Efficacy of daily and alternate-day dosing regimens with the combination buprenorphine-naloxone tablet
Efficacy of daily and alternate-day dosing regimens with the combination buprenorphine-naloxone tablet
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DOI：
10.1016/s0376-8716(99)00074-5
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发表时间：
2000-02-01
影响因子：
4.2
通讯作者：
Mikulich, SK
中科院分区：
文献类型：
--
作者：
Amass, L;Kamien, JB;Mikulich, SK
这项研究评估了丁丙诺啡8 mg和纳洛酮2 mg组成的联合片剂隔日治疗的疗效，以及增加每日维持剂量是否对于维持有效的隔日治疗是必要的。26名完成16天基线的阿片类药物依赖门诊患者进入了一项双盲、安慰剂对照、三交叉试验。每天服用21天的联合药片与两个不同的21天交替服用丁丙诺啡的时间段进行了比较，受试者每隔一天服用8或16毫克的联合药片，并在中间一天服用安慰剂。54%(14/26)的受试者完成了研究，但只有两名受试者在16毫克的隔日条件下退出了研究。在完成研究的受试者中，药物依从性、非法阿片类药物使用以及受试者和观察者对阿片类药物效果的评估没有区分每日和隔日治疗。然而，与每天8毫克或16毫克的隔日治疗相比，隔日服用8毫克的患者的瞳孔直径显著增大。这些数据重复了早先描述了丁丙诺啡交替日维持剂量倍数治疗的可接受性的早期发现，并通过建立丁丙诺啡-纳洛酮联合每日和隔日给药方案的临床疗效来扩展这些发现。这项研究还表明，在使用每日剂量倍数的隔日治疗期间，结果略有改善。(C)2000爱思唯尔爱尔兰科学有限公司。保留所有权利。
This study evaluated the efficacy of a combination tablet formulation of buprenorphine containing 8 mg of buprenorphine and 2 mg of naloxone for every other day treatment and whether increasing the daily maintenance dose was essential for maintaining an efficacious alternate-day treatment. Twenty-six opioid-dependent outpatients completing a 16-day baseline entered a double blind, placebo-controlled, triple crossover trial. Twenty-one days of daily combination tablet administration were compared to two different 21-day periods of alternate-day buprenorphine administration where subjects received either 8 or 16 mg of the combination tablet every other day with placebo on the interposed day. Fifty-four percent (14/26) of subjects completed the study, but only two subjects dropped out during the 16-mg alternate-day condition. Rates of medication compliance, illicit opioid use and subject- and observer-rated measures of opioid effects did not distinguish daily from alternate-day treatments in subjects completing the study. However, pupillary diameter was significantly increased during 8-mg alternate-day compared to the 8-mg daily or 16-mg alternate-day treatment. These data replicate earlier findings describing the acceptability of alternate-day buprenorphine treatment using multiples of the daily maintenance dose and extend these findings by establishing the clinical efficacy of daily and alternate-day dosing regimens with the combination buprenorphine-naloxone tablet. This study also suggests slightly improved outcomes during alternate-day treatment using multiples of the daily dose. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.