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新型阿片类药物丁丙诺啡治疗慢性疼痛的安全性与有效性

Safety And Efficacy Of The Unique Opioid Buprenorphine For The Treatment Of Chronic Pain.

作者信息

Pergolizzi Joseph V, Raffa Robert B

机构信息

NEMA Research, Inc., Naples, FL, USA.

Neumentum, Palo Alto, CA, USA.

出版信息

J Pain Res. 2019 Dec 13;12:3299-3317. doi: 10.2147/JPR.S231948. eCollection 2019.

Abstract

BACKGROUND

Chronic pain is associated with decreased quality of life and is one of the most common reasons adults seek medical care, making treatment imperative for many aspects of patient well-being. Chronic pain management typically involves the use of Schedule II full μ-opioid receptor agonists for pain relief; however, the increasing prevalence of opioid addiction is a national crisis that is impacting public health and social and economic welfare. Buprenorphine is a Schedule III partial μ-opioid receptor agonist that is an equally effective but potentially safer treatment option for chronic pain than full μ-opioid receptor agonists. The purpose of this review is to provide an overview of the clinical efficacy and safety of the transdermal and buccal formulations of buprenorphine, which are approved by the Food and Drug Administration for chronic pain, compared with that of extended-release full μ-opioid receptor agonists.

METHODS

Controlled or randomized controlled clinical trial information was retrieved from EMBASE, Medline, and PubMed using the search terms "buprenorphine" AND "chronic" AND "pain."

RESULTS

A total of 33 clinical studies were ultimately used in this review, including 29 (88%) on transdermal buprenorphine and 4 (12%) on buprenorphine buccal film. Although the measure of pain intensity varied among studies, each of these 33 trials demonstrated efficacy for buprenorphine in pain relief. A total of 28 studies also assessed safety, with each concluding that buprenorphine was generally well tolerated.

CONCLUSION

Comparison of current clinical data along with results of responder and safety analyses support the use of buprenorphine over full μ-opioid receptor agonists for effective preferential treatment of chronic pain; however, head-to-head clinical studies are warranted.

摘要

背景

慢性疼痛与生活质量下降相关,是成年人寻求医疗护理的最常见原因之一,因此对患者健康的多个方面而言,治疗势在必行。慢性疼痛管理通常涉及使用附表II类完全μ-阿片受体激动剂来缓解疼痛;然而,阿片类药物成瘾患病率的不断上升是一场影响公众健康以及社会和经济福利的全国性危机。丁丙诺啡是附表III类部分μ-阿片受体激动剂,对于慢性疼痛而言,它是一种与完全μ-阿片受体激动剂同样有效但可能更安全的治疗选择。本综述的目的是概述丁丙诺啡经皮制剂和口腔贴片制剂(已获美国食品药品监督管理局批准用于治疗慢性疼痛)与缓释完全μ-阿片受体激动剂相比的临床疗效和安全性。

方法

使用检索词“丁丙诺啡”、“慢性”和“疼痛”从EMBASE、Medline和PubMed中检索对照或随机对照临床试验信息。

结果

本综述最终共纳入33项临床研究,其中29项(88%)关于丁丙诺啡经皮制剂,4项(12%)关于丁丙诺啡口腔贴片。尽管各研究中疼痛强度的测量方法有所不同,但这33项试验均证明丁丙诺啡在缓解疼痛方面有效。共有28项研究还评估了安全性,每项研究均得出结论,丁丙诺啡总体耐受性良好。

结论

对当前临床数据以及反应者和安全性分析结果的比较支持使用丁丙诺啡而非完全μ-阿片受体激动剂来有效优先治疗慢性疼痛;然而,仍需要进行直接比较的临床研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d441/6917545/6151bc6694c6/JPR-12-3299-g0001.jpg

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