钛铌锆β钛合金低弹性模量内固定材料的生物相容性研究  

In vivo biocompatibility of beta titanium alloys for internal fixation instruments

作　　者：贾庆卫[1] 宁聪琴[1] 丁冬雁[2] 汤亭亭[1] 严孟宁[1] 周新社[1] 戴尅戎[1] 

机构地区：[1]上海交通大学附属第九人民医院骨科 [2]上海交通大学复合材料研究所,上海200011

出　　处：《中国矫形外科杂志》2008年第9期694-697,共4页Orthopedic Journal of China

基　　金：国家自然科学基金项目(No·30400448)

摘　　要：[目的]通过体内实验的方法对新型β型钛合金(Ti-Nb-Zr)骨折内固定材料的生物相容性进行评价。[方法](1)改良的鼠气囊模型(the air pouch model):健康成年SD大鼠24只,皮下充气造模后将钛铌铣β型钛合金(Ti-Nb-Zr)颗粒混悬液注入气囊,收集囊内液体采用ELISA方法测定IL-6和TNF-α,用囊壁组织学切片进行炎症细胞反应分级和囊壁厚度测量,并与传统的钛铅钒合金(Ti-6Al-4V)进行比较。(2)接骨板植入模型:将Ti-Nb-Zr做成接骨板固定在兔的胫骨上,于手术后4、8、12、24、36周分别观察接骨板周围的纤维膜形成情况和Ti-Nb-Zr-骨界面骨结合情况,并与不锈钢接骨板比较。[结果](1)Ti-6Al-4V、Ti-Nb-Zr两种颗粒注入气囊48h后都能引起TNF-α分泌量显著升高(P<0·05),两组比较,Ti-6Al-4V组明显高于Ti-Nb-Zr组(P<0·05)。两种材料均不能引起IL-6分泌的显著增加(P>0·05)。Ti-Nb-Zr组气囊囊壁厚度明显小于Ti-6Al-4V组(P<0·001)。(2)Ti-Nb-Zr接骨板周围软组织反应与不锈钢相近。植入后4周,新生骨痂开始覆盖Ti-Nb-Zr接骨板的两侧,8周时骨痂甚至部分覆盖接骨板和螺钉的表面形成"骨盖板"现象。12周时,骨与Ti-Nb-Zr接骨板的界面为直接接触,中间无软组织间隔。螺钉与骨也能形成较为牢固的钉-骨直接接触。[结论]低弹性模量Ti-Nb-Zrβ钛合金具有优良的体内组织相容性,是一种有前途的骨折内固定材料。[Objective] To develop new beta titanium alloys made of titanium, niobium and zirconium （Ti-Nb-Zr） which have higher strength, lower moduli of elasticity. Its biocompatibility in vivo is evaluated in this paper. [ Method] （1） 24 SD rats were used in the modified air pouch model experiments. Air was injected subcutaneously on the back of rats to form the pouches and the Ti-Nb-Zr particles were introduced into them. The liquid in the pouches was harvested 48 hours later for IL-6 and TNF- αELISA procedure and the capsules for histology examination. All the results were compared with Ti-6Al-4V. （2） Ti-Nb-Zr bone plates were fixed onto tibias of rabbits. The capsules around the plates and the bone under them were observed at 4, 8, 12, 24 and 36 weeks respectively. Ti-Nb-Zr-bone interfaces were emphasized in this procedure. This time the control material was stainless steel. [Result] （1） Ti-Nb-Zr and Ti-6Al-4V particles made the air pouches secret more TNF-α than that of the control （P 〈 0. 05） . Ti-6Al-4V particles made the effect more prominent than Ti-Nb-Zr particles did （P 〈0. 05）. This effect was not seen in IL-6 menstruations experiments. The thickness of the air pouches was different in two groups. It was thinner in the Ti-Nb-Zr group than that in Ti-6Al-4V group （P 〈 0. 001 ）. （2） After 4 weeks of Ti-Nb-Zr bone plates＇implantation the new callus formed beside the plates. The ＂callus overlay the plate＂ phenomenon was seen after 8 weeks. In 12 weeks a kind of direct integration had formed in the bone-plates interfaces. No soft tissue was seen in them. The same direct integration was also seen in the bone-screw interfaces. [ Conclusion ] The Ti-Nb-Zr beta titanium alloys developed in this study have lower modulus and high biocompatibility both. Its perfect biocompatibility in vivo shows that it is a promising material for internal fixation instruments.

关 键 词：内固定 钛铌锆 生物相容性材料 体内研究 

分 类 号：R318.08[医药卫生—生物医学工程]