邹花一阳,孙伟,盛燕辉,敬雷,王榕生,曹欢,李鹏,徐蓓蓓,徐天华,孔祥清

• 1:南京医科大学第一附属医院心内科

摘要(Abstract)：

目的 探索非侵入性体外聚焦功率超声（FPU）肾周脂肪改性治疗原发性高血压病的安全性及有效性。方法 （1）安全性研究：拟入选健康家猪分为FPU组及对照组，完成FPU肾周脂肪改性及1周、4周、8周随访，评估治疗安全性及改性后肾周脂肪组织结构变化。（2）临床探索研究：拟入选原发性高血压病患者，完成FPU肾周脂肪改性及1个月、6个月随访，评估安全性事件和血压变化，主要有效终点定义为6个月随访时诊室血压及24 h动态血压变化。结果 （1）安全性研究：共入选16只健康家猪，FPU组及对照组各8只，顺利完成FPU肾周脂肪改性及1周、4周、8周随访。随访过程中无动物死亡、器官损伤等严重安全事件发生，血生化等安全性指标未见异常。FPU组家猪术后1周、4周、8周组织病理结果提示，肾周脂肪结构明显破坏伴组织纤维化且以8周变化最明显。（2）临床探索研究：共入选原发性高血压病患者21例，均完成FPU肾周脂肪改性及1个月、6个月随访。研究中未见死亡、器官损伤等严重不良事件发生，血生化等安全性指标未见异常。6个月随访时患者诊室收缩压较基线下降了（18.1±13.7）mmHg(P<0.001)，舒张压下降了（13.9±11.3）mmHg(P<0.001),24 h平均动态收缩压下降了（11.3±13.2）mmHg(P=0.003),24 h平均动态舒张压下降了（7.3±8.5）mmHg(P=0.002)。其中诊室收缩压下降>10 mmHg占比为66.7%(14/21)。结论 动物实验基础研究和小样本临床研究表明FPU肾周脂肪改性具有良好的安全性且可有效降压。

关键词(KeyWords)： 原发性高血压病;肾周脂肪改性;聚焦功率超声

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 邹花一阳,孙伟,盛燕辉,敬雷,王榕生,曹欢,李鹏,徐蓓蓓,徐天华,孔祥清

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