Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial
Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial
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DOI：
10.1016/s0140-6736(08)60954-x
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发表时间：
2008-06-01
期刊：
影响因子：
168.9
通讯作者：
Mazlan, Mahmud
中科院分区：
文献类型：
--
作者：
Schottenfeld, Richard S.;Chawarski, Marek C.;Mazlan, Mahmud
背景扩大获得有效治疗海洛因依赖的机会是世界卫生优先事项，这也将减少艾滋病毒的传播。我们比较了纳曲酮、丁丙诺啡和不额外治疗I在接受戒毒和随后的药物咨询的患者在维持海洛因戒断、防止复发和减少艾滋病毒危险行为方面的有效性。方法通过计算机生成的随机序列，将126名来自马来西亚一家门诊研究诊所和戒毒计划的海洛因依赖者随机分配到24周的手动指导药物咨询和维持治疗中，纳曲酮(n=43)、丁丙诺啡(n=44)和安慰剂(n=39)。药物是在双盲和双模拟的基础上给药的。通过每周三次尿检评估的主要结果是首次使用海洛因的天数、海洛因复发的天数(连续三次阿片类药物尿检阳性)、最长连续戒毒天数以及在6个月内艾滋病毒危险行为的减少。这项研究在登记22个月后终止，因为丁丙诺啡在临时安全性分析中显示出更好的疗效。分析采用意向治疗。这项研究在ClinicalTrials.gov上注册，编号为NCT00383045。我们观察到在首次使用海洛因前的几天内，我们观察到了一致的线性对比(p=0。0009)，海洛因复发天数(p=0。最长连续戒断天数(p=0.0007)，丁丙诺啡效果最好，安慰剂效果最差。与纳曲酮(危险比1.87[95%CI 1.21-2.88])或安慰剂(2.02[1.29-3.16])相比，丁丙诺啡与首次使用海洛因的时间有关。服用丁丙诺啡后，海洛因复发的时间(2.7[1.38-3.42])和最长连续戒断天数(平均59天[95%可信区间43-76]比24天[13-35]；p=0)也显著高于安慰剂组。然而，对于这些结果，丁丙诺啡和纳曲酮之间的差异并不显著。纳曲酮和安慰剂之间的差异对任何结果都没有显著影响。在所有三种治疗方法中，艾滋病毒风险行为都比基线显著减少(p=0.003)，但三组之间的减少没有显著差异。解释说，我们的发现支持了丁丙诺啡维持治疗作为一种有效的公共卫生方法的广泛传播，以减少与海洛因依赖相关的问题。
Background Expansion of access to effective treatments for heroin dependence is a worldwide health priority that will also reduce HIV transmission. We compared the efficacy of naltrexone, buprenorphine, and no additional treatment I in patients receiving detoxification and subsequent drug counselling, for maintenance of heroin abstinence, prevention of relapse, and reduction of HIV risk behaviours.Methods 126 detoxified heroin-dependent patients, from an outpatient research clinic and detoxification programme in Malaysia, were randomly assigned by a computer-generated randomisation sequence to 24 weeks of manual-guided drug counselling and maintenance with naltrexone (n=43), buprenorphine (n=44), or placebo (n=39). Medications were administered on a double-blind and double-dummy basis. Primary outcomes, assessed by urine testing three times per week, were days to first heroin use, days to heroin relapse (three consecutive opioid-positive urine tests), maximum consecutive days of heroin abstinence, and reductions in HIV risk behaviours over 6 months. The study was terminated after 22 months of enrolment because buprenorphine was shown to have greater efficacy in an interim safety analysis. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00383045.Findings We observed consistent, linear contrasts in days to first heroin use (p=0 . 0009), days to heroin relapse (p=0 . 009), and maximum consecutive days abstinent (p=0.0007), with all results best for buprenorphine and worst for placebo. Buprenorphine was associated with greater time to first heroin use than were naltrexone (hazard ratio 1.87 [95% CI 1.21-2.88]) or placebo (2.02 [1.29-3.16]). With buprenorphine, we also recorded significantly greater time to heroin relapse (2.7 [1.38-3.42]), and maximum consecutive days abstinent than with placebo (mean days 59 [95% CI 43-76] vs 24 [13-35]; p=0. 003); however, for these outcomes, differences between buprenorphine and naltrexone were not significant. Differences between naltrexone and placebo were not significant for any outcomes. HIV risk behaviours were significantly reduced from baseline across all three treatments (p=0.003), but the reductions did not differ significantly between the three groups.Interpretation Our findings lend support to the widespread dissemination of maintenance treatment with buprenorphine as an effective public-health approach to reduce problems associated with heroin dependence.Funding US National Institute on Drug Abuse.