藿香正气瞿唐饮对本质性高血压的疗效：随机、双盲、安慰剂对照试验

IF 4.2 2区医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE

Journal of Integrative Medicine-Jim Pub Date : 2024-07-01 DOI:10.1016/j.joim.2024.05.002

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Participants aged 18–80 years, exhibiting traditional Chinese medicine syndromes of blood stasis, yang hyperactivity or phlegm, along with grades 1 or 2 hypertension, were randomly categorized into two groups. 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The intervention group was given HQQR granules alongside conventional hypertension treatment, while the control group was given placebo granules in addition to conventional treatment for 12 weeks.</p></div><div><h3>Main outcome measures</h3><p>The primary outcome was clinic blood pressure, whereas secondary outcomes included metabolic indices (e.g., homeostasis model assessment of insulin resistance [HOMA-IR], total cholesterol [TC], low-density lipoprotein cholesterol and triglyceride), target organ damage indices (left ventricular mass index and urinary albumin creatinine ratio [UACR]) and inflammation indices (interleukin-6 [IL-6] and high-sensitivity C-reactive protein [hs-CRP]).</p></div><div><h3>Results</h3><p>HQQR’s primary components were identified as salvianolic acid B, emodin and ferulic acid. 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引用次数: 0

摘要

背景高血压是一种常见病，也是冠心病的重要危险因素。本研究评估了 HQQR 对血瘀、阳亢、痰浊型高血压患者控制血压的疗效。采用薄层色谱法和高效液相色谱法鉴定 HQQR 的主要成分。研究对象年龄在18-80岁之间，具有中医血瘀、阳亢、痰浊等证候，并伴有1或2级高血压，被随机分为两组。干预组在常规高血压治疗的基础上服用 HQQR 颗粒，对照组在常规治疗的基础上服用安慰剂颗粒，疗程 12 周、主要结果是临床血压，次要结果包括代谢指数（如胰岛素抵抗的稳态模型评估[HOMA-IR]、总胆固醇[TC]、低密度脂蛋白胆固醇和甘油三酯）、靶器官损伤指数（左心室质量指数和尿白蛋白肌酐比值[UACR]）和炎症指数（白细胞介素6[IL-6]和高敏C反应蛋白[hs-CRP]）。结果HQQR的主要成分被确定为丹参酚酸B、大黄素和阿魏酸。在 216 名参与者（每组 108 人）中，与对照组相比，干预组的临床收缩压（[136.24 ± 7.63] vs [130.06 ± 8.50] mmHg）、门诊舒张压（[84.34 ± 8.72] vs [80.46 ± 6.05] mmHg）、家庭收缩压（[131.64 ± 8.74] vs [122.36 ± 8.45] mmHg）和家庭舒张压（[78.47 ± 9.53] vs [71.79 ± 6.82] mmHg）均有明显改善（P < 0.001）。HQQR 可降低非卧床血压（24 小时收缩压：[133.75 ± 10.49] vs [132.46 ± 8.84] mmHg，24 小时舒张压：[84.12 ± 8.01] vs [82.11 ± 7.45] mmHg），HOMA-IR（[4.09 ± 1.72] vs [3.98 ± 1.44]）、TC（[4.66 ± 1.47] vs [3.75 ± 1.81] mmol/L）和 UACR（75.94 [5.12, 401.12] vs 45.61 [4.26, 234.26]）也有所改善。此外，HQQR 还降低了 hs-CRP（1.46 [0.10, 10.53] vs 0.57 [0.12, 3.99] mg/L）和 IL-6（6.69 [2.00, 29.74] vs 5.27 [2.00, 9.73] pg/mL），且未报告副作用（P < 0.001）。结论本研究强调了使用 HQQR 在改善高血压患者血压、糖脂代谢和炎症方面的治疗潜力。试验注册ChiCTR2000035092 (https://www.chictr.org.cn/)。本文引用如前：Xie J, Ma YL, Gui MT, Yao L, Li JH, Wang MZ, Zhou XJ, Wang YF, Zhao MY, Cao H, Lu B, Fu DY.藿雪前阳瞿潭方对高血压的疗效：随机、双盲、安慰剂对照试验J Integr Med 2024; 22(4)：485-493.

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Efficacy of Huoxue Qianyang Qutan Recipe on essential hypertension: A randomized, double-blind, placebo-controlled trial

Background

Hypertension, a prevalent disease, is a significant risk factor for coronary heart disease. Huoxue Qianyang Qutan Recipe (HQQR), a traditional Chinese herbal remedy, has been used for treating hypertension over several years.

Objective

This study assesses HQQR’s efficacy for controlling blood pressure among patients with hypertension related to blood stasis, yang hyperactivity and phlegm.

Design, setting, participants and interventions

A randomized controlled trial was conducted at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, China, from July 2020 to June 2022. Major components of HQQR were identified using thin-layer chromatography and high-performance liquid chromatography. Participants aged 18–80 years, exhibiting traditional Chinese medicine syndromes of blood stasis, yang hyperactivity or phlegm, along with grades 1 or 2 hypertension, were randomly categorized into two groups. The intervention group was given HQQR granules alongside conventional hypertension treatment, while the control group was given placebo granules in addition to conventional treatment for 12 weeks.

Main outcome measures

The primary outcome was clinic blood pressure, whereas secondary outcomes included metabolic indices (e.g., homeostasis model assessment of insulin resistance [HOMA-IR], total cholesterol [TC], low-density lipoprotein cholesterol and triglyceride), target organ damage indices (left ventricular mass index and urinary albumin creatinine ratio [UACR]) and inflammation indices (interleukin-6 [IL-6] and high-sensitivity C-reactive protein [hs-CRP]).

Results

HQQR’s primary components were identified as salvianolic acid B, emodin and ferulic acid. Of the 216 participants (108 in each group), compared to the control, the intervention group exhibited significant improvements (P < 0.001) in clinic systolic blood pressure ([136.24 ± 7.63] vs [130.06 ± 8.50] mmHg), clinic diastolic blood pressure ([84.34 ± 8.72] vs [80.46 ± 6.05] mmHg), home systolic blood pressure ([131.64 ± 8.74] vs [122.36 ± 8.45] mmHg) and home diastolic blood pressure ([78.47 ± 9.53] vs [71.79 ± 6.82] mmHg). HQQR demonstrated a reduction in ambulatory blood pressure (24-hour systolic blood pressure: [133.75 ± 10.49] vs [132.46 ± 8.84] mmHg and 24-hour diastolic blood pressure: [84.12 ± 8.01] vs [82.11 ± 7.45] mmHg) and an improvement in HOMA-IR ([4.09 ± 1.72] vs [3.98 ± 1.44]), TC ([4.66 ± 1.47] vs [3.75 ± 1.81] mmol/L) and UACR (75.94 [5.12, 401.12] vs 45.61 [4.26, 234.26]). Moreover, HQQR demonstrated a decrease in hs-CRP (1.46 [0.10, 10.53] vs 0.57 [0.12, 3.99] mg/L) and IL-6 (6.69 [2.00, 29.74] vs 5.27 [2.00, 9.73] pg/mL), with no reported side effects (P < 0.001).

Conclusion

This study highlights the therapeutic potential of HQQR use in ameliorating blood pressure, glycolipid metabolism, and inflammation in patients with hypertension.

Trial registration

ChiCTR2000035092 (https://www.chictr.org.cn/).

Please cite this article as: Xie J, Ma YL, Gui MT, Yao L, Li JH, Wang MZ, Zhou XJ, Wang YF, Zhao MY, Cao H, Lu B, Fu DY. Efficacy of Huoxue Qianyang Qutan Recipe on essential hypertension: A randomized, double-blind, placebo-controlled trial. J Integr Med 2024; 22(4): 485–493.

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来源期刊

Journal of Integrative Medicine-Jim Medicine-Complementary and Alternative Medicine

CiteScore

9.20

自引率

4.20%

发文量

3319

期刊介绍： The predecessor of JIM is the Journal of Chinese Integrative Medicine (Zhong Xi Yi Jie He Xue Bao). With this new, English-language publication, we are committed to make JIM an international platform for publishing high-quality papers on complementary and alternative medicine (CAM) and an open forum in which the different professions and international scholarly communities can exchange views, share research and their clinical experience, discuss CAM education, and confer about issues and problems in our various disciplines and in CAM as a whole in order to promote integrative medicine. JIM is indexed/abstracted in: MEDLINE/PubMed, ScienceDirect, Emerging Sources Citation Index (ESCI), Scopus, Embase, Chemical Abstracts (CA), CAB Abstracts, EBSCO, WPRIM, JST China, Chinese Science Citation Database (CSCD), and China National Knowledge Infrastructure (CNKI). JIM Editorial Office uses ThomsonReuters ScholarOne Manuscripts as submitting and review system (submission link: http://mc03.manuscriptcentral.com/jcim-en). JIM is published bimonthly. Manuscripts submitted to JIM should be written in English. Article types include but are not limited to randomized controlled and pragmatic trials, translational and patient-centered effectiveness outcome studies, case series and reports, clinical trial protocols, preclinical and basic science studies, systematic reviews and meta-analyses, papers on methodology and CAM history or education, conference proceedings, editorials, commentaries, short communications, book reviews, and letters to the editor. Our purpose is to publish a prestigious international journal for studies in integrative medicine. To achieve this aim, we seek to publish high-quality papers on any aspects of integrative medicine, such as acupuncture and traditional Chinese medicine, Ayurveda medicine, herbal medicine, homeopathy, nutrition, chiropractic, mind-body medicine, taichi, qigong, meditation, and any other modalities of CAM; our commitment to international scope ensures that research and progress from all regions of the world are widely covered. These ensure that articles published in JIM have the maximum exposure to the international scholarly community. JIM can help its authors let their papers reach the widest possible range of readers, and let all those who share an interest in their research field be concerned with their study.