柳叶刀：降低高血压的革命性新设备—ROX Coupler

  近日，发表在国际杂志The Lancet上的一篇研究论文中，来自玛丽王后大学的研究人员开发出了一种革命性的设备，其可以帮助那些血压不受控制的高血压患者降低血压，该设备的降压效果优于传统药物的治疗效果。

  文章中研究人员将这种新型设备命名为“Coupler”（联合ROX医疗公司开发），其是一种回形针大小的植入物，可以在机体麻醉的情况下植入大腿的动脉和静脉之间，随后研究人员开始进行随机盲端临床试验，在83名患者中将Coupler疗法和常规药物疗法进行对比，其中44名患者接受ROX Coupler疗法，结果显示，接受Coupler疗法的患者的血压得到了明显持续性的下降，同时高血压引发的并发症和入院率也下降了。

  Coupler疗法同时也适用于那些利用肾交感神经去除术治疗高血压失败的患者，这就表明，Coupler可以利用不同的机制来有效控制患者机体的血压；然而此前并未进行肾交感神经去除术的患者利用Coupler治疗后血压的下降或更为明显一些，研究者指出，这种基于新型设备的疗法是可逆、快速而且是无痛的。

  研究者Melvin Lobo说道，当前治疗高血压的药物主要集中于激素类或神经调节类的药物，而新型疗法比如肾交感神经去除术又主要是集中对肾神经系统进行作用，新型设备Coupler则可以读血压循环的不同方面进行有效的靶向作用从而来实现控制血压的目的，而该设备作为抗高血压的一种新型设备而言其对于控制动脉僵硬度也有重要的作用。本研究结果显示，利用ROX Coupler治疗高血压的新型疗法为患者和医生们提供了一种可选择的方法来治疗高血压，为改善高血压患者的机体健康和生活质量带来了极大帮助。

  然而和所有疗法一样，Coupler设备也存在一定的副作用，大约29%接受该设备治疗的患者出现了腿部肿胀的情况，这就意味着后期研究者还需要采取一定的措施来处理这种情况。研究者Lobo表示，高血压是非常危险的，其往往会引发中风、心脏病发生及慢性肾脏疾病等，我们必须寻找到可以有效控制患者血压升高的方法，而新型设备Coupler的开发就为有效控制高血压带来了革命性的胜利。

  目前研究人员需要进行更多的研究来评估新型设备Coupler对患者的长期效应，而更好地理解该设备的安全性及其工作原理也为后期很好地将其应用于治疗高血压中奠定了基础。（转化医学网360zhyx.com）

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转化医学网推荐的原文摘要：

Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial
The Lancet doi:10.1016/S0140-6736(14)62053-5
Dr Melvin D Lobo, FRCP, Prof Paul A Sobotka, MD, Prof Alice Stanton, FRCPI, Prof John R Cockcroft, FRCP, Neil Sulke, MD, Eamon Dolan, FRCPI, Prof Markus van der Giet, MD, Prof Joachim Hoyer, MD, Stephen S Furniss, FRCP, John P Foran, MD, Adam Witkowski, MD, Prof Andrzej Januszewicz, PhD, Prof Danny Schoors, MD, Prof Konstantinos Tsioufis, MD, Benno J Rensing, MD, Benjamin Scott, MD, Prof G André Ng, FRCP, Christian Ott, MD, Prof Roland E Schmieder, MD, for the ROX CONTROL HTN Investigators
Background
Hypertension contributes to cardiovascular morbidity and mortality. We assessed the safety and efficacy of a central iliac arteriovenous anastomosis to alter the mechanical arterial properties and reduce blood pressure in patients with uncontrolled hypertension.
Methods
We enrolled patients in this open-label, multicentre, prospective, randomised, controlled trial between October, 2012, and April, 2014. Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment. Patients were randomly allocated in a 1:1 ratio to undergo implantation of an arteriovenous coupler device plus current pharmaceutical treatment or to maintain current treatment alone (control). The primary endpoint was mean change from baseline in office and 24 h ambulatory systolic blood pressure at 6 months. Analysis was by modified intention to treat (all patients remaining in follow-up at 6 months). This trial is registered with ClinicalTrials.gov, number NCT01642498.
Findings
83 (43%) of 195 patients screened were assigned arteriovenous coupler therapy (n=44) or normal care (n=39). Mean office systolic blood pressure reduced by 26·9 (SD 23·9) mm Hg in the arteriovenous coupler group (p<0·0001) and by 3·7 (21·2) mm Hg in the control group (p=0·31). Mean systolic 24 h ambulatory blood pressure reduced by 13·5 (18·8) mm Hg (p<0·0001) in arteriovenous coupler recipients and by 0·5 (15·8) mm Hg (p=0·86) in controls. Implantation of the arteriovenous coupler was associated with late ipsilateral venous stenosis in 12 (29%) of 42 patients and was treatable with venoplasty or stenting.
Interpretation
Arteriovenous anastomosis was associated with significantly reduced blood pressure and hypertensive complications. This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension.
Funding
ROX Medical.