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盐酸他喷他多缓释片治疗慢性疼痛患者。

Tapentadol extended release for chronic pain patients.

机构信息

NEMA Research, Inc., Naples, Florida, USA.

出版信息

Adv Ther. 2013 Jan;30(1):14-27. doi: 10.1007/s12325-013-0002-y. Epub 2013 Jan 15.

Abstract

INTRODUCTION

Chronic pain reduces quality of life, utilizes healthcare resources, and increases healthcare costs. It is widespread, but generally inadequately treated or managed, partly due to several obstacles, including a limited number of mechanistic options for long-term pharmacologic agents. Opioids are generally the primary class of analgesic prescribed, but because of associated side effects during long-term treatment, many patients become noncompliant or discontinue treatment. A long-term use analgesic with a good benefit/risk ratio is advantageous.

METHODS

A literature search for randomized trials using tapentadol extended release (ER) for noncancer chronic pain patients was conducted. Databases searched included PubMed, MEDLINE, EMBASE, and Google Scholar, using key terms "tapentadol," "prolonged release," "extended release," and "chronic pain" individually or in combination. The results were synthesized and evaluated.

RESULTS

A total of six randomized, controlled studies were identified. Chronic pain conditions analyzed included low back, osteoarthritis, and diabetic peripheral neuropathy. Treatment arms consisted most often of placebo, tapentadol ER (100-250 mg twice daily [b.i.d.]), and/or oxycodone CR (controlled release) (20-50 mg b.i.d.). Subjects treated with tapentadol ER had significant reduction in pain intensity compared to placebo controls and similar efficacy to oxycodone CR. Overall, the safety profile was superior to that of oxycodone CR in regards to reduction in side effects, reduced severity of side effects (particularly gastrointestinal related), and lower study discontinuation rates.

CONCLUSION

The two mechanisms of analgesic action of tapentadol, combined with an ER, appears to provide equal efficacy to a strong controlled-release opioid while providing greater gastrointestinal tolerability. The reduction in incidence and severity of gastrointestinal side effects correlated with a higher compliance rate. These findings suggest that tapentadol ER might be a viable alternative to conventional strong opioids for pain management for chronic pain patients.

摘要

简介

慢性疼痛降低生活质量,消耗医疗资源,并增加医疗成本。它很普遍,但通常治疗或管理不当,部分原因是长期药物治疗的机制选择有限。阿片类药物通常是开处方的主要类别的镇痛药,但由于长期治疗期间的相关副作用,许多患者变得不遵守或停止治疗。具有良好效益/风险比的长期使用镇痛药是有利的。

方法

对使用盐酸他喷他多缓释片(ER)治疗非癌性慢性疼痛患者的随机试验进行了文献检索。搜索的数据库包括 PubMed、MEDLINE、EMBASE 和 Google Scholar,分别使用“tapentadol”、“prolonged release”、“extended release”和“chronic pain”作为关键词进行单独或组合搜索。对结果进行了综合评估。

结果

共确定了六项随机对照研究。分析的慢性疼痛病症包括腰痛、骨关节炎和糖尿病周围神经病变。治疗组最常见的是安慰剂、盐酸他喷他多 ER(100-250mg 每日两次 [b.i.d.])和/或盐酸羟考酮控释片(CR)(20-50mg b.i.d.)。与安慰剂对照组相比,接受盐酸他喷他多 ER 治疗的患者疼痛强度显著减轻,与盐酸羟考酮 CR 疗效相当。总体而言,在减少副作用、降低副作用严重程度(特别是胃肠道相关)和降低研究停药率方面,盐酸他喷他多 ER 的安全性优于盐酸羟考酮 CR。

结论

盐酸他喷他多的两种镇痛作用机制,加上 ER,似乎提供了与强力控释阿片类药物相同的疗效,同时具有更好的胃肠道耐受性。胃肠道副作用的发生率和严重程度降低与更高的顺应性相关。这些发现表明,盐酸他喷他多 ER 可能是慢性疼痛患者疼痛管理的传统强效阿片类药物的可行替代品。

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