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妊娠或产后使用缓释丁丙诺啡(CAM2038)的注意事项

What to Expect With Pregnant or Postpartum Prescribing of Extended-Release Buprenorphine (CAM2038).

作者信息

Lofwall Michelle R, Young Jessica L, Hansen Zachary, Wachman Elisha M, Wilder Christine, Guille Constance, Charles Jasmin E, Leeman Lawrence, Gray Jessica R, Winhusen T John

机构信息

Departments of Behavioral Science and Psychiatry, Center on Drug and Alcohol Research, University of Kentucky College of Medicine, Lexington, KY, USA.

Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, TN, USA.

出版信息

J Clin Gynecol Obstet. 2023 Dec;12(3):110-116. doi: 10.14740/jcgo919. Epub 2023 Dec 28.

Abstract

Weekly and monthly CAM2038 (Brixadi) extended-release subcutaneous buprenorphine (XR bup) has been available in Europe and Australia for several years and was approved by the Food and Drug Administration in May 2023. Little is known about the clinical experience of patients and providers using this new medication during prenatal care. Two cases of pregnant persons with opioid use disorder receiving weekly XR bup in an ongoing randomized multi-site outpatient clinical trial are presented along with a brief review of the pharmacology and literature on XR bup formulations. The cases in pregnancy illustrate how treatment with the weekly formulation is initiated including how to make dose adjustments, which may be necessary given the longer half-life; it takes 1 month to achieve steady state. Injection site pain with medication administration was time limited and managed readily. Other injection site reactions experienced included subcutaneous erythema and induration that was delayed in onset and typically mild, resolving with minimal intervention. Delivery management and breastfeeding recommendations while on weekly XR bup were not different compared to sublingual buprenorphine (SL bup). Weekly XR bup is a new treatment for opioid use disorder that may be used in the obstetric population. Obstetric and addiction medicine clinicians should be aware of this new formulation as its use is expected to increase.

摘要

每周一次和每月一次的CAM2038(Brixadi)长效皮下注射丁丙诺啡(长效丁丙诺啡)已在欧洲和澳大利亚上市数年,并于2023年5月获得美国食品药品监督管理局批准。关于患者和医疗服务提供者在产前护理中使用这种新药的临床经验,我们所知甚少。本文介绍了两例在一项正在进行的多中心随机门诊临床试验中接受每周一次长效丁丙诺啡治疗的阿片类物质使用障碍孕妇病例,并简要回顾了长效丁丙诺啡制剂的药理学及相关文献。这两例孕期病例说明了如何开始使用每周一次的制剂进行治疗,包括如何进行剂量调整,鉴于其较长的半衰期,这可能是必要的;达到稳态需要1个月时间。给药时的注射部位疼痛是有时间限制的,并且很容易处理。其他经历过的注射部位反应包括皮下红斑和硬结,其发作延迟且通常较轻,只需极少干预即可消退。与舌下丁丙诺啡相比,每周一次长效丁丙诺啡治疗期间的分娩管理和母乳喂养建议并无不同。每周一次长效丁丙诺啡是一种可用于产科人群的阿片类物质使用障碍新疗法。产科和成瘾医学临床医生应了解这种新制剂,因为预计其使用将会增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6464/10906993/ff68512a380d/nihms-1969790-f0001.jpg

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