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本文引用的文献

1
Antihypertensive Medication Regimens Used by US Adults With Hypertension and the Potential for Fixed-Dose Combination Products: The National Health and Nutrition Examination Surveys 2015 to 2020.美国高血压成年人使用的降压药物方案及固定剂量复方制剂的应用潜力:2015 年至 2020 年全国健康和营养调查。
J Am Heart Assoc. 2023 Jun 6;12(11):e028573. doi: 10.1161/JAHA.122.028573. Epub 2023 May 9.
2
Heterogeneity in Cardiovascular Disease Risk Factors Among Latino Immigrant Subgroups: Evidence From the 2010 to 2018 National Health Interview Survey.拉美裔移民亚群心血管疾病危险因素的异质性:来自 2010 至 2018 年国家健康访谈调查的证据。
J Am Heart Assoc. 2023 May 16;12(10):e027433. doi: 10.1161/JAHA.122.027433. Epub 2023 May 9.
3
Efficacy and Safety of Low-Dose Triple and Quadruple Combination Pills vs Monotherapy, Usual Care, or Placebo for the Initial Management of Hypertension: A Systematic Review and Meta-analysis.低剂量三联和四联组合药物与单药治疗、常规护理或安慰剂在高血压初始治疗中的疗效和安全性:系统评价和荟萃分析。
JAMA Cardiol. 2023 Jun 1;8(6):606-611. doi: 10.1001/jamacardio.2023.0720.
4
Evolving Science on Cardiovascular Disease Among Hispanic/Latino Adults: JACC International.心血管疾病领域的科学进展:美国心脏病学会杂志国际版。
J Am Coll Cardiol. 2023 Apr 18;81(15):1505-1520. doi: 10.1016/j.jacc.2023.02.023.
5
Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial.一种用于治疗高血压的四重超低剂量治疗方案(QUARTET USA)的疗效和安全性:一项随机对照试验的原理和设计。
Am Heart J. 2022 Dec;254:183-193. doi: 10.1016/j.ahj.2022.09.004. Epub 2022 Sep 15.
6
Moving Beyond the Individual: Multilevel Solutions for Equitable Hypertension Control.超越个体层面:实现公平高血压控制的多层次解决方案。
Circ Cardiovasc Qual Outcomes. 2022 Sep;15(9):e009374. doi: 10.1161/CIRCOUTCOMES.122.009374. Epub 2022 Sep 6.
7
Inclusion of Under-Represented Racial and Ethnic Groups in Cardiovascular Clinical Trials.纳入代表性不足的种族和族裔群体进行心血管临床试验。
Heart Lung Circ. 2022 Sep;31(9):1263-1268. doi: 10.1016/j.hlc.2022.06.668. Epub 2022 Jul 16.
8
Cardiovascular Disease Mortality Among Hispanic Versus Non-Hispanic White Adults in the United States, 1999 to 2018.1999 年至 2018 年美国西班牙裔与非西班牙裔白人成年人的心血管疾病死亡率。
J Am Heart Assoc. 2022 Apr 5;11(7):e022857. doi: 10.1161/JAHA.121.022857. Epub 2022 Apr 1.
9
Beyond Diversity - Time for New Models of Health.超越多样性——新型健康模式的时代已来。
N Engl J Med. 2022 Feb 10;386(6):503-505. doi: 10.1056/NEJMp2115149. Epub 2022 Feb 5.
10
Initial treatment with a single pill containing quadruple combination of quarter doses of blood pressure medicines versus standard dose monotherapy in patients with hypertension (QUARTET): a phase 3, randomised, double-blind, active-controlled trial.在高血压患者中,使用包含四分之一剂量的四种降压药物的单片复方制剂进行单药初始治疗与标准剂量单药治疗的疗效比较(QUARTET):一项 3 期、随机、双盲、阳性对照试验。
Lancet. 2021 Sep 18;398(10305):1043-1052. doi: 10.1016/S0140-6736(21)01922-X. Epub 2021 Aug 29.

评估在联邦合格健康中心网络中使用四重超低剂量治疗高血压的双盲随机对照试验的过程(QUARTET USA):功效和安全性。

Process Evaluation of a Double-Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA).

机构信息

Division of Health System Innovation and Research, Department of Population Health Sciences Spencer Fox Eccles School of Medicine at the University of Utah Salt Lake City UT.

Feinberg School of Medicine Northwestern University Chicago IL.

出版信息

J Am Heart Assoc. 2024 Jan 2;13(1):e032236. doi: 10.1161/JAHA.123.032236. Epub 2023 Dec 29.

DOI:10.1161/JAHA.123.032236
PMID:38156601
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10863813/
Abstract

BACKGROUND

This convergent parallel-design mixed-methods process evaluation of the QUARTET USA (Quadruple Ultra-Low-Dose Treatment for Hypertension USA) clinical trial (NCT03640312) explores patient and health care professional perceptions about the use of low-dose quadruple therapy (LDQT) as a novel strategy for hypertension management.

METHODS AND RESULTS

A survey of all 62 patients enrolled in the QUARTET USA trial was conducted. A subsample of 13 patients and 11 health care professionals, recruited via purposive sampling, took part in semistructured interviews. At enrollment, 68% of participants (mean [SD] age, 51.7 [11.5] years; 56% self-identified as Hispanic: Mexican ethnicity, 16% as Hispanic: other ethnicity, 16% as Black race, 8% as White race, and 1.6% as South Asian race) reported that their current health depended on blood pressure medications, and 48% were concerned about blood pressure medications. At trial completion, 80% were satisfied with LDQT, 96% were certain the benefits of taking LDQT outweighed the disadvantages, and 96% reported that LDQT was convenient to take. Both patients and health care professionals found LDQT acceptable because it reduced patients' perceived pill burden and facilitated medication adherence. Health care professionals stated that a perceived limitation of LDQT was the inability to titrate doses. Steps to facilitate LDQT implementation include introducing stepped-care combinations and treatment protocols, inclusion in clinical practice guidelines, and eliminating patient cost barriers.

CONCLUSIONS

LDQT was an acceptable strategy for hypertension treatment among patients and health care professionals involved in the QUARTET USA clinical trial. Although LDQT was generally perceived as beneficial for maintaining patients' blood pressure control and facilitating adherence, some clinicians perceived limitations in titration inflexibility, adverse effects, and costs.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03640312.

摘要

背景

本项 QUARTET USA(美国四重超低剂量治疗高血压)临床试验(NCT03640312)的收敛平行设计混合方法过程评估探讨了患者和医疗保健专业人员对使用低剂量四联疗法(LDQT)作为高血压管理新策略的看法。

方法和结果

对 QUARTET USA 试验中纳入的所有 62 名患者进行了调查。通过目的性抽样,招募了 13 名患者和 11 名医疗保健专业人员作为亚组进行半结构访谈。入组时,68%的参与者(平均[标准差]年龄,51.7[11.5]岁;56%自认为是西班牙裔:墨西哥裔,16%是西班牙裔:其他族裔,16%是黑人,8%是白人,1.6%是南亚裔)报告称他们目前的健康状况取决于血压药物,48%担心血压药物。在试验完成时,80%的人对 LDQT 满意,96%的人确信服用 LDQT 的益处超过了缺点,96%的人报告 LDQT 服用方便。患者和医疗保健专业人员都认为 LDQT 是可以接受的,因为它降低了患者对药物的负担,并促进了药物的依从性。医疗保健专业人员表示,LDQT 的一个局限性是无法调整剂量。促进 LDQT 实施的步骤包括引入阶梯式治疗组合和治疗方案、纳入临床实践指南以及消除患者费用障碍。

结论

LDQT 是参与 QUARTET USA 临床试验的患者和医疗保健专业人员治疗高血压的一种可接受的策略。虽然 LDQT 通常被认为有利于维持患者的血压控制和促进其依从性,但一些临床医生认为剂量调整缺乏灵活性、不良反应和成本存在局限性。

注册

网址:https://www.clinicaltrials.gov;唯一标识符:NCT03640312。