随机对照试验
物理疗法
疱疹后神经痛
心情
焦虑
可视模拟标度
纤维肌痛
萧条(经济学)
睡眠(系统调用)
失眠症
不利影响
匹兹堡睡眠质量指数
简短疼痛清单
作者
Rainer Sabatowski,Rafael Gálvez,David A. Cherry,Florence Jacquot,Emmanuelle Vincent,Pascal Maisonobe,Mark Versavel
出处
期刊:Pain
[Ovid Technologies (Wolters Kluwer)]
日期:2004-05-01
卷期号:109 (1): 26-35
被引量:465
标识
DOI:10.1016/j.pain.2004.01.001
摘要
Abstract This study was designed to assess the efficacy and safety of pregabalin—a novel α2-δ ligand with analgesic, anxiolytic, and anticonvulsant activity—for treating neuropathic pain in patients with post-herpetic neuralgia (PHN). Two hundred and thirty-eight patients were randomised into this multicentre, doubleblind, placebo-controlled trial to receive 150 (n=81), 300 mg/day (n=76) pregabalin, or placebo (n=81) for 8 weeks. Among the exclusion criteria was failure to respond to previous treatment for PHN with gabapentin at doses ≥1200 mg/day. Endpoint mean pain scores were significantly reduced in patients receiving 150 or 300 mg/day pregabalin compared with placebo. Efficacy was observed as early as week 1 and was maintained throughout the study. Significantly more patients in both pregabalin groups (150 mg, 26%; 300 mg, 28%) were responders (≥50% decrease in mean pain score from baseline to endpoint) than in the placebo group (10%). Additionally, by week 1 and for the study's duration, 150 and 300 mg/day pregabalin significantly reduced weekly mean sleep interference scores. More pregabalin-treated patients than placebo-treated patients reported that they were ‘much improved’ or ‘very much improved’. Health-related quality-of-life (HRQoL) measurements using the SF-36 Health Survey demonstrated improvement in the mental health domain for both pregabalin dosages, and bodily pain and vitality domains were improved in the 300 mg/day group. The most frequent adverse events were dizziness, somnolence, peripheral oedema, headache, and dry mouth. Pregabalin efficaciously treated the neuropathic pain of PHN. Additionally, pregabalin was associated with decreased sleep interference and significant improvements in HRQoL measures.
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