中国组织工程研究

中国组织工程研究 ›› 2021, Vol. 25 ›› Issue (6): 849-853.doi: 10.3969/j.issn.2095-4344.2386

• 数字化骨科Digital orthopedics • 上一篇    下一篇

3D打印椎间融合器置入治疗脊髓型颈椎病：颈椎曲度及椎间高度恢复的半年随访

刘正蓬，王雅辉，张义龙，明  颖，孙志杰，孙  贺   

  1. 承德医学院附属医院，河北省承德市   067000
  • 收稿日期:2020-02-26 修回日期:2020-03-04 接受日期:2020-04-18 出版日期:2021-02-28 发布日期:2020-12-03
  • 通讯作者: 孙贺，承德医学院附属医院，河北省承德市 067000
  • 作者简介:刘正蓬，男，1983年生，满族，主治医师，主要从事脊柱外科基础与临床研究。
  • 基金资助:
    2015年承德市科学技术研究与发展计划项目(20157060)

Application of 3D printed interbody fusion cage for cervical spondylosis of spinal cord type: half-year follow-up of recovery of cervical curvature and intervertebral height

Liu Zhengpeng, Wang Yahui, Zhang Yilong, Ming Ying, Sun Zhijie, Sun He   

  1. Affiliated Hospital of Chengde Medical University, Chengde 067000, Hebei Province, China
  • Received:2020-02-26 Revised:2020-03-04 Accepted:2020-04-18 Online:2021-02-28 Published:2020-12-03
  • Contact: Sun He, Affiliated Hospital of Chengde Medical University, Chengde 067000, Hebei Province, China
  • About author:Liu Zhengpeng, Attending physician, Affiliated Hospital of Chengde Medical University, Chengde 067000, Hebei Province, China
  • Supported by:
    the Science and Technology Research and Development Plan Project of Chengde in 2015, No. 20157060

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摘要：

文题释义：
3D打印椎间融合器：是利用3D打印技术制作而成，为椎间融合器设计创新带来了新机遇，与传统设计比较，3D打印椎间融合器集成了利于骨融合的多孔结构，且植入模型与患者解剖及功能匹配度高，生物相容性好。
应激反应：为个体非特异性反应，在生理上可表现为皮质醇、去甲肾上腺素等分泌量增多；由于生物材料植入过程中机体内环境会产生一定改变，出现不同程度免疫、应激反应，因此测定围术期皮质醇、去甲肾上腺素表达可反映机体应激情况。

背景：近期临床研究发现，生物材料植入过程中机体内环境会产生一定改变，出现不同程度的免疫、应激反应，且不同生物材料机体免疫、应激反应亦有明显差异。
目的：探讨3D打印椎间融合器在脊髓型颈椎病中的应用效果及对患者血清皮质醇、去甲肾上腺素水平的影响。
方法：选择2015年7月至2018年7月承德医学院附属医院收治的脊髓型颈椎病患者63例，其中男40例，女23例，年龄30-78岁，按照随机数字表分为研究组(n=31)、对照组(n=32)，均接受颈椎前路减压植骨融合内固定治疗，研究组术中植入3D打印椎间融合器，对照组植入聚醚醚酮材料椎间融合器及同种异体骨。对比两组手术情况、并发症发生情况，术前及术后1，3 d检测血清皮质醇、去甲肾上腺素水平，术前及术后1周、6个月检测颈椎曲度、椎间高度，术后6个月统计轴性症状。试验获得承德医学院附属医院伦理委员会批准。
结果与结论：①两组手术时间、术中出血量、住院时间比较差异无显著性意义(P > 0.05)；②研究组31例发生螺钉松动1例、植入物移动1例，对照组32例中发生螺钉松动3例、免疫排斥3例、植入物移动2例、植入物塌陷1例，研究组并发症发生率低于对照组(P < 0.05)；③两组术后1，3 d的皮质醇、去甲肾上腺素水平均高于术前(P < 0.05)，但研究组低于对照组(P < 0.001)；④两组术后1周、6个月的颈椎曲度、椎间高度均高于术前(P < 0.05)，且研究组高于对照组(P < 0.05)；⑤研究组术后6个月轴性症状轻于对照组(P < 0.05)；⑥结果表明，3D打印椎间融合器应用于脊髓型颈椎病可减少并发症，促进颈椎曲度、椎间高度恢复，提高颈椎稳定性，且机体应激反应、轴性症状轻。

https://orcid.org/0000-0003-1631-4058 (刘正蓬)
中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

关键词: 骨, 植入物, 颈椎病, 3D打印, 椎间融合器, 颈椎曲度, 椎间高度, 皮质醇, 去甲肾上腺素

Abstract: BACKGROUND: Recent clinical studies have found that during the implantation of biomaterials, the internal environment of the body will change to a certain extent, and different levels of immunity and stress responses will occur. There are also obvious differences in the immune and stress responses of different biological materials. 
OBJECTIVE: To investigate the effect of 3D printed interbody fusion cage on patients with cervical spondylosis of spinal cord type and its effect on serum cortisol and norepinephrine levels. 
METHODS: Sixty-three patients with cervical spondylotic myelopathy who were admitted to the Affiliated Hospital of Chengde Medical University from July 2015 to July 2018 were selected, including 40 males and 23 females, aged 30-78 years old. The patients were randomly divided into a research group (n=31) and a control group (n=32) according to a random number table. All patients received anterior cervical decompression and bone graft fusion and internal fixation. Patients in the research group were implanted with 3D printed intervertebral fusion cage during operation. The patients in the control group were implanted with polyetheretherketone interbody fusion cage and allogeneic bone. The operation and complications of the two groups were compared. Serum cortisol and norepinephrine levels were detected before and 1 and 3 days after operation. Cervical curvature and intervertebral height were measured before surgery, 1 week, and 6 months after surgery. Axial symptoms were counted at 6 months after surgery. The trial was approved by the Ethics Committee of the Affiliated Hospital of Chengde Medical University. 
RESULTS AND CONCLUSION: (1) Operation time, intraoperative blood loss and hospitalization time were not significantly different between the two groups (P > 0.05). (2) Among 31 cases, there were 1 case of screw loosening and 1 case of implant movement in the research group. Among 32 cases, there were 3 cases of screw loosening, 3 cases of immune rejection, 2 cases of implant movement, and 1 case of implant collapse in the control group. The incidence of complications was lower in the research group than that in the control group (P < 0.05). (3) At 1 and 3 days after operation, the levels of cortisol and norepinephrine were higher in both groups than those before surgery (P < 0.05), but above levels were lower in the research group than in the control group (P < 0.001). (4) The cervical curvature and intervertebral height at 1 week and 6 months after operation in both groups were higher than those before surgery (P < 0.05), and above indexes were higher in the research group than in the control group (P < 0.05). (5) The axial symptom in the research group was lighter than that in the control group at 6 months after operation (P < 0.05). (6) The results show that the application of 3D printed interbody fusion cage to cervical spondylotic myelopathy can reduce complications, promote the recovery of cervical curvature and intervertebral height, and improve the stability of cervical spine, and the body’s stress response and axial symptoms are mild.

Key words: bone, implant, cervical spondylotic myelopathy, 3D printing, interbody fusion cage, cervical curvature, intervertebral height, cortisol, norepinephrine

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