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聚乙二醇与甲泼尼龙琥珀酸钠治疗犬椎间盘突出症的安慰剂对照、前瞻性、随机临床试验

A Placebo-Controlled, Prospective, Randomized Clinical Trial of Polyethylene Glycol and Methylprednisolone Sodium Succinate in Dogs with Intervertebral Disk Herniation.

作者信息

Olby N J, Muguet-Chanoit A C, Lim J-H, Davidian M, Mariani C L, Freeman A C, Platt S R, Humphrey J, Kent M, Giovanella C, Longshore R, Early P J, Muñana K R

机构信息

College of Veterinary Medicine, Atlanta, Georgia.

Center of Comparative Medicine and Translational Research, Atlanta, Georgia.

出版信息

J Vet Intern Med. 2016 Jan-Feb;30(1):206-14. doi: 10.1111/jvim.13657. Epub 2015 Oct 31.

DOI:10.1111/jvim.13657
PMID:26520829
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4913663/
Abstract

BACKGROUND

Acute intervertebral disk herniation (IVDH) is a common cause of spinal cord injury in dogs and currently there is no proven medical treatment to counter secondary injury effects. Use of methylprednisolone sodium succinate (MPSS) or polyethylene glycol (PEG) as neuroprotectants is advocated but controversial because neither treatment has been tested in placebo-controlled, randomized, blinded trials in dogs.

HYPOTHESIS

Polyethylene glycol will improve the outcome of severe spinal cord injury caused by IVDH compared to MPSS or placebo.

ANIMALS

Client-owned dogs with acute onset of thoracolumbar IVDH causing paralysis and loss of nociception for <24 hours.

METHODS

Dogs were randomized to receive MPSS, PEG, or placebo; drugs appeared identical and group allocation was masked. Drug administration was initiated once the diagnosis of IVDH was confirmed and all dogs underwent hemilaminectomy. Neurologic function was assessed 2, 4, 8, and 12 weeks postoperatively using an open field gait score (OFS) as the primary outcome measure. Outcomes were compared by the Wilcoxon rank sum test.

RESULTS

Sixty-three dogs were recruited and 47.6% recovered ambulation. 17.5% developed progressive myelomalacia but there was no association with group. There was no difference in OFS among groups. Although full study power was not reached, conditional power analyses indicated the futility of continued case recruitment.

CONCLUSIONS

This clinical trial did not show a benefit of either MPSS or PEG in the treatment of acute, severe thoracolumbar IVDH when used as adjunctive medical treatment administered to dogs presenting within 24 hours of onset of paralysis.

摘要

背景

急性椎间盘突出症(IVDH)是犬脊髓损伤的常见原因,目前尚无经证实的药物治疗方法来对抗继发性损伤效应。有人主张使用甲泼尼龙琥珀酸钠(MPSS)或聚乙二醇(PEG)作为神经保护剂,但存在争议,因为这两种治疗方法均未在犬的安慰剂对照、随机、双盲试验中进行过测试。

假设

与MPSS或安慰剂相比,聚乙二醇将改善由IVDH引起的严重脊髓损伤的预后。

动物

由客户拥有的犬,急性胸腰段IVDH发作,导致瘫痪和痛觉丧失<24小时。

方法

将犬随机分为接受MPSS、PEG或安慰剂组;药物外观相同,且分组情况保密。一旦确诊IVDH,即开始给药,所有犬均接受半椎板切除术。术后2、4、8和12周使用旷场步态评分(OFS)作为主要结局指标评估神经功能。通过Wilcoxon秩和检验比较结局。

结果

招募了63只犬,47.6%恢复行走。17.5%发生进行性脊髓软化,但与分组无关。各组间OFS无差异。尽管未达到充分的研究效能,但条件效能分析表明继续招募病例毫无意义。

结论

当用作对瘫痪发作24小时内就诊的犬进行辅助药物治疗时,该临床试验未显示MPSS或PEG对治疗急性、严重胸腰段IVDH有益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/849e/4913663/d4b09c56932d/JVIM-30-206-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/849e/4913663/d4b09c56932d/JVIM-30-206-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/849e/4913663/d4b09c56932d/JVIM-30-206-g001.jpg

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