人工颈椎间盘的假体结构及应用特点

doi:10.3969/j.issn.2095-4344.2014.26.029

摘要/Abstract

摘要：

背景：目前人工颈椎间盘假体设计和使用都得到了很大的发展，主要有低磨擦滑动面、弹簧系统、橡胶制成的人工颈椎间盘及其他各种弹性假体。
目的：总结人工颈椎间盘假体结构特点及在骨科的应用现状。
方法：由第一作者以“人工颈椎间盘；假体；椎间盘突出症”和“Artificial Cervical Disc；prosthesis ; intervertebral disc herniation；the surgical therapy”为关键词，分别在CNKI(2000至2013年)和PubMed数据库(1960至2013年)http://www.ncbi.nlm.nih.gov/PubMed)检索近年文献，检索内容为人工颈椎间盘假体在骨科的应用。计算机在CNKI数据库检索出200篇文献，在PubMed数据库检索出56篇文献，阅读标题和摘要进行筛选，保留符合纳入标准的40篇归纳总结。
结果与结论：人工颈椎间盘假体类似椎间盘生理功能，材料具有耐磨损、耐疲劳、抗腐蚀等特点，它类似于人体椎间盘的生理和生物力学载荷功能，保持了脊柱的稳定和运动功能，避免了邻近节段的退变加速。文章重点对Bryan、Mobi-C、PCM、Prodisc-C、Prestige及CerviCore人工颈椎间盘结构做了介绍。人工颈椎间盘置换的短期疗效已得到认可，但是它不能完全替代颈前路植骨融合内固定，是治疗颈椎退变性椎间盘疾病的又一主要手段。

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

全文链接：

关键词: 植入物, 人工假体, 人工颈椎间盘, 假体, 颈椎病, 椎间盘突出症, 外科治疗

Abstract:

BACKGROUND: The design and use of artificial cervical disc prosthesis have great development, such as rubber-made artificial cervical disc with low-friction sliding surface and spring system, and other various elastic prostheses.
OBJECTIVE: To summarize structural characteristics and present application of artificial cervical disc prosthesis.
METHODS: The first author searched CNKI (2000-2013) and PubMed databases (1960-2013) http://www.ncbi.nlm.nih.gov/PubMed for literatures on application of artificial cervical disc prosthesis. The key words included artificial cervical disc, prosthesis, intervertebral disc herniation, the surgical therapy. 200 literatures and 56 literatures were respectively searched in CNKI and the PubMed. Titles and abstracts were read. A total of 40 literatures were in accordance with inclusion criteria and included.
RESULTS AND CONCLUSION: Artificial cervical disc prosthesis was consistent with physiological functions of intervertebral disk. The material is characterized by abrasion, fatigue resistance and corrosion resistance, is similar to physiological and biomechanical function of human disc, maintains the stability of the spine and motor function, and avoids the accelerated degeneration of adjacent segments. Articles mainly introduced the structure of Bryan, Mobi-C, PCM, Prodisc-C, Prestige and CerviCore artificial cervical disc. Short-period therapeutic effects of artificial cervical disc replacement have obtained approval. However, it cannot completely replace anterior cervical fusion, but is another manner to treat cervical degenerative disc disease.

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

全文链接：

Key words: cervical spondylosis, intervertebral disk, prostheses and implants

中图分类号:

R318

颜端国. 人工颈椎间盘的假体结构及应用特点[J]. 中国组织工程研究, 2014, 18(26): 4260-4264.

Yan Duan-guo. Prosthesis structure and application features of artificial cervical disc[J]. Chinese Journal of Tissue Engineering Research, 2014, 18(26): 4260-4264.

图/表（结果） 6

2.1 人工颈椎间盘假体生理学和生物力学标准 人工颈椎间盘假体要求材料组织相容性好，耐腐蚀、耐磨损和抗疲劳；应能承受多年的生物力学负荷，它植入后应具备正常脊柱的曲线弧度和重建颈椎的前凸角度，不可对后方小关节形成过重的生物力学负荷；可以重建椎间隙的高度和稳定性，缓冲震荡力量，恢复脊柱的生理运动功能，可以使脊柱在矢状面、冠状面及水平方向保持生物力学运动，可以抵抗超负荷运动及可以对抗轴向压缩的力量，但是至今为止，尚没有一种人工颈椎间盘假体完全符合全部标准^[4-7]。

2.2 人工颈椎间盘假体 Bryan人工颈椎间盘属于非限制型人工颈椎间盘，是当前使用最广泛的人工颈椎间盘，Vincent Bryan 在20世纪90年代设计了Bryan人工颈椎间盘，它呈一体化设计，假体设计有14，15，16，17，18 mm 5种规格，高度全部为815 mm。整个假体由上下两片钛合金外壳和中间的聚亚氨酯髓核组成，钛合金外壳表面为多孔涂层设计，利于骨长入，提供固定的稳定性(图1)^[8]。聚亚氨酯髓核有2 mm的平移范围和11°的活动度设计。聚亚氨酯壳包绕着髓核附着在合金壳内形成一个密室，限制可能产生的碎屑外漏。密室内的生理盐水被钛合金封闭于内，起到降低摩擦的作用，前方的突起可以限制假体的后移同时提供植入时的把持固定作用^[9-10]。

国外Kim等^[11]对颈椎前路融合内固定和Bryan人工颈椎间盘假体置换进行了大样本量的对照试验统计学研究，463例需要手术的颈椎病患者随机分组，手术后随访2年。结果显示：颈椎功能障碍指数评分、重返工作时间、颈臂痛视觉模拟量表评分和健康调查简表评分Bryan人工颈椎间盘组都优于颈椎前路融合内固定组；Bryan人工颈椎间盘组术后并发症低于对比组。Ren等^[12]对Bryan人工颈椎间盘置换患者治疗后随访，JOA评分，颈椎功能障碍指数，neck disability index 评分优于对照组而且颈椎活动度满意。

国内贺宝荣等^[13]对照研究Bryan人工颈椎间盘置换后疗效和置换前后颈椎活动度大小。结果显示疗效和颈椎活动度满意。

Mobi-C人工颈椎间盘假体由法国LDR公司研发，Mobi-C假体是由上下两端板及中间人工髓核构成的球窝状结构假体，端板外表面喷钛涂层和倒齿锚固来实现固定。该假体活动方式为非限制型，髓核的设计可以在运动中自动调节到正常瞬间旋转中心的位置，最大限度模拟正常椎间盘的生理运动功能，同时保持颈椎一定的前凸状态^[14](图2)。

Mobi-C人工颈椎间盘在欧洲已有千例以上的应用，但中国应用不多。鲍达等的研究表明：在合理选择适应证的前提下，采用 Mobi-C人工颈椎间盘治疗退行性颈椎病患，近期疗效满意；在平均16.5个月的随访期内未见异位骨化；远期疗效需要进一步临床观察^[15]。

Cervitech PCM(porous coated motion)颈椎人工椎间盘属于半限制型假体，在临床上使用广泛，它的上下板是使用钴铬合金材料生产，大小与相邻椎体的表面匹配，表面采用了羟基磷灰石喷涂技术，因此终板表面密集内向微小孔隙，是骨长入假体的基本平台，为锯齿状表面设计，以实现良好的生物固定。中间的人工髓核材料为超高分子量聚乙烯(图3)。滑动核心位于假体的尾侧，这些设计使假体具有整体性，微动性和稳定性，因此手术置入方便，模仿了颈椎伸屈的活动的生理功能^[16]。

Pimenta等^[17]研究了单节段 Cervitech PCM植入和多节段植入的疗效对比差别，随访NDI评分，VAS评分，自评满意率无显著差异。结果表明Cervitech PCM人工椎间盘植入对多节段颈椎退行性疾病效果满意。Prodisc-C是一种临床上常用的颈椎人工椎间盘，它属于限制型假体。假体由钴-铬合金的终板和超高分子聚乙烯材料制成的球窝关节构成，它由 2个带矢状面翼状样物固定的钴铬合金板构成，上下板都有开槽的中央嵴和钛金属涂层表面，固定于上面和下面椎体上。假体活动部分由固定在上位椎体上的凹陷的部分和下位椎体上的突出于表面的球形部分组成(图4)。这种设计能使假体达到即刻稳定和生物固定，并且能够产生3个轴向的旋转，同时限制平移活动，保护小关节免受过度的应力。

Anak-wenze等^[18]对神经根型颈椎病患者行ProDisc- C置换术和颈椎前路融合内固定术对照研究，结果表明：神经功能、颈臂痛视觉模拟量表评分两者都有明显效果。颈椎功能障碍指数评分，ProDisc-C置换术组优于颈椎前路融合内固定术组，并且颈椎前路融合内固定术组的二次手术率明显降低。

Prestige假体属于半限制型假体，经历了PrestigeⅠ和PrestigeⅡ二代。PrestigeⅡ使用钛和陶瓷复合材料，假体的耐磨性能良好。为球臼设计。上下终板接触面为双轨设计，上面終板为球形，下面終板为椭圆形，上终板在水平方向上能够前后移动。该假体保证了假体与椎板固定滑轨的藕和，并且有两个金属嵴，提供早期稳定性，它的粗糙面设计，有利于骨质长入，形成生物固定^[19](图5)。

Mummaneni等^[20]行大样本量Prestige置换术和颈椎前路融合内固定术对比研究，随访时间2年，结果显示：颈椎功能障碍指数Prestige组好于颈椎前路融合内固定术组，并且术后并发症和再次手术率Prestige置换术减低。

CerviCore假体属于非限制型假体，是一种金属对金属的鞍形关节设计，它可以在屈伸运动时保持尾端椎体的旋转轴和侧弯时保持头端椎体的旋转轴;可以模拟椎体钩突的功能。在旋转和侧弯时增加椎间孔间隙。上下端板表面喷钛涂层和倒齿锚固来形成生物固定^[21](图6)。

2.3 人工颈椎间盘置换适应证、禁忌证 人工颈椎间盘置换适应证无统一的“金”标准，目前国内多参考欧美标准，但是严重的椎间隙狭窄、颈椎畸形、后纵韧带骨化、中重度小关节炎、严重骨质疏松症、颈椎结构性失稳、颈椎创伤、肿瘤、风湿性关节炎、强直性脊柱炎等是肯定的禁忌证。

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