去细胞同种异体神经修复材料临床应用初步报告

目的 观察去细胞同种异体神经修复材料(hANG)修复周围神经缺损的安全性和临床疗效.方法 对指固有神经缺损10～20 mm 4例5侧,用hANG(广州中大医疗器械有限公司提供)移植桥接神经缺损,其中急诊一期手术移植3例4侧,二期手术移植1例1侧,均为单侧指固有神经移植.在10倍手术显微镜下进行神经清创修复,确保移植物两端的神经断端均无损伤,以9-0显微缝合线端端间断缝合.未使用免疫抑制药物.术后随访1～3个月,通过手术部位物理检查及血生化和免疫检测以评价hANG移植的安全性.采用英国医学研究会评定标准评价指神经功能,以观察hANG修复指神经缺损的临床疗效.结果 4例伤口均一期愈合,未发生免疫排斥反应、过敏性反应、感染、肝肾毒副作用等不良反应.术后1～3个月血生化检测均正常.所有hANG移植侧指神经功能恢复良好,其中2例移植侧术后3个月两点分辨觉为8 mm(S3~+,优).结论 hANG移植修复指神经缺损在短期内未发现移植物被排斥或对人体产生毒性反应,神经功能恢复良好.

A preliminary clinical report on bridging digital nerve defect with human acellular nerve graft

Objective To evaluate the safety and efficacy of the human acellular nerve allograft (hANG)for nerve repair in the clinical setting,and report the early outcomes of bridging digital nerve defect with the hANG. Methods Four patients with 5 digital nerve injuries were included in this pilot study.The nerves defect ranged from 10-20 mm and were bridged with the hANG(manufactured by Zhongda Medical Equipment Co.,Ltd,Guangzhou,China).Four digital nerve acute injuries in 3 patients were repaired with hANG primarily,while the nerve in another patient was reconstructed secondarily.The procedure was performed under a 10-manifying operating microscope.The nerve stumps were debrided until the normal fascicles could be seen.hANG was inserted between the proximal and distal stumps and end-to-end neurorrhaphy was performed with 9-0 sutures.Postoperative cares included dressing change and administration of antibiotics.No immunosuppressants had been used.The follow-up time ranged from 1 to 3 months.The wound and blood sample were examined for the safety of hANG.The nerve function Wag evaluated according to the scoring system proposed by the Nerve Injuries Committee of the British Medical Research Council. Results All wounds healed primarily.The adverse effects,such as rejection,allergy,infection,and toxicity to the liver and kidney were absent.The results of blood biochemistry test were within the normal range.The injured nerve achieved good functional recovery.In 2 cages,the 2 point discrimination(2PD)was 8mm(S3~+,excellent). Conclusion Based on the short term follow-up,using hANG to repair digital nerve defect as long as 20mm was safe,and the nerve functional recovery is pretty good.