成人Fontan循环患者应用安立生坦的初步研究  

A preliminary research of adult patients with Fontan circulation who take Ambrisentan tablets

作　　者：尚小珂 卢蓉 柳梅[2] 尹海涛 肖书娜 张刚成 秦长瑜 张长东 

机构地区：[1]武汉市亚洲心脏病医院心外科导管室,湖北省武汉市430022 [2]武汉市第一医院ICU [3]陕西省汉中市铁路医院心内科导管室

出　　处：《中国心血管病研究》2015年第4期303-307,共5页Chinese Journal of Cardiovascular Research

基　　金：国家十二五科技支撑项目（编号：2011BAI11B15）

摘　　要：目的 研究Fontan循环成人患者使用选择性内皮素受体拮抗剂安立生坦的安全性,评估其对患者血流动力学的影响.方法 选取2010年1月至2014年6月在武汉亚洲心脏病医院行Fontan手术后的18岁以上患者47例,设计为共6个月的前瞻性单中心开放性研究.试验开始前所有患者查静脉血全血细胞计数、肝功能、肾功能和静息时经皮血氧饱和度;试验开始后患者口服安立生坦5 mg,1次/d.以上检查在试验开始的第15天、30天、60天、120天和180天重复进行.基线和第6个月时记录患者6 min步行距离和Borg呼吸困难指数及对纽约心功能评估,经胸的心脏超声心动图评估左心室射血分数.在整个研究过程中监测不良事件.观察指标为主要观察指标和其他观察指标,包括临床不良事件及血流动力学评估.结果 共有5例患者完成了6个月研究,所有患者没有发生不良事件.经皮血氧饱和度检测较前明显上升,差异有统计学意义（P=0.04）,其他方面差异均未见统计学意义.结论 在6个月的时间内Fontan循环成人患者应用安立生坦有较好的耐受性.但在较大样本的患者中,应用安立生坦的安全性和耐受性仍然未知,需进行更大规模的研究.Objective The primary purpose of this study was to study Fontan circulation of adult patients with selective endothelin receptor antagonist ＂Ambrisentan tablets＂ security, followed by assessment of their impact on the patient＇s hemodynamics. Methods Patients who were over 18 years old did Fontan surgery in Wuhan Asia Heart Hospital, the study design was a prospective single-center open-label study of a total of six months, all patients before the start of the test to check blood complete blood count, liver function and kidney function, transcutaneous oxygen saturation at rest. When the test began, the patient should oral Ambrisentan tablets 5 mg, once a day. These checks in the fifteenth days of the beginning of the test, 30 days, 60 days, 120 days and 180 days should be repeated. It should be recorded 6 minutes walking distance and Borg dyspnea index and the New York Heart Association functional assessment, transthoracic echocardiography to assess ventricular ejection fraction at baseline and the sixth month, monitoring adverse events throughout the study. Observing indexes including main observation indexes and other indexes, including clinical adverse events and hemodynamic evaluation. Results A total of 5 patients completed 6 months of study, all patients without adverse events. Transcutaneous oxygen saturation detected a marked increase over the previous, the difference was statistically significant （P=0.04）, no statistically significant differences in other aspects. Conclusion Within six months, adult patients with Fontan circulation who took Ambrisentan tablets had better tolerability. But in a larger sample of patients, the application of ＂Ambrisentan tablets＂ safety and tolerability are still unknown, it should need for larger studies.

关 键 词：Fontan循环 选择性内皮素受体拮抗剂 安立生坦 肺动脉压力 全肺阻力 

分 类 号：R654.2[医药卫生—外科学]