多孔磷酸三钙人工骨修复腔隙性骨缺损的随机对照研究

摘要

Objective To evaluate the clinical outcomes of a hovel porous β-tricalcium phosphate (β-TCP)and control allograft for the repair of lacunar bone defects caused by solitary bone cyst curettage.Methods From January 2003 to December 2008,the patients with solitary bone cyst were randomized into an experimental(55 cases)and a control(40 cases)group.The control group received particulate allograft bone as the graft material,and the experimental group received β-TCP.At 1 week,1,2,3,6,12,24,48months after surgery,a new radiographic scoring system was employed to calculate the biodegradation of bone graft and evaluate the influence of multiple factors.Histologic characteristic of the degradation process of β-TCP were also evaluated.Results All the cases were followed up for average 28.4 months.Radiographic semi-quantitative analysis revealed that the biodegradation effieiencies were not significantly difierent between β-TCP and allografts(P=0.424).Degradation percentage of the implanted β-TCP or allograft was higher in younger patients than those in the older ones.Degradation of β-TCP was significantly higher than that of allografts over 3 years after surgery(P=0.04).In the experimental group,β-TCP degradation was greater in the loose packing treatment than that in the dense packing treatment (P=0.03).Histological observation demonstrated that the process of new bone formation accompanied the degradation of β-TCP.Conclusion The interporous β-TCP could be an advantageous alternative to allografts for repair bone defects caused by bone cyst.The clinical application of β-TCP is safe and reliable,which shows better biodegradation and osteogenesis than allografts in long-term follow-up.%目的 评价多孔磷酸三钙(β-tricalcium phosphate,β-TCP)修复腔隙性骨缺损的临床效果,探讨其成骨愈合机制.方法 2003年1月至2008年12月,随机选择应用多孔β-TCP人工骨颗粒材料修复孤立性骨囊肿刮除术后骨缺损55例(实验组),或应用异体骨颗粒材料修复40例(对照组).术后1周、1、2、3、6、12、24及48个月摄X线片,采用自定的X线影像学半定量方法观察植骨材料的降解和成骨情况,计算植骨材料降解率,分析不同年龄组、不同随访时间段、不同植骨方式的材料降解率.组织病理学检查观察β-TCP人工骨降解成骨过程.结果 全部病例随访7～48个月,平均28.4个月.终末随访X线片示β-TCP人工骨和异体骨均能修复骨缺损.实验组(81.5%±23.2%)与对照组(77.9%±19.4%)材料降解率无统计学差异(t=0.803,P=0.424).实验组与对照组均表现出年龄越小植骨降解率越高的趋势;术后3年以上,实验组降解率高于对照组(t=29.893,P=0.04);采用打压植骨法时对照组降解率高于实验组(t=39.233,P=0.00),实验组组内比较疏松植骨法降解率高于打压植骨法(t=8.342,P=0.03).组织病理学结果显示β-TCP降解与成骨同时进行,新骨内可见骨细胞和骨陷窝.结论 多孔β-TCP人工骨修复腔隙性骨缺损的临床效果和异体骨相似,随时间延长降解效果逐渐优于异体骨.