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长效纳曲酮治疗艾滋病诊所中阿片类药物和酒精使用障碍的可行性与安全性:一项试点/可行性随机试验

Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: a pilot/feasibility randomized trial.

作者信息

Korthuis Philip T, Lum Paula J, Vergara-Rodriguez Pamela, Ahamad Keith, Wood Evan, Kunkel Lynn E, Oden Neal L, Lindblad Robert, Sorensen James L, Arenas Virgilio, Ha Doan, Mandler Raul N, McCarty Dennis

机构信息

Oregon Health and Science University, Portland, OR, USA.

University of California, San Francisco, CA, USA.

出版信息

Addiction. 2017 Jun;112(6):1036-1044. doi: 10.1111/add.13753. Epub 2017 Feb 8.

DOI:10.1111/add.13753
PMID:28061017
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5408318/
Abstract

BACKGROUND AND AIMS

HIV-infected people with substance use disorders are least likely to benefit from advances in HIV treatment. Integration of extended-release naltrexone (XR-NTX) into HIV clinics may increase engagement in the HIV care continuum by decreasing substance use. We aimed to compare (1) XR-NTX treatment initiation, (2) retention and (3) safety of XR-NTX versus treatment as usual (TAU) for treating opioid use disorder (OUD) and/or alcohol use disorder (AUD) in HIV clinics.

DESIGN

Non-blinded randomized trial of XR-NTX versus pharmacotherapy TAU.

SETTING

HIV primary care clinics in Vancouver, BC, Canada and Chicago, IL, USA.

PARTICIPANTS

Fifty-one HIV-infected patients seeking treatment for OUD (n = 16), AUD (n = 27) or both OUD and AUD (n = 8).

MEASUREMENTS

Primary outcomes were XR-NTX initiation (receipt of first injection within 4 weeks of randomization) and retention at 16 weeks. Secondary outcomes generated point estimates for change in substance use, HIV viral suppression [HIV RNA polymerase chain reaction (pcr) < 200 copies/ml] and safety.

FINDINGS

Two-thirds (68%) of participants assigned to XR-NTX initiated treatment, and 88% of these were retained on XR-NTX at 16 weeks. In comparison, 96% of TAU participants initiated treatment, but only 50% were retained on medication at 16 weeks. Mean days of opioid use in past 30 days decreased from 17.3 to 4.1 for TAU and from 20.3 to 7.7 for XR-NTX. Mean heavy drinking days decreased from 15.6 to 5.7 for TAU and 12.5 to 2.8 for XR-NTX. Among those with OUD, HIV suppression improved from 67 to 80% for XR-NTX and 58 to 75% for TAU. XR-NTX was well tolerated, with no precipitated withdrawals and one serious injection-site reaction.

CONCLUSIONS

Extended-release naltrexone (XR-NTX) is feasible and safe for treatment of opioid use disorder and alcohol use disorder in HIV clinics. Treatment initiation appears to be lower and retention greater for XR-NTX compared with treatment as usual (clinicaltrials.gov NCT01908062).

摘要

背景与目的

患有物质使用障碍的艾滋病毒感染者最不可能从艾滋病毒治疗进展中获益。将长效纳曲酮(XR-NTX)纳入艾滋病毒诊所可能会通过减少物质使用来提高对艾滋病毒护理连续过程的参与度。我们旨在比较(1)XR-NTX治疗的启动情况、(2)保留率以及(3)在艾滋病毒诊所中使用XR-NTX与常规治疗(TAU)治疗阿片类物质使用障碍(OUD)和/或酒精使用障碍(AUD)的安全性。

设计

XR-NTX与药物常规治疗的非盲随机试验。

地点

加拿大不列颠哥伦比亚省温哥华和美国伊利诺伊州芝加哥的艾滋病毒初级保健诊所。

参与者

51名寻求治疗OUD(n = 16)、AUD(n = 27)或OUD和AUD两者(n = 8)的艾滋病毒感染者。

测量指标

主要结局为XR-NTX启动(随机分组后4周内接受首次注射)和16周时的保留率。次要结局生成了物质使用变化、艾滋病毒病毒抑制[艾滋病毒RNA聚合酶链反应(PCR)<200拷贝/毫升]和安全性的点估计值。

研究结果

分配到XR-NTX组的参与者中有三分之二(68%)开始治疗,其中88%在16周时继续接受XR-NTX治疗。相比之下,TAU组96%的参与者开始治疗,但16周时只有50%继续接受药物治疗。TAU组过去30天阿片类物质的平均使用天数从17.3天降至4.1天,XR-NTX组从20.3天降至7.7天。TAU组重度饮酒的平均天数从15.6天降至5.7天,XR-NTX组从12.5天降至2.8天。在患有OUD的患者中,XR-NTX组的艾滋病毒抑制率从67%提高到80%,TAU组从58%提高到75%。XR-NTX耐受性良好,没有引发戒断反应,仅有1例严重的注射部位反应。

结论

长效纳曲酮(XR-NTX)在艾滋病毒诊所治疗阿片类物质使用障碍和酒精使用障碍是可行且安全的。与常规治疗相比,XR-NTX的治疗启动率似乎较低,但保留率较高(clinicaltrials.gov NCT01908062)。

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