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新的治疗方法可以快速治愈常见的高血压 精选
2025-2-16 19:58
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新的治疗方法可以快速治愈常见的高血压

诸平

据伦敦玛丽女王大学(Queen Mary University of London)2025年2月15日提供的消息,新的治疗方法可以快速治愈常见的高血压(New Treatment Offers Quick Cure for Common Cause of High Blood Pressure)。

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A new minimally invasive treatment called Triple T uses ultrasound-guided radiofrequency ablation to precisely target and destroy adrenal nodules that cause a hidden form of high blood pressure. Early trials show it is safe and effective, potentially potentially sparing millions from invasive surgery and long-term medication.

一种革命性的新疗法被称为靶向热疗法(Targeted Thermal Therapy简称Tripel T),为原发性醛固酮增多症(一种激素紊乱)引起的高血压患者提供了一种比手术更安全、更快速的治疗方法。{A revolutionary new treatment called Targeted Thermal Therapy (Tripel T) offers a safer, faster alternative to surgery for patients with high blood pressure caused by Primary Aldosteronism, a hormonal disorder.}

靶向热疗法(Triple T)是一种新的微创疗法,可以取代肾上腺手术治疗原发性醛固酮增多症(Primary Aldosteronism),这是高血压的一种隐性原因。早期试验显示出令人鼓舞的结果,进一步的研究正在进行之中。

来自英国伦敦玛丽女王大学、巴茨健康NHS信托(Barts Health NHS Trust)和伦敦大学学院(University College London)的医生们开创了一种简单、微创的治疗方法,称为靶向热疗法(Triple T)。这种创新的方法有可能彻底改变高血压的一种常见但经常被忽视的原因。相关研究结果于2025年2月7日已经在《柳叶刀》(The Lancet)杂志网站发表——Giulia Argentesi, Xilin Wu, Alexander Ney, Emily Goodchild, Kate Laycock, Yun-Ni Lee, Russell Senanayake, James MacFarlane, Elisabeth Ng, Jessica Kearney, Sam O’Toole, Jackie Salsbury, Nick Carroll, Daniel Gillett, John A Tadross, Alison Marker, Edmund M Godfrey, George Goodchild, Jonathan P Bestwick, Mark Gurnell, Heok Cheow, Stephen P Pereira, William M Drake, Morris J Brown, Jose Bastos, Elena D Benu, Elizabeth Cervi, Patrizia Ebano, Razeen Mahroof, Iulia Munteanu, August Palma, Patrick Wilson. FABULAS study group. Endoscopic, ultrasound-guided, radiofrequency ablation of aldosterone-producing adenomas (FABULAS): a UK, multicentre, prospective, proof-of-concept trial. The Lancet, 2025 Feb 7: S0140-6736(24)02755-7. DOI: 10.1016/S0140-6736(24)02755-7. Epub 7 February 2025.

参与此项研究的有来自英国伦敦玛丽女王大学(Endocrine Hypertension, Department of Clinical Pharmacology and Precision Medicine, William Harvey Research Institute, Queen Mary University of London, London, UK; Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London, London, UK)、英国伦敦的巴茨健康NHS信托(Departments of Endocrinology and Gastroenterology, St Bartholomew's Hospital, Barts Health NHS Trust, London, UK)、英国大学学院(University College London Institute for Liver and Digestive Health, University College London, London, UK)、英国大学学院医院(University College London Hospital, London, UK)、英国剑桥的阿登布鲁克斯医院(Departments of Endocrinology, Endoscopy, Histopathology, Nuclear Medicine, and Radiology, Addenbrookes Hospital, Cambridge, UK)、英国剑桥大学和剑桥大学NIHR生物医学研究中心(Institute of Metabolic Science, University of Cambridge and Cambridge NIHR Biomedical Research Centre, Cambridge Biomedical Campus, Cambridge, UK)、英国谢菲尔德的皇家哈拉姆郡医院(Department of Endocrinology, Royal Hallamshire Hospital, Sheffield, UK)以及英国伦敦巴茨和伦敦NIHR生物医学研究中心(Barts and the London NIHR Biomedical Research Centre, London, UK)的研究人员。

此研究结果表明,通过进一步的测试,这一突破可以帮助全球数百万目前未被诊断和治疗的人。在英国,Triple T在科学上被称为内窥镜超声引导射频消融术(endoscopic ultrasound-guided radiofrequency ablation),与伦敦大学学院(University College London)、大学学院医院NHS信托(University College Hospital NHS Trust)、剑桥大学NHS信托(Cambridge University NHS Trust)和剑桥大学(University of Cambridge)的研究人员合作进行了严格的评估。

导致高血压的一种隐性原因A hidden cause of high blood pressure

1/3的成年人患有高血压,其中1/20的人患有原发性醛固酮增多症。然而,只有不到1%的患者被诊断出来。

当一个或两个肾上腺的微小良性结节产生过量的醛固酮时,就会出现这种情况。醛固酮是一种通过增加体内盐分水平来升高血压的激素。原发性醛固酮增多症患者通常对标准降压药物反应不佳,心脏病发作、中风和肾衰竭的风险更高。

改变游戏规则的替代手术A game-changing alternative to surgery

到目前为止,唯一有效的治疗原发性醛固酮增多症的方法是手术切除整个肾上腺,需要全身麻醉,住院2 - 3天,恢复期数周。因此,许多患者得不到治疗。

通过选择性地破坏小肾上腺结节而不切除腺体,Triple T提供了一种比手术更快、更安全的替代方法。这是由于诊断扫描的最新进展,使用分子染料可以准确地识别和定位即使是最小的肾上腺结节。左肾上腺的细胞紧挨着胃,从那里可以直接瞄准。

这种新的治疗方法利用波能,采用了两种成熟的医疗技术:将射频(radiofrequency)或微波(microwaves)通过插入故障组织的小针产生热量,造成可控的烧伤;超声波利用反射声波来制作手术过程的实时视频。

和常规的内窥镜检查一样,在Triple T中,一个微小的内部摄像头在使用超声波和光线的情况下通过口腔进入胃部。内窥镜医师可以看到肾上腺,并将一根细针从胃精确地插入结节。短暂的高温会破坏结节,但不会伤害周围的健康组织。这种微创方法只需20分钟,无需内部或外部切口。

成功的试验显示出希望Successful trial shows promise

这项研究被称为FABULAS,这个名字是超声引导下射频内窥镜消融可行性研究(Feasibility study of radiofrequency endoscopic ABlation, with ULtrasound guidance)的首字母缩略词,作为一种非手术、肾上腺保留治疗醛固酮分泌腺瘤(aldosterone-producing adenomas)的方法。

FABULAS28例原发性醛固酮增多症患者中测试了Triple T,这些患者的分子扫描在左肾上腺中发现了一个产生激素的结节。新的手术被发现是安全有效的,大多数患者在6个月后激素水平恢复正常。许多参与者能够停止所有降压药,没有复发的情况。

FABULAS研究的共同资深作者、伦敦玛丽女王大学内分泌高血压教授(Professor of Endocrine Hypertension at Queen Mary University of London)莫里斯·布朗(Morris Brown)说:“醛固酮激素在伦敦被发现已有70年了,一年后,美国首例因醛固酮产生的肿瘤而患上严重高血压的患者也被发现。这位病人的医生杰罗姆·康恩(Jerome Conn)预测,也许只是稍微夸张一点,有一天,所有高血压的10%~20%可能会被追溯到一个或两个腺体的可治愈的结节。我们现在能够实现这一前景,在诊断和治疗方面提供21世纪的突破。”

其中一位试验参与者米歇尔娜·阿尔菲耶里(Michelina Alfieri)分享了她的经历:“在此研究之前,尽管我多次去看全科医生,但我多年来一直患有令人虚弱的头痛。作为一名全职工人和单亲母亲,我的日常生活受到了严重影响。这种非侵入性治疗使我立即恢复了正常生活。我非常感谢团队给了我这个选择。”

下一步是什么?What’s next?

FABULAS的成功引发了一项名为WAVE的更大规模随机试验,该试验将Triple T与传统肾上腺手术进行比较。结果预计将于2027年公布。

FABULAS首席研究员,伦敦大学学院肝脏和消化健康研究所(UCL Institute for Liver and Digestive Health)的肝病学与胃肠病学教授斯蒂芬·佩雷拉(Stephen Pereira)补充说:“经过适当的培训,这种侵入性较小的技术可以在英国和国际范围内广泛应用于内窥镜检查单位。”

阿登布鲁克医院临床内分泌学主任(Clinical Endocrinology Lead at Addenbrooke’s Hospital)和剑桥大学临床内分泌学教授(Professor of Clinical Endocrinology at the University of Cambridge)马克·格内尔(Mark Gurnell)说:“这一突破之所以成为可能,要归功于新型PET示踪分子(PET tracer molecules)的合作开发,它使我们能够首次精确定位和治疗肾上腺结节,从而实现非侵入性诊断。由于这项工作,我们最终可能能够诊断和治疗更多患有原发性醛固酮增多症的人,降低他们患心血管疾病和其他并发症的风险,并减少依赖长期降压药的人数。”

高血压治疗向前迈进了一大步A major step forward for hypertension treatment

对于数百万患有未确诊的原发性醛固酮增多症的人来说,这项研究带来了新的希望。安全的靶向热疗,口送,可以取代大手术,使恢复更快,效果更好。

随着进一步研究的进行,这种突破性的治疗方法可能很快成为世界范围内的标准程序,改变对这种可治愈的高血压患者的护理。

这项研究主要由巴茨慈善机构(Barts Charity)、英国国家健康与护理研究所(National Institute for Health and Care Research简称NIHR)通过巴茨和剑桥生物医学研究中心(Barts and Cambridge Biomedical Research Centres简称BRCs)以及英国心脏基金会(British Heart Foundation)提供支持。

随后将进行一项更大规模的随机试验,名为WAVE,将对120名患者进行TTTTriple T trial)和传统手术的比较。结果预计将于2027年公布。

上述介绍仅供参考,欲了解更多信息敬请注意浏览原文相关报道

Abstract

Background: Unilateral aldosterone-producing adrenal adenomas (APAs) are the potentially curable cause of 5% of all cases of hypertension. Their localisation (via adrenal vein sampling [AVS]) and removal (by laparoscopic adrenalectomy) require invasive procedures that are unattractive to patients. Molecular imaging-located, endoscopic ultrasound-guided trans-gastric radiofrequency ablation (EUS-RFA) is a potential novel, minimally invasive alternative to AVS and total adrenalectomy for the treatment of APAs in the left adrenal gland, which is very close to the stomach. We aimed to determine whether EUS-RFA can safely target a heterogeneous set of such tumours without damaging the rest of the adrenal gland or adjacent organs.

Methods: We conducted a three-centre feasibility study in the UK of EUS-RFA as a non-surgical, adrenal-sparing treatment for left-sided APAs. Eligible participants were men and women aged 18 years or older, with a diagnosis of primary aldosteronism under the Endocrine Society's criteria, and with evidence of a left-sided APA, diagnosed by AVS or PET-CT. Recruitment was done in three groups, with data from the first four patients in the previously recruited group being reviewed by an independent Safety Committee before proceeding. We performed molecular imaging on two occasions, first to diagnose and locate the APA, and later to quantify the degree of ablation. Following a fine-needle biopsy for later confirmation of APA diagnosis, ablation was performed using a 19G ablation catheter. Its manipulation under continuous ultrasound guidance permitted an incremental number of 10-20 s treatments (also known as burns) as the study progressed. The primary endpoint was safety, judged by the occurrence of prespecified major hazards (gastric and adrenal puncture: perforation, haemorrhage, or infarction of major organs) 24 h or 48 h post-ablation. Secondary endpoints were reductions in the proportion of radiotracer uptake by the ablated APA compared with the contralateral adrenal on molecular imaging at 3 months, and international consensus criteria for biochemical and clinical success (reductions in plasma aldosterone to renin ratio and blood pressure 6 months post-RFA).

Findings: Between Feb 21, 2018, and Feb 10, 2023, 44 patients were screened and 28 participants were recruited (21 [75%] male and seven [25%] female, mean age 57·7 years [SD 10·3]; 16 [57%] White, 11 [39%] Black, and one [4%] Asian). The 28 participants underwent 35 ablations on one (21 [75%]) or two (seven [25%]) occasions. All PET-CT-positive nodules were identified by the endoscopic ultrasound probe and successfully penetrated by biopsy and ablation catheters. None of the prespecified major hazards occurred in any patient. Localised reduction of radiotracer uptake by the PET-CT-positive APAs at 3 months was associated with complete or partial biochemical cure in 21 participants (75% [95% CI 55-91]), and with complete or partial cure of hypertension (clinical cure) in 12 participants (43% [24-61]). In four participants, disappearance of the APA on molecular imaging was associated with a systolic blood pressure under 135 mm Hg and diastolic blood pressure under 85 mm Hg off all antihypertensive treatment.

Interpretation: EUS-RFA appears a safe alternative to total adrenalectomy for the treatment of left-sided APAs and has the potential to completely cure primary aldosteronism and hypertension when most of the APA is ablated. These findings have informed the design of a pivotal study of thermal ablation versus surgery, which will determine the full benefits of EUS-RFA.

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