CAJ | 학술논문

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CeraTM(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＞2.0 μg/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.
목적 평개생물도자도막봉도기(도자봉도기)치료인동좌향우분류형선천성심장병(선심병)중원기적안전성화유효성.방법 대광동성심혈관병연구소심인과성공식입봉도기적98례환인진행수방,기중실간격결손(VSD)44례,방간격결손(ASD) 18례,동맥도관미폐(PDA)36례.시험조선용생물도자도막봉도기CeraTM(도자봉도기),대조조선용보통얼태합금봉도기(보통봉도기),소유병례술후정기재문진진행상규체격검사、심전도、심장채초검사,술후5년진행혈얼측정.결과 5년내공87례환인완성술후심장채초급심전도수방,수방솔88.78％,중위수방시간위52.86(11.28～69.73)개월,2조환인심강내경변화、심률실상발생방면차이균무통계학의의,잔여분류、판막반류발생솔균교저.대조조2례PDA환인술후좌폐동맥혈류속도증쾌.2조술전생장발육락후적환인술후4년완전회복정상.술후4년빈발호흡도감염인수시험조、대조조분위별4례(10.0％)、5례(11.6％),여환자호흡도감염차수균재정상범위.술후5년시험조2례、대조조3례환자혈얼질량농도＞2.0 μg/L,여환자균위정상범위,2조비교차이무통계학의의(Z=-0.145,P=0.884).결론 도자봉도기치료인동좌향우분류형선심병성공솔고、병발증발생솔저,여보통봉도기상비,기유효성화안전성상당,가이응용우인과환인.
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 Cardiology,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 defect (ASD),and 36 cases with patent ductus arteriosus.All subjects were assigned to experimental groups (ceramic membrane occluder CeraTM) or control group (nitinol occluder).The transthoracic echocardiography,electrocardiography and clinical examination were observed in 12 months after the procedure and yearly thereafter.Serum nickel concentration 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 statistically 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 complete 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 respiratory infections had no significant recurrence within 4 years after the procedure.The number of serum nickel concentration ＞ 2.0 μg/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-right shunt congenital heart disease in children,when compared to the general nitinol occluder.The Ceramic membrane occluder is appropriate for clinical application in children.