Schottenfeld R S, Pakes J, O'Connor P, Chawarski M, Oliveto A, Kosten T R
Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA.
Biol Psychiatry. 2000 Jun 15;47(12):1072-9. doi: 10.1016/s0006-3223(99)00270-x.
Buprenorphine is a promising alternative to methadone or levo-acetyl alpha methadol for opioid agonist maintenance treatment, and thrice-weekly dosing would facilitate its use for this purpose.
After a 3-day induction, opioid-dependent patients (n = 92) were randomly assigned to daily clinic attendance and 12-weeks maintenance treatment with sublingual buprenorphine administered double blind either daily (n = 45; 16 mg/70 kg) or thrice weekly (n = 47; 34 mg/70 kg on Fridays and Sundays and 44 mg/70 kg on Tuesdays). Outcome measures include retention, results of 3x/week urine toxicology tests, and weekly self-reported illicit drug use.
There were no significant differences at baseline in important social, demographic, and drug-use features. Retention was 71% in the daily and 77% in the 3x/week conditions. The proportion of opioid-positive urine tests decreased significantly from baseline in both groups and averaged 57% (daily) and 58% in 3x/week. There were no significant differences between groups in self-reported number of bags of heroin used for any day of the week, including Thursdays (48-72 hours following the last buprenorphine dose for subjects in the 3x/week condition), or in medication compliance (92%, 91%) and counseling attendance (82%, 82%).
At an equivalent weekly dose of 112 mg/70 kg, thrice-weekly and daily sublingual buprenorphine appear comparable in efficacy with regard to retention and reductions in illicit opioid and other drug use. These findings support the potential for utilizing thrice-weekly buprenorphine dosing in novel settings.
丁丙诺啡是用于阿片类激动剂维持治疗的美沙酮或左乙酰-α-美沙多的一种有前景的替代药物,每周三次给药将便于其用于此目的。
经过3天的诱导期后,阿片类药物依赖患者(n = 92)被随机分配至每日到诊所就诊,并接受为期12周的维持治疗,采用双盲法给予舌下丁丙诺啡,每日给药(n = 45;16 mg/70 kg)或每周三次(n = 47;周五和周日为34 mg/70 kg,周二为44 mg/70 kg)。结果指标包括留存率、每周三次尿液毒理学检测结果以及每周自我报告的非法药物使用情况。
在重要的社会、人口统计学和药物使用特征方面,两组在基线时无显著差异。每日给药组的留存率为71%,每周三次给药组为77%。两组阿片类药物阳性尿液检测比例均较基线时显著下降,每日给药组平均为57%,每周三次给药组为58%。在自我报告的每周任何一天使用的海洛因袋数方面,两组之间无显著差异,包括周四(每周三次给药组在最后一剂丁丙诺啡给药后48 - 72小时),在药物依从性(92%,91%)和咨询就诊率(82%,82%)方面也无显著差异。
在每周等效剂量为1,12 mg/70 kg时,舌下丁丙诺啡每周三次给药和每日给药在留存率以及减少非法阿片类药物和其他药物使用方面的疗效似乎相当。这些发现支持了在新环境中使用每周三次丁丙诺啡给药的可能性。