Safety and efficacy of a nerve matrix membrane as a collagen nerve wrapping: a randomized, single-blind, multicenter clinical trial  

作　　者：Yong-Bin Gao Zhi-Gang Liu Guo-Dong Lin Yang Guo Lei Chen Bo-Tao Huang Yao-Bin Yin Chen Yang Li-Ying Sun Yan-Bo Rong Shanlin Chen 

机构地区：[1]Department of Hand Surgery,Beijing Jishuitan Hospital,Beijing,China [2]Department of Hand Surgery,The First Bethune Hospital of Jilin University,Changchun,Jilin Province,China [3]Department of Hand and Foot Surgery,Yantai Yuhuangding Hospital,Yantai,Shandong Province,China

出　　处：《Neural Regeneration Research》2021年第8期1652-1659,共8页中国神经再生研究（英文版）

基　　金：supported by the Wu Jieping Medical Foundation of China,No. 320.6750.17273 (to YBG)。

摘　　要：A new nerve matrix membrane derived from decellularized porcine nerves has been shown to retain the major extracellular matrix components, and to be effective in preventing adhesion between the nerve anastomosis sites and the surrounding tissues in a rat sciatic nerve transection model, thereby enhancing regeneration of the nerve. The effectiveness of the membrane may be attributed to its various bioactive components. In this prospective, randomized, single-blind, parallel-controlled multicenter clinical trial, we compared the safety and efficacy of the new nerve matrix membrane with a previously approved bovine tendon-derived type I collagen nerve wrapping. A total of 120 patients with peripheral nerve injury were recruited from Beijing Jishuitan Hospital, The First Bethune Hospital of Jilin University, and Yantai Yuhuangding Hospital, China. The patients were randomly assigned to undergo end-to-end and tension-free neurorrhaphy with nerve matrix membrane(n = 60, 52 male, 8 female, mean age 41.34 years, experimental group) or tendon-derived collagen nerve wrapping(n = 60, 42 male, 18 female, mean age 40.17 years, control group). Patients were followed-up at 14 ± 5, 30 ± 7, 90 ± 10 and 180 ± 20 days after the operation. Safety evaluation included analyses of local and systemic reactions, related laboratory tests, and adverse reactions. Efficacy evaluation included a static 2-point discrimination test, a moving 2-point discrimination test, and a Semmes–Weinstein monofilament examination. Sensory nerve function was evaluated with the British Medical Research Council Scale and Semmes–Weinstein monofilament examination. The ratio(percentage) of patients with excellent to good results in sensory nerve recovery 180 ± 20 days after the treatment was used as the primary effectiveness index. The percentages of patients with excellent to good results in the experimental and control groups were 98.00% and 94.44%, respectively, with no significant difference between the two groups. There were no significant differen

关 键 词：clinical trial extracellular matrix nerve conduit nerve matrix nerve repair neural regeneration NEURORRHAPHY peripheral nerve injury sensory nerve recovery 

分 类 号：R745[医药卫生—神经病学与精神病学]