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评价度洛西汀在烧伤患者中的镇痛效果:一项开放标签随机对照试验。

Evaluation of the analgesic effects of duloxetine in burn patients: An open-label randomized controlled trial.

机构信息

Faculty of Pharmacy and Pharmaceutical Sciences, Kerman University of Medical Sciences, Kerman, Iran.

Department of Surgery, Kerman University of Medical Sciences, Kerman, Iran.

出版信息

Burns. 2019 May;45(3):598-609. doi: 10.1016/j.burns.2018.10.011. Epub 2018 Nov 20.

DOI:10.1016/j.burns.2018.10.011
PMID:30470568
Abstract

OBJECTIVES

To evaluate efficacy of addition of duloxetine to usual analgesic regimens in management of burn pain.

METHODS

In a 3-week open label randomized controlled trial, burn patients were assigned to the intervention (duloxetine 60mg/day+usual analgesic regimens) or control group (usual analgesic regimens: morphine±acetaminophen±gabapentin). Intensity and quality of background pain and severity of procedural pain were evaluated using neuropathic pain scale (NPS) and visual analog scale (VAS), respectively. The primary outcome measure was "intensity" item of the NPS (evaluating intensity of the background pain).

RESULTS

Forty six patients (age: 35.5±6.3 years, TBSA: 36.7±15%) (23 per group) completed the study. At baseline, scores of the "intensity" item were 9.13±1.42 and 9.13±1.86 (P=1) in the intervention and control group, respectively. Comparison of difference in mean changes from baseline to the end of the study showed that addition of duloxetine only significantly reduced the scores of the "intensity" {1.74 (95% CI: 0.61 to 2.86); P=0.003}, and "hot" {1.39 (95% CI: 0.166 to 2.614) P=0.02} items and score of the VAS {2.13 (95% CI: 1.476 to 2.784) P<0.001}. The most reported adverse effects were nausea and insomnia in the both groups.

CONCLUSION

Addition of duloxetine may increase efficacy of the other analgesics in reduction of the burn pain.

摘要

目的

评估度洛西汀联合常规镇痛方案治疗烧伤疼痛的疗效。

方法

在一项为期 3 周的开放性标签随机对照试验中,烧伤患者被分配到干预组(度洛西汀 60mg/天+常规镇痛方案)或对照组(常规镇痛方案:吗啡±对乙酰氨基酚±加巴喷丁)。使用神经性疼痛量表(NPS)和视觉模拟量表(VAS)分别评估背景疼痛的强度和质量以及操作疼痛的严重程度。主要观察指标为 NPS 的“强度”条目(评估背景疼痛的强度)。

结果

46 例患者(年龄:35.5±6.3 岁,TBSA:36.7±15%)(每组 23 例)完成了研究。基线时,干预组和对照组的“强度”项评分分别为 9.13±1.42 和 9.13±1.86(P=1)。从基线到研究结束时的平均变化差异比较显示,度洛西汀的添加仅显著降低了“强度”项的评分[1.74(95%CI:0.61 至 2.86);P=0.003]、“热”项[1.39(95%CI:0.166 至 2.614);P=0.02]和 VAS 评分[2.13(95%CI:1.476 至 2.784);P<0.001]。两组最常见的不良反应为恶心和失眠。

结论

度洛西汀的添加可能会增加其他镇痛药物治疗烧伤疼痛的疗效。

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