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美沙酮联合氯胺酮治疗神经性慢性疼痛:一项随机、双盲、活性对照临床试验

Management of Neuropathic Chronic Pain with Methadone Combined with Ketamine: A Randomized, Double Blind, Active-Controlled Clinical Trial.

作者信息

Rigo Flavia Karine, Trevisan Gabriela, Godoy Maria C, Rossato Mateus Fortes, Dalmolin Gerusa D, Silva Mariane A, Menezes Mirian S, Caumo Wolnei, Ferreira Juliano

机构信息

Graduation Core of Santa Casa de Belo Horizonte, Department of Biomedicin and Medicin, Belo Horizonte, MG, Brazil; Department of Health, University of South of Santa Catarina - UNESC, Criciuma - SC, Brazil.

Department of Health, University of South of Santa Catarina - UNESC, Criciuma - SC, Brazil.

出版信息

Pain Physician. 2017 Mar;20(3):207-215.

PMID:28339433
Abstract

BACKGROUND

Methadone and ketamine are used in neuropathic pain management. However, the benefits of both drugs association are uncertain in the treatment of neuropathic pain.

OBJECTIVE

Our primary objective was test the hypothesis that oral methadone combined with oral ketamine is more effective than oral methadone or ketamine alone in reducing neuropathic pain.

STUDY DESIGN

We conducted a randomized, double blind, active-controlled parallel-group clinical trial.

METHODS

Forty-two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive oral methadone (n = 14), ketamine (n = 14), or methadone plus ketamine (n = 14) over a 3-month period.

RESULTS

During these 90 days, we observed pain scores using a visual analogical scale (VAS), allodynia, burning/shooting pain, and some side effects. All treatments were effective in reducing pain scores by at least 40%. However, a significant improvement in pain was observed only in the ketamine alone group compared with both the methadone or methadone/ketamine groups. No significant differences were observed among the treatment groups for the reduction of burning or shooting pain, while ketamine alone was more effective than methadone or methadone/ketamine for the reduction of allodynia.

LIMITATIONS

Formal assessment for awareness of the allocation was not performed, some co-intervention bias may have occurred, our results could be only relevant to the patient population investigated and the use of VAS as the primary outcome detect changes in pain intensity but not to assess neuropathic pain symptoms.

CONCLUSION

This study indicates that ketamine was better than methadone or methadone/ketamine for treating neuropathic pain.Key words: Multimodal analgesia, refractory pain, NMDA receptor, opioid.

摘要

背景

美沙酮和氯胺酮用于神经性疼痛管理。然而,两种药物联合使用在神经性疼痛治疗中的益处尚不确定。

目的

我们的主要目的是检验以下假设:口服美沙酮联合口服氯胺酮在减轻神经性疼痛方面比单独使用口服美沙酮或氯胺酮更有效。

研究设计

我们进行了一项随机、双盲、活性对照平行组临床试验。

方法

42例对传统治疗无效的神经性疼痛患者在3个月期间被随机分配接受口服美沙酮(n = 14)、氯胺酮(n = 14)或美沙酮加氯胺酮(n = 14)治疗。

结果

在这90天内,我们使用视觉模拟量表(VAS)观察疼痛评分、异常性疼痛、烧灼样/刺痛样疼痛以及一些副作用。所有治疗在将疼痛评分降低至少40%方面均有效。然而,与美沙酮组或美沙酮/氯胺酮组相比,仅氯胺酮组的疼痛有显著改善。各治疗组在减轻烧灼样或刺痛样疼痛方面未观察到显著差异,而单独使用氯胺酮在减轻异常性疼痛方面比美沙酮或美沙酮/氯胺酮更有效。

局限性

未进行分配方案的正式评估,可能发生了一些联合干预偏倚,我们的结果可能仅与所研究的患者群体相关,并且使用VAS作为主要结局仅能检测疼痛强度的变化,而不能评估神经性疼痛症状。

结论

本研究表明,氯胺酮在治疗神经性疼痛方面优于美沙酮或美沙酮/氯胺酮。关键词:多模式镇痛、难治性疼痛、NMDA受体、阿片类药物

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