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对难治性海洛因成瘾者使用海洛因的医学处方:两项随机对照试验。

Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials.

作者信息

van den Brink Wim, Hendriks Vincent M, Blanken Peter, Koeter Maarten W J, van Zwieten Barbara J, van Ree Jan M

机构信息

Central Committee on the Treatment of Heroin Addicts (CCBH), Stratenum, Universiteitsweg 100, 3584 CG Utrecht, Netherlands.

出版信息

BMJ. 2003 Aug 9;327(7410):310. doi: 10.1136/bmj.327.7410.310.

Abstract

OBJECTIVE

To determine whether supervised medical prescription of heroin can successfully treat addicts who do not sufficiently benefit from methadone maintenance treatment.

DESIGN

Two open label randomised controlled trials.

SETTING

Methadone maintenance programmes in six cities in the Netherlands.

PARTICIPANTS

549 heroin addicts.

INTERVENTIONS

Inhalable heroin (n = 375) or injectable heroin (n = 174) prescribed over 12 months. Heroin (maximum 1000 mg per day) plus methadone (maximum 150 mg per day) compared with methadone alone (maximum 150 mg per day). Psychosocial treatment was offered throughout.

MAIN OUTCOME MEASURES

Dichotomous, multidomain response index, including validated indicators of physical health, mental status, and social functioning.

RESULTS

Adherence was excellent with 12 month outcome data available for 94% of the randomised participants. With intention to treat analysis, 12 month treatment with heroin plus methadone was significantly more effective than treatment with methadone alone in the trial of inhalable heroin (response rate 49.7% v 26.9%; difference 22.8%, 95% confidence interval 11.0% to 34.6%) and in the trial of injectable heroin (55.5% v 31.2%; difference 24.3%, 9.6% to 39.0%). Discontinuation of the coprescribed heroin resulted in a rapid deterioration in 82% (94/115) of those who responded to the coprescribed heroin. The incidence of serious adverse events was similar across treatment conditions.

CONCLUSIONS

Supervised coprescription of heroin is feasible, more effective, and probably as safe as methadone alone in reducing the many physical, mental, and social problems of treatment resistant heroin addicts.

摘要

目的

确定在监督下开具海洛因医疗处方能否成功治疗那些从美沙酮维持治疗中获益不足的成瘾者。

设计

两项开放标签随机对照试验。

地点

荷兰六个城市的美沙酮维持治疗项目。

参与者

549名海洛因成瘾者。

干预措施

在12个月内开具可吸入海洛因(n = 375)或注射用海洛因(n = 174)处方。将海洛因(最大剂量每日1000毫克)加美沙酮(最大剂量每日150毫克)与单独使用美沙酮(最大剂量每日150毫克)进行比较。全程提供心理社会治疗。

主要结局指标

二分法多领域反应指数,包括经验证的身体健康、精神状态和社会功能指标。

结果

依从性良好,94%的随机参与者有12个月的结局数据。在意向性分析中,在可吸入海洛因试验中,海洛因加美沙酮治疗12个月比单独使用美沙酮治疗显著更有效(反应率49.7%对26.9%;差异22.8%,95%置信区间11.0%至34.6%),在注射用海洛因试验中也是如此(55.5%对31.2%;差异24.3%,9.6%至39.0%)。停用联合开具的海洛因后,82%(94/115)对联合开具的海洛因有反应的人病情迅速恶化。各治疗组严重不良事件的发生率相似。

结论

在监督下联合开具海洛因处方对于减少治疗抵抗性海洛因成瘾者的诸多身体、心理和社会问题是可行的、更有效的,且可能与单独使用美沙酮一样安全。

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