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从研究到现实世界:临床试验网络十年中的丁丙诺啡。

From research to the real world: buprenorphine in the decade of the Clinical Trials Network.

机构信息

Pacific Region Node, University of California, Los Angeles, USA.

出版信息

J Subst Abuse Treat. 2010 Jun;38 Suppl 1(Suppl 1):S53-60. doi: 10.1016/j.jsat.2010.01.009.

Abstract

The National Institute on Drug Abuse (NIDA) established the National Drug Abuse Treatment Clinical Trials Network (CTN) in 1999 to bring researchers and treatment providers together to develop a clinically relevant research agenda. Initial CTN efforts addressed the use of buprenorphine, a mu-opioid partial agonist, as treatment for opioid dependence. Strong evidence of buprenorphine's therapeutic efficacy was demonstrated in clinical trials involving several thousand opioid-dependent participants, and in 2002, the Food and Drug Administration approved buprenorphine for the treatment of opioid dependence. With the advent of a sublingual tablet containing both buprenorphine and naloxone to mitigate abuse and diversion (Suboxone), buprenorphine appeared poised to be the first-line treatment for opioid addiction. Notwithstanding its many attributes, certain implementation barriers remained to be addressed in CTN studies, and these efforts have brought a body of knowledge on buprenorphine to frontline clinicians. The purpose of this article is to review CTN-based buprenorphine research and related efforts to overcome challenges to the implementation of buprenorphine therapy in mainstream practice. Furthermore, this article explores current issues and future challenges that may require additional CTN efforts.

摘要

美国国家药物滥用研究所(NIDA)于 1999 年成立了国家药物滥用治疗临床试验网络(CTN),旨在将研究人员和治疗提供者聚集在一起,制定具有临床相关性的研究议程。CTN 的初步工作旨在探讨丁丙诺啡(一种μ-阿片类部分激动剂)作为治疗阿片类药物依赖的用途。涉及数千名阿片类药物依赖参与者的临床试验有力地证明了丁丙诺啡的治疗效果,并且在 2002 年,食品和药物管理局批准丁丙诺啡用于治疗阿片类药物依赖。随着含有丁丙诺啡和纳洛酮的舌下片剂(Suboxone)的出现,该药物可以减轻滥用和转移的风险,丁丙诺啡似乎有望成为阿片类药物成瘾的一线治疗药物。尽管它有许多优点,但 CTN 研究仍需要解决某些实施障碍,这些努力为一线临床医生提供了丁丙诺啡方面的知识。本文旨在回顾基于 CTN 的丁丙诺啡研究以及相关努力,以克服在主流实践中实施丁丙诺啡治疗的挑战。此外,本文还探讨了可能需要额外的 CTN 努力的当前问题和未来挑战。

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