中国自主研发去肾神经术器械治疗高血压临床试验数据的特色  

Characteristics of Clinical Trial Data of Hypertension Treatment with Renal Denervation Devices Independently Developed in China

作　　者：王沛坚[1] 陈威[2] 董徽[3] 马为[4,5] WANG Peijian;CHEN Wei;DONG Hui;MA Wei(Department of Cardiology,The First Affiliated Hospital of Chengdu Medical College,Chengdu 610500,Sichuan,China;Provincial Clinical Medicine College of Fujian Medical University,Department of Cardiology,Fujian Provincial Hospital,Fuzhou University Affiliated Provincial Hospital,Fuzhou 350001,Fujian,China;Department of Cardiology,National Center for Cardiovascular Diseases and Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China;Department of Cardiology,Peking University First Hospital,Beijing 100034,China;Echocardiography Center Laboratory,Cardiovascular Disease Research Institute,Peking University First Hospital,Beijing 100034,China)

机构地区：[1]成都医学院第一附属医院心血管内科,四川成都610500 [2]福建医科大学省立临床学院福州大学省立医院心血管内科,福建福州350001 [3]中国医学科学院北京协和医学院国家心血管病中心阜外医院心血管内科,北京100037 [4]北京大学第一医院心血管内科,北京100034 [5]北京大学第一医院心血管疾病研究所超声心动图中心实验室,北京100034

出　　处：《心血管病学进展》2024年第10期880-884,共5页Advances in Cardiovascular Diseases

摘　　要：经皮去肾神经术(RDN)是继治疗性生活方式改善以及药物治疗之外的第三种降压手段。目前,国内已经完成了三项RDN临床研究,Iberis-HTN研究、Netrod-HTN研究以及SMART研究。三项研究均入选了未控制的高血压人群,进行射频RDN治疗,分别采用6个月时的24小时动态血压、诊室收缩压和复合终点(包括诊室收缩压达标率<140 mmHg)以及抗高血压药负荷指数作为重要终点。初步证明了中国人进行RDN治疗的有效性和安全性。三项研究也显示了中国特色。在器械设计方面,无论是Iberis多电极肾动脉射频消融导管具有经桡动脉路径行RDN的功能,还是SyMapCath TM导管具备肾神经标测/选择性消融的特点以及Netrod网状多电极肾动脉射频消融导管都与国外设计有所不同。国内临床研究设计所提出的药物负荷指数方法也逐渐被认可。期待进一步开展RDN的基础、临床研究,促进高血压以及相关疾病的治疗。Renal denervation(RDN)is the third method of antihypertension in addition to therapeutic lifestyle improvement and medication.At present,three RDN clinical studies(Iberis-HTN study,Netrod-HTN study and SMART study)have been completed in China.All three studies enrolled uncontrolled hypertension patients for radiofrequency RDN treatment.24-hour ambulatory blood pressure,office systolic blood pressure,and composite endpoints including office systolic blood pressure control rate(<140 mmHg)and antihypertensive drug composite index at 6 months were used as primary endpoints,respectively.The efficacy and safety of RDN in Chinese were preliminarily proved.Three studies also show Chinese characteristics.In terms of device design,Iberis multi-electrode renal artery radiofrequency ablation catheter has the function of RDN via radial artery route.SyMapCath TM catheter has the characteristics of msRDN and Netrod multi-electrode renal artery radiofrequency ablation catheter is different from foreign designs.The antihypertensive drug composite index proposed in domestic clinical trial is recognized by other trials.We look forward to further basic and clinical RDN research to promote the treatment of hypertension and related diseases.

关 键 词：高血压 去肾神经术 降压治疗 

分 类 号：R544.1[医药卫生—心血管疾病]