Oxcarbazepine in painful diabetic neuropathy: results of a dose-ranging study
Oxcarbazepine in painful diabetic neuropathy: results of a dose-ranging study
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DOI：
10.1111/j.1600-0404.2006.00631.x
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发表时间：
2006-06-01
影响因子：
3.5
通讯作者：
Wan, Y
中科院分区：
文献类型：
--
作者：
Beydoun, A;Shaibani, A;Wan, Y
目的 - 在一项为期 16 周的多中心、双盲、安慰剂对照、剂量范围研究中评估奥卡西平对糖尿病神经病变患者的疗效和安全性。方法 - 共有 347 名患者被随机分配至奥卡西平 600 mg/天 (n = 83)、1,200 mg/天 (n = 87)、1,800 mg/天 (n = 88) 或安慰剂 (n = 89)。主要功效变量是平均视觉模拟量表（VAS）评分从基线到研究最后一周的变化。结果 - 奥卡西平组和安慰剂组之间的主要疗效变量没有差异。 1,200 毫克/天和 1,800 毫克/天组均显示出统计学显着性趋势（分别为 P = 0.101、P = 0.096）。在整个双盲治疗阶段，奥卡西平 1,200 毫克/天（P = 0.038）和 1,800 毫克/天（P = 0.005）组和安慰剂组之间的总体平均每周 VAS 评分存在统计学显着差异。结论 - 尽管主要疗效变量未达到统计学显着性，但与安慰剂相比，每天服用奥卡西平 1,200 和 1,800 毫克的患者的 VAS 评分有所改善。奥卡西平可以为患有疼痛性糖尿病神经病变的患者提供具有临床意义的疼痛缓解。
Objectives - To evaluate the efficacy and safety of oxcarbazepine in patients with diabetic neuropathy in a multicenter, double-blind, placebo-controlled, dose-ranging 16-week study. Methods - A total of 347 patients were randomized to oxcarbazepine 600 mg/day (n = 83), 1,200 mg/day (n = 87), 1,800 mg/day (n = 88), or placebo (n = 89). The primary efficacy variable was change in mean visual analog scale (VAS) score from baseline to the last week of the study. Results - No difference between any oxcarbazepine group and the placebo group was noted for the primary efficacy variable. Both the 1,200- and 1,800-mg/day groups showed a trend toward statistical significance (P = 0.101, P = 0.096, respectively). Statistically significant differences were found between the oxcarbazepine 1,200-mg/day (P = 0.038) and 1,800-mg/day (P = 0.005) groups and placebo in the overall mean weekly VAS scores for the entire double-blind treatment phase. Conclusions - Although the primary efficacy variable did not reach statistical significance, patients taking oxcarbazepine 1,200 and 1,800 mg/day showed improvements in VAS scores compared with placebo. Oxcarbazepine may provide clinically meaningful pain relief in patients with painful diabetic neuropathy.