Ling W, Wesson D R, Charuvastra C, Klett C J
Los Angeles Addiction Treatment Research Center, Calif., USA.
Arch Gen Psychiatry. 1996 May;53(5):401-7. doi: 10.1001/archpsyc.1996.01830050035005.
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.
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.
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.
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.
丁丙诺啡是μ-阿片受体的部分激动剂，已被提议作为传统全激动剂维持疗法治疗阿片类药物成瘾的替代方案。我们报告了一项临床试验，比较了长期固定剂量丁丙诺啡维持治疗与低剂量和高剂量美沙酮维持治疗的相对安全性和有效性。
225名寻求治疗的阿片类药物成瘾者（46名女性，179名男性）被随机双盲分配，在1年的时间里接受每日8毫克丁丙诺啡、每日30毫克美沙酮或每日80毫克美沙酮维持治疗。在研究中点和结束时检查疗效的客观和主观指标（尿液毒理学、戒断率、渴望和戒断症状），并在整个52周的研究期间将安全数据制成表格。
在26周和52周时间点，接受高剂量美沙酮维持治疗的患者在戒断率、阿片类药物使用和阿片类药物渴望指标上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。未观察到与丁丙诺啡相关的严重不良健康影响。
在本研究条件下，每日8毫克丁丙诺啡维持治疗的疗效似乎未达最佳。需要继续研究，以将这些结果与其他研究小组报告的更积极结果相协调。该剂量的丁丙诺啡长期维持治疗没有明显的健康风险。
