Regis University School of Pharmacy, Denver, Colorado.
Pharmacotherapy. 2018 Mar;38(3):382-389. doi: 10.1002/phar.2086. Epub 2018 Feb 23.
Chronic inflammatory diseases are complex to treat and have an impact on a large number of patients. Due to the difficulty of treating these diseases and the great impact on quality of life, patients often seek off-label, complimentary, or alternative medicines to gain relief from symptoms. Low-dose naltrexone has been used off-label for treatment of pain and inflammation in multiple sclerosis, Crohn's disease, fibromyalgia, and other diseases. Naltrexone is a mu-opioid receptor antagonist indicated by the U.S. Food and Drug Administration for opioid and alcohol dependence. It is hypothesized that lower than standard doses of naltrexone inhibit cellular proliferation of T and B cells and block Toll-like receptor 4, resulting in an analgesic and antiinflammatory effect. It is the purpose of this review to examine the evidence of the safety, tolerability, and efficacy of low-dose naltrexone for use in chronic pain and inflammatory conditions. Currently, evidence supports the safety and tolerability of low-dose naltrexone in multiple sclerosis, fibromyalgia, and Crohn's disease. Fewer studies support the efficacy of low-dose naltrexone, with most of these focusing on subjective measures such as quality of life or self-reported pain. These studies do demonstrate that low-dose naltrexone has subjective benefits over placebo, but evidence for more objective measures is limited. However, further randomized controlled trials are needed to determine the efficacy of low-dose naltrexone due to insufficient evidence supporting its use in these disease states. This review provides practitioners with the extent of low-dose naltrexone evidence so that they can be cognizant of situations where it may not be the most appropriate therapy.
慢性炎症性疾病的治疗较为复杂,会影响大量患者。由于这些疾病难以治疗且极大地影响生活质量,因此患者通常会寻求超说明书、补充性或替代性药物来缓解症状。低剂量纳曲酮已被用于治疗多发性硬化症、克罗恩病、纤维肌痛症和其他疾病的疼痛和炎症,属于超说明书用药。美国食品和药物管理局批准纳曲酮用于治疗阿片类药物和酒精依赖,其作用机制为作为μ-阿片受体拮抗剂,抑制 T 和 B 细胞的增殖并阻断 Toll 样受体 4,从而产生镇痛和抗炎作用。本文旨在探讨低剂量纳曲酮治疗慢性疼痛和炎症性疾病的安全性、耐受性和疗效的证据。目前,有证据支持低剂量纳曲酮在多发性硬化症、纤维肌痛症和克罗恩病中的安全性和耐受性。但支持低剂量纳曲酮疗效的证据较少,这些研究大多集中在生活质量或自我报告的疼痛等主观指标上。这些研究确实表明,与安慰剂相比,低剂量纳曲酮具有主观获益,但对于更客观的指标的证据有限。然而,由于缺乏对其在这些疾病状态下使用的证据,因此还需要进一步的随机对照试验来确定低剂量纳曲酮的疗效。本文为临床医生提供了低剂量纳曲酮的证据范围,以便他们了解在哪些情况下该药物可能不是最合适的治疗选择。