经皮去肾神经术治疗高血压临床试验的展望  

Prospects for clinical trials of renal denervation in the treatment of hypertension

作　　者：周力力 张毅[1] 王捷[3] ZHOU Li-li;ZHANG Yi;WANG Jie(Department of Cardiology,Shanghai Tenth People’s Hospital,Shanghai 200072,China;Tongji University School of Medicine,Shanghai 200092,China;Jiangsu Province Hospital,Nanjing 210029,China)

机构地区：[1]上海市第十人民医院心内科,上海200072 [2]同济大学医学院,上海200092 [3]江苏省人民医院,江苏南京210029

出　　处：《中国介入心脏病学杂志》2024年第6期334-337,共4页Chinese Journal of Interventional Cardiology

基　　金：国家自然基金面上项目(82370300)。

摘　　要：高血压作为最常见的心血管疾病,存在患病率高、知晓率低、控制率低的问题。由于药物治疗的局限性,近十年来,经皮去肾神经术(RDN)作为一种新兴的治疗高血压介入手段脱颖而出。经过长达十余年的循证医学研究证明了该技术在降压方面的有效性与安全性。目前,RDN临床试验的挑战在于患者为了控制血压而无法避免对降压药物进行调整,从而对RDN降压效果产生干扰。无论是Simplicity HTN-36个月试验和REQUIRE试验等失败案例,还是SPYRAL与RADIANCE系列试验,其结果都表明RDN临床试验的结果评估需要纳入降压药物的变化。因为降压药物与介入手术治疗是影响血压水平的两个决定因素,所以评估RDN的降压疗效时不得不考虑患者降压药物的调整,还要回答一个重大临床问题即RDN术后患者是否可以少服以至不服用药物。我国的SMART研究不再以单纯的血压可以降低的mmHg数,而是以高血压防治指南中的治疗目标即诊室血压达标率为主要终点之一;引入了预设的“药物负荷指数”并将诊室收缩压(OSBP)达标率和降压用药变化作为临床试验的复合终点。其结果证明了RDN作为降压的辅助疗法,可以显著降低患者的药物负荷水平,将患者的OSBP控制达标。在未来的RDN临床试验中,应当充分考虑药物负荷的影响,明确血压指标和受试人群。RDN治疗高血压的临床试验方式会更加多元化,包括更能回答临床重大问题和符合治疗指南的有效性终点、更多种消融能量平台的尝试、术中手术终点的判定和试验对照组的设定等。Hypertension,as the most common cardiovascular disease,has high prevalence,low awareness,and poor control rates.Due to the limitations of pharmacotherapy,renal denervation(RDN)has emerged in the past decade as a novel interventional therapy for hypertension.Over a decade of evidence-based medical research has demonstrated the efficacy and safety of this technique in lowering blood pressure.Currently,a major challenge in RDN trials is the unavoidable adjustments of antihypertensives required to control blood pressure,which interfere with the efficacy of RDN.Whether the failed cases like Simplicity HTN-3 of six month and REQUIRE trials or trials of SPYRAL and RADIANCE series,the results indicate that the assessment of RDN clinical trials must include changes in antihypertensive drug burdens.Since both antihypertensives and interventional procedures influence blood pressure levels,adjustments in antihypertensives must be considered when evaluating the RDN.We also need to address a major clinical question of whether patients can reduce or even discontinue medication after RDN.SMART study introduced the predefined“Medication Burden Index”and applied the control rate of target office systolic blood pressure(OSBP)and change in antihypertensives drug burden as a composite endpoint for the clinical trial,which demonstrated that RDN,as an adjunctive therapy,significantly reduced patients’drug burden while achieved target OSBP control.Future RDN trials should fully consider the impact of drug burden,clearly define blood pressure parameters,and identify the target population.Additionally,design of RDN trials would become more diverse,including efficacy endpoints that better answer important clinical questions per guideline,various ablation energies,readout of efficient ablaton during RDN,and proper control groups.

关 键 词：高血压 经皮去肾神经术 药物负荷 临床研究 血压 

分 类 号：R541[医药卫生—心血管疾病]