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使用ADCON-L抑制腰椎间盘手术后的硬膜外纤维化及相关症状:初步报告。

Use of ADCON-L to inhibit postoperative peridural fibrosis and related symptoms following lumbar disc surgery: a preliminary report.

作者信息

Petrie J L, Ross J S

机构信息

Gliatech Inc., Cleveland, OH 44122, USA.

出版信息

Eur Spine J. 1996;5 Suppl 1:S10-7. doi: 10.1007/BF00298567.

Abstract

STUDY DESIGN

This was a prospective, randomized, multicenter, double-blind study.

OBJECTIVES

The study evaluated the use of ADCON-L Anti-Adhesion Barrier Gel to inhibit peridural fibrosis and reduce fibrosis-related symptoms after first-time lumbar discectomy.

SUMMARY OF BACKGROUND DATA

Peridural scarring causes tethering of dura and nerve roots, contributing to pain and functional limitation, and that symptoms are evident by 6 months after surgery.

METHODS

Following discectomy, ADCON-L was applied to patients in the active treatment group. Outcome measures were reduction of peridural scar and postoperative pain.

RESULTS

There is an association between peridural scar and recurrent radicular pain. Patients having extensive peridural scar were three times more likely to experience recurrent radicular pain than those patients with less extensive scarring. ADCON-L inhibited peridural scar. Compared to the control group, there was a 23% reduction in the number of patients with extensive peridural scar and a 120% increase in the number of patients having minimal or no scar. ADCON-L reduced the incidence of activity-related pain. There was up to a 50% reduction in the number of patients reporting increased pain while doing typical activities of daily living.

CONCLUSIONS

ADCON-L is safe, reduces peridural fibrosis, and improves postoperative patient outcome.

摘要

研究设计

这是一项前瞻性、随机、多中心、双盲研究。

目的

本研究评估了ADCON-L抗粘连屏障凝胶在首次腰椎间盘切除术后抑制硬膜外纤维化和减轻纤维化相关症状的应用。

背景数据总结

硬膜外瘢痕形成导致硬脑膜和神经根粘连,引起疼痛和功能受限,且症状在术后6个月时明显。

方法

椎间盘切除术后,将ADCON-L应用于积极治疗组患者。观察指标为硬膜外瘢痕的减少和术后疼痛情况。

结果

硬膜外瘢痕与复发性神经根性疼痛之间存在关联。硬膜外瘢痕广泛的患者出现复发性神经根性疼痛的可能性是瘢痕较少患者的三倍。ADCON-L可抑制硬膜外瘢痕。与对照组相比,硬膜外瘢痕广泛的患者数量减少了23%,瘢痕极少或无瘢痕的患者数量增加了120%。ADCON-L降低了与活动相关的疼痛发生率。在进行日常典型活动时报告疼痛加重 的患者数量最多减少了50%。

结论

ADCON-L安全有效,可减少硬膜外纤维化,改善术后患者预后。

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