A CONTROLLED TRIAL OF BUPRENORPHINE TREATMENT FOR OPIOID DEPENDENCE
A CONTROLLED TRIAL OF BUPRENORPHINE TREATMENT FOR OPIOID DEPENDENCE
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DOI：
10.1001/jama.267.20.2750
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发表时间：
1992-05-27
影响因子：
120.7
通讯作者：
FUDALA, PJ
中科院分区：
文献类型：
--
作者：
JOHNSON, RE;JAFFE, JH;FUDALA, PJ
客观。-评估丁丙诺啡短期维持/解毒的疗效。一项随机、双盲、平行组研究，比较丁丙诺啡8 mg/d、美沙酮60 mg/d和美沙酮20 mg/d在17周维持期后8周脱毒期的效果。马里兰州巴尔的摩成瘾研究中心的门诊设施。162名寻求阿片类药物依赖治疗的志愿者。除了药物治疗外，还提供了使用复发预防模型的咨询，但不是必需的。保留时间在治疗中，尿液样本阴性阿片类药物，并未能保持禁欲。在整个维持阶段，丁丙诺啡（42%）的保留率显著高于美沙酮（20 mg/d）（20%，P <.04）;丁丙诺啡（53%，P <0.001）和美沙酮60 mg/d（44%，P <0.04）的阿片类药物阴性尿样百分比显著高于美沙酮20 mg/d（29%）。美沙酮20 mg/d组在维持阶段未能维持戒断的发生率显著高于丁丙诺啡组（P <0.03）。在解毒阶段，在阿片类药物阴性尿样方面，未观察到组间差异。在整个25周内，丁丙诺啡（30%，P <0.01）和美沙酮60 mg/d（20%，P <0.05）的保留率显著高于美沙酮20 mg/d（6%）。所有治疗均耐受良好，自我报告的不良反应相似。接受咨询的患者百分比在两组之间没有差异。丁丙诺啡与美沙酮60 mg/d同样有效，在减少非法阿片类药物使用和维持患者治疗25周方面均优于美沙酮20 mg/d。
Objective.-To assess the efficacy of buprenorphine for short-term maintenance/detoxification.Design.-A randomized, double-blind, parallel group study comparing buprenorphine, 8 mg/d, methadone, 60 mg/d, and methadone, 20 mg/d, in a 17-week maintenance phase followed by an 8-week detoxification phase.Setting.-Outpatient facilities at the Addiction Research Center, Baltimore, Md.Patients.-One hundred sixty-two volunteers seeking treatment for opioid dependence.Intervention.-In addition to the medication, counseling using a relapse prevention model was offered but not required.Primary Outcome Measures.-Retention time in treatment, urine samples negative for opioids, and failure to maintain abstinence.Results.-Throughout the maintenance phase, retention rates were significantly greater for buprenorphine (42%) than for methadone, 20 mg/d (20%, P < .04); the percentage of urine samples negative for opioids was significantly greater for buprenorphine (53%, P < .001) and methadone, 60 mg/d (44%, P < .04), than for methadone, 20 mg/d (29%). Failure to maintain abstinence during the maintenance phase was significantly greater for methadone, 20 mg/d, than for buprenorphine (P < .03). During the detoxification phase, no differences were observed between groups with respect to urine samples negative for opioids. For the entire 25 weeks, retention rates for buprenorphine (30%, P < .01) and methadone, 60 mg/d (20%, P < .05), were significantly greater than for methadone, 20 mg/d (6%). All treatments were well tolerated, with similar profiles of self-reported adverse effects. The percentages of patients who received counseling did not differ between groups.Conclusions.-Buprenorphine was as effective as methadone, 60 mg/d, and both were superior to methadone, 20 mg/d, in reducing illicit opioid use and maintaining patients in treatment for 25 weeks.