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曲马多治疗脊髓损伤后神经病理性疼痛:一项随机、双盲、安慰剂对照试验。

Tramadol in neuropathic pain after spinal cord injury: a randomized, double-blind, placebo-controlled trial.

作者信息

Norrbrink Cecilia, Lundeberg Thomas

机构信息

Spinalis SCI Unit, Karolinska University Hospital, Stockholm, Sweden.

出版信息

Clin J Pain. 2009 Mar-Apr;25(3):177-84. doi: 10.1097/AJP.0b013e31818a744d.

Abstract

OBJECTIVES

To assess the efficacy and safety of tramadol for relieving neuropathic pain after spinal cord injury (SCI).

METHODS

Thirty-six patients with SCI and neuropathic pain were enrolled in a randomized, double-blind, placebo-controlled trial, and 35 patients were included in the intention-to-treat analysis based on all patients taking at least 1 dose of study medication. Of the intention-to-treat population, 23 were randomized to treatment with tramadol and 12 to placebo. Patients were given study medication for 4 weeks, starting with 3 times 50 mg tramadol daily or 3 times 1 tablet of placebo.

RESULTS

At evaluation, 4 weeks after the treatment initiation, ratings of pain intensity were lower in those randomized to tramadol compared with those on placebo. Pain severity scores on the Multidimensional Pain Inventory had also decreased in patients on tramadol. No between-group differences in pain affect were observed. Adverse events were substantial and caused 43% of those on tramadol and 17% on placebo to withdraw from the study.

DISCUSSION

Tramadol might be tried for neuropathic pain after SCI after the use of gabapentin/pregabalin, and tricyclic antidepressants have been found to be insufficient. Titration should be slow and individual, to minimize the risk of adverse events.

摘要

目的

评估曲马多缓解脊髓损伤(SCI)后神经性疼痛的疗效和安全性。

方法

36例患有SCI和神经性疼痛的患者被纳入一项随机、双盲、安慰剂对照试验,基于所有服用至少1剂研究药物的患者,35例患者被纳入意向性分析。在意向性分析人群中,23例被随机分配接受曲马多治疗,12例接受安慰剂治疗。患者接受研究药物治疗4周,起始剂量为每日3次,每次50mg曲马多或每日3次,每次1片安慰剂。

结果

在治疗开始4周后的评估中,随机接受曲马多治疗的患者的疼痛强度评分低于接受安慰剂治疗的患者。曲马多治疗的患者在多维疼痛量表上的疼痛严重程度评分也有所下降。未观察到组间疼痛影响方面的差异。不良事件较为严重,导致43%服用曲马多的患者和17%服用安慰剂的患者退出研究。

讨论

在使用加巴喷丁/普瑞巴林且发现三环类抗抑郁药疗效不足后,可尝试使用曲马多治疗SCI后的神经性疼痛。滴定应缓慢且个体化,以尽量降低不良事件的风险。

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