From the Department of Anesthesiology, Intensive Care Medicine and Multidisciplinary Pain Centre, Ziekenhuis Oost-Limburg, Genk, Belgium (P.V., J.V.Z., M.P., P.D.V., R.M., R.H.); Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands (P.V., K.V.); Faculty of Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium (P.V.); and Department of Anatomy, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands (T.K., E.R.).
Anesthesiology. 2015 Feb;122(2):399-406. doi: 10.1097/ALN.0000000000000508.
Less than 50% of patients experience sufficient pain relief with current drug therapy for neuropathic pain. Minocycline shows promising results in rodent models of neuropathic pain but was not studied in humans with regard to the treatment of neuropathic pain.
In this randomized, double-blind, placebo-controlled clinical trial, patients with subacute lumbar radicular pain received placebo, amitriptyline 25 mg, or minocycline 100 mg once a day (n = 20 per group) for 14 days. Primary outcome measure was the pain intensity in the leg as measured by a numeric rating scale ranging from 0 to 10 on days 7 and 14. Secondary outcome measures were the reduction of neuropathic pain symptoms in the leg as determined with a neuropathic pain questionnaire, consumption of rescue medication, and adverse events on days 7 and 14.
Sixty patients were randomized and included in an intention-to-treat analysis. After 14 days, patients in the minocycline and amitriptyline groups reported a reduction of 1.47 (95% confidence interval, 0.16-2.83; P = 0.035) and 1.41 (95% confidence interval, 0.05-2.78; P = 0.043), respectively, in the numeric rating scale compared to the placebo group. No differences were seen in the neuropathic pain questionnaire values at any time point during treatment between the three groups. The rate of adverse events in the amitriptyline group was 10% versus none in the minocycline and placebo groups. No differences were noted in the consumption of rescue medication.
Although both groups differed from placebo, their effect size was small and therefore not likely to be clinically meaningful.
目前用于治疗神经性疼痛的药物疗法，仅有不到 50%的患者能获得充分的疼痛缓解。米诺环素在神经性疼痛的啮齿动物模型中显示出良好的效果，但尚未在人类中研究其对神经性疼痛的治疗作用。
在这项随机、双盲、安慰剂对照的临床试验中，患有亚急性腰椎神经根痛的患者接受安慰剂、阿米替林 25 mg 或米诺环素 100 mg 每天一次（每组 20 人），共 14 天。主要观察指标是第 7 天和第 14 天通过数字评分量表（范围为 0 至 10）测量腿部的疼痛强度。次要观察指标是腿部神经病理性疼痛症状的减轻程度，通过神经病理性疼痛问卷确定，第 7 天和第 14 天的救援药物使用量以及不良反应。
60 名患者被随机分配并纳入意向治疗分析。14 天后，米诺环素组和阿米替林组患者的数字评分量表评分分别减少了 1.47（95%置信区间，0.16-2.83；P = 0.035）和 1.41（95%置信区间，0.05-2.78；P = 0.043），与安慰剂组相比。在治疗期间的任何时间点，三组之间的神经病理性疼痛问卷值均无差异。阿米替林组的不良反应发生率为 10%，而米诺环素组和安慰剂组均为 0。救援药物的使用量无差异。
尽管两组与安慰剂相比均有差异，但它们的效应量较小，因此可能在临床上没有意义。
