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（ Z = -0. 145,P = 0.884）. Conclusions The Ceramic membrane occluder has similar efficacy and safety with a high success rate and low complication rate for left - to - rig）it shunt congenital heart disease in children, when com- pared to the general nitinol occluder. The Ceramic membrane occluder is appropriate for clinical application in children.
出处
《中华实用儿科临床杂志》
CAS
CSCD
北大核心
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）
关键词
生物陶瓷镀膜封堵器
先天性心脏病
介入治疗
随访
Ceramic membrane occluder
Congenital heart disease
Catheter closure
Follow - up
