生物陶瓷镀膜封堵器治疗儿童左向右分流型先天性心脏病的中远期随访研究  

Study on Ceramic membrane occluder for left - to - right shunt congenital heart disease in children： a mid and long - term follow - up result

作　　者：谢育梅[1] 邱庆欢 张智伟[1] 张爱华[3] 李俊杰[1] 李渝芬[1] 潘微[1] 陈雄英[1] 申俊君[1] 

机构地区：[1]广东省心血管病研究所心儿科,广东省人民医院(广东省医学科学院),广东省华南结构性心脏病重点实验室,广州510100 [2]广东医学院附属南山医院心内科 [3]广东省职业病防治院毒化监测所,广东省职业病防治重点实验室

出　　处：《中华实用儿科临床杂志》2015年第11期818-822,共5页Chinese Journal of Applied Clinical Pediatrics

基　　金：基金项目：广东省自然科学基金（S2011010005440）

摘　　要：目的评价生物陶瓷镀膜封堵器（陶瓷封堵器）治疗儿童左向右分流型先天性心脏病（先心病）中远期的安全性和有效性。方法对广东省心血管病研究所心儿科成功植入封堵器的98例患儿进行随访，其中室间隔缺损（VSD）44例，房间隔缺损（ASD）18例，动脉导管未闭（PDA）36例。试验组选用生物陶瓷镀膜封堵器Cera”（陶瓷封堵器），对照组选用普通镍钛合金封堵器（普通封堵器），所有病例术后定期在门诊进行常规体格检查、心电图、心脏彩超检查，术后5年进行血镍测定。结果5年内共87例患儿完成术后心脏彩超及心电图随访，随访率88．78％，中位随访时间为52．86（11．28～69．73）个月，2组患儿心腔内径变化、心律失常发生方面差异均无统计学意义，残余分流、瓣膜返流发生率均较低。对照组2例PDA患儿术后左肺动脉血流速度增快。2组术前生长发育落后的患儿术后4年完全恢复正常。术后4年频发呼吸道感染人数试验组、对照组分为别4例（10．0％）、5例（11．6％），余患者呼吸道感染次数均在正常范围。术后5年试验组2例、对照组3例患者血镍质量浓度〉2．0μg/L，余患者均为正常范围，2组比较差异无统计学意义（Z=-0．145，P=0．884）。结论陶瓷封堵器治疗儿童左向右分流型先心病成功率高、并发症发生率低，与普通封堵器相比，其有效性和安全性相当，可以应用于儿科患儿。Objective To evaluate safety and efficacy of the Ceramic membrane occluder for left - to - right shunt congenital heart diseases in children. Methods The follow - ups were made in Department of Pediatric Cardiolo- gy, Guangdong Cardiovascular Institute in a total of 98 cases with congenital heart diseases, in which the implantation of percutaneous devices was attempted,including 44 cases of ventricular septal defect （VSD） , 18 cases of atrial septal de- feet （ASD）,and 36 cases with patent ductus arteriosus. All subjects were assigned to experimental groups （ceramic membrane oecluder CeraTM） or control group （nitinol occluder）. The transthoraeic eehocardiography, electrocardio- graphy and clinical examination were observed in 12 months after the procedure and yearly thereafter. Serum nickel con- centration was tested in 5 years after the procedure. Results Total follow - up data were obtained from 87 patients （88.78%） within 1 to 5 years after the procedure,and the mean follow - up time was 52.86 months（ 11.28 - 69.73 months）. The variation cardiac chambers dimension and arrhythmia complication at each time points were not statisti- cally significant between the 2 groups, and the rate of residual shunt and valve regurgitation were very low in both groups. The blood flow velocity of left pulmonary artery increased in 2 patients. Patients with failure to thrive had com- plete recovery of growth in 4 years after the procedure in 2 groups. The number of respiratory tract infections in trial group and control group were 4 cases （ 10.0% ） and 5 cases （ 11.6% ） respectively,while other subjects with frequent re- spiratory infections had no significant recurrence within 4 years after the procedure. The number of serum nickel concen- tration 〉 2.0 p^g/L in trial group and control group were 2 cases and 3 cases respectively ,while all other patients were at a normal level and the serum nickel concentration was not statistically significant between the 2 groups within 5 years after procedure

关 键 词：生物陶瓷镀膜封堵器 先天性心脏病 介入治疗 随访 

分 类 号：R726.5[医药卫生—儿科]