一种非戊二醛化学体系处理的生物瓣膜材料的生物相容性研究  

Biocompatibility of bioprosthetic heart valve materials with a non-glutaraldehyde-based chemical treatment

作　　者：温晓晓 张坤 潘孔荣 汪文涛 潘文志 WEN Xiaoxiao;ZHANG Kun;PAN Kongrong;WANG Wentao;PAN Wenzhi(Peijia Medical Limited,Suzhou,215000,Jiangsu,P.R.China;Department of Cardiology,Zhongshan Hospital,Fudan University,Research Unit of Cardiovascular Techniques and Devices,Chinese Academy of Medical Sciences,Shanghai,200032,P.R.China)

机构地区：[1]沛嘉医疗科技(苏州)有限公司,江苏苏州215000 [2]复旦大学附属中山医院心内科中国医学科学院心血管技术与器械创新单元,上海200032

出　　处：《中国胸心血管外科临床杂志》2022年第12期1653-1659,共7页Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

摘　　要：目的研究一种基于非戊二醛化学体系处理的生物瓣膜材料的生物相容性,为其临床应用提供安全性数据。方法所有实验均参照GB/T16886系列标准:采用噻唑蓝法进行体外细胞毒性实验;取15只豚鼠,分为实验组(n=10)和对照组(n=5),进行皮肤致敏实验;取3只新西兰大白兔,每只动物左右两侧背部各取5个点作为实验部位和对照部位,进行皮内反应实验;取20只ICR小鼠,随机分为4组:实验组(极性介质)、对照组(极性介质)、实验组(非极性介质)、对照组(非极性介质),每组5只,开展急性全身毒性实验;取40只SD大鼠,分为实验组(n=20)和对照组(n=20),开展亚慢性全身毒性实验。结果非戊二醛化学体系处理的生物瓣膜材料100%样品浸提液的细胞活力为75.2%,皮肤致敏阳性率为0.0%,皮内反应最终计分为0分,急性全身毒性实验中实验组与对照组动物体重差异无统计学意义(P>0.05),亚慢性全身毒性实验中实验组与对照组体重、主要器官重量、血常规和血生化数据差异均无统计学意义(P>0.05)。结论非戊二醛化学体系处理的生物瓣膜材料具有良好的生物相容性,符合国家相关标准,有可能应用于临床瓣膜置换中。Objective To study the biocompatibility of bioprosthetic heart valve material with a nonglutaraldehyde-based treatment,and to provide the safety data for the clinical application.Methods All the tests were conducted according to GB/T16886 standards.The in vitro cytotoxicity was determined by methyl thiazolyl tetrazolium assay.Fifteen guinea pigs were divided into a test group(n=10)and a control group(n=5)in the skin sensitization test.Three New Zealand white rabbits were used in the intradermal reactivity test.Five sites on both sides of the rabbit back were set as test sites and control sites,respectively.In the acute systemic toxicity test,a total of 20 ICR mice were randomly assigned to 4 groups:a test group(polar medium),a control group(polar medium),a test group(non-polar medium)and a control group(non-polar medium),5 in each group.Forty SD rats were divided into a test group(n=20)and a control group(n=20)in the subchronic systemic toxicity test.Results The viability of the 100%extracts of the bioprosthetic heart valve material with a non-glutaraldehyde-based treatment was 75.2%.The rate of positive reaction was 0.0%.The total intradermal reactivity test score was 0.There was no statistical difference in the body weight between the test group and control group in the acute systemic toxicity test.There was no statistical difference in the body weight,organ weight,organ weight/body weight ratio,blood routine test or blood biochemistry between the test group and control group in the subchronic systemic toxicity test.Conclusion The bioprosthetic heart valve material with a non-glutaraldehyde-based treatment has satisfying biocompatibility,which conforms to relevant national standards.The material might be a promising material for application in valve replacement.

关 键 词：生物瓣膜 牛心包 碳二亚胺 生物相容性 毒性反应 

分 类 号：R318.08[医药卫生—生物医学工程]