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经替代口服途径滥用可压碎的处方阿片类药片。

Relative Abuse of Crush-Resistant Prescription Opioid Tablets via Alternative Oral Modes of Administration.

机构信息

Inflexxion, Inc., Waltham, Massachusetts.

Collegium Pharmaceutical, Inc., Canton, Massachusetts, USA.

出版信息

Pain Med. 2018 Aug 1;19(8):1613-1627. doi: 10.1093/pm/pnx151.

Abstract

OBJECTIVE

Some crush-resistant tablet formulations (CRTs) reduce prescription opioid abuse by nonoral routes of administration (ROAs), especially insufflation and injection, while oral abuse increases. Oral abuse involving product manipulation vs swallowing whole for CRTs and comparators was examined.

METHODS

Abuse by oral modes of administration (e.g., swallowing whole, chewing, dissolving in the mouth), was examined using the ASI-MV, a computerized, clinical interview for adults in substance abuse treatment from January 2009 to March 2015. CRTs (reformulated oxycodone extended-release [ER], reformulated oxymorphone ER, and tapentadol ER) were compared with non-CRT versions, morphine ER, and oxycodone immediate-release single entity. Analyses employed descriptive statistics and logistic regression.

RESULTS

Among 364,329 unique assessments, 18,135 patients reported oral abuse of the CRTs and comparators examined. CRTs had a higher prevalence of oral abuse involving product manipulation than comparators (P < 0.0001) among all abusers of product. Oral abuse involving product manipulation for CRTs was greater among the subset of patients reporting oral abuse and significantly higher than comparators (P < 0.003). CRTs were significantly less likely than comparators to be swallowed whole (P < 0.0001) and significantly more likely to be chewed (P < 0.003). CRTs were more likely to be dissolved in the mouth than most comparators.

CONCLUSIONS

Results suggest the need for abuse-deterrent formulations designed to reduce abuse by oral administration with product manipulation, such as chewing. Advances in this area may reduce the overall abuse of prescription opioids and interrupt the progression from abuse by swallowing whole to oral administration involving product manipulation and other ROAs.

摘要

目的

一些抗压片剂制剂(CRTs)通过非口服途径(ROAs)减少处方阿片类药物滥用,尤其是鼻吸和注射,而口服滥用则增加。研究了 CRTs 及对照药物的口服滥用涉及产品操纵而非整粒吞服的情况。

方法

2009 年 1 月至 2015 年 3 月,使用计算机化的成人药物滥用治疗临床访谈工具 ASI-MV,检查了通过口服途径(例如整粒吞服、咀嚼、在口中溶解)滥用的情况。与非 CRT 版本、吗啡 ER 和即释盐酸羟考酮单体制剂相比,比较了 CRTs(改良型羟考酮缓释片、改良型羟吗啡酮缓释片和盐酸他喷他多缓释片)。分析采用描述性统计和逻辑回归。

结果

在 364329 个唯一评估中,有 18135 名患者报告了 CRTs 及所检查的对照药物的口服滥用情况。在所有产品滥用者中,CRTs 的口服滥用涉及产品操纵的发生率高于对照药物(P<0.0001)。在报告口服滥用的患者亚组中,口服滥用涉及产品操纵的 CRTs 发生率更高,明显高于对照药物(P<0.003)。与对照药物相比,CRTs 整粒吞服的可能性显著较低(P<0.0001),咀嚼的可能性显著较高(P<0.003)。CRTs 比大多数对照药物更有可能在口中溶解。

结论

结果表明需要设计旨在减少通过口服途径滥用涉及产品操纵的防滥用制剂,如咀嚼。该领域的进展可能会减少处方类阿片药物的整体滥用,并阻止从整粒吞服滥用发展为涉及产品操纵和其他 ROAs 的口服滥用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d286/6084581/1745ebb0e355/pnx151f1.jpg

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