舌下含服丁丙诺啡-纳洛酮膜与片剂治疗阿片类药物依赖的随机对照试验。
A randomised controlled trial of sublingual buprenorphine-naloxone film versus tablets in the management of opioid dependence.
机构信息
Langton Centre, South Eastern Sydney Local Health District, NSW 2010, Australia.
出版信息
Drug Alcohol Depend. 2013 Jul 1;131(1-2):119-26. doi: 10.1016/j.drugalcdep.2012.12.009. Epub 2013 Jan 12.
BACKGROUND
Buprenorphine-naloxone sublingual film was introduced in 2011 in Australia as an alternative to tablets. This study compared the two formulations on subjective dose effects and equivalence, trough plasma levels, adverse events, patient satisfaction, supervised dosing time, and impact upon treatment outcomes (substance use, psychosocial function).
METHODS
92 buprenorphine-naloxone tablet patients were recruited to this outpatient multi-site double-blind double-dummy parallel group trial. Patients were randomised to either tablets or film, without dose changes, over a 31 day period.
RESULTS
No significant group differences were observed for subjective dose effects, trough plasma buprenorphine or norbuprenorphine levels, adverse events and treatment outcomes. Buprenorphine-naloxone film took significantly less time to dissolve than tablets (173±71 versus 242±141s, p=0.007, F=7.67).
CONCLUSIONS
The study demonstrated dose equivalence and comparable clinical outcomes between the buprenorphine-naloxone film and tablet preparations, whilst showing improved dispensing times and patient ratings of satisfaction with the film.
背景
丁丙诺啡-纳洛酮舌下膜于 2011 年在澳大利亚推出，作为片剂的替代品。本研究比较了这两种制剂在主观剂量效应和等效性、谷血浆水平、不良事件、患者满意度、监督给药时间以及对治疗结果（物质使用、心理社会功能）的影响。
方法
92 名丁丙诺啡-纳洛酮片剂患者被招募参加这项门诊多地点双盲双模拟平行组试验。患者在 31 天内随机分配至片剂或膜剂，不改变剂量。
结果
在主观剂量效应、谷血浆丁丙诺啡或去甲丁丙诺啡水平、不良事件和治疗结果方面，两组间无显著差异。丁丙诺啡-纳洛酮膜剂的溶解时间明显短于片剂（173±71 与 242±141s，p=0.007，F=7.67）。
结论
该研究表明，丁丙诺啡-纳洛酮膜剂和片剂制剂具有等效的剂量和相似的临床结果，同时显示出改善的配药时间和患者对膜剂的满意度评分。
Zotero 插件