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在慢性疼痛患者中进行的齐美利定与安慰剂对照试验期间,视觉诱发电位作为报告的副作用的预测指标。

Visual evoked potentials as a predictor of reported side effects during a trial of zimelidine vs. placebo in chronic pain patients.

作者信息

von Knorring L, Johansson F

出版信息

Psychiatry Res. 1979 Dec;1(3):225-30. doi: 10.1016/0165-1781(79)90003-9.

Abstract

Before a double-blind controlled study of zimelidine, a new, rather specific inhibitor of serotonin uptake, in patients with chronic pain, visual evoked potentials (EPs) to stimuli of varying intensities were recorded. During the trial the blood levels of zimelidine and its active metabolite norzimelidine were estimated. Side effects were rated by a physician before and after the trial. No significant difference in frequency of side effects could be found between the zimelidine and the placebo groups. Furthermore, there was no significant relationship between the blood levels of the active drug or its metabolite and the frequency of side effects. Instead, a significant relationship was found in the total group between the frequency of side effects and the tendency to react with an increase in maximum amplitude of the EP when stimulus intensity was increased (i.e., augmenting). The same trend was clear both in the zimelidine group and in the placebo group. Thus the augmenting/reducing response in visual EPs seems to be a predictor of the side effects reported irrespective of the drugs given.

摘要

在对一种新型、相对特异性的5-羟色胺摄取抑制剂齐美利定进行双盲对照研究之前,对慢性疼痛患者记录了不同强度刺激下的视觉诱发电位(EPs)。在试验期间,对齐美利定及其活性代谢物去甲齐美利定的血药浓度进行了测定。试验前后由医生对副作用进行评分。齐美利定组和安慰剂组之间在副作用发生率上未发现显著差异。此外,活性药物或其代谢物的血药浓度与副作用发生率之间没有显著关系。相反,在整个研究组中发现,副作用发生率与当刺激强度增加时EP最大波幅增加的反应倾向(即增强反应)之间存在显著关系。在齐美利定组和安慰剂组中这种相同趋势均很明显。因此,视觉EPs中的增强/减弱反应似乎是所报告副作用的一个预测指标,而与所给予的药物无关。

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