The Immune Toxicity Evaluation And Clinical Research Of The Spray Splint

Objective:In accordance with national standards, a series of immune toxicity experiments are carried out to provide reliable theoretical basis of the spray splint. And through the spray splint and traditional splint in application of Colles fracture comparative study, to investigate the clinical application of results.Methods:1 Immune toxicity:According to ISO/TS 10993—20:2005 Immune toxicity evaluation of medical devices standard and special-request of splint, we selected a serial of reasonable experiments, including chronic inflammation text, hypersensitivity text, humoral immunity text and cellular immunity text. chronic inflammation text:using a direct contact method, gained tissue slice and done pathological examination after 1,4 weeks. hypersensitivity text:using the maximum dose of allergen, observed the sensitization after stimulated guinea pigs with extracts, calculated sensitization rate, assessed the level of sensitization. humoral immunity text and cellular immunity text:using a direct contact method, draw blood after 1,4 weeks to determine IgG,IgA,IgM,IgE by ELISA Kit and T cell subset by flow cytometry. At the same time, Executed mouse and weigh spleen.2 Clinical research:66 cases of Colles fractures were randomly divided into 2groups:the spray splint group,24 cases:the traditional splint group,22 cases. By comparing and analyzing the average operation time, the fixation effect measuring with X-ray after 4 weeks, the clinical recovery after 6-8 weeks, to evaluate the clinical effect.Results:1 Immune toxicity:chronic inflammation text:The activities of animals had no significant difference, pathological examination showed that tissue slice had no specificity change such as Macrophages and Allogeneic Macro cell. Only 2 tissue slice in positive group found Lymphocyte and infiltrate moderately. (2) hypersensitivity text:The experimental group did not find red and swollen any time after stimulating, scoring was 0, sensibilization rate was not 0. There was no significant difference between the experimental group and negative group (P>0.05), and significant difference between the experimental group and positive group (P>0.05), indicating that the material had no sensibilization. (3) humoral immunity text and cellular immunity text: Examination showed that IgG,IgA,IgM,IgE,CD4,CD8,CD4/CD8 was no significant difference between the experimental group and negative group (P>0.05), spleen weight was too (P>0.05).2 Clinical research:The average operation time and he fixation effect in the spray splint group were good more than the traditional splint group (P<0.05), but there was no significance (P>0.05) in the clinical recovery between the spray splint group and the traditional splint group.Conclusions:A series of study showed that the spray splint was no significant Immune toxicity, and had a good bio-security. And it had been researched that the spray splint could effectively keep fixation stability and promote fracture healing.