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透明质酸酶在神经根病选择性神经根阻滞中的有效性评估:一项双盲对照临床试验。

An evaluation of the effectiveness of hyaluronidase in the selective nerve root block of radiculopathy: a double blind, controlled clinical trial.

作者信息

Ko Sang-Bong, Vaccaro Alexander R, Chang Ho-Jin, Shin Dong-Young

机构信息

Department of Orthopaedic Surgery, Daegu Catholic University Medical College, Daegu, Korea.

Department of Orthopaedic Surgery, Thomas Jefferson University, Philadelphia, PA, USA.

出版信息

Asian Spine J. 2015 Feb;9(1):83-9. doi: 10.4184/asj.2015.9.1.83. Epub 2015 Feb 13.

Abstract

STUDY DESIGN

Prospective, double-blind, randomized controlled trial.

PURPOSE

To determine the ability of hyaluronidase to provide longer lasting pain relief and functional improvement in patients with lumbar radiculopathy.

OVERVIEW OF LITERATURE

Selective nerve root block (SNRB) is a good treatment option in lumbar radiculopathy. We studied the effectiveness of hyaluronidase when added to the traditional SNRB regimen.

METHODS

A sample size of 126 patients per group was necessary. A sample of 252 patients who underwent an injection procedure with or without hyaluronidase due to radiculopathy was included in this study. The patients were randomly divided into two groups: the control (C) group and the hyaluronidase (H) group. After SNRB due to radiculopathy, the visual analog scale (VAS) was compared at 2, 4, 6, 8, and 12 weeks between the two groups, and the Oswestry disability index (ODI) was compared at 12 weeks between the two groups.

RESULTS

Both groups seemed to have general improvement in VAS, but in C group, the VAS was higher than the H group 2 and 4 weeks after the surgery, and the difference in time-group change between 2 groups was statistically significant (p <0.05). ODI improved in both groups, and the difference in time-group change between 2 groups was not statistically significant (p >0.05).

CONCLUSIONS

The rebound pain (the re-occurrence of pain within 2-4 weeks after injection) that occurs within 2-4 weeks after the injection of the routine regimen can be reduced when hyaluronidase is added to the routine SNRB regimen.

摘要

研究设计

前瞻性、双盲、随机对照试验。

目的

确定透明质酸酶能否为腰椎神经根病患者提供更持久的疼痛缓解和功能改善。

文献综述

选择性神经根阻滞(SNRB)是腰椎神经根病的一种良好治疗选择。我们研究了在传统SNRB方案中添加透明质酸酶的有效性。

方法

每组需要126例患者的样本量。本研究纳入了252例因神经根病接受有无透明质酸酶注射治疗的患者。患者被随机分为两组:对照组(C组)和透明质酸酶组(H组)。在因神经根病进行SNRB后,比较两组在第2、4、6、8和12周时的视觉模拟评分(VAS),并在第12周时比较两组的Oswestry功能障碍指数(ODI)。

结果

两组的VAS似乎都有总体改善,但在C组中,术后2周和4周时VAS高于H组,两组在时间-组间变化上的差异具有统计学意义(p<0.05)。两组的ODI均有所改善,两组在时间-组间变化上的差异无统计学意义(p>0.05)。

结论

在常规SNRB方案中添加透明质酸酶时,可减少常规方案注射后2至4周内出现的反弹痛(注射后2至4周内疼痛复发)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ba2/4330224/355f223e1d52/asj-9-83-g001.jpg

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