国产牛心包补片在羊肺动脉和主动脉补片实验中的安全性和有效性

Safety and effectiveness of domestic bovine pericardium as ovine pulmonary artery and descending aorta patch

目的本研究对国产牛心包补片的安全性和有效性进行评价,为进一步临床应用提供实验基础。方法采用绵羊肺动脉及降主动脉补片植入模型,以4只羊作为实验组,在肺动脉干和降主动脉干两处共植入8枚国产牛心包补片;以2只羊作为对照组,在肺动脉干和降主动脉干两处共植入4枚进口牛心包补片。术前对所有动物进行常规生化检查,术后第1个月、第2个月随访超声心动图,第3个月时进行取材,比较两组植入补片的内皮化、炎症和钙化程度等。结果 (1)所有动物均存活,未发生手术相关并发症;(2)超声心动图第1个月、第2个月的结果显示肺动脉和主动脉补片内无缝合处漏血、无钙化、无血栓形成、无赘生物、无明显动脉瘤样扩张;(3)肉眼观察两组补片均无内膜增生,厚度和韧度较术前无明显改变;两组补片内膜光滑,均无肉眼可见的钙化和异物。(4)微生物学检测提示两组补片均未出现微生物感染,均有良好的内皮化,均有炎症细胞浸润,坏死、钙化程度差异无显著统计学意义。结论国产牛心包补片在绵羊肺动脉和主动脉补片试验中具有良好的安全性和有效性。

Objective To evaluate the safety and effectiveness of a newly domestic bovine pericardium using a juvenile sheep model and to provide proof for clinical use. Methods Under the off-pump condition,8 domestic bovine pericardiums were implanted into the pulmonary artery and the descending aorta of 4 juvenile sheep as the trial group. As the control group, four imported bovine pericardiums were implanted into two juvenile sheep.Before the surgery, the juvenile sheep were given a physical examination and some laboratory tests. Ultrasonic cardiographs were taken after 1 month and 2 months of implantation. Sheep were sacrificed after 90 days and compared with the extent of endothelialization, inflammation and calcification of the two groups. Results （1） All the juvenile sheep survived without any complications.（2） Ultrasonic cardiograph showed the absence of leakage, thrombus, calcification, neoplasm or any structural deterioration.（3） Gross examination showed there was no intimal hyperplasia. The thickness and tenacity of all patches had no change compared with the pre-operation condition. All the patches showed smooth and pliable faces without degeneration, as well as absence of macroscopically calcification.（4） There was not any positive result in microbiological tests in both groups. The degree of inflammation, necrosis and calcification had no significant differencs between the two groups. Conclusions The data shows that the domestic bovine pericardium, a newly developed Chinese domestic-design and manufactured bovine pericardium, can exhibit long-term satisfactory safety and efficacy in the implantation of the pulmonary artery and the descending aorta of juvenile sheep.