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评估具有滥用防御特性的改良型缓释羟考酮在减少物质滥用评估者(使用成瘾严重程度指数多媒体版(ASI-MV))中阿片类药物非口服滥用方面的有效性。

Evaluating the effectiveness of reformulated extended-release oxycodone with abuse-deterrent properties on reducing non-oral abuse among individuals assessed for substance abuse treatment with the Addiction Severity Index-Multimedia Version (ASI-MV).

机构信息

Janssen Pharmaceuticals, LLC, Raritan, NJ, USA.

Uprise Health/Inflexxion, Irvine, CA, USA.

出版信息

Curr Med Res Opin. 2023 Apr;39(4):579-587. doi: 10.1080/03007995.2023.2178080. Epub 2023 Feb 22.

Abstract

OBJECTIVE

Original brand extended-release (ER) oxycodone tablets (OC) for oral use were reformulated (ORF) with abuse-deterrent properties (ADP) against inhalation and injection routes in August 2010. This product transition provided an opportunity to compare "before and after" reformulation abuse trends. Our goal was to assess the change in abuse of brand oxycodone ER from before and after introduction of ORF.

METHODS

Change in self-reported non-oral "OxyContin" abuse in the previous 30 days during two years pre- and four years post-reformulation was assessed among adults evaluated for substance use and treatment planning using the Addiction Severity Index-Multimedia Version (ASI-MV). Comparator opioids were used to provide a frame of reference for changes in abuse due to competing population-level opioid abuse interventions and other factors unrelated to the reformulation. A proportion (PR) and abuse report dispensing ratio (ARDR) are reported because a single measure of abuse has not been identified that can optimally describe opioid abuse or changes in opioid abuse.

RESULTS

Interrupted time-series analyses indicated an immediate decline in non-oral abuse measures post-reformulation (PR = -52.1%; ARDR = -32.2%). Significant decreases from pre- to post-reformulation in non-oral abuse overall were observed (PR [95% CI] = -30.7% [-46.9%, -9.5%]; ARDR = -29.3% [-37.5%, -20.1%]). Comparator opioids did not demonstrate similar trends over the period.

CONCLUSIONS

Methodology applied in this study suitably assessed the effectiveness of an ADP product. Among individuals assessed for substance use, a differential decline in non-oral abuse of brand ER oxycodone was observed since introduction of ORF.

摘要

目的

原品牌延长释放(ER)羟考酮片剂(OC)用于口服,于 2010 年 8 月进行了配方改革(ORF),具有针对吸入和注射途径的滥用防御特性(ADP)。这次产品转型提供了一个比较“前后”配方改革滥用趋势的机会。我们的目标是评估品牌羟考酮 ER 在引入 ORF 前后滥用情况的变化。

方法

使用成瘾严重程度指数多媒体版本(ASI-MV),评估在配方改革前两年和后四年期间,接受药物使用评估和治疗计划的成年人中,自我报告的前 30 天内非口服“OxyContin”滥用的变化。使用比较类阿片药物为由于竞争人群水平阿片类药物滥用干预和其他与配方改革无关的因素导致的滥用变化提供参考框架。报告比例(PR)和滥用报告配药比例(ARDR),因为尚未确定能够最佳描述阿片类药物滥用或阿片类药物滥用变化的单一滥用衡量标准。

结果

中断时间序列分析表明,配方改革后非口服滥用指标立即下降(PR = -52.1%;ARDR = -32.2%)。从配方改革前到后,总体上观察到非口服滥用的显著下降(PR[95%CI] = -30.7%[-46.9%,-9.5%];ARDR = -29.3%[-37.5%,-20.1%])。同期比较类阿片药物并未显示出类似趋势。

结论

本研究中应用的方法适合评估 ADP 产品的有效性。在接受药物使用评估的个体中,自 ORF 引入以来,品牌 ER 羟考酮的非口服滥用呈下降趋势。

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