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分子成像与肾上腺静脉采血用于检测可手术治愈的原发性醛固酮增多症:一项患者自身前瞻性试验

Molecular Imaging Versus Adrenal Vein Sampling for the Detection of Surgically Curable Primary Aldosteronism : A Prospective Within-Patient Trial.

作者信息

Goodchild Emily, Wu Xilin, Senanayake Russell, MacFarlane James, Argentesi Giulia, Laycock Kate, Bashari Waiel A, Cabrera Claudia P, O'Toole Samuel M, Salsbury Jackie, Benu Daniela, Lee Yun-Ni, Chua Aldons C N, Matson Matthew, Koo Brendan, Parvanta Laila, Hilliard Nicholas, Kosmoliaptsis Vasilis, Marker Alison, Berney Daniel M, Drew Kiera, Tan Wilson, Foo Roger, Mein Charles A, Wozniak Eva, Kearney Jessica, Savage Emanuel, Sahdev Anju, Bird Nicholas, Smith Graham, Hird Matthew, Warnes Victoria, Gillett Daniel, Dawnay Anne, Adeyeye Elizabeth, Aigbirhio Franklin, McIntosh Alasdair, McConnachie Alex, Cruickshank J Kennedy, Cheow Heok, Gurnell Mark, Drake William M, Brown Morris J

机构信息

Clinical Pharmacology and Precision Medicine, William Harvey Research Institute, Queen Mary University of London; NIHR Barts Cardiovascular Biomedical Research Centre, Barts and The London School of Medicine and Dentistry, Queen Mary University of London; and Department of Endocrinology, St. Bartholomew's Hospital, Barts Health NHS Trust, London, United Kingdom (E.G., X.W., G.A., K.L., Y.-N.L., J.K., W.M.D., M.J.B.).

Metabolic Research Laboratories, Institute of Metabolic Science, University of Cambridge; NIHR Cambridge Biomedical Research Centre, Cambridge Biomedical Campus; and Department of Diabetes and Endocrinology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom (R.S., J.M., W.A.B., M.G.).

出版信息

Ann Intern Med. 2025 Mar;178(3):336-347. doi: 10.7326/ANNALS-24-00761. Epub 2025 Mar 4.

DOI:10.7326/ANNALS-24-00761
PMID:40030172
Abstract

BACKGROUND

Primary aldosteronism (PA) causes hypertension and is potentially surgically curable when it is caused by a unilateral aldosterone-producing adrenal adenoma (APA). Adrenal vein sampling (AVS) is required to guide surgery, but it is invasive, is technically difficult, and has limited availability.

OBJECTIVE

To determine whether the accuracy of post-dexamethasone [C]metomidate ([C]MTO) positron emission tomography-computed tomography, a diagnostic test for APAs, is superior or noninferior to the accuracy of AVS in predicting outcomes from unilateral adrenalectomy, and whether [C]MTO is interchangeable with its longer-half-life analogue, para-chloro-2-[F]fluoroethyletomidate ([F]CETO).

DESIGN

Prospective within-patient comparison of diagnostic interventions. (ClinicalTrials.gov: NCT02945904).

SETTING

Three referral centers.

PARTICIPANTS

174 patients with PA desiring surgery if a unilateral source of PA was diagnosed.

INTERVENTION

[C]MTO and AVS in 169 patients, plus [F]CETO in the final 31.

MEASUREMENTS

International consensus criteria for biochemical and clinical success at 6 and 24 months after surgery; κ statistic and Bland-Altman analyses comparing predictions of surgical outcomes by [C]MTO and [F]CETO.

RESULTS

Eighty-nine of 169 (52.7%), 78 of 169 (46.2%), and 43 of 169 (25.4%) patients were predicted to have unilateral PA by [C]MTO, AVS, or both, respectively. One hundred of 169 (59.1%) were assigned to adrenalectomy by the multidisciplinary team; primary outcome data were available for 156 of 169. Predictions were most accurate for complete or partial biochemical success ([C]MTO, 71.3% [95% CI, 61.0% to 80.1%]; AVS, 62.8% [CI, 52.2% to 72.6%]) and least accurate for complete clinical success (home blood pressure <135/85 mm Hg off treatment). The 95% CIs around differences between accuracies crossed zero, excluding superiority for [C]MTO, but not the prespecified lower bound of -17%, allowing [C]MTO to be declared noninferior to AVS. [F]CETO and [C]MTO agreed in 29 of 31 patients (κ = 0.85 [CI, 0.68 to 1.00]).

LIMITATION

The accuracy of [C]MTO could be assessed only in the surgical group.

CONCLUSION

Molecular imaging is an accurate, noninvasive alternative to AVS.

PRIMARY FUNDING SOURCE

National Institute for Health and Care Research.

摘要

背景

原发性醛固酮增多症(PA)可导致高血压,若由单侧醛固酮分泌性腺瘤(APA)引起,则有可能通过手术治愈。肾上腺静脉采血(AVS)是指导手术所必需的,但它具有侵入性,技术难度大,且应用受限。

目的

确定地塞米松后[C]米托咪酯([C]MTO)正电子发射断层扫描 - 计算机断层扫描(一种APA的诊断测试)在预测单侧肾上腺切除术后结果方面的准确性是否优于或不劣于AVS的准确性,以及[C]MTO是否可与其半衰期更长的类似物对氯 - 2 - [F]氟乙基米托咪酯([F]CETO)互换。

设计

对诊断干预措施进行前瞻性患者内比较。(ClinicalTrials.gov:NCT02945904)。

地点

三个转诊中心。

参与者

174例PA患者,若诊断为单侧PA来源则希望接受手术。

干预措施

169例患者接受[C]MTO和AVS,最后31例还接受[F]CETO。

测量指标

术后6个月和24个月时生化和临床成功的国际共识标准;比较[C]MTO和[F]CETO对手术结果预测的κ统计量和Bland - Altman分析。

结果

169例患者中,分别有89例(52.7%)、78例(46.2%)和43例(25.4%)通过[C]MTO、AVS或两者被预测为单侧PA。169例中有100例(59.1%)被多学科团队分配进行肾上腺切除术;169例中有156例可获得主要结局数据。对于完全或部分生化成功,预测最为准确([C]MTO,71.3%[95%CI,61.0%至80.1%];AVS,62.8%[CI,52.2%至72.6%]),对于完全临床成功(治疗停药后家庭血压<135/85 mmHg)预测最不准确。准确性差异的95%CI跨越零点,排除了[C]MTO的优越性,但未排除预先设定的-17%下限,因此可宣布[C]MTO不劣于AVS。31例患者中有29例[F]CETO和[C]MTO结果一致(κ = 0.85[CI,0.68至1.00])。

局限性

[C]MTO的准确性仅能在手术组中评估。

结论

分子成像技术是一种准确、无创的AVS替代方法。

主要资金来源

国家卫生与保健研究所。

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