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系统评价加巴喷丁和普瑞巴林治疗儿童和青少年疼痛的疗效和安全性。

Systematic Review of the Efficacy and Safety of Gabapentin and Pregabalin for Pain in Children and Adolescents.

机构信息

From the Clinical Pharmacology and Toxicology Research Group, Discipline of Pharmacology, University of Sydney, New South Wales, Australia.

出版信息

Anesth Analg. 2019 Apr;128(4):811-819. doi: 10.1213/ANE.0000000000003936.

Abstract

The barriers to opioid use in some countries necessitate the need to identify suitable alternatives or adjuncts for pain relief. The gabapentinoids (gabapentin and pregabalin) are approved for the management of persistent pain in adults, but not in children. Searches were conducted in Embase, Medline, Scopus, and Web of Science up until November 2017, for randomized controlled trials that investigated the analgesic effects of gabapentin or pregabalin in children and adolescents <18 years of age. A total of 7 publications were identified, 5 regarding gabapentin as prophylactic postsurgical pain relief for either adenotonsillectomy (n = 3) or scoliosis surgery (n = 2), and 1 for gabapentin treatment of chronic regional pain syndrome/neuropathic pain. One study investigated the efficacy of pregabalin as a treatment for fibromyalgia. Based on the studies' primary outcomes alone, neither of the chronic pain studies involving gabapentin and pregabalin showed significant efficacy compared with amitriptyline or placebo, respectively. Two of the prophylactic gabapentin studies for adenotonsillectomy and idiopathic scoliosis surgery reported significantly fewer children requiring analgesia and lower opioid requirement, respectively, compared with placebo. Two of the identified clinical trials (conducted by the same first author) on the efficacy of gabapentin for prophylactic postadenotonsillectomy pain relief were omitted from narrative synthesis due to clear evidence of fabricated data. Overall, this review identified a paucity of evidence for the analgesic effect and safety of gabapentinoids in children. We also suggest audit of any current evidence-based practice and clinical guidelines that have cited the research studies with fabricated data.

摘要

在一些国家,阿片类药物的使用存在障碍,因此需要寻找合适的替代品或辅助药物来缓解疼痛。加巴喷丁类药物(加巴喷丁和普瑞巴林)已被批准用于治疗成人持续性疼痛,但不适用于儿童。本研究检索了 Embase、Medline、Scopus 和 Web of Science 数据库,截至 2017 年 11 月,共纳入了 7 项随机对照试验,这些试验评估了加巴喷丁或普瑞巴林对 18 岁以下儿童和青少年的镇痛效果。共确定了 7 篇文献,其中 5 篇为预防性术后镇痛研究,涉及腺样体扁桃体切除术(n = 3)或脊柱侧弯手术(n = 2),1 篇为加巴喷丁治疗慢性区域性疼痛综合征/神经病理性疼痛。1 项研究调查了普瑞巴林治疗纤维肌痛的疗效。仅基于研究的主要结局,涉及加巴喷丁和普瑞巴林的 2 项慢性疼痛研究与阿米替林或安慰剂相比,均未显示出显著疗效。2 项预防性加巴喷丁治疗腺样体扁桃体切除术和特发性脊柱侧弯手术的研究报告称,与安慰剂相比,分别有更多的儿童需要镇痛,阿片类药物的需求更低。由于存在明显的伪造数据证据,2 项关于加巴喷丁预防腺样体扁桃体切除术后疼痛的疗效的已确定临床试验(由同一位第一作者进行)被排除在叙述性综合分析之外。总体而言,本综述发现加巴喷丁类药物在儿童中的镇痛效果和安全性的证据不足。我们还建议对任何引用了有伪造数据的研究的当前循证实践和临床指南进行审核。

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