| Objective:6%β-TCP/PDLLA,12%β-TCP/PDLLA,PDLLA are made of CASPs (Centrum-vertebra-fracture-repairing absorbable supporting plugger)and cylinders. CASP were implanted under the gluteus maximus and cylinders were implanted into femoral condyle of rabbits.The venous blood was drawn before operation and 2, 4,8,16,24 weeks after operation for the general blood measurement,the indexes of inflammation,the functional indexe of liver and kidney.The index was compared with the PDLLA group,the control group and the preoperative.the animals were killed,livers and kidneys were carried out general observation and pathological observation,to evaluate the biological safety of 6%β-TCP/PDLLA, 12%β-TCP/PDLLA CASP.Method:According to the evaluated criteria of absorbably medical implanted materials and animal trial recommended in GB/T 16886.16-2003.Select 54 New Zealand white rabbits,weight(2.5±0.3)kg,were randomly divided into four groups:6%β-TCP/PDLLA group(n=14),12%β-TCP/PDLLA group(n=14), PDLLA group(n=14)and the control group(n=8).The venous blood was drawn of eight rabbits electing from each group before operation for the general blood measurement,the indexes of inflammation,the functional indexe of liver and kidney. the CASPs and cylinders that make from 6%β-TCP/PDLLA,12%β-TCP/PDLLA, PDLLA were implanted under the gluteus maximus and the femoral condyle of rabbits respectively.Control group had the same operation,but didnot implanted any materials.The venous blood was drawn 2,4,8,16,24 weeks after operation of eight rabbits electing from each group for the same examination,two rabbits were killed of each group of the first three groups 4,12,24 weeks after operation.livers and kidneys were carried out general observation and pathological observation.Results:WBC and CRP of PDLLA group and the control group showed significant difference comparing with the indexes of preoperative in 2 weeks after operation(P＜0.05).the indexes between the two groups showed no significant difference(P＞0.05).in other time points,the indexes compared with the indexes of preoperative was no significant difference(P＞0.05),between the two groups showed no significant difference(P＞0.05).WBC and CRP of 6%β-TCP/PDLLA group and 12%β-TCP/PDLLA group in various time points compared with the indexes of preoperative respectively showed no significant difference(P＞0.05).The indexes of 6%β-TCP/PDLLA group and 12%β-TCP/PDLLA group in various time points showed no significant difference between each other in each group(P＞0.05),while in each time point compared with the indexes of PDLLA and control groups respectively showed no significant Difference(P＞0.05).the other results of 6%β-TCP/PDLLA group and 12%β-TCP/PDLLA compared with the results of PDLLA group and the control group respectively was no significant difference in various time points(P＞0.05);the other results of PDLLA group compared with the results of control group was no significant difference in various time points(P＞0.05); Other results of the 4 groups compared with the results of preoperative respectively showed no significant difference(P＞0.05),other results of each group between each time point was no significant difference(P＞0.05).specimen observation of Livers, kidneys hadnot edema,congestion,fibrosis and sarcoidosis ban blocks and empty necrosis,pathological slices found no clear pathological changes.Conclusion:1.The inflammatory indicators(WBC,CRP)of PDLLA group and the control group increased in 2 weeks after operation and were normal in other time points.It was accord with the performance of inflammatory changes.2.The time of inflammation in 6%β-TCP/PDLLA group,12%β-TCP/PDLLA group shorted than the time of inflammation in PDLLA group and the control group.3.CASP making from 6%β-TCP/PDLLA,12%β-TCP/PDLLA,PDLLA had no influence on the blood system,liver and kidney function within 24 weeks after operation.4.CASP making from 6%β-TCP/PDLLA,12%β-TCP/PDLLA has good biological safety.
|
PDF Full Text Request