Int J Clin Pract. 2006 Sep;60(9):1060-7. doi: 10.1111/j.1742-1241.2006.01069.x.
The aim of this study was to evaluate the tolerability, safety and efficacy of pregabalin in Indian patients with peripheral neuropathic pain. In this prospective, multicenter, non-comparative, open-label study, patients with peripheral neuropathic pain (n = 111) received pregabalin in doses ranging from 75 to 300 mg twice daily for 3 weeks. Primary efficacy measures included weekly pain score and the Visual Analogue Scale (VAS) score of the Short-Form McGill Pain Questionnaire (SF-MPQ). Despite a short study duration, a significant reduction was seen in weekly pain score (p < 0.0001), as well as VAS score of SF-MPQ (p < 0.0001). Significant improvements were also seen in other pain-related endpoints, weekly sleep interference score, quality of life measures, and patient and clinician ratings of global improvement. Pregabalin was well tolerated, and the most common adverse events were dizziness and somnolence. The short study duration precluded the assessment of longer term safety issues such as weight gain. This study has demonstrated the safety, tolerability and efficacy of pregabalin for peripheral neuropathic pain in Indian patients.
本研究的目的是评估普瑞巴林对印度外周神经病理性疼痛患者的耐受性、安全性和疗效。在这项前瞻性、多中心、非对照、开放标签研究中，外周神经病理性疼痛患者（n = 111）接受了每日两次、剂量范围为75至300毫克的普瑞巴林治疗，为期3周。主要疗效指标包括每周疼痛评分以及简短麦吉尔疼痛问卷（SF-MPQ）的视觉模拟量表（VAS）评分。尽管研究持续时间较短，但每周疼痛评分（p < 0.0001）以及SF-MPQ的VAS评分（p < 0.0001）均显著降低。在其他与疼痛相关的终点指标、每周睡眠干扰评分、生活质量指标以及患者和临床医生对整体改善的评分方面也有显著改善。普瑞巴林耐受性良好，最常见的不良事件是头晕和嗜睡。研究持续时间较短，无法评估体重增加等长期安全性问题。本研究证明了普瑞巴林对印度外周神经病理性疼痛患者的安全性、耐受性和疗效。
Zotero 插件