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加巴喷丁治疗截肢后幻肢痛:一项随机、双盲、安慰剂对照、交叉研究。

Gabapentin in postamputation phantom limb pain: a randomized, double-blind, placebo-controlled, cross-over study.

作者信息

Bone Margaret, Critchley Peter, Buggy Donal J

机构信息

Departments of Anaesthesia and Pain Management, University Hospitals of Leicester NHS Trust, Leicester General Hosptial, Leicester, UK.

出版信息

Reg Anesth Pain Med. 2002 Sep-Oct;27(5):481-6. doi: 10.1053/rapm.2002.35169.

DOI:10.1053/rapm.2002.35169
PMID:12373695
Abstract

BACKGROUND AND OBJECTIVES

Severe phantom limb pain after surgical amputation affects 50% to 67% of patients and is difficult to treat. Gabapentin is effective in several syndromes of neuropathic pain. Therefore, we evaluated its analgesic efficacy in phantom limb pain.

METHODS

Patients attending a multidisciplinary pain clinic with phantom limb pain were enrolled into this randomized, double-blind, placebo-controlled, cross-over study. Other anticonvulsant therapy was discontinued. Each treatment was 6 weeks separated by a 1-week washout period. Codeine/paracetamol was allowed as rescue analgesia. The daily dose of gabapentin was titrated in increments of 300 mg to 2400 mg or the maximum tolerated dose. Patients were assessed at weekly intervals. The primary outcome measure was visual analog scale (VAS) pain intensity difference (PID) compared with baseline at the end of each treatment. Secondary measures were indices of sleep interference, depression (Hospital Anxiety and Depression [HAD] scale), and activities of daily living (Bartel Index).

RESULTS

Nineteen eligible patients (mean age, 56 years; range, 24 to 68 years; 16 men) were randomized, of whom 14 completed both arms of the study. Both placebo and gabapentin treatments resulted in reduced VAS scores compared with baseline. PID was significantly greater than placebo for gabapentin therapy at the end of the treatment (3.2 +/- 2.1 v 1.6 +/- 0.7, P =.03). There were no significant differences between placebo and gabapentin therapy in terms of the number of tablets of rescue medication required, sleep interference, HAD scale, or Bartel Index. The medication was well tolerated with few reports of adverse effects.

CONCLUSIONS

After 6 weeks, gabapentin monotherapy was better than placebo in relieving postamputation phantom limb pain. There were no significant differences in mood, sleep interference, or activities of daily living, but a type II error cannot be excluded for these variables.

摘要

背景与目的

手术截肢后严重的幻肢痛影响50%至67%的患者,且难以治疗。加巴喷丁对几种神经性疼痛综合征有效。因此,我们评估了其对幻肢痛的镇痛效果。

方法

将患有幻肢痛并前往多学科疼痛诊所就诊的患者纳入这项随机、双盲、安慰剂对照、交叉研究。停止其他抗惊厥治疗。每次治疗为期6周,中间间隔1周的洗脱期。可使用可待因/对乙酰氨基酚作为解救镇痛药。加巴喷丁的每日剂量以300mg递增至2400mg或最大耐受剂量。每周对患者进行评估。主要结局指标是与每种治疗结束时的基线相比的视觉模拟量表(VAS)疼痛强度差异(PID)。次要指标是睡眠干扰指数、抑郁(医院焦虑与抑郁[HAD]量表)和日常生活活动(Barthel指数)。

结果

19名符合条件的患者(平均年龄56岁;范围24至68岁;16名男性)被随机分组,其中14名完成了研究的两个阶段。与基线相比,安慰剂和加巴喷丁治疗均使VAS评分降低。治疗结束时,加巴喷丁治疗的PID显著高于安慰剂(3.2±2.1对1.6±0.7,P = 0.03)。在所需解救药物片剂数量、睡眠干扰、HAD量表或Barthel指数方面,安慰剂和加巴喷丁治疗之间无显著差异。该药物耐受性良好,不良反应报告较少。

结论

6周后,加巴喷丁单药治疗在缓解截肢后幻肢痛方面优于安慰剂。在情绪、睡眠干扰或日常生活活动方面无显著差异,但不能排除这些变量存在II类错误。

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