A controlled trial comparing buprenorphine and methadone maintenance in opioid dependence.
A controlled trial comparing buprenorphine and methadone maintenance in opioid dependence.
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DOI：
10.1001/archpsyc.1996.01830050035005
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发表时间：
1996-05
影响因子：
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通讯作者：
W. Ling;D. Wesson;C. Charuvastra;Klett Cj
中科院分区：
文献类型：
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作者：
W. Ling;D. Wesson;C. Charuvastra;Klett Cj
丁丙诺啡是μ-阿片受体的部分激动剂，其已被提出作为用于治疗阿片成瘾的传统完全激动剂维持疗法的替代方案。我们报告的临床试验中，长期固定剂量的丁丙诺啡维持的相对安全性和有效性进行了检查相比，低剂量和高剂量的美沙酮维持。方法225例寻求治疗的阿片类药物成瘾者（46例女性，179例男性）以双盲方式随机接受8 mg/d丁丙诺啡、30 mg/d美沙酮或80 mg/d美沙酮维持治疗1年。在研究中点和终止时检查了疗效的客观和主观指标（尿液毒理学、尿潴留、渴求和戒断症状），并对整个52周研究期间的安全性数据制表。结果：在26周和52周的时间点上，分配到高剂量美沙酮维持治疗组的患者在保留、阿片类药物使用和阿片类药物渴望方面的表现明显优于低剂量美沙酮组或丁丙诺啡组。后两组在这些指标上的表现几乎相同。未发现丁丙诺啡对健康造成严重不良影响。结论：在本研究的条件下，丁丙诺啡维持在8 mg/d似乎低于最佳疗效。需要继续进行研究，以使这些调查结果与其他调查小组报告的更积极的结果相一致。长期维持该剂量的丁丙诺啡没有明显的健康风险。
BACKGROUND Buprenorphine is a partial agonist at the mu-opioid receptor that has been proposed as an alternative to traditional full agonist maintenance therapy for the treatment of opioid addiction. We report on a clinical trial in which the relative safety and efficacy of long-term fixed-dose buprenorphine maintenance was examined in comparison to low- and high-dose methadone maintenance. METHODS Two hundred twenty-five treatment-seeking opioid addicts (46 women, 179 men) were randomly assigned to receive, in a double-blind manner, either 8 mg/d of buprenorphine, 30 mg/d of methadone, or 80 mg/d of methadone maintenance over a 1-year period. Objective and subjective measures of efficacy (urine toxicology, retention, craving, and withdrawal symptoms) were examined at the study midpoint and at termination, and safety data were tabulated over the entire 52-week study period. RESULTS Patients assigned to high-dose methadone maintenance performed significantly better on measures of retention, opioid use, and opioid craving than either the low-dose methadone or the buprenorphine group at both 26-week and 52-week time points. Performance on these measures was virtually identical between the latter two groups. No serious adverse health effects attributable to buprenorphine were noted. CONCLUSIONS Buprenorphine maintenance at 8 mg/d appears to be less than optimally efficacious under the conditions of the present study. Continued research is needed to reconcile these findings with the more positive results reported by other investigative groups. There are no apparent health risks associated with long-term buprenorphine maintenance at this dosage.