摘要
背景:前期动物实验证实,骨诱导活性材料有良好的组织相容性和很强的成骨能力,用于临床修复腭裂骨缺损是否也具有同样作用尚需进一步研究。目的:植入成品骨诱导活性材料修复腭裂硬组织缺损,以植入后3个月CT扫描三维重建硬腭组织评估其可行性。设计、时间及地点:随机对照前瞻性临床实验,于2007-01/2008-04在贵阳市口腔医院完成。材料:成骨诱导活性材料(复合骨形态发生蛋白的牛松质骨植骨体)由天津中津生物发展有限公司提供,为白色块状,大小1.0cm×1.0cm×0.3cm,质量0.5g。方法:随机选取20例年龄在2～12岁的先天性正中Ⅱ度腭裂患者,随机平均分成对照组和植骨组,对照组采用常规的单纯两瓣法修复腭部软组织缺损;植骨组采用两瓣法修复腭部软组织缺损的同时,植入骨诱导活性材料修复硬腭骨组织缺损。主要观察指标:对比观察软组织愈合情况;术后3个月CT检查并三维重建硬腭组织,对比观察裂隙两边成骨组织情况。结果:术后7d对照组和植骨组患者腭部软组织均达到良好的一期愈合,无排异反应;术后3个月CT扫描及三维重建显示:植骨组骨诱导活性材料完全骨化并与周围骨组织融合,新生骨组织与原有骨组织无明显差异,硬腭连续性得到恢复。对照组腭部软组织封闭良好,硬腭骨组织连续性较术前没有明显改变,裂隙仍然存在,但可以看到裂隙在一定程度上变窄。结论:骨诱导活性材料组织相容性好,成骨作用明显。应用骨诱导活性材料修复腭裂骨缺损,能有效弥补腭裂的硬腭骨性缺损,更好地恢复硬腭的完整性,为腭部肌肉等软组织正常解剖结构的恢复提供了可能。
BACKGROUND： Previous animal experiments demonstrated that osteoinduction active material （OAM） has superior histocompatibility and strong osteogenic potential, however, whether it has same effect on repairing cleft palate still uncertain. OBJECTIVE： To repair cleft palate using OAM implantation, in addition, to investigate its feasibility by using CT three-dimensional reconstruction at 3 months later. DESIGN, TIME AND SETTING： A randomized controlled clinical experiment was performed in Guiyang Stomatological Hospital, from January 2007 to April 2008. MATERIALS： OAM （Bovince cancellous bone graft rod compositing with bone morphogenetic protein）, sized 1.0 cm×1.0 cm× 0.3 cm, weighing 0.5 g, were provided by Zimbabwe Biology Development Co., Ltd., Tianjin. METHODS： A total of 20 patients with congenital meso immaturity cleft palate, aged 2-12 years, were randomly and evenly divided into control and bone grafting groups. Orthodox simplex two-flap operation was used to repair cleft palate in the control group, and two-flaps operation was adopt to repair soft tissue meanwhile implant OAM to repair bone defects in cleft hard palate in bone grafting group. MAIN OUTCOME MEASURES： Comparison of the coalesced condition of the soft tissue; CT and three-dimensional reconstruction was used to examine the hard palate appearance at the third month at 3 months after operation. RESULTS： The soft tissue achieved well primary healing without rejection at day 7 in both groups. CT and three-dimensional reconstruction displayed that the OAM had completely calcificated with the virgin bone tissue, the neogenesis bone tissue had no obviously distinction at the third month in bone grafting group. The succession of hard palate had well recovered. Though soft tissues at pars palatalis sealed, the gap still existed in the control group. CONCLUSION： OAM has satisfactory histocompatibility and no rejection with normal tissue. It has conspicuous osteogenesis by using OAM to repair bone defects in cleft palate. This ef
出处
《中国组织工程研究与临床康复》
CAS
CSCD
北大核心
2009年第42期8225-8228,共4页
Journal of Clinical Rehabilitative Tissue Engineering Research
基金
贵阳市科技局资助项目(2003-08)~~
