中国循证儿科杂志2025，Vol.20Issue(3)：190-196,7.DOI:10.3969/j.issn.1673-5501.2025.03.006
重组人脑利钠肽治疗儿童先天性心脏病术后心功能低下疗效及安全性的单中心随机双盲平行对照试验
Recombinant human brain natriuretic peptide in the treatment of postoperative cardiac dysfunction in children with congenital heart disease:A single center randomized double-blind parallel controlled trial on the efficacy and safety
摘要
Abstract
Background The traditional therapeutic drugs for cardiac dysfunction after congenital heart disease surgery in children have side effects such as increased cardiac oxygen consumption.In adults,recombinant human brain natriuretic peptide(rhBNP)has been shown to effectively improve low cardiac function without obvious adverse reactions,but it's therapeutic effect and safety in children,especially young children,remain to be explored.Objective To evaluate the efficacy and safety of rhBNP in the treatment of postoperative low cardiac function in children with congenital heart disease.Design A single center,randomized,double-blind,parallel-controlled clinical trial.Methods Children with hypocardiac function(LVEF≤53％)after congenital heart disease surgery were enrolled from the Children's Hospital of Fudan University between October 2022 and March 2025.The children were randomly divided into control group and treatment group using the random number table method.Double-blinding was employed in this study.(1)Control group:traditional anti-cardiac dysfunction treatment+0.9％sodium chloride;(2)Medication group:traditional anti-cardiac hypofunction treatment+rhBNP treatment.The efficacy and safety of the two groups were compared through the following indicators.(1)Evaluation of therapeutic effect:left ventricular ejection fraction(LVEF),left ventricular end-systolic volume Index(LVESVI),left ventricular end-diastolic volume index(LVEDVI),stroke volume index(SVI),cardiac index(CI),cardiopulmonary ratio,central venous pressure(CVP),N-terminal pro-B-type natriuretic peptide(NT-proBNP),cardiac troponin Ⅰ(CTnⅠ)and soluble growth stimulation expressed gene2 ST2(sST2);(2)Evaluation of safety:systolic blood pressure(SBP)and diastolic blood pressure(DBP),urine output,hepatic and renal function,electrolyte levels,and lactate levels.The medical staff involved in the study were responsible for enrollment and implementation of the study.Main outcome measures Left ventricular ejection fraction(LVEF).Results A total of 100 children were enrolled,with 50 in the control group and 50 in the medication group.All the enrolled children completed the implementation of the design and the observation of all the indicators.Compared with control group,the medication group showed a significant increase in LVEF,SVI and CI(P＜0.05),and the differences in the increases were significant compared with those in control group(P＜0.05).LVESVI,LVEDVI and cardiopulmonary ratio decreased significantly in medication group(P＜0.05),and the differences in the decreases were significantly greater than those in the control group(P＜0.05).The CVP in the medication group was more effectively reduced(P＜0.05).In medication group,NT-proBNP,CTnⅠ and sST2 levels decreased significantly(P＜0.05).Compared with the control group,there was no significant differences in SBP and DBP,urine output,hepatic and renal function,electrolyte and lactate levels(P＞0.05).Conclusion rhBNP is effective and safe in the treatment of cardiac dysfunction after congenital heart disease surgery in children.关键词
儿童/先天性心脏病术后/重组人脑利钠肽/心功能低下Key words
Child/Postoperative congenital heart disease/Recombinant human brain natriuretic peptide/Cardiac dysfunction引用本文复制引用
宓亚平,刘芳,叶明,孙淑娜..重组人脑利钠肽治疗儿童先天性心脏病术后心功能低下疗效及安全性的单中心随机双盲平行对照试验[J].中国循证儿科杂志,2025,20(3):190-196,7.基金项目
上海市科学技术委员会上海市2022年度"科技创新行动计划"医学创新研究专项,重组人脑利钠肽治疗儿童难治性重症心力衰竭的疗效和安全性研究:22Y11909300 （）
