0.52 vs 0.52 mg/kg; P = .97) or in the use of adjunctive therapy (22.6% vs 25.5%; P = .68) between groups.

CONCLUSION

Refinement of a standard methadone weaning protocol using PK modeling was associated with reduced duration of opioid weaning and shortened length of stay for pharmacologic treatment of NAS.

摘要

目的

评估使用优化的美沙酮戒断方案治疗新生儿戒断综合征(NAS)的效果,该方案使用药代动力学(PK)建模制定,与标准美沙酮戒断相比。

研究设计

这项前后队列研究评估了 2012 年 1 月至 2015 年 3 月期间在俄亥俄州西南部的 6 个托儿所中的 1 个住院接受美沙酮治疗的 360 名患有 NAS 的婴儿。最初,婴儿使用标准美沙酮戒断方案(n = 267)进行治疗。从 2014 年 7 月开始,使用 PK 建模开发的修订版美沙酮戒断方案治疗婴儿(n = 93)。使用线性混合模型计算调整后的主要结局的平均值,包括美沙酮治疗的总持续时间、总美沙酮剂量和住院时间,比较两种戒断方案之间的差异。作为次要结局,检查了 NAS 治疗中辅助治疗的使用情况。

结果

接受修订方案治疗的 NAS 婴儿的美沙酮治疗持续时间(13.1 天与 16.4 天;P <.001)和住院治疗持续时间(18.3 天与 21.7 天;P <.001)更短。接受标准美沙酮戒断的婴儿相比,接受标准美沙酮戒断的婴儿接受的美沙酮总剂量(0.52 毫克/千克与 0.52 毫克/千克;P =.97)或辅助治疗的使用(22.6%与 25.5%;P =.68)无差异。

结论

使用 PK 建模对标准美沙酮戒断方案进行优化,可减少阿片类药物戒断的持续时间,并缩短 NAS 药物治疗的住院时间。

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