Strain E C, Stitzer M L, Liebson I A, Bigelow G E
Department of Psychiatry, Johns Hopkins University School of Medicine, Francis Scott Key Medical Center, Baltimore, MD 21224.
Am J Psychiatry. 1994 Jul;151(7):1025-30. doi: 10.1176/ajp.151.7.1025.
This study compared the efficacy of buprenorphine and methadone in the treatment of opioid dependence.
Participants (N = 164) were relatively treatment-naive, opioid-dependent applicants to a 26-week treatment program who were randomly assigned to either methadone or buprenorphine treatment. Dosing was double-blind and double-dummy. Patients were stabilized on a regimen of either methadone, 50 mg, or buprenorphine, 8 mg, with dose changes possible through week 16 of treatment. Urine samples were collected three times a week, and weekly counseling was provided.
Buprenorphine (mean dose = 8.9 mg/day) and methadone (mean dose = 54 mg/day) were equally effective in sustaining retention in treatment, compliance with medication, and counseling regimens. In both groups, 56% of patients remained in treatment through the 16-week flexible dosing period. Overall opioid-positive urine sample rates were 55% and 47% for buprenorphine and methadone groups, respectively; cocaine-positive urine sample rates were 70% and 58%. Evidence was obtained for the effectiveness of dose increases in suppressing opioid, but not cocaine, use among those who received dose increases.
The results of this study provide further support for the utility of buprenorphine as a new medication in the treatment of opioid dependence and demonstrate efficacy equivalent to that of methadone when used during a clinically guided flexible dosing procedure.
本研究比较了丁丙诺啡和美沙酮治疗阿片类药物依赖的疗效。
参与者(N = 164)为相对未接受过治疗的阿片类药物依赖者,他们申请参加一个为期26周的治疗项目,并被随机分配接受美沙酮或丁丙诺啡治疗。给药采用双盲双模拟法。患者分别以50毫克美沙酮或8毫克丁丙诺啡的方案进行稳定治疗,在治疗的第16周前剂量可能会改变。每周收集三次尿液样本,并提供每周一次的咨询服务。
丁丙诺啡(平均剂量 = 8.9毫克/天)和美沙酮(平均剂量 = 54毫克/天)在维持治疗保留率、药物依从性和咨询方案方面同样有效。在两组中,56%的患者在16周的灵活给药期内一直接受治疗。丁丙诺啡组和美沙酮组的总体阿片类药物阳性尿液样本率分别为55%和47%;可卡因阳性尿液样本率分别为70%和58%。有证据表明,在接受剂量增加的患者中,剂量增加在抑制阿片类药物使用方面有效,但对可卡因使用无效。
本研究结果为丁丙诺啡作为治疗阿片类药物依赖的新药的实用性提供了进一步支持,并表明在临床指导的灵活给药过程中使用时,其疗效与美沙酮相当。