Maintenance of the long-term effectiveness of tramadol in treatment of the pain of diabetic neuropathy
Maintenance of the long-term effectiveness of tramadol in treatment of the pain of diabetic neuropathy
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DOI：
10.1016/s1056-8727(00)00060-x
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发表时间：
2000-03-01
影响因子：
3
通讯作者：
Kamin, M
中科院分区：
文献类型：
--
作者：
Harati, Y;Gooch, C;Kamin, M
目的：本研究的目的是在一项为期6周的双盲随机试验后，评估曲马多在6个月开放延长期中的疗效和安全性。研究设计和方法：完成双盲研究的疼痛性糖尿病神经病变患者有资格参加长达6个月的开放延长研究。所有患者接受曲马多50- 400mg /天治疗。在开放延长的第一天（双盲期的最后一天）和30、90和180天分别记录自我给药的疼痛强度评分（评分0-4分，从无到极度疼痛）和疼痛缓解评分（评分- 1-4分，从较差到完全缓解）。结果：共有117例患者（曲马多前56例，安慰剂前61例）进入研究。在研究的第一天，先前接受安慰剂治疗的患者的平均疼痛强度评分（2.2 +/- 1.02 vs. 1.4 +/- 0.93, P < 0.001）明显高于前曲马多患者，疼痛缓解评分（0.9 +/- 1.43 vs. 2.2 +/- 1.27, P < 0.001）低于前曲马多患者。到第90天，两组的平均疼痛强度评分均为1.4，并在整个研究过程中保持不变。30天后，前安慰剂组和前曲马多组的平均疼痛缓解评分（2.4 +/- 1.09 vs 2.2 +/- 1.14）相似，并在研究期间保持不变。4例患者因疼痛缓解无效而停止治疗；13例患者因不良事件停药。最常见的不良反应是便秘、恶心和头痛。结论：曲马多能长期缓解糖尿病神经病变的疼痛。(C) 2000 Elsevier Science Inc.；版权所有。
Objective: The objective of this study was to evaluate the efficacy and safety of tramadol in a 6-month open extension following a 6-week double-blind randomized trial. Research design and methods: Patients with painful diabetic neuropathy who completed the double-blind study were eligible for enrollment in an open extension of up to 6 months. All patients received tramadol 50-400 mg/day. Self-administered pain intensity scores (scale 0-4; none to extreme pain) and pain relief scores (scale - 1-4; worse to complete relief) were recorded the first day of the open extension (last day of the double-blind phase) and at 30, 90, and 180 days. Results: A total of 117 patients (56 former tramadol and 61 former placebo) entered the study. On the first day of the study, patients formerly treated with placebo had a significantly higher mean pain intensity score (2.2 +/- 1.02 vs. 1.4 +/- 0.93, P < 0.001) and a lower pain relief score (0.9 +/- 1.43 vs. 2.2 +/- 1.27, P < 0.001) than former tramadol patients. By Day 90, both groups had mean pain intensity scores of 1.4, which were maintained throughout the study. Mean pain relief scores (2.4 +/- 1.09 vs. 2.2 +/- 1.14) were similar after 30 days in the former placebo and former tramadol groups, respectively and were maintained for the duration of the study. Four patients discontinued therapy due to ineffective pain relief; 13 patients discontinued due to adverse events. The most common adverse events were constipation, nausea, and headache. Conclusions: Tramadol provides long-term relief of the pain of diabetic neuropathy. (C) 2000 Elsevier Science Inc. All rights reserved.