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丙戊酸钠低剂量在根性疼痛管理中的疗效评估及其与药代动力学参数的关系。

Evaluation of sodium valproate low dose efficacy in radicular pain management and it's relation with pharmacokinetics parameters.

作者信息

Ghasemian Mona, Owlia Mohammad Bagher, Mosaddegh Mohammad Hossein, Nejad Masoud Nakhaie, Sohrevardi Seyed Mojtaba

机构信息

Department of Clinical Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.

Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.

出版信息

Biomedicine (Taipei). 2020 Sep 1;10(3):33-40. doi: 10.37796/2211-8039.1039. eCollection 2020.

Abstract

BACKGROUND

Radiculopathy due to lumbar or cervical disc disease is the most common chronic neuropathic pain in adults. The aim of present study was evaluation of low dose of sodium valproate (VPA) on radicular pain and determining VPA pharmacokinetics.

MATERIALS AND METHODS

In this double blind randomized placebo control clinical study, 80 patients with established lumbar or cervical radicular pain, have been randomly allocated into two study groups: 40 have received sodium valproate 200 mg/day and Celecoxib 100 mg/day and acetaminophen 500 mg PRN as rescue medication, and second group has received placebo, Celecoxib and acetaminophen. Quantitative assessment of pain was done by visual analogue scale (VAS) prior to perform the intervention and after ten days (treatment duration). Blood sample has been taken for determining mean through concentration after five half-lives. Evaluation of plasma concentration of VPA and that of efficacy on pain score relationship by comparing VAS before and after the therapy was done.

RESULTS

Group A and B have demonstrated significant alleviation in mean VAS score; -21.97 ± 25.41, -14.39 ± 23.03 respectively (P < 0.001). The mean plasma concentration of VPA in group A was: 26.9 ± 13.5 mg/L. Moreover, no significant correlation was seen between pain score with age, gender, and weight (p > 0.05).

CONCLUSION

Low dose of sodium valproate especially together with NSAIDs demonstrated good efficacy in lumbar and cervical radicular pain management.

摘要

背景

腰椎或颈椎间盘疾病所致神经根病是成年人中最常见的慢性神经性疼痛。本研究的目的是评估低剂量丙戊酸钠(VPA)对神经根性疼痛的疗效并确定VPA的药代动力学。

材料与方法

在这项双盲随机安慰剂对照临床研究中,80例确诊为腰椎或颈椎神经根性疼痛的患者被随机分为两个研究组:40例患者接受丙戊酸钠200mg/天、塞来昔布100mg/天以及对乙酰氨基酚500mg按需服用作为急救药物,第二组接受安慰剂、塞来昔布和对乙酰氨基酚。在干预前和干预十天后(治疗持续时间)通过视觉模拟评分法(VAS)对疼痛进行定量评估。在五个半衰期后采集血样以测定平均血药浓度。通过比较治疗前后的VAS评估VPA的血浆浓度及其对疼痛评分关系的疗效。

结果

A组和B组的平均VAS评分均有显著改善;分别为-21.97±25.41、-14.39±23.03(P<0.001)。A组VPA的平均血浆浓度为:26.9±13.5mg/L。此外,疼痛评分与年龄、性别和体重之间未见显著相关性(p>0.05)。

结论

低剂量丙戊酸钠尤其是与非甾体抗炎药联合使用时,在腰椎和颈椎神经根性疼痛的治疗中显示出良好疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8281/7721468/8f8e65274b6c/bmed-10-03-033f1.jpg

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