Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial
Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial
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DOI：
10.1185/030079906x80404
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发表时间：
2006-02-01
影响因子：
2.3
通讯作者：
Rigaudy, L
中科院分区：
文献类型：
--
作者：
van Seventer, R;Feister, HA;Rigaudy, L
目的：本试验评估了每日两次 (BID) 服用普瑞巴林缓解与带状疱疹后神经痛 (PHN) 相关的神经性疼痛的有效性和安全性。研究设计和方法：这项为期 13 周的双盲安慰剂对照研究将 370 名 PHN 患者随机分为普瑞巴林（150、300 或 600 毫克/天 BID）或安慰剂。主要疗效指标：主要疗效指标是终点平均值每日疼痛日记中的疼痛评分。次要疗效指标包括每日睡眠日记的终点平均睡眠干扰评分和患者总体印象变化（PGIC）。安全性评估包括不良事件 (AE)、身体和神经系统检查、12 导联心电图、生命体征和实验室测试。结果：普瑞巴林在终点时提供显着的、与剂量成比例的疼痛缓解：平均疼痛评分与安慰剂的差异，150 毫克/天，-0.88，p = 0.0077； 300毫克/天，-1.07，p = 0.0016； 600 毫克/天，-1.79，p= 0.0003。每周平均疼痛评分早在第 1 周就显着改善。从第 1 周开始 (p < 0.01)，与安慰剂相比，所有普瑞巴林组的睡眠干扰在终点时也显着改善 (p < 0.001)。研究终止时，150 mg/天 (p = 0.02) 和 600 mg/天 (p = 0.003) 组的患者比安慰剂组更有可能报告总体改善。大多数 AE 为轻度或中度。在接受普瑞巴林治疗的患者中，13.5% 因 AE 退出，最常见的是头晕（16 名患者，5.8%）、嗜睡（8 名，2.9%）或共济失调（7 名，2.5%）。结论：普瑞巴林，BID 给药，可减轻与 PHN 相关的神经性疼痛，且耐受性良好。它还减少了疼痛对睡眠的干扰程度。普瑞巴林的效果早在第 1 周就显现出来，并在整个 13 周的研究中持续存在。
Objective:This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuropathic pain associated with postherpetic neuralgia (PHN).Research design and methods: The 13-week, double-blind, placebo-controlled study randomized 370 patients with PHN to pregabalin (150, 300, or 600 mg/day BID) or placebo.Main outcome measures: Primary efficacy measure was endpoint mean pain score from daily pain diaries. Secondary efficacy measures included endpoint mean sleep-interference score from daily sleep diaries and Patient Global Impression of Change (PGIC). Safety evaluations included adverse events (AEs), physical and neurologic examinations, 12-lead ECG, vital signs, and laboratory testing.Results: Pregabalin provided significant, dose-proportional pain relief at endpoint: difference from placebo in mean pain score, 150 mg/day, -0.88, p = 0.0077; 300mg/day, -1.07, p = 0.0016; 600mg/day, -1.79, p= 0.0003. Weekly mean pain scores significantly improved as early as week 1. Sleep interference in all pregabalin groups was also significantly improved at endpoint, compared with placebo (p < 0.001), beginning at week 1 (p < 0.01). At study termination, patients in the 150 (p = 0.02) and 600 mg/day (p = 0.003) groups were more likely to report global improvement than were those in the placebo group.Most AEs were mild or moderate. Among pregabalin-treated patients, 13.5% withdrew due to AEs, most commonly for dizziness (16 patients, 5.8%), somnolence (8, 2.9%), or ataxia (7, 2.5%).Conclusions: Pregabalin, dosed BID, reduced neuropathic pain associated with PHN and was well tolerated. It also reduced the extent to which pain interfered with sleep. Pregabalin's effects were seen as early as week 1 and were sustained throughout the 13-week study.