自固化磷酸钙人工骨修复不同病因骨缺损94例

背景:自体骨移植由于生物相容性好,被认为是最佳的植骨材料,但其数量远远不能满足临床需要,加之髂骨取骨所导致的并发症较多,故寻找一种能替代自体骨的材料仍是当前研究的热点.目的:探讨自固化磷酸钙人工骨(calcium phosphate cement, CPC)填充修复骨缺损的生物相容性及成骨性能.设计、时间及地点:自身对照观察,于2001-02/2004-09义乌市中心医院骨科收治的骨缺损患者94例.对象:骨缺损患者94例,其中骨折塌陷复位后骨缺损63例,骨髓炎20例,骨囊肿6例,骨纤维异常增殖症4例,内生软骨瘤1例.骨缺损范围为1cm×1cm～4cm×20cm.方法:CPC由上海瑞邦生物材料有限公司生产(国食药器械监准]字2005字3460304号(更)),CPC粉末与固化液按3.0g:1mL比例调制,CPC充填量为3～42g,其中单纯CPC填充修复74例(胸腰椎骨折行椎体成形38例,骨折复位后空腔充填25例,良性骨肿瘤病灶刮除后充填11例),载药CPC填充修复骨髓炎20例.主要观察指标:CPC植入后有无过敏或毒性反应,有无皮疹或高热,血钙、磷、碱性磷酸酶的指标,植入后12个月X射线片观察植入CPC与宿主骨接触情况和CPC降解成骨情况.结果:本组94例均获随访,植入后14个月随访94例,植入后24个月随访76例,植入后36个月随访47例,植入后48个月随访36例.CPC能在人体内30min内初步固化.全部患者植入后未见过敏或毒性反应,无皮疹或高热,血钙、磷、碱性磷酸酶均正常,切口无瘙痒感.X射线片随访显示,植入CPC与宿主骨接触紧密,界面处未见间隙存在,骨缺损处的解剖形状完全或大部分恢复,未见脱落现象,随访时部分患者CPC部分降解成骨.9例发生植入后伤口渗出,为淡黄色清亮稀薄分泌物,细菌培养阴性,经换药后伤口愈合良好.20例载药CPC患者在随访时均未见骨髓炎复发,CPC均未完全降解成骨.结论:单纯CPC填充修复骨缺损,载药CPC填充修复治疗骨髓炎与宿主生物相容性好,安全有效,并发症少.

Autosolidifying calcium phosphate cement in the repair of bone defects due to different etiology among 94 cases

BACKGROUND: Due to good biocompatibility, autologous bone has been considered as the optimal graft, but its source is too limited to meet the clinical requirements. In addition, the harvesting of iliac bone is associated with significant morbidity, thus searching for a substitute material of autologous bone graft is a current topic of study.OBJECTIVE: To study the biocompatibility and osteogenesis capacity of autosolidifying calcium phosphate cement (CPC) in the repair of bone defects.DESIGN, TIME AND SETTING: A self-control observation was performed among 94 patients who were admitted at the Department of Orthopedics in Yiwu Central Hospital (Yiwu, Zhejiang, China) from February 2001 to September 2004.PARTICIPANTS: Ninety-four patients with bone defects were involved in this study. The underlying cause of bone defects was fracture collapse and reduction in 63 cases, osteomyelitis in 20 cases, bone cyst in 6 cases, fibrous dysplasia in 4 cases and enchondroma in 1 case. The area of bone defects ranged from 1cm×1cm to 4cm×20cm.METHODS: CPC was the product of Shanghai Rebone Biomaterials Co., Ltd (License N0. 2005-3460304, China). CPC powder was mixed with solidifying liquid according to the ratio of 3.0g: 1mL, and the filling dose of CPC was 3-42g. There were 74 cases implanted with pure CPC, including 38 cases with thoracolumbar fracture undergoing vertebroplasty, 25 cases with fracture undergoing open repair, and 11 cases underwent focal debridement of benign bone tumor. in another 20 cases of osteomyelitis, drug-loaded CPC was implanted.MAIN OUTCOME MEASURES: After the CPC implantation, all patients were observed according to the following indexes: allergic or toxic reaction, rash or high fever, levels of serum calcium, phosphors and alkaline phosphatase. X-ray radiography at month 12 after implantation was employed to observe the osseointegration of the implanted CPC to host bone and the degradation of CPC.RESULTS: All 94 patients were followed up for 14 months, and 76 of them for 24 months, 47 of them for 36 months, and 36 of them for 48 months. CPC developed primary solidification in human body within 30 minutes. Neither allergic or toxic reaction nor rash or high fever were found in all patients. The levels of serum calcium, phosphors and alkaline phosphatase were noted to be normal. No case companied with the itching in incision. The radiological examination showed that. the implanted CPC was directly bonded to the bone at the interface, and the bone contour at the defect sites was completely or partly restored. Degeneration and new bone were formed in some of the patients. Incision oozing light yellow fluids occurred in 9 cases, the bacterial culture was detected as negative, and all wounds healed through dressing changes. In the 20 cases implanted with drug-loaded CPC, no cases experienced recurrence of osteomyelitis and CPC degeneration was not complete.CONCLUSION: With good biocompatibility, safety and few complications, CPC is a good substitute for autologous bone graft in the repair of bone defects, and drug-loaded CPC is a selective treatment for osteomyelitis.