Duloxetine vs. placebo in patients with painful diabetic neuropathy
Duloxetine vs. placebo in patients with painful diabetic neuropathy
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DOI：
10.1016/j.pain.2005.03.029
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发表时间：
2005-07-01
期刊：
影响因子：
7.4
通讯作者：
Iyengar, S
中科院分区：
文献类型：
--
作者：
Goldstein, DJ;Lu, YL;Iyengar, S
本研究的目的是检验度洛西汀（一种平衡且有效的血清素和去甲肾上腺素双重再摄取抑制剂）在治疗糖尿病周围神经病理性疼痛中的有效性和安全性。血清素和去甲肾上腺素被认为可以通过下行疼痛通路抑制疼痛。在一项为期 12 周、多中心、双盲研究中，457 名因 1 型或 2 型糖尿病引起的多发性神经病而出现疼痛的患者被随机分配接受度洛西汀 20 mg/d（20 mg QD）、60 mg/d（60 mg QD）、120 mg/d（60 mg BID）或安慰剂治疗：密歇根评分至少为 3 分证实诊断神经病变筛查仪。主要疗效指标是 24 小时平均疼痛评分的每周平均评分，该评分按照 11 分 (0-10) 李克特量表（无疼痛到可能最严重的疼痛）进行评分，并根据两次现场访问之间的日记评分计算得出。与安慰剂相比，度洛西汀 60 和 120 mg/d 在 24 小时平均疼痛评分方面表现出统计学上显着的改善，从随机分组后 1 周开始一直持续到 12 周的试验。度洛西汀在几乎所有次要指标（包括健康相关结果指标）上也与安慰剂区分开来。与安慰剂相比，所有三个积极治疗组中有更多患者的 24 小时平均疼痛评分降低了 50%。度洛西汀治疗被认为是安全且耐受性良好的，只有不到 20% 的患者因不良事件而停药。 60 和 120 mg/d 的度洛西汀治疗糖尿病周围神经性疼痛是安全有效的。 (C) 2005 年国际疼痛研究协会。由 Elsevier B.V. 出版。保留所有权利。
The aim of this study was to examine the efficacy and safety of duloxetine, a balanced and potent dual reuptake inhibitor of serotonin and norepinephrine, in the management of diabetic peripheral neuropathic pain. Serotonin and norepinephrine are thought to inhibit pain via descending pain pathways. In a 12-week, multicenter, double-blind study, 457 patients experiencing pain due to polyneuropathy caused by Type 1 or Type 2 diabetes mellitus were randomly assigned to treatment with duloxetine 20 mg/d (20 mg QD), 60 mg/d (60 mg QD), 120 mg/d (60 mg BID), or placebo: The diagnosis was confirmed by a score of at least 3 on the Michigan Neuropathy Screening Instrument. The primary efficacy measure was the weekly mean score of the 24-h Average Pain Score, which was rated on an 11-point (0-10) Likert scale (no pain to worst possible pain) and computed from diary scores between two site visits. Duloxetine 60 and 120 mg/d demonstrated statistically significant greater improvement compared with placebo on the 24-h Average Pain Score, beginning 1 week after randomization and continuing through the 12-week trial. Duloxetine also separated from placebo on nearly all the secondary measures including health-related outcome measures. Significantly more patients in all three active-treatment groups achieved a 50% reduction in the 24-h Average Pain Score compared with placebo. Duloxetine treatment was considered to be safe and well tolerated with less than 20 percent discontinuation due to adverse events. Duloxetine at 60 and 120 mg/d was safe and effective in the management of diabetic peripheral neuropathic pain. (C) 2005 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.