Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence
Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence
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DOI：
10.1056/nejmoa055255
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发表时间：
2006-07-27
影响因子：
158.5
通讯作者：
Schottenfeld, Richard S.
中科院分区：
文献类型：
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作者：
Fiellin, David A.;Pantalon, Michael V.;Schottenfeld, Richard S.
背景：对于在初级保健机构中基于办公室的丁丙诺啡 - 纳洛酮治疗阿片类药物依赖，咨询的最佳水平以及药物发放的频率尚未确定。
方法：我们进行了一项为期24周的随机对照临床试验，166名患者被分配到三种治疗方案中的一种：标准医疗管理且每周发放一次或每周发放三次药物，或者强化医疗管理且每周发放三次药物。标准医疗管理是简短的、手册指导的、以医学为重点的咨询；强化管理与之相似，但每次咨询时间延长。主要观察结果是自我报告的非法阿片类药物使用频率、阿片类药物阴性尿液样本的百分比以及连续戒除非法阿片类药物的最长周数。
结果：三种治疗方案在阿片类药物阴性尿液样本的平均百分比方面疗效相似（标准医疗管理且每周发放一次药物为44%；标准医疗管理且每周发放三次药物为40%；强化医疗管理且每周发放三次药物为40%；P = 0.82），在患者连续戒除非法阿片类药物的最长周数方面也是如此。所有三种治疗方案都与非法阿片类药物使用频率较基线显著降低相关，但治疗方案之间无显著差异。在24周时仍留在研究中的患者比例在接受标准医疗管理且每周发放一次药物（48%）、标准医疗管理且每周发放三次药物（43%）以及强化医疗管理且每周发放三次药物（39%）的患者之间无显著差异（P = 0.64）。丁丙诺啡 - 纳洛酮治疗的依从性各不相同；依从性提高与治疗结果改善相关。
结论：在初级保健中因阿片类药物依赖接受丁丙诺啡 - 纳洛酮治疗的患者中，每周简短咨询且每周发放一次药物的疗效与每周延长咨询且每周发放三次药物的疗效无显著差异。需要有提高丁丙诺啡 - 纳洛酮依从性的策略。（ClinicalTrials.gov编号，NCT00023283）
Background: The optimal level of counseling and frequency of attendance for medication distribution has not been established for the primary care, office-based buprenorphine-naloxone treatment of opioid dependence.Methods: We conducted a 24-week randomized, controlled clinical trial with 166 patients assigned to one of three treatments: standard medical management and either once-weekly or thrice-weekly medication dispensing or enhanced medical management and thrice-weekly medication dispensing. Standard medical management was brief, manual-guided, medically focused counseling; enhanced management was similar, but each session was extended. The primary outcomes were the self-reported frequency of illicit opioid use, the percentage of opioid-negative urine specimens, and the maximum number of consecutive weeks of abstinence from illicit opioids.Results: The three treatments had similar efficacies with respect to the mean percentage of opioid-negative urine specimens (standard medical management and once-weekly medication dispensing, 44 percent; standard medical management and thrice-weekly medication dispensing, 40 percent; and enhanced medical management and thrice-weekly medication dispensing, 40 percent; P=0.82) and the maximum number of consecutive weeks during which patients were abstinent from illicit opioids. All three treatments were associated with significant reductions from baseline in the frequency of illicit opioid use, but there were no significant differences among the treatments. The proportion of patients remaining in the study at 24 weeks did not differ significantly among the patients receiving standard medical management and once-weekly medication dispensing (48 percent) or thrice-weekly medication dispensing (43 percent) or enhanced medical management and thrice-weekly medication dispensing (39 percent) (P=0.64). Adherence to buprenorphine-naloxone treatment varied; increased adherence was associated with improved treatment outcomes.Conclusions: Among patients receiving buprenorphine-naloxone in primary care for opioid dependence, the efficacy of brief weekly counseling and once-weekly medication dispensing did not differ significantly from that of extended weekly counseling and thrice-weekly dispensing. Strategies to improve buprenorphine-naloxone adherence are needed. (ClinicalTrials.gov number, NCT00023283.)