Gordh Torsten E, Stubhaug Audun, Jensen Troels S, Arnèr Staffan, Biber Björn, Boivie Jörgen, Mannheimer Clas, Kalliomäki Jarkko, Kalso Eija
Multidisciplinary Pain Center, Uppsala University Hospital, S-751 85 Uppsala, Sweden Department of Anaesthesiology, University of Oslo, Rikshospitalet University Hospital, 0027 Oslo, Norway Department of Neurology, Danish Pain Research Centre, Aarhus University Hospital, Aarhus Sygehus Noerrebrogaede 44, Aarhus 8000, Denmark Pain Clinic, Department of Anaesthesiology, Karolinska University Hospital, Solna, S-171 76 Stockholm, Sweden Department of Anaestesiology, Umeå University Hospital S-901 85 Umeå, Sweden Department of Neurology, Linköping University Hospital, S-581 85 Linköping, Sweden Multidisciplinary Pain Center, Department of Medicine, Sahlgrenska University Hospital, Östra 41685 Göteborg, Sweden Department of Rehabilitation, Lund University Hospital S-221 85 Lund, Sweden Pain Clinic, Department of Anaesthesiology and Intensive Care Medicine, Helsinki University Central Hospital, Haartmaninkatu 2A, 00029 HUS, Finland.
Pain. 2008 Aug 31;138(2):255-266. doi: 10.1016/j.pain.2007.12.011. Epub 2008 Feb 6.
A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p=0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p=0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p=0.0016). Both the Patient (p=0.023) and Clinician (p=0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness.
开展了一项双盲、随机、安慰剂对照的交叉多中心研究，以评估加巴喷丁治疗创伤性或术后外周神经损伤所致神经性疼痛的疗效和安全性，使用剂量最高达2400毫克/天。该研究包括两周的导入期、两个为期五周的治疗期，中间间隔三周的洗脱期。主要疗效变量是从基线到治疗最后一周的平均疼痛强度评分的变化。其他变量包括疼痛缓解、健康相关生活质量（SF-36）、疼痛对睡眠的干扰、临床医生和患者对变化的整体印象以及不良反应。九个中心共随机分配了120名患者，其中22人退出。主要结局疗效变量的治疗之间无统计学显著差异。然而，与安慰剂相比，加巴喷丁提供了显著更好的疼痛缓解（p = 0.015）。与安慰剂相比，更多使用加巴喷丁的患者疼痛至少减轻了30%（p = 0.040），并且与安慰剂相比，加巴喷丁治疗期间疼痛对睡眠的干扰明显更少（p = 0.0016）。患者（p = 0.023）和临床医生（p = 0.037）对变化的整体印象均表明，与安慰剂相比，加巴喷丁的反应更好。加巴喷丁耐受性良好。最常见的不良反应是头晕和疲劳。
