阿片类药物依赖初级保健中的美沙酮诱导治疗：一项实用随机试验（ANRS Methaville）
Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).
作者信息
Carrieri Patrizia Maria, Michel Laurent, Lions Caroline, Cohen Julien, Vray Muriel, Mora Marion, Marcellin Fabienne, Spire Bruno, Morel Alain, Roux Perrine
机构信息
INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.
INSERM, Research Unit 669, Paris, France; Univ Paris-Sud and Univ Paris Descartes, UMR-S0669, Paris, France; Centre Pierre Nicole, Paris, France.
出版信息
PLoS One. 2014 Nov 13;9(11):e112328. doi: 10.1371/journal.pone.0112328. eCollection 2014.
OBJECTIVE
Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC.
METHODS
In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively.
RESULTS
In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively).
CONCLUSIONS
Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence.
TRIAL REGISTRATION
Number Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511.
目的
在许多国家，美沙酮的覆盖率较低，部分原因是美沙酮诱导仅在专科护理（SC）中可行。这项多中心实用性试验比较了两种诱导模式（初级护理（PC）和专科护理）下美沙酮治疗的效果。
方法
本研究已在ClinicalTrials.Gov（NCT00657397）注册，未接受美沙酮治疗至少1个月或正在接受丁丙诺啡治疗但需要换药的阿片类药物依赖个体被随机分配到法国10个地点的初级护理组（N = 155）或专科护理组（N = 66）开始接受美沙酮治疗。访视安排在第0、3、6和12个月。主要结局是在12个月时自我报告已戒除街头阿片类药物（第12个月）（对初级护理组有一个潜在的15%非劣效性假设）。次要结局是随访期间的戒除情况、参与治疗（即完成诱导期）、留存率以及对医生提供解释的满意度。主要分析采用意向性分析（ITT）。混合模型和对数秩检验分别用于评估两组（初级护理组与专科护理组）对戒除过程和留存率的影响。
结果
在ITT分析中（初级护理组n = 155，专科护理组n = 66），比较戒除街头阿片类药物的参与者比例，初级护理组和专科护理组在第12个月时分别有85/155（55%）和22/66（33%）的参与者被归类为戒除街头阿片类药物。该ITT分析显示初级护理组具有非劣效性（21.5 [7.7; 35.3]）。初级护理组在参与治疗和对医生提供解释的满意度方面显著高于专科护理组。两组在美沙酮留存率和随访期间的戒除情况相当（分别为p = 0.47，p = 0.39）。
结论
在适当条件下，初级护理中的美沙酮诱导对医生和患者而言都是可行且可接受的。在减少街头阿片类药物使用以及确保阿片类药物依赖治疗的参与度和留存率方面，其效果与专科护理诱导相当。
试验注册
Eudract编号2008 - 001338 - 28；ClinicalTrials.gov：NCT00657397；国际标准随机对照试验编号注册ISRCTN31125511。
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