中华实用儿科临床杂志
中華實用兒科臨床雜誌
중화실용인과림상잡지
Journal of Applied Clinical Pediatrics
2014年
6期
459-463
,共5页
梁东坡%张智伟%王树水%张旭%谢兆丰%曾国洪
樑東坡%張智偉%王樹水%張旭%謝兆豐%曾國洪
량동파%장지위%왕수수%장욱%사조봉%증국홍
生物可吸收支架%铁%肺动脉%先天性心脏病%儿童
生物可吸收支架%鐵%肺動脈%先天性心髒病%兒童
생물가흡수지가%철%폐동맥%선천성심장병%인동
Bioabsorbable stent%Iron%Pulmonary artery%Congenital heart disease%Child
目的 了解生物可吸收铁基肺动脉支架在猪肺动脉中的可吸收降解性和生物安全性.方法 小型猪19只应用随机数字表进行随机分组.其中3只为空白对照组;10只为支架植入A组,于肺动脉内仅植入1个支架;6只为支架植入B组,于肺动脉内分别植入2个支架.术后进行随访至24个月.统计学方法采用随访资料多个时间点多组处理的重复测量资料方差分析.结果 术后随访肺动脉血流速度(F分组×时间=1.06,P =0.40)、右心室压力(F分组×时间=0.58,P=0.86)各组间比较差异无统计学意义,提示未发生血管再狭窄情况.肺动脉管径扩张率支架植入A、B组与对照组之间比较差异有统计学意义(F分组=3.57,P =0.05;F时间=12.89,P ＜0.001;F分组×时间=2.99,P=0.03),提示在随访期内支架对血管能维持较好的扩张作用.血清铁水平各组比较差异无统计学意义(F分组×时间=0.94,P=0.52).随访期内所有试验动物均成活至随访终点,均未出现支架不良反应造成的严重不良事件.结论 生物可吸收铁基支架在动物体内发生一定程度的降解并有较好的生物安全性与稳定性.
目的 瞭解生物可吸收鐵基肺動脈支架在豬肺動脈中的可吸收降解性和生物安全性.方法 小型豬19隻應用隨機數字錶進行隨機分組.其中3隻為空白對照組;10隻為支架植入A組,于肺動脈內僅植入1箇支架;6隻為支架植入B組,于肺動脈內分彆植入2箇支架.術後進行隨訪至24箇月.統計學方法採用隨訪資料多箇時間點多組處理的重複測量資料方差分析.結果 術後隨訪肺動脈血流速度(F分組×時間=1.06,P =0.40)、右心室壓力(F分組×時間=0.58,P=0.86)各組間比較差異無統計學意義,提示未髮生血管再狹窄情況.肺動脈管徑擴張率支架植入A、B組與對照組之間比較差異有統計學意義(F分組=3.57,P =0.05;F時間=12.89,P ＜0.001;F分組×時間=2.99,P=0.03),提示在隨訪期內支架對血管能維持較好的擴張作用.血清鐵水平各組比較差異無統計學意義(F分組×時間=0.94,P=0.52).隨訪期內所有試驗動物均成活至隨訪終點,均未齣現支架不良反應造成的嚴重不良事件.結論 生物可吸收鐵基支架在動物體內髮生一定程度的降解併有較好的生物安全性與穩定性.
목적 료해생물가흡수철기폐동맥지가재저폐동맥중적가흡수강해성화생물안전성.방법 소형저19지응용수궤수자표진행수궤분조.기중3지위공백대조조;10지위지가식입A조,우폐동맥내부식입1개지가;6지위지가식입B조,우폐동맥내분별식입2개지가.술후진행수방지24개월.통계학방법채용수방자료다개시간점다조처리적중복측량자료방차분석.결과 술후수방폐동맥혈류속도(F분조×시간=1.06,P =0.40)、우심실압력(F분조×시간=0.58,P=0.86)각조간비교차이무통계학의의,제시미발생혈관재협착정황.폐동맥관경확장솔지가식입A、B조여대조조지간비교차이유통계학의의(F분조=3.57,P =0.05;F시간=12.89,P ＜0.001;F분조×시간=2.99,P=0.03),제시재수방기내지가대혈관능유지교호적확장작용.혈청철수평각조비교차이무통계학의의(F분조×시간=0.94,P=0.52).수방기내소유시험동물균성활지수방종점,균미출현지가불량반응조성적엄중불량사건.결론 생물가흡수철기지가재동물체내발생일정정도적강해병유교호적생물안전성여은정성.
Objective To monitor the degradation and bio-safety features of the bioabsorbable iron-based stent planted in the pig pulmonary artery.Methods A total of 19 miniature pigs were randomly assigned into 3 groups.Three cases were assigned as the control group; ten cases were assigned as stent implantation group A with one stent implanted in the pig pulmonary artery; the other six cases were assigned as stent implantation group B with two stents implanted in the pig pulmonary artery.Follow-up studies for 24 months were conducted in all cases.Repeated measures ANOVA were used to collect and analyze statistical processing data at multiple time points of the follow-up.Results After surgery,pulmonary artery blood flow velocity and right ventricular pressure were measured by echocardiography and cardiac catheterization.There was no significant difference in pulmonary artery blood flow velocity (Fgroup×time =1.06,P =0.40) and right ventricular pressure (Fgroup ×time =0.58,P =0.86) among each group,and no vascular renarrow circumstance was indicated.Pulmonary artery diameter expansion rate between stent group and control group was statistically different (Fgroup =3.57,P =0.05 ; Ftime =12.89,P ＜ 0.001 ; Fgroup ×time =2.99,P =0.03),suggesting that the stent could maintain a good expansion of the role of vascular in the follow-up period even though in degradation.Difference in the level of serum iron concentrations among the groups was not statistically significant (Fgroup ×time =0.94,P =0.52),suggesting that there was no evidence of iron overload.All animals survived to the follow-up endpoint,and no serious side effects caused by stent implantation were found.Conclusions Bioabsorbable iron-based stent planted in the pig pulmonary artery may experience a certain degree of degradation,and it is safe and stabile in animals.
