Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA.
NewGround Pharmaceutical Consulting LLC, Foster City, California, USA.
Clin Transl Sci. 2021 Jul;14(4):1231-1249. doi: 10.1111/cts.12994. Epub 2021 May 1.
In this paper, we review the management of neonatal opioid withdrawal syndrome (NOWS) and clinical pharmacology of primary treatment agents in NOWS, including morphine, methadone, buprenorphine, clonidine, and phenobarbital. Pharmacologic treatment strategies in NOWS have been mostly empirical, and heterogeneity in dosing regimens adds to the difficulty of extrapolating study results to broader patient populations. As population pharmacokinetics (PKs) of pharmacologic agents in NOWS become more well-defined and knowledge of patient-specific factors affecting treatment outcomes continue to accumulate, PK/pharmacodynamic modeling and simulation will be powerful tools to aid the design of optimal dosing regimens at the patient level. Although there is an increasing number of clinical trials on the comparative efficacy of treatment agents in NOWS, here, we also draw attention to the importance of optimizing the dosing regimen, which can be arguably equally important at identifying the optimal treatment agent.
在本文中，我们回顾了新生儿阿片类戒断综合征（NOWS）的管理以及 NOWS 中主要治疗药物的临床药理学，包括吗啡、美沙酮、丁丙诺啡、可乐定和苯巴比妥。NOWS 的药物治疗策略主要是经验性的，剂量方案的异质性增加了将研究结果外推到更广泛的患者群体的难度。随着 NOWS 中药物的群体药代动力学（PK）变得更加明确，以及影响治疗结果的患者特定因素的知识不断积累，PK/药效动力学建模和模拟将成为辅助患者个体优化剂量方案的有力工具。尽管 NOWS 中治疗药物比较疗效的临床试验越来越多，但在这里，我们还提请注意优化剂量方案的重要性，这可以说是在确定最佳治疗药物时同样重要。
