在接受纳曲酮长效制剂或丁丙诺啡-纳洛酮治疗的阿片类药物依赖者中，疼痛并未增加：一项为期 3 个月的随机研究和为期 9 个月的开放性治疗随访研究。
No increased pain among opioid-dependent individuals treated with extended-release naltrexone or buprenorphine-naloxone: A 3-month randomized study and 9-month open-treatment follow-up study.
机构信息
Department of R&D in Mental Health, Akershus University Hospital, Lørenskog, Norway.
Norwegian Center for Addiction Research, University of Oslo, Oslo, Norway.
出版信息
Am J Addict. 2019 Feb;28(2):77-85. doi: 10.1111/ajad.12859. Epub 2019 Jan 31.
BACKGROUND AND OBJECTIVES
It is presently unclear whether extended-release naltrexone hydrochloride treatment induces pain or aggravates existing pain among individuals with opioid use disorders. We assessed changes in pain among individuals receiving treatment with either extended-release naltrexone hydrochloride or buprenorphine-naloxone hydrochloride.
METHODS
This randomized prospective open-label clinical study included 143 participants (aged 18-60 years) with opioid dependencies, recruited from outpatient addiction clinics at five urban hospitals in Norway. After in-patient detoxification from opioids, patients were randomized to 12-week treatment with either long-acting naltrexone (380 mg intramuscularly injected every four weeks) or buprenorphine-naloxone (flexible 4-16 mg sublingual doses daily). This phase was followed by a 9-month open-treatment study with the participant's choice of either naltrexone or buprenorphine-naloxone. Changes in pain were assessed every 4 weeks using the Norwegian Short-Form of McGill Pain Questionnaire.
RESULTS
Throughout the study period, we found no increase in mean sensory pain, affective pain, or present pain intensity on the McGill Pain Questionnaire, in either treatment group, including the subgroups of participants with chronic pain. Participants who switched from buprenorphine-naloxone to extended-release naltrexone treatment after week 12 reported no increase in pain intensity during longer-term treatment. Women experienced significantly more affective pain symptoms than men (p = .01).
DISCUSSION AND CONCLUSIONS
Among individuals with opioid use disorder, switching from daily opioid use to long-acting naltrexone did not induce pain, or aggravate mild-to-moderate chronic pain.
SCIENTIFIC SIGNIFICANCE
In opioid-dependent individuals, mild-to-moderate chronic pain was not influenced by opioid agonist or antagonist treatment.
TRIAL REGISTRATION
Clinicaltrials.gov #NCT01717963, first registered: Oct 28, 2012. Protocol version # 3C, June 12th 2012. (Am J Addict 2018;XX:1-9).
背景与目的
目前尚不清楚盐酸纳曲酮缓释片治疗是否会引起阿片类药物使用障碍患者的疼痛或加重其现有疼痛。我们评估了接受盐酸纳曲酮缓释片或丁丙诺啡-纳洛酮治疗的个体的疼痛变化。
方法
这项随机前瞻性开放标签临床试验纳入了 143 名（年龄 18-60 岁）阿片类药物依赖者，他们来自挪威 5 家城市医院的门诊成瘾诊所。在阿片类药物脱毒住院治疗后，患者被随机分配接受为期 12 周的长效纳曲酮（每四周肌肉注射 380mg）或丁丙诺啡-纳洛酮（灵活的 4-16mg 舌下每日剂量）治疗。随后是为期 9 个月的开放治疗期，参与者可选择纳曲酮或丁丙诺啡-纳洛酮治疗。使用挪威 McGill 疼痛问卷的简短形式，每 4 周评估一次疼痛变化。
结果
在整个研究期间，我们发现无论在哪个治疗组（包括慢性疼痛亚组），在感觉疼痛、情感疼痛或当前疼痛强度的 McGill 疼痛问卷评分上，均值均未增加。12 周后从丁丙诺啡-纳洛酮转为盐酸纳曲酮缓释片治疗的参与者在长期治疗期间报告疼痛强度没有增加。女性的情感疼痛症状明显多于男性（p=0.01）。
讨论与结论
在阿片类药物使用障碍者中，从每日阿片类药物使用转为长效纳曲酮治疗不会引起疼痛，也不会加重轻度至中度慢性疼痛。
科学意义
在阿片类药物依赖者中，轻度至中度慢性疼痛不受阿片类激动剂或拮抗剂治疗的影响。
临床试验注册
Clinicaltrials.gov #NCT01717963，首次注册：2012 年 10 月 28 日。方案版本 #3C，2012 年 6 月 12 日。（美国成瘾杂志 2018；XX：1-9）。
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