背景:慢性炎症是动脉粥样硬化(As)的主要病理特征。炎症可能会加速斑块的发展,这是导致纤维帽变薄和斑块脆弱破裂的关键因素。目前,目前仍缺乏临床治疗。有必要找到一种安全有效的治疗As炎症的方法。四妙勇安汤(SMYA)具有潜在的抗炎和保护斑块作用。该方案旨在评估疗效,安全,SMYA治疗颈动脉粥样硬化斑块的机制。
方法:SMYA临床试验的评估设计为随机,双盲,安慰剂对照研究。样本量共86例,干预组和对照组分别为43例。干预组服用SMYA,对照组服用SMYA安慰剂。该药物每10周持续14天,总共50周。我们将使用颈动脉高分辨率磁共振成像(HR-MRI)来测量斑块。采用斑块最小纤维帽厚度(PMFCT)作为主要结果。次要结果包括斑块纤维帽体积,纤维帽的体积百分比,富含脂质的坏死核心(LRNC)体积,LRNC的体积百分比,斑块内部出血量,斑块内部出血体积百分比,斑块钙化量,斑块钙化的体积百分比,管腔狭窄率,平均和最大血管壁厚,血管壁容积,容器壁总载荷,颈动脉粥样硬化评分,hs-CRP,IL-1β和IL-6,血脂和血糖水平,血压,和体重。
结论:我们预计As斑块患者将通过抑制炎症以增强斑块稳定性而从SMYA得到改善。本研究通过HR-MRI分析斑块,以评估SMYA的临床疗效和安全性。此外,我们进行转录组分析,蛋白质组学分析,并对参与者的血液和粪便进行宏基因组分析,以研究SMYA抗As斑块的机制。这是第一个通过直接抑制炎症反应观察和治疗As斑块的前瞻性中医试验。如果成功,这一发现将对As斑块的治疗和药物开发有价值,尤其是在“他汀类药物时代”。
背景:该试验于2020年10月15日在中国临床试验.gov上注册,编号为ChiCTR2000039062(http://www。chictr.org.cn)。
BACKGROUND: Chronic inflammation is the major pathological feature of Atherosclerosis(As). Inflammation may accelerate plaque to develop, which is a key factor resulting in the thinning of the fibrous cap and the vulnerable rupture of plaque. Presently, clinical treatments are still lacking. It is necessary to find a safe and effective treatment for As inflammation. Simiaoyongan Decoction (SMYA) has potential anti-inflammatory and plaque protection effects. This protocol aims to evaluate the efficacy, safety, and mechanism of SMYA for patients with carotid atherosclerotic plaque.
METHODS: The assessment of SMYA clinical trial is designed as a randomized, double-blind, placebo-controlled study. The sample size is 86 cases in total, with 43 participants in the intervention group and the control group respectively. The intervention group takes SMYA, while the control group takes SMYA placebo. The medication lasts for 14 days every 10 weeks, with a total of 50 weeks. We will use carotid artery high resolution magnetic resonance imaging (HR-MRI) to measure plaque. The plaque minimum fiber cap thickness (PMFCT) is adopted as the primary outcome. The secondary outcomes include plaque fiber cap volume, volume percentage of fiber cap, lipid-rich necrotic core (LRNC) volume, volume percentage of LRNC, internal bleeding volume of plaque, internal bleeding volume percentage of plaque, plaque calcification volume, volume percentage of plaque calcification, lumen stenosis rate, average and a maximum of vessel wall thickness, vessel wall volume, total vessel wall load, carotid atherosclerosis score, hs-CRP, IL-1β and IL-6, the level of lipid profiles and blood glucose, blood pressure, and body weight.
CONCLUSIONS: We anticipate that patients with As plaque will be improved from SMYA by inhibiting inflammation to enhance plaque stability. This study analyzes plaque by using HR-MRI to evaluate the clinical efficacy and safety of SMYA. Moreover, we conduct transcriptome analysis, proteomic analysis, and metagenomic analysis of blood and stool of participants to study the mechanism of SMYA against As plaque. This is the first prospective TCM trial to observe and treat As plaque by inhibiting inflammatory reaction directly. If successful, the finding will be valuable in the treatment of As plaque and drug development, especially in the \"statin era\".
BACKGROUND: This trial is registered on Chinese Clinical Trials.gov with number ChiCTR2000039062 on October 15, 2020 ( http://www.chictr.org.cn ).