鞘内催产素治疗神经性疼痛:一项随机对照交叉试验

James C. Eisenach, Regina S. Curry, Timothy T Houle
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摘要

目的:探讨鞘内催产素与安慰剂对慢性神经性疼痛患者疼痛和超敏反应的影响。研究设计:随机、对照、双盲交叉研究设置:门诊临床研究单位。受试者:年龄在18岁到70岁之间,患有神经性疼痛,至少持续6个月。方法:受试者接受两次鞘内盲注射催产素或生理盐水,间隔至少7天,每隔4小时测量持续神经性疼痛(VAS:视觉模拟评分)和超敏区域。主要终点为VAS疼痛,采用线性混合效应模型进行分析。次要结果是每隔7天的口头疼痛强度评分和注射后4小时的过敏区域和引起的疼痛。结果:由于招募缓慢和资金限制,在计划的40名受试者中有5名完成后,研究提前停止。注射前疼痛强度为4.75 +/- 0.99,注射后疼痛强度下降幅度大于安慰剂,为1.61 +/- 0.87。和2.49 +/- 0.87 (p=0.003)。注射催产素后一周的每日疼痛评分低于生理盐水(2.53 +/- 0.89 vs 3.66 +/- 0.89;p = 0.001)。根据测试的方式,催产素和安慰剂之间的过敏反应在相反的方向上有少量的不同。没有研究药物相关的不良反应。讨论:虽然研究对象数量有限,但在所有受试者中,催产素比安慰剂更能减轻疼痛。脊髓后叶催产素在这一人群中的进一步研究是必要的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Intrathecal oxytocin for neuropathic pain: A randomized, controlled, cross-over trial
Objective: To investigate the effect of intrathecal oxytocin compared to placebo on pain and hypersensitivity in individuals with chronic neuropathic pain. Study design: Randomized, controlled, double-blind cross-over study Setting: Outpatient clinical research unit. Subjects: Individuals between ages of 18 and 70 years with neuropathic pain caudal to the umbilicus for at least 6 months. Methods: Individuals received two blinded intrathecal injections of either oxytocin or saline, separated by at least 7 days, and ongoing neuropathic pain (VAS: visual analog scale) and areas of hypersensitivity were measured at intervals for 4 hours. The primary outcome was VAS pain, analyzed by linear mixed effects model. Secondary outcomes were verbal pain intensity scores at intervals for 7 days and areas of hypersensitivity and elicited pain for 4 hr after injections. Results: The study was stopped early after completion of 5 of 40 subjects planned due to slow recruitment and funding limitations. Pain intensity prior to injection was 4.75 +/- 0.99 and modeled pain intensity decreased more after oxytocin than placebo to 1.61 +/- 0.87.and 2.49 +/- 0.87, respectively (p=0.003). Daily pain scores were lower in the week following injection of oxytocin than saline (2.53 +/- 0.89 vs 3.66 +/- 0.89; p=0.001). Hypersensitivity differed between oxytocin and placebo by small amounts in opposite directions depending on modality tested. There were no study drug related adverse effects. Discussion: Although limited by the small number of subjects studied, oxytocin reduced pain more than placebo in all subjects. Further study of spinal oxytocin in this population is warranted.
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