Liu Yansheng, Xie Jia-Xin, Niu Fang, Xu Zhexi, Tan Pengju, Shen Caihong, Gao Hongkun, Liu Song, Ma Zhengwen, So Kwok-Fai, Wu Wutian, Chen Chen, Gao Sujuan, Xu Xiao-Ming, Zhu Hui
Kunming International Spine and Spinal Cord Injury Treatment Center, Kunming Tongren Hospital; Clinical Center for Spinal Cord Injury, Kunming General Hospital of Chengdu Military Command, Kunming, Yunnan Province, China.
Clinical Center for Spinal Cord Injury, Kunming General Hospital of Chengdu Military Command, Kunming, Yunnan Province, China.
Neural Regen Res. 2021 May;16(5):820-829. doi: 10.4103/1673-5374.297080.
Although a large number of trials in the SCI field have been conducted, few proven gains have been realized for patients. In the present study, we determined the efficacy of a novel combination treatment involving surgical intervention and long-term weight-bearing walking training in spinal cord injury (SCI) subjects clinically diagnosed as complete or American Spinal Injury Association Impairment Scale (AIS) Class A (AIS-A). A total of 320 clinically complete SCI subjects (271 male and 49 female), aged 16-60 years, received early (≤ 7 days, n = 201) or delayed (8-30 days, n = 119) surgical interventions to reduce intraspinal or intramedullary pressure. Fifteen days post-surgery, all subjects received a weight-bearing walking training with the "Kunming Locomotion Training Program (KLTP)" for a duration of 6 months. The neurological deficit and recovery were assessed using the AIS scale and a 10-point Kunming Locomotor Scale (KLS). We found that surgical intervention significantly improved AIS scores measured at 15 days post-surgery as compared to the pre-surgery baseline scores. Significant improvement of AIS scores was detected at 3 and 6 months and the KLS further showed significant improvements between all pair-wise comparisons of time points of 15 days, 3 or 6 months indicating continued improvement in walking scores during the 6-month period. In conclusion, combining surgical intervention within 1 month post-injury and weight-bearing locomotor training promoted continued and statistically significant neurological recoveries in subjects with clinically complete SCI, which generally shows little clinical recovery within the first year after injury and most are permanently disabled. This study was approved by the Science and Research Committee of Kunming General Hospital of PLA and Kunming Tongren Hospital, China and registered at ClinicalTrials.gov (Identifier: NCT04034108) on July 26, 2019.
尽管在脊髓损伤（SCI）领域已经进行了大量试验，但患者获得的已证实的疗效却很少。在本研究中，我们确定了一种新型联合治疗方法的疗效，该方法包括手术干预和长期负重步行训练，用于临床诊断为完全性或美国脊髓损伤协会损伤量表（AIS）A级（AIS-A）的脊髓损伤（SCI）患者。共有320名年龄在16至60岁之间的临床完全性SCI患者（男性271例，女性49例）接受了早期（≤7天，n = 201）或延迟（8 - 30天，n = 119）手术干预，以减轻椎管内或髓内压力。术后15天，所有患者接受了为期6个月的“昆明运动训练方案（KLTP）”负重步行训练。使用AIS量表和10分制的昆明运动量表（KLS）评估神经功能缺损和恢复情况。我们发现，与术前基线评分相比，手术干预显著提高了术后15天测得的AIS评分。在术后3个月和6个月时检测到AIS评分有显著改善，并且KLS在15天、3个月或6个月的所有两两时间点比较中进一步显示出显著改善，表明在6个月期间步行评分持续改善。总之，在损伤后1个月内进行手术干预并结合负重运动训练，可促进临床完全性SCI患者持续且具有统计学意义的神经功能恢复，这类患者在损伤后的第一年通常很少有临床恢复，大多数会永久性残疾。本研究经中国人民解放军昆明总医院和昆明同仁医院科研委员会批准，并于2019年7月26日在ClinicalTrials.gov上注册（标识符：NCT04034108）。
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