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With the radiologic technology and the rapid development of fractures, fractures tend to be more invasive methods. Percutaneous injection of bone growth factors, with less trauma, broad indications of the advantages that can be directly input to the efficient inducer of bone fractures, bone defects and nonunion site. Large segment of clinical fractures in patients with nonunion higher incidence, such as closed reduction of the fracture site to inject bone growth factors will increase the probability of fracture healing. For nonunion patients, including fixed or external fixation perfect circumstances, you can take local injection of bone growth factor treatment, expanding the non-surgical treatment indications. Therefore, the injectable bone growth factors will have broad prospects for development. I will bBMP, bFGF and PVP composite together, developed into injectable BMP (IBMP). In this study, the fibrin glue (FSG) as the carrier injection IBMP explore the feasibility of, and conducted clinical trial. One, FSG IBMP release carrier for experimental study Objective: To observe IBMP effect on coagulation and FSG FSG right IBMP osteogenic activity, and to explore the feasibility of FSG as IBMP solvent, Methods: IBMP powder dissolved in advance FSG body in plastic part or parts of thrombin, thrombin and then were with FSG part or portion of the main rubber compound for the gel to observe the solidification time, and then implanted in mouse muscle compound bag, composite analysis of two methods osteogenic conditions, and simple IBMP implant group compared. Results: Two compound method, the solidification time is no significant change, and the use of plastic body will IBMP previously dissolved the Ministry of Fourth Military Medical University master's degree thesis a score composed of bone implant activity was significantly higher than that of implantation IBMP groups. Conclusion: FSG is an ideal vehicle for IBMP. Second, pre-clinical research ... JBMP biocompatibility tests Objective: IBMP product biocompatibility testing, drug testing designated by the State Department to obtain biocompatibility test certificate for the IBMP product can legally and safely provide the basis for the clinical application. Methods: The national health departments to develop biomaterials and biological products evaluation criteria for the guidelines, conducted IBMP acute toxicity test, allergy test, hemolysis test, cytotoxicity test, trial and intramuscular implantation of bone implant tests. Results: IBMP not cause acute toxicity in mice; did not cause an allergic reaction in guinea pigs; rabbit erythrocyte hemolysis rate of 9% a knife, no hemolysis; vitro cytotoxic response indicator R = 0.25 Sichuan, no cytotoxicity; bone in the rabbit intramuscular implants and mice implanted within, does not produce fibrous capsule and did not cause lymphocyte infiltration of inflammatory cells. Conclusion: the Shaanxi Provincial Institute for Drug detection and identification: IBMP biocompatibility test results, with a combined state of biological material and biological products standards. Three, IBMP preliminary clinical study Objective: To investigate IBMP promoting effect on fracture healing. Methods: 66 cases of fracture were treated with surgery, while at the fracture site as the carrier applied locally to FSG IBMP. Including 50 males and 16 females; age of 10.75 years, mean 37 years old knife. Use IBMp parts totaling 69, including: bone cavity 27, femur 22, the limb 12, ulna 5, talus 1, a subtalar arthrodesis, ankle arthrodesis a three. Fresh fractures, 35 cases, 22 cases of nonunion, old bone Xin eight cases, one case of osteonecrosis. Multiple fractures door cases, 22 cases of fracture. Open fractures in 7 cases, 58 cases of closed fractures. Pathologic fracture one case. Through the postoperative follow-up, patients were observed for IBMPNSG systemic and local reactions and IBMP / FSG promoting effect on fracture healing. Results: The body of the iMP / FSG no obvious rejection, fracture healing well. Conclusion: IBMPNSG is good for injection fracture healing promoter.
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