两种仿生双相陶瓷生物骨的异位成骨作用-中国组织工程与临床康复2007年1期目次

两种仿生双相陶瓷生物骨的异位成骨作用

沈铁城1，夏青1，黄永辉1，徐晓峰1，崔福斋2，田进1

AIM： To observe the healing time and the repairing effects of bone after nano-hydroxyapatite/collagen (NHAC) implantation and study its clinical application in orthopaedics.

METHODS： From March 2003 to March 2005, there were 32 cases with bone defects enrolled from Affiliated Hospital of Jiangsu University, and they all underwent surgical procedure but had bone defects, as well as 5 cases with nonunion, 4 cases with benign bone tumor and 4 cases with spondylolysis. All of them were diagnosed by X ray according to self-designed standard of this clinical experiment, and knew the treatment scheme and agreed.①In the bone defects after bone fracture, it was comminuted fracture in all parts of four limbs, after operation and reduction it presented bone defects. So NHAC was implanted.②In the nonunion of bone, we excised the scar and ossified tissue in fracture, and reamed the medullary cavity, and then implanted the NHAC.③In the benign bone tumor, NHAC was implanted after excision of diseased bone.④In the spondylolysis, NHAC together with autograft were implanted in 2 cases after decompression, RF reduction and internal fixation. In one case, autologous bone was implanted in his left side while NHAC was implanted in the right side. Another one case received the operation of autologous bone implantation, but the healing isthmus was not solid, so NHAC was implanted.

RESULT: Totally 42 cases were followed up.①Among the 29 cases of bone defects, 25 cases got clinical healing from 2 to 7 months after operation. As for other 4 cases, one case of ulnar bone defect showed nonunion after NHAC had been implanted for 2 years, and got healing effect at 2 years and 9 months after implantation; In one case of comminuted bone fracture in upper and middle tibial bone, a few of bone scars were observed at 15 months after implantation. The other two were reoperated for restoration and internal fixation, because of broken fixator as the patients exerted a heavy burden on the suffering broken limb.②Among those 5 bone nonunion cases, 2 cases got healing 9 months later; 3 cases got nonunion after only NHAC implantation, including 2 cases got healing after reoperation by autologous bone implantation in 1 year.③Among 4 cases with benign bone tumor, we got good results in 2 cases of bone cyst. But in the other 2 cases of osteofibrous dysplasia, we reoperated with autograft of bone and got healing.④Among the 4 cases of spondylolisthesis, the preoperative symptoms (backleg pain) of 3 cases disappeared, and the broken shadows were not found through X-ray, while the rest one still felt benumbed and pain in lower limbs and presented no healing via X ray.

CONCLUSION: NHAC has good biocompatibility and biodegradability. After being implanted in bodies, it has good conductibility, and can be used in bone defects induced by crushed bone fracture in limbs; but it has no osteal conductivity, for bone defect caused by nonunion and benign bone tumor etc. we should use NHAC together with autograft.

1Department of Orthopaedics, Affiliated Hospital of Jiangsu University, Zhenjiang 212001, Jiangsu Province, China; 2Department of Materials Science and Engineering, Tsinghua University, Beijing 100000, China

Shen Tie-cheng, Professor, Chief physician, Department of Orthopaedics, Affiliated Hospital of Jiangsu University, Zhenjiang 212001, Jiangsu Province, China
stc986@sina.com

Received: 2006-09-02
Accepted: 2006-10-25

摘要
目的：观察纳米晶胶原基骨材料（简称人工骨）植入后骨愈合的时间和骨修复效果，探讨人工骨在骨科临床的应用范围。
方法：于2003－03/2005－03选择江苏大学附属医院骨科收治的骨折后骨缺损患者32例，骨不连患者5例，骨肿瘤患者4例，腰椎峡部裂患者4例。均符合本临床试验所制定的诊断标准，并经X射线片确诊，患者均知情同意。①骨折后骨缺损患者：均为四肢各部位粉碎性骨折，经切开复位后有骨缺损，采用人工骨植入骨缺损处。②骨不连患者：将骨折端瘢痕及硬化骨切除、髓腔打通后，植入人工骨。③良性骨肿瘤患者：将病骨刮除后植入人工骨。④腰椎峡部裂患者：在减压，RF复位、内固定后有2例行自体骨与人工骨混合植
入，1例左侧行自体骨、右侧行人工骨植入，另1例在原来行自体骨植骨基础上因愈合欠牢固，而在原植骨处加植人工骨。
结果：42例患者获得随访。①骨折后骨缺损患者29例，25例在术后2~7个月先后达临床愈合。另4例中，1例尺骨缺损植人工骨处术后2年尚无骨痂形成，术后2年9个月骨缺损处愈合；1例胫骨中上段粉碎骨折于术后15个月见原骨缺损植人工骨处骨痂形成不多。其余2例为术后过早负重，发生钢板断裂，给予重新手术复
位、固定。②骨不连患者5例，有2例于术后9个月愈合，3例单纯植人工骨者未愈，其中2例再手术行自体骨移植，术后1年愈合。③良性骨肿瘤患者4例，骨囊肿2例术后未见复发。骨纤维结构不良2例，术后再次手术，改行自体骨移植。④腰椎峡部裂患者4例，3例术前腰腿痛症状消失，复查X射线片见原峡部断裂影消
失。1例仍感下肢麻痛，复查X射线片见植骨愈合欠佳。
结论：纳米晶胶原基骨材料具有良好的生物相容性及生物可降解性能，植入体内具有良好的骨传导作用，可用于四肢粉碎性骨折所致的骨缺损；因其不具备骨诱导成分，对于骨不连、良性骨肿瘤等所致骨缺损，宜将纳米晶胶原基骨材料和自体骨混合使用。
关键词：纳米羟基磷灰石/胶原复合材料；骨缺损；骨移植

沈铁城，夏青，黄永辉，徐晓峰，崔福斋，田进纳米晶胶原基骨材料在骨科疾病中的应用[J].中国组织工程研究与临床康复，2007，11(1):48-51
[www.zglckf.com/zglckf/ejournal/upfiles/07-1/1k-48(ps).pdf]

1江苏大学附属医院骨科，江苏省镇江市 212001；2清华大学材料科学与工程系，北京市 100000

沈铁城，男，1945年生，江苏省镇江市人，汉族，1970年上海第一医学院毕业，教授，主任医师，主要从事脊柱外科、创伤骨科的研究。
stc986@sina.com

中图分类号:R318.08 文献标识码:A
文章编号:1673-8225
(2007)01-00048-03

收稿日期：2006-09-02
修回日期：2006-10-25
(06-50-9-6573/Y·Y)

课题背景：课题获镇江市科技局科研基金资助,与清华大学材料系协作进行的“纳米晶胶原基骨材料”临床试验，属国家高技术研究发展计划课题的内容。该课题名称为胶原基硬组织修复材料的仿生制备及应用（2001AA326050）。该材料技术被Nature Materials给予很高评价并有中国和美国发明专利。项目相关研究获国际材料研究联合会2003年SOMIYA奖。

创新要点：实验为纳米晶胶原基骨材料的临床试验，应用于骨折后骨缺损、良性骨肿瘤、骨不连及腰椎疾患需植骨的患者，观察其效果。实验结果以病例描述、随访调查和典型患者的实证资料（X射线片）为举证基础，证实该材料具有较好的生物相容性和可降解性，可应用于骨折后骨缺损的治疗。因其缺乏骨诱导能力，应用于良性骨肿瘤、骨不连等疾患时，需与自体骨或骨髓干细胞联合使用。结果对该产品的临床使用有一定的指导意义。

同行评价：在国家自然科学基金和国家高技术研究发展计划等专项基金资助下，清华大学崔福斋等人成功研制了纳米晶胶原基骨材料并申请多项国内外专利。该材料经过动物实验等初步证明具有较好的生物相容性和传导成骨能力，但需临床实验验证。本文从临床角度研究了材料植入人体后的临床效果，为同类材料的临床使用提供了病例依据。