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英夫利昔单抗(一种抗TNF-α单克隆抗体)对椎间盘突出吸收的影响:一项随机对照研究。

The effect of infliximab, a monoclonal antibody against TNF-alpha, on disc herniation resorption: a randomized controlled study.

作者信息

Autio Reijo A, Karppinen Jaro, Niinimäki Jaakko, Ojala Risto, Veeger Nic, Korhonen Timo, Hurri Heikki, Tervonen Osmo

机构信息

Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland.

出版信息

Spine (Phila Pa 1976). 2006 Nov 1;31(23):2641-5. doi: 10.1097/01.brs.0000244616.64962.9e.

DOI:10.1097/01.brs.0000244616.64962.9e
PMID:17077730
Abstract

STUDY DESIGN

Randomized, controlled study.

OBJECTIVE

To evaluate the effect of infliximab on herniated nucleus pulposus (HNP) resorption.

SUMMARY OF BACKGROUND DATA

Although the effects of tumor necrosis factor alpha (TNF-alpha) on HNP resorption are not fully understood, TNF-alpha appears to be an essential mediator in HNP resorption.

METHODS

As part of a substudy of the FIRST II study, magnetic resonance images (MRIs) were obtained from 21 patients who were candidates for discectomy at weeks 0, 2, 12, and 26 after receiving a single infusion of either 5 mg/kg infliximab (11 patients) or placebo (10 patients). The volume (mm3) of HNP, thickness (mm) and extent (%) of rim enhancement, and presence of nerve root edema were assessed.

RESULTS

HNP volume decreased significantly from baseline to 6 months in both treatment groups (P < 0.01), with no difference noted between the infliximab and placebo groups. By week 2, rim enhancement thickness increased significantly in the infliximab group compared with the placebo group (P = 0.003). Two patients in each group required back surgery before the 6-month assessment.

CONCLUSIONS

Infliximab did not appear to interfere with disc herniation resorption over a 6-month period.

摘要

研究设计

随机对照研究。

目的

评估英夫利昔单抗对椎间盘突出症(HNP)吸收的影响。

背景数据总结

尽管肿瘤坏死因子α(TNF-α)对HNP吸收的作用尚未完全明确,但TNF-α似乎是HNP吸收的重要介质。

方法

作为FIRST II研究的一项子研究,对21例计划行椎间盘切除术的患者在接受单次输注5 mg/kg英夫利昔单抗(11例患者)或安慰剂(10例患者)后的第0、2、12和26周进行磁共振成像(MRI)检查。评估HNP的体积(mm³)、边缘强化的厚度(mm)和程度(%)以及神经根水肿情况。

结果

两个治疗组的HNP体积从基线到6个月均显著减小(P < 0.01),英夫利昔单抗组与安慰剂组之间无差异。到第2周时,英夫利昔单抗组的边缘强化厚度与安慰剂组相比显著增加(P = 0.003)。每组各有2例患者在6个月评估前需要进行背部手术。

结论

在6个月的时间里,英夫利昔单抗似乎并未干扰椎间盘突出的吸收。

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