Chappuy Mathieu, Trojak Benoit, Nubukpo Philippe, Bachellier Jérôme, Bendimerad Patrick, Brousse Georges, Rolland Benjamin
Service universitaire d'addictologie de Lyon (SUAL), centre hospitalier Le Vinatier, 95, boulevard Pinel, 69678 Bron, France; Service d'addictologie, groupement hospitalier centre, hospices civils de Lyon, 69003 Lyon, France; Centre de soins, d'accompagnement et de prévention en addictologie, groupement hospitalier nord, hospices civils de Lyon, 69004 Lyon, France.
Service hospitalo-universitaire d'addictologie, CHU de Dijon, 21079 Dijon, France; Inserm U1093 cognition, action et plasticité sensorimotrice, UFR staps, université de Bourgogne Franche Comté, 21078 Dijon, France.
Therapie. 2020 May 19. doi: 10.1016/j.therap.2020.05.008.
Buprenorphine and methadone are the two main opioids agonist treatments approved for opioid use disorder. Buprenorphine is a partial agonist of the mu-opioid receptors, which has been merely available through sublingual form until now. In practice, the use of buprenorphine is smoother than that of methadone, and it induces reduced risks of overdose. However, sublingual buprenorphine also exposes to risks (e.g., withdrawal, misuse) and constraints (e.g., daily intake). Three new galenic formulations of prolonged-release buprenorphine (PRB) are being commercialized and should allow some improvements in patients' comfort and safety. This narrative review aims to describe the main technical features and efficacy and safety data of these PRBs, as well as patients' and professionals' expectancies and concerns, using data of the scientific literature and the regulatory texts. PRBs consist of one subcutaneous implant and two subcutaneous injection depots. Sixmo®/Probuphine® is a six-month-long implant which needs to be surgically placed and removed and is approved for subjects previously treated with a maximum daily dose of 8mg of sublingual buprenorphine, and can be used only for two successive periods of six months before the subject needs to be switched back to sublingual form. Sublocade® is a one-month-long depot formulation that is indicated in switch from sublingual buprenorphine, and which proposes only two dose schemes, i.e., 100 and 300mg monthly. Buvidal®/Brixadi® is a one-week- or one-month-long depot formulation with multiple dosages, which can be used in initiation or in switched from sublingual formulations. While opioid users report some concerns with a risk of coercive use of long-acting forms of buprenorphine, both users and professionals deem that these new specialties could be particularly appreciated in stabilized patients bothered with the daily intake of the treatments, or specific situations at risk of treatment dropout (e.g., following hospital discharge or prison release).
丁丙诺啡和美沙酮是两种被批准用于阿片类物质使用障碍的主要阿片类激动剂治疗药物。丁丙诺啡是μ-阿片受体的部分激动剂,到目前为止仅能通过舌下给药形式获得。在实际应用中,丁丙诺啡的使用比美沙酮更平稳,且其过量使用风险更低。然而,舌下含服丁丙诺啡也存在风险(如戒断反应、滥用)和限制(如每日给药)。三种新型长效丁丙诺啡(PRB)剂型正在商业化,有望在患者舒适度和安全性方面有所改善。本叙述性综述旨在利用科学文献和监管文件数据,描述这些PRB的主要技术特征、疗效和安全性数据,以及患者和专业人员的期望与担忧。PRB包括一种皮下植入剂和两种皮下注射储库剂型。Sixmo®/Probuphine®是一种为期六个月的植入剂,需要通过手术植入和取出,已获批用于先前接受过每日最大剂量8mg舌下丁丙诺啡治疗的受试者,且在受试者需要换回舌下给药形式之前,仅可连续使用两个为期六个月的疗程。Sublocade®是一种为期一个月的储库剂型,适用于从舌下丁丙诺啡转换治疗的患者,仅提供两种剂量方案,即每月100mg和300mg。Buvidal®/Brixadi®是一种为期一周或一个月的储库剂型,有多种剂量,可用于初始治疗或从舌下剂型转换治疗。虽然阿片类药物使用者对长效丁丙诺啡存在被强制使用的风险表示担忧,但使用者和专业人员都认为,这些新剂型对于因每日治疗给药而困扰的稳定患者或存在治疗中断风险的特定情况(如出院后或出狱后)可能特别适用。