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加巴喷丁用于治疗成人慢性神经性疼痛和纤维肌痛。

Gabapentin for chronic neuropathic pain and fibromyalgia in adults.

作者信息

Moore R Andrew, Wiffen Philip J, Derry Sheena, McQuay Henry J

机构信息

Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Pain Research Unit, Churchill Hospital, Oxford, Oxfordshire, UK, OX3 7LJ.

出版信息

Cochrane Database Syst Rev. 2011 Mar 16(3):CD007938. doi: 10.1002/14651858.CD007938.pub2.

Abstract

BACKGROUND

This review updates parts of two earlier Cochrane reviews investigating effects of gabapentin in chronic neuropathic pain (pain due to nerve damage). Antiepileptic drugs are used to manage pain, predominantly for chronic neuropathic pain, especially when the pain is lancinating or burning.

OBJECTIVES

To evaluate the analgesic effectiveness and adverse effects of gabapentin for chronic neuropathic pain management.

SEARCH STRATEGY

We identified randomised trials of gabapentin in acute, chronic or cancer pain from MEDLINE, EMBASE, and CENTRAL. We obtained clinical trial reports and synopses of published and unpublished studies from Internet sources. The date of the most recent search was January 2011.

SELECTION CRITERIA

Randomised, double-blind studies reporting the analgesic and adverse effects of gabapentin in neuropathic pain with assessment of pain intensity and/or pain relief, using validated scales. Participants were adults aged 18 and over.

DATA COLLECTION AND ANALYSIS

Two review authors independently extracted data. We calculated numbers needed to treat to benefit (NNTs), concentrating on IMMPACT (Initiative on Methods, Measurement and Pain Assessment in Clinical Trials) definitions of at least moderate and substantial benefit, and to harm (NNH) for adverse effects and withdrawal. Meta-analysis was undertaken using a fixed-effect model.

MAIN RESULTS

Twenty-nine studies (3571 participants), studied gabapentin at daily doses of 1200 mg or more in 12 chronic pain conditions; 78% of participants were in studies of postherpetic neuralgia, painful diabetic neuropathy or mixed neuropathic pain. Using the IMMPACT definition of at least moderate benefit, gabapentin was superior to placebo in 14 studies with 2831 participants, 43% improving with gabapentin and 26% with placebo; the NNT was 5.8 (4.8 to 7.2). Using the IMMPACT definition of substantial benefit, gabapentin was superior to placebo in 13 studies with 2627 participants, 31% improving with gabapentin and 17% with placebo; the NNT was 6.8 (5.6 to 8.7). These estimates of efficacy are more conservative than those reported in a previous review. Data from few studies and participants were available for other painful conditions.Adverse events occurred significantly more often with gabapentin. Persons taking gabapentin can expect to have at least one adverse event (66%), withdraw because of an adverse event (12%), suffer dizziness (21%), somnolence (16%), peripheral oedema (8%), and gait disturbance (9%). Serious adverse events (4%) were no more common than with placebo.There were insufficient data for comparisons with other active treatments.

AUTHORS' CONCLUSIONS: Gabapentin provides pain relief of a high level in about a third of people who take if for painful neuropathic pain. Adverse events are frequent, but mostly tolerable. More conservative estimates of efficacy resulted from using better definitions of efficacy outcome at higher, clinically important, levels, combined with a considerable increase in the numbers of studies and participants available for analysis.

摘要

背景

本综述更新了两项早期Cochrane综述的部分内容,这两项综述研究了加巴喷丁对慢性神经性疼痛(神经损伤所致疼痛)的影响。抗癫痫药物用于治疗疼痛,主要用于慢性神经性疼痛,尤其是当疼痛呈刺痛或灼痛时。

目的

评估加巴喷丁治疗慢性神经性疼痛的镇痛效果和不良反应。

检索策略

我们从MEDLINE、EMBASE和CENTRAL中识别出加巴喷丁用于急性、慢性或癌痛的随机试验。我们从互联网来源获取了已发表和未发表研究的临床试验报告及摘要。最近一次检索日期为2011年1月。

入选标准

随机、双盲研究,报告加巴喷丁在神经性疼痛中的镇痛和不良反应,并使用经过验证的量表评估疼痛强度和/或疼痛缓解情况。参与者为18岁及以上的成年人。

数据收集与分析

两位综述作者独立提取数据。我们计算了获益所需治疗人数(NNTs),重点关注临床试验中方法、测量和疼痛评估倡议(IMMPACT)对至少中度和显著获益的定义,以及不良反应和停药的伤害所需治疗人数(NNHs)。采用固定效应模型进行荟萃分析。

主要结果

29项研究(3571名参与者)在12种慢性疼痛情况下研究了每日剂量为1200毫克或更高的加巴喷丁;78%的参与者参加了带状疱疹后神经痛、糖尿病性疼痛性神经病变或混合性神经性疼痛的研究。根据IMMPACT对至少中度获益的定义,在14项有2831名参与者的研究中,加巴喷丁优于安慰剂,43%使用加巴喷丁的参与者病情改善,使用安慰剂的为26%;NNT为5.8(4.8至7.2)。根据IMMPACT对显著获益的定义,在13项有2627名参与者的研究中,加巴喷丁优于安慰剂,31%使用加巴喷丁的参与者病情改善,使用安慰剂的为17%;NNT为6.8(5.6至8.7)。这些疗效估计比之前综述中报告的更为保守。其他疼痛情况的研究和参与者数据较少。加巴喷丁组不良事件的发生明显更频繁。服用加巴喷丁的人预计至少会发生一次不良事件(66%),因不良事件停药(12%),出现头晕(21%)、嗜睡(16%)、外周水肿(8%)和步态障碍(9%)。严重不良事件(4%)并不比安慰剂更常见。与其他活性治疗方法进行比较的数据不足。

作者结论

加巴喷丁能使约三分之一服用它治疗神经性疼痛的人获得高水平的疼痛缓解。不良事件频繁,但大多可耐受。使用更高、具有临床重要性水平的更好疗效结果定义,再加上可用于分析的研究和参与者数量大幅增加,导致对疗效的估计更为保守。

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