Efficacy of Bosentan in Patients after Fontan Procedures：a Double-blind, Randomized Controlled Trial

作     者：尚小珂 卢蓉 张喜 张长东 肖书娜 柳梅 王斌 董念国 

作者机构：Cardiac Surgery Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan 430022 China SinoScript LLC Vernon Connecticut 06066 USA Department of Intervention Wuhan Asia Heart Hospital Wuhan 430022 China Department of Radiology The Keck School of Medicine University of Southern California California 90033 USA 

出 版 物：《Journal of Huazhong University of Science and Technology(Medical Sciences)》 (华中科技大学学报（医学英德文版）)

年 卷 期：2016年第36卷第4期

页      面：534-540页

核心收录：

学科分类：0831[工学-生物医学工程（可授工学、理学、医学学位）] 0710[理学-生物学] 1002[医学-临床医学] 1001[医学-基础医学(可授医学、理学学位)] 100210[医学-外科学(含：普外、骨外、泌尿外、胸心外、神外、整形、烧伤、野战外)] 0805[工学-材料科学与工程（可授工学、理学学位）] 0703[理学-化学] 0836[工学-生物工程] 10[医学] 

基　　金：supported by the National Natural Science Foundation of China(No.31330029) 

主　　题：Fontan procedure Bosentan prognosis pulmonary hypertension pulmonary vascular resistance 

摘      要：Fontan surgery is a widely used palliative procedure that significantly improves the survival period of patients with complex congenital heart disease（CHD）. However, it does not decrease postoperative complication rate. Previous studies suggested that elevated mean pulmonary artery pressure（m PAP） and vascular resistance lead to decreased exercise tolerance and myocardial dysfunction. Therapy with endothelial receptor antagonists（Bosentan） has been demonstrated to improve the patients＇ prognosis. A double-blind, randomized controlled trial was performed to explore the efficacy of Bosentan in treating patients who underwent the Fontan procedure. Eligible participants were randomly divided into Bosentan group and control group. Liver function was tested at a local hospital and the results were reported to the phone inspector every month. If the results suggested abnormal liver function, treatment would be adjusted or terminated. All the participants finished the follow-up study, with no patients lost to follow-up. Unblinding after 2-year follow-up, no mortality was observed in either group. However, secondary end-points were found to be significantly different in the comparable groups. The cardiac function and 6-min walking distance in the Bosentan group were significantly superior to those in the control group（P=0.018 and P=0.027）. Bosentan could improve New York Heart Association（NYHA） functional status and improve the results of the 6-min walking test（6MWT） in Fontan patients post-surgery, and no other benefits were observed. Furthermore, a primary meta-analysis study systematically reviewed all the similar clinical trails worldwide and concluded an overall NYHA class improvement in Fontan patients who received Bosentan treatments.