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聚乙醇酸导管用于人类指神经重建的随机前瞻性研究。

A randomized prospective study of polyglycolic acid conduits for digital nerve reconstruction in humans.

作者信息

Weber R A, Breidenbach W C, Brown R E, Jabaley M E, Mass D P

机构信息

Department of Surgery, Scott & White Memorial Hospital and Clinic, Temple, Texas, USA.

出版信息

Plast Reconstr Surg. 2000 Oct;106(5):1036-45; discussion 1046-8. doi: 10.1097/00006534-200010000-00013.

DOI:10.1097/00006534-200010000-00013
PMID:11039375
Abstract

This article reports the first randomized prospective multicenter evaluation of a bioabsorbable conduit for nerve repair. The study enrolled 98 subjects with 136 nerve transections in the hand and prospectively randomized the repair to two groups: standard repair, either end-to-end or with a nerve graft, or repair using a polyglycolic acid conduit. Two-point discrimination was measured by a blinded observer at 3, 6, 9, and 12 months after repair. There were 56 nerves repaired in the control group and 46 nerves repaired with a conduit available for follow-up. Three patients had a partial conduit extrusion as a result of loss of the initially crushed skin flap. The overall results showed no significant difference between the two groups as a whole. In the control group, excellent results were obtained in 43 percent of repairs, good results in 43 percent, and poor results in 14 percent. In those nerves repaired with a conduit, excellent results were obtained in 44 percent, good results in 30 percent, and poor results in 26 percent (p = 0.46). When the sensory recovery was examined with regard to length of nerve gap, however, nerves with gaps of 4 mm or less had better sensation when repaired with a conduit; the mean moving two-point discrimination was 3.7 +/- 1.4 mm for polyglycolic acid tube repair and 6.1 +/- 3.3 mm for end-to-end repairs (p = 0.03). All injured nerves with deficits of 8 mm or greater were reconstructed with either a nerve graft or a conduit. This subgroup also demonstrated a significant difference in favor of the polyglycolic acid tube. The mean moving two-point discrimination for the conduit was 6.8 +/- 3.8 mm, with excellent results obtained in 7 of 17 nerves, whereas the mean moving two-point discrimination for the graft repair was 12.9 +/- 2.4 mm, with excellent results obtained in none of the eight nerves (p < 0.001 and p = 0.06, respectively). This investigation demonstrates improved sensation when a conduit repair is used for nerve gaps of 4 mm or less, compared with end-to-end repair of digital nerves. Polyglycolic acid conduit repair also produces results superior to those of a nerve graft for larger nerve gaps and eliminates the donor-site morbidity associated with nerve-graft harvesting.

摘要

本文报道了首例关于用于神经修复的生物可吸收导管的随机前瞻性多中心评估。该研究纳入了98名手部有136处神经横断伤的受试者,并将修复方法前瞻性随机分为两组:标准修复,即端端吻合或使用神经移植,或使用聚乙醇酸导管进行修复。在修复后3、6、9和12个月,由一名不知情的观察者测量两点辨别觉。对照组有56条神经进行了修复,46条使用导管修复的神经可供随访。3例患者因最初受压的皮瓣丢失导致部分导管挤出。总体结果显示两组整体无显著差异。对照组中,43%的修复效果为优,43%为良,14%为差。在使用导管修复的神经中,44%的效果为优,30%为良,26%为差(p = 0.46)。然而,当根据神经缺损长度检查感觉恢复情况时,缺损4mm或更小的神经使用导管修复时感觉更好;聚乙醇酸管修复的平均移动两点辨别觉为3.7±1.4mm,端端修复为6.1±3.3mm(p = 0.03)。所有缺损8mm或更大的损伤神经均用神经移植或导管进行重建。该亚组也显示出聚乙醇酸管具有显著优势。导管修复的平均移动两点辨别觉为6.8±3.8mm,17条神经中有7条效果为优,而移植修复的平均移动两点辨别觉为12.9±2.4mm,8条神经中无一例效果为优(分别为p < 0.001和p = 0.06)。本研究表明,与指神经端端修复相比,对于4mm或更小的神经缺损,使用导管修复可改善感觉。对于更大的神经缺损,聚乙醇酸导管修复的效果也优于神经移植,并且消除了与采集神经移植相关的供区并发症。

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