| 许建霞,王涵,连环,王春仁.冠脉支架系统的血液相容性测试[J].中国药事,2020,34(8):940-948 |
| 冠脉支架系统的血液相容性测试 |
| Blood Compatibility Test of Coronary Stent System |
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| DOI：10.16153/j.1002-7777.2020.08.013 |
| 中文关键词: 冠脉支架系统 血液相容性 体外凝血 颈静脉短期血栓形成 支架原位植入 溶血 |
| 英文关键词: coronary stent system blood compatibility in vitro coagulation short-term jugular thrombosis coronary stent in situ implantation hemolysis |
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| 中文摘要: |
| 目的：通过对一个冠脉支架系统血液相容性的全面检测，介绍所用的血液相容性测试方法。 方法：以上市的金属药物洗脱支架为产品对照进行体外凝血试验、体内比格犬颈静脉短期血栓形成试验，不用产品对照进行冠脉支架原位植入血栓形成试验和直接光学法溶血试验，对一个聚乳酸基全降解雷帕霉素洗脱冠脉支架系统的血液相容性进行全面检测。结果：供试输送系统和支架的凝血及输送系统的短期血栓形成与产品对照无明显差异，供试冠脉支架的血栓形成及溶血性能、输送系统的溶血性能均可被接受。结论：供试冠脉支架系统的血液相容性可被接受。目前的冠脉支架系统血液相容性试验方法基本可满足需要，但有待于进一步优化并形成标准化的试验方法。 |
| 英文摘要: |
| Objective: To introduce the blood compatibility test method through the comprehensive detection of a coronary stent system's blood compatibility. Methods: The in vitro coagulation test and short-term jugular vein thrombosis test in Beagle dogs were carried out with the listed metal drug-eluting stent as the product control. The coronary stent in situ implantation thrombosis test and direct optical hemolysis test were carried out without product control. The blood compatibility of a polylactic acid-based fully degradable rapamycin-eluting coronary stent system was comprehensively detected. Results: There was no significant difference in the short-term thrombus formation of the test delivery system, the coagulation property of stent and delivery system compared with those of the product control. The thrombosis and hemolysis properties of the coronary stent and the hemolysi s performance of the delivery system were acceptable. Conclusion: The blood compatibility of the coronary stent system is acceptable. The current blood compatibility test method of coronary stent system can basically meet the needs, but it needs to be further optimized so as to form standardized test methods. |
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