承担医疗器械和药品包装质量检验检测等技术支撑工作；承担医疗器械和药品包装质量分析、安全有效性研究及相关科技创新平台建设工作；承担医疗器械和药品包装有关国家标准、行业标准及检验方法、技术规范的研究及制修订工作，并开展相关培训；承担医疗器械和药品包装技术审评、风险会商、专项检查、体系核查、人员培训的技术支撑和辅助性工作；承担医疗器械和药品包装新材料、新产品、新工艺和新方法技术开发、技术转化、技术咨询和技术服务等工作。
ObjectiveTo investigate the biological effect of medical recombinant human-derived collagen functional dressings in wound healing. MethodsMTT assay and RTCA assay were used to detect cell toxicity and proliferation. Scratch assay and Transwell cell migration assay were used to detect cell motility and migration ability. Enzyme-linked immunosorbent assay was used to detect the contents of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-endothelial cell adhesion molecule (CD31) in the supernatant of four types of cells. After animal surgery, the surgical wound was taken at 1 week, 4 weeks and 13 weeks, respectively, for hematoxylin eosin (HE) staining and immunohistochemistry to observe the inflammatory response and CD31 expression of the wound. Results Medical recombinant human-derived collagen functional dressing promotes cell proliferation and migration, enhances wound angiogenesis by upregulating the expression of VEGF, FGF, and CD31 in human dermal vascular endothelial cells (HDVEC) and human vascular endothelial cells (HVEC), thereby improving local blood supply to the wound, regulating the inflammatory response of the wound, and accelerating wound healing. ConclusionRecombinant type Ⅲ humanized collagen plays an important role in wound healing.
Objective The full name of vertebroplasty is percutaneous vertebroplasty(PVP).It is a clinical technique that injects bone cement into the diseased vertebral body to achieve strengthening of the vertebra.The research on the safety and efficacy of bone cement is the basis for clinical application.In this study,vertebroplasty is used to evaluate and compare the safety and efficacy of Tecres and radiopaque bone cement in experimental pigs,and to determine the puncture method suitable for pigs and the pre-clinical evaluation method for the safety and efficacy of bone cement.Methods Twenty-four experimental pigs(with a body weight of 60-80 kg)were randomly divided into an experimental group(Group A)and a control group(Group B).Group A was the Tecres bone cement group,and Group B was the radiopaque bone cement group,with 12 pigs in each group.Under the monitoring of a C-arm X-ray machine,the materials were implanted into the 1st lumbar vertebra(L1)and 4th lumbar vertebra(L4)of the pigs via percutaneous puncture using the unilateral pedicle approach.The animals were euthanized at 4 weeks and 26 weeks after the operation,respectively.The L4 vertebrae were taken for compressive strength testing,and the L1 vertebrae were taken for hard tissue pathological examination to observe the inflammatory response,bone necrosis,and degree of osseointegration at the implantation site.Results The test results of compressive strength between groups A and B showed no significant difference at 4 weeks and 26 weeks after bone cement implantation(P＞0.05).Observation under an optical microscope(x100)revealed that at 4 weeks postoperatively,both groups A and B showed that the bone cement was surrounded by proliferative fibrous tissue,with lymphocyte infiltration around it.The bone cement was combined with bone tissue,the trabecular arrangement was disordered,and osteoblasts and a small amount of osteoid were formed.At 26 weeks postoperatively,bone cement was visible in both groups A and B.The new bone tissue was mineralized,the trabeculae were fused,the trabecular structure was regular and dense with good continuity,and no obvious inflammatory reaction was observed.Conclusion In experimental pig vertebrae,there were no significant differences observed in the compressive strength,inflammation response,bone destruction,and integration with the bone between Tecres and non-radiopaque bone cement.Both exhibited good biocompatibility and osteogenic properties.It indicates that using vertebroplasty to evaluate the safety and efficacy of bone cement in pigs is scientifically sound.
