CAJ | 학술논문

背景：目前冠状动脉支架的主要研究方向是高生物相容性的全降解生物材料及药物控释体系。 　　目的：评价2种新型生物全降解药物支架置入小型猪冠状动脉后的安全性。 　　方法：普通生物全降解支架为在聚左旋乳酸本体中融入抗增殖药物紫杉醇，新型生物全降解支架为在聚左旋乳酸及紫杉醇的基础上融入一种新型纳米材料无定形磷酸钙。①将普通生物全降解支架和新型生物全降解支架各5枚在冠状动脉造影下分别随机置入小型猪的冠状动脉，每种支架5头。于置入前和置入后28 d行血生化及C-反应蛋白水平检测；术后28 d冠状动脉造影观察支架置入段管腔通畅情况。②在微创显微镜辅助下于兔右髂外动脉分别置入普通生物全降解支架和新型生物全降解支架管状半成品(材料成分与上述支架一致)，每种支架7只，在术前和术后28 d检测血尿素氮及肌酐水平。 　　结果与结论：置入后28 d两组猪谷丙转氨酶、谷草转氨酶、三酰甘油、总胆固醇、低密度脂蛋白及C-反应蛋白水平与置入前相比均无明显变化，但尿素氮、肌酐水平均明显高于置入前(P<0.05)；两组支架置入段血管均血流通畅、无血栓迹象和狭窄形成。支架置入前后两组兔肌酐和尿素氮水平无明显变化。表明新型生物全降解药物支架置入健康小型猪冠状动脉后是相对安全的，并且支架具有良好的组织相容性。
배경：목전관상동맥지가적주요연구방향시고생물상용성적전강해생물재료급약물공석체계。 　　목적：평개2충신형생물전강해약물지가치입소형저관상동맥후적안전성。 　　방법：보통생물전강해지가위재취좌선유산본체중융입항증식약물자삼순，신형생물전강해지가위재취좌선유산급자삼순적기출상융입일충신형납미재료무정형린산개。①장보통생물전강해지가화신형생물전강해지가각5매재관상동맥조영하분별수궤치입소형저적관상동맥，매충지가5두。우치입전화치입후28 d행혈생화급C-반응단백수평검측；술후28 d관상동맥조영관찰지가치입단관강통창정황。②재미창현미경보조하우토우가외동맥분별치입보통생물전강해지가화신형생물전강해지가관상반성품(재료성분여상술지가일치)，매충지가7지，재술전화술후28 d검측혈뇨소담급기항수평。 　　결과여결론：치입후28 d량조저곡병전안매、곡초전안매、삼선감유、총담고순、저밀도지단백급C-반응단백수평여치입전상비균무명현변화，단뇨소담、기항수평균명현고우치입전(P<0.05)；량조지가치입단혈관균혈류통창、무혈전적상화협착형성。지가치입전후량조토기항화뇨소담수평무명현변화。표명신형생물전강해약물지가치입건강소형저관상동맥후시상대안전적，병차지가구유량호적조직상용성。
BACKGROUND:At present, the main research fields about coronary stents are the whole degradation biological materials with high biocompatibility and drug control ed release systems. OBJECTIVE: To evaluate the safety after the two novel biodegradable stents implanted in coronary arteries in porcine models. METHODS:The normal ful y biodegradable stents were made up of the poly-L-lactide and the antiproliferative drugs paclitaxel, and the novel biodegradable stents were added in amorphic calcium phosphate at the basis of normal biodegradable stents. (1) Five normal ful y biodegradable stents were randomly implanted into the coronary arteries of five porcines, and five novel biodegradable stents were randomly implanted into the coronary arteries of the remaining five porcines by coronary angiography. The blood biochemistry and C-reactive protein levels were measured pre-operation and at 28 days after operation. Coronary angiography was utilized to observe the lumen unobstructed at 28 days after surgery. (2) Under a microscope, seven normal ful y biodegradable stents and seven novel biodegradable stents were implanted into right external iliac arteries of 14 rabbits. Blood urea nitrogen and creatinine levels were measured before surgery and at 28 days after operation. RESULTS AND CONCLUSION:At 28 days after operation, there were no significant changes in porcine glutamic-pyruvic transaminase, aspartate aminotransferase, triacylglycerol, total cholesterol, low density lipoprotein and C-reactive protein levels compared with that before operation, but urea nitrogen and creatinine levels were significantly higher than that before operation (P<0.05). The result of coronary angiography showed that no in-stent thrombosis or stenosis was detected in either group. There was no significant difference in urea nitrogen and creatinine levels in both groups. These results suggested that it is safe and compatible after the two novel biodegradable stents implanted in coronary arteries of porcine models, and the stents had good histocompatibility.