Translational Pain Research, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
Clin J Pain. 2013 Apr;29(4):281-8. doi: 10.1097/AJP.0b013e318258993e.
To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg).
This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titration, 8 weeks of stable dosing, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score from Baseline to Week 10 using Baseline Observation Carried Forward (BOCF) imputation.
Four-hundred and fifty-two patients (mean age 65.6 y, BMI 29 Kg/m) were randomized. Baseline average daily pain intensity score during the week prior to randomization was 6.6 and 6.5 for the G-GR and placebo treatment groups, respectively. Three hundred and seventy-seven patients completed the study (84% G-GR, 83% placebo). G-GR significantly reduced BOCF change in average daily pain intensity compared with placebo (-2.1 vs. -1.6; G-GR vs. placebo, P=0.013). Compared with placebo, more G-GR-treated patients reported "much" or "very much" improvement (patient global impression of change, 43% vs. 34%; P<0.0434), and G-GR reduced sleep interference (-2.3 vs. -1.59; P<0.0001), although neither endpoint was considered statistically significant based on a stringent hierarchical statistical paradigm. Other secondary endpoints showed similar trends. The most common adverse events were dizziness (G-GR, 11.3% vs. placebo, 1.7 %) and somnolence (G-GR, 5.4% vs. placebo, 3.0%).
Once-daily G-GR 1800 mg was effective and well tolerated for the relief of pain in patients with postherpetic neuralgia.
评估每日一次胃滞留型加巴喷丁（G-GR；1800mg）制剂的安全性和疗效。
这是一项为期 11 周、双盲、随机、安慰剂对照的 3 期临床试验，纳入了带状疱疹后神经痛患者。患者接受了为期 2 周的剂量滴定、8 周的稳定剂量治疗和 1 周的剂量渐减。主要终点是使用基线观察延续（BOCF）插补，从基线到第 10 周时平均每日疼痛强度评分的变化。
452 例患者（平均年龄 65.6 岁，BMI 29kg/m2）被随机分组。随机分组前一周的基线平均每日疼痛强度评分分别为 G-GR 和安慰剂治疗组的 6.6 和 6.5。377 例患者完成了研究（84%的 G-GR 组，83%的安慰剂组）。与安慰剂相比，G-GR 显著降低了平均每日疼痛强度的 BOCF 变化（-2.1 对-1.6；G-GR 对安慰剂，P=0.013）。与安慰剂相比，更多的 G-GR 治疗患者报告“明显”或“非常明显”改善（患者整体印象变化，43%对 34%；P<0.0434），并且 G-GR 降低了睡眠干扰（-2.3 对-1.59；P<0.0001），尽管根据严格的分层统计范式，这两个终点都没有统计学意义。其他次要终点也显示出类似的趋势。最常见的不良事件是头晕（G-GR，11.3%对安慰剂，1.7%）和嗜睡（G-GR，5.4%对安慰剂，3.0%）。
每日一次的 G-GR 1800mg 对带状疱疹后神经痛患者的疼痛缓解有效且耐受良好。
