1-year retention and social function after buprenorphine-assisted relapse prevention treatment for heroin dependence in Sweden: a randomised, placebo-controlled trial
1-year retention and social function after buprenorphine-assisted relapse prevention treatment for heroin dependence in Sweden: a randomised, placebo-controlled trial
复制标题
瑞典海洛因依赖丁丙诺啡辅助预防复吸治疗后的 1 年保留率和社会功能：随机安慰剂对照试验
DOI：
10.1016/s0140-6736(03)12600-1
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发表时间：
2003-02-22
期刊：
影响因子：
168.9
通讯作者：
Heilig, M
中科院分区：
文献类型：
--
作者：
Kakko, J;Svanborg, KD;Heilig, M
背景
部分阿片受体激动剂丁丙诺啡已被建议用于治疗海洛因依赖，但关于其有效性的长期、安慰剂对照研究较少。我们旨在评估丁丙诺啡联合强化心理社会治疗对海洛因依赖的1年疗效。
方法
40名年龄在20岁以上、符合《精神障碍诊断与统计手册》第四版（DSM - IV）阿片类药物依赖标准至少1年，但不符合瑞典美沙酮维持治疗法律标准的个体，被随机分配接受每日丁丙诺啡治疗（固定剂量为舌下含服16mg，持续12个月；至少6个月每日监督给药，之后可能给予带回家的剂量）或丁丙诺啡6天递减方案，之后使用安慰剂。所有患者都参加认知行为团体治疗以预防复发，接受每周一次的个体咨询，并每周三次提交受监督的尿液样本进行分析以检测非法药物使用情况。我们的主要终点是1年治疗保留率，采用意向性治疗分析。
结果
丁丙诺啡组和安慰剂组的1年治疗保留率分别为75%和0%（p = 0.0001；风险比58.7 [95%置信区间7.4 - 467.4]）。在继续接受治疗的患者中，尿液筛查非法阿片类药物、中枢兴奋剂、大麻素和苯二氮䓬类药物呈阴性的比例约为75%。
解释
丁丙诺啡与强化心理社会治疗相结合是安全且高效的，应该被纳入海洛因依赖者可选择的治疗方案中。
Background The partial opiate-receptor agonist buprenorphine has been suggested for treatment of heroin dependence, but there are few long-term and placebo-controlled studies of its effectiveness. We aimed to assess the 1-year efficacy of buprenorphine in combination with intensive psychosocial therapy for treatment of heroin dependence.Methods 40 individuals aged older than 20 years, who met DSM-IV criteria for opiate dependence for at least 1 year, but did not fulfil Swedish legal criteria for methadone maintenance treatment were randomly allocated either to daily buprenorphine (fixed dose 16 mg sublingually for 12 months; supervised daily administration for a least 6 months, possible take-home doses thereafter) or a tapered 6 day regimen of buprenorphine, thereafter followed by placebo. All patients participated in cognitive-behavioural group therapy to prevent relapse, received weekly individual counselling sessions, and submitted thrice weekly supervised urine samples for analysis to detect illicit drug use. Our primary endpoint was 1-year retention in treatment and analysis was by intention to treat.Findings 1-year retention in treatment was 75% and 0% in the buprenorphine and placebo groups, respectively (p=0.0001; risk ratio 58.7 [95% CI 7.4-467.4]). Urine screens were about 75% negative for illicit opiates, central stimulants, cannabinoids, and benzodiazepines in the patients remaining in treatment.Interpretation The combination of buprenorphine and intensive psychosocial treatment is safe and highly efficacious, and should be added to the treatment options available for individuals who are dependent on heroin.