新型聚氨酯心脏瓣膜的组织相容性试验

Histocompatibility of a novel polyurethane material for construction of prosthetic heart valve

摘要: 目的: 评价由聚已二酸亚己酯（PDMS）与二甲基硅醚聚合物（PHMO）所构建的新型聚氨酯弹性体作为人工心脏瓣膜材料的可行性。方法: 用此材料做致敏试验、全身急性毒性试验和致癌实验，评价其组织相容性。结果: 此材料组织相容性良好，致敏试验提示新型聚氨酯材料较对照组有较明显的防止过敏的性能（P<0.05,P<0.01）；全身急性毒性试验显示出明显的低毒性（P<0.01）；致癌实验提示未见肿瘤样变化。结论: 此种新型聚氨酯材料符合人工心脏瓣膜材料组织相容性的要求。

Abstract: AIM: To evaluate the histocompatibility of a novel polyurethane material used for the construction of prosthetic heart valves. METHODS: Evaluations including hemolysis, stimulation and systemic acute toxicity tests were performed. Polyurethane extracts were injected subcutaneously (SC) in rabbits and intravenously (IV) in mice. Histological and animal responses after 72 h were studied. RESULTS: This material has displayed good histocompatibility. No toxicity was observed. Primary skin irritation test showed no erythema, eschar or edema. CONCLUSION: This novel polyurethane material meets the requirements for material characteristics used for the construction of prosthetic heart valves.