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阿片类药物依赖患者皮下持续释放丁丙诺啡缓释注射剂单臂实施试验的结果。

Outcomes of a single-arm implementation trial of extended-release subcutaneous buprenorphine depot injections in people with opioid dependence.

机构信息

National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.

National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia.

出版信息

Int J Drug Policy. 2022 Feb;100:103492. doi: 10.1016/j.drugpo.2021.103492. Epub 2021 Nov 1.

DOI:10.1016/j.drugpo.2021.103492
PMID:34736130
Abstract

BACKGROUND

Opioid agonist treatment (OAT) is an effective intervention for opioid dependence. Extended-release buprenorphine injections (BUP-XR) may have additional potential benefits over sublingual buprenorphine. This single-arm trial evaluated outcomes among people receiving 48 weeks of BUP-XR in diverse community healthcare settings in Australia, permitting examination of outcomes when BUP-XR is delivered in standard practice.

METHODS

Participants were recruited from a network of specialist public drug treatment services, primary care and some private practices in three states. Following a minimum 7 days on 8-32 mg of sublingual buprenorphine (±naloxone), participants received monthly subcutaneous BUP-XR injections administered by a healthcare practitioner and completed monthly research interviews. The primary endpoint was retention in treatment at 48 weeks.

FINDINGS

Participants (n = 100) were 28% women, mean age 44 years with a long history of OAT (median 5.8 years); heroin was the most common opioid of concern (58%). Treatment retention at 24 and 48 weeks was 86% and 75%, respectively. Participants with past-month injecting drug use (OR 0.23; 95%CI: 0.09-0.61) or heroin use (OR 0.23; 95%CI: 0.08-0.65) at baseline had lower odds of being retained in treatment to 48 weeks. Reductions in multiple forms of extra-medical drug use were observed. Improvements in quality of life, participation in employment, and treatment satisfaction measures were also observed.

INTERPRETATION

This real-world implementation study of BUP-XR demonstrated high retention and treatment satisfaction. This study provides important additional data on the uptake and experience of clients, with relevance for policy makers, health service planners, administrators, and practitioners.

FUNDING

Indivior.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03809143.

摘要

背景

阿片类激动剂治疗(OAT)是治疗阿片类药物依赖的有效干预措施。与舌下丁丙诺啡相比,延长释放丁丙诺啡注射剂(BUP-XR)可能具有额外的潜在益处。这项单臂试验在澳大利亚的各种社区医疗保健环境中评估了接受 48 周 BUP-XR 治疗的人群的结果,允许在标准实践中提供 BUP-XR 时检查结果。

方法

参与者从三个州的专业公共药物治疗服务网络、初级保健和一些私人诊所招募。在接受 8-32 毫克舌下丁丙诺啡(±纳洛酮)至少 7 天后,参与者每月接受一次由医疗保健从业者管理的皮下 BUP-XR 注射,并完成每月的研究访谈。主要终点是 48 周时的治疗保留率。

结果

参与者(n=100)中 28%为女性,平均年龄为 44 岁,有长期的 OAT 病史(中位数为 5.8 年);最常见的阿片类药物是海洛因(58%)。24 周和 48 周时的治疗保留率分别为 86%和 75%。基线时有过去一个月注射吸毒(OR 0.23;95%CI:0.09-0.61)或使用海洛因(OR 0.23;95%CI:0.08-0.65)的参与者,到 48 周时保留治疗的可能性较低。观察到多种形式的非医疗药物使用减少。生活质量、参与就业和治疗满意度方面也有所改善。

解释

这项关于 BUP-XR 的真实世界实施研究显示了高保留率和治疗满意度。这项研究提供了关于客户接受度和经验的重要补充数据,对政策制定者、卫生服务规划者、管理人员和从业者具有重要意义。

资金来源

Indivior。

试验注册

ClinicalTrials.gov 标识符:NCT03809143。

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