Chen Tielong, Zheng Jianwu, Bao Cheng, Wang Yu, Wang Shiwang, Liang Lu, Zhang Li, Zhang Hui, Ji Chaoxia, Wang Jian, Zhang Xudong, Zhu Guangli, Zhu Houyong
Department of Cardiology, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People's Republic of China.
Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People's Republic of China.
J Inflamm Res. 2024 Nov 2;17:8047-8060. doi: 10.2147/JIR.S490896. eCollection 2024.
Despite statins and other medications central to atherosclerotic cardiovascular disease (ASCVD) secondary prevention, stable coronary artery disease (SCAD) patients remain at significant cardiovascular risk, partly due to residual inflammation risk (RIR). This study aims to assess if adding Guanxinning to standard ASCVD therapy further mitigates RIR in SCAD patients.
In a prospective, randomized, single-blind endpoint design, 50 patients with SCAD who received ASCVD standardized treatment strategy were randomly assigned to either take Guanxinning tablets (4 tablets, thrice daily) or no Guanxinning tablets and were followed up for an average of 12 weeks. The primary outcomes were changes in inflammation-related indicators, including interleukin-2 (IL-2), IL-4, IL-6, tumor necrosis factor-α (TNF-α), and high sensitivity C-reactive protein (hs-CRP).
Compared with the control group, the intervention group showed significantly greater decreases in the levels of IL-2, IL-6, TNF-α, and hs-CRP (all P < 0.05). However, there was no significant difference in the IL-4 level between the two groups (P > 0.05). Compared with the control group, there were also significant improvements in endothelial function-related indicators (vascular endothelial growth factor (VEGF), nitric oxide (NO), and peroxisome proliferator-activated receptor-γ (PPAR-γ)), blood lipid profile (total cholesterol (Tch), low-density lipoprotein cholesterol (LDL-C)), and chest pain related scores (angina and Traditional Chinese medicine syndrome scores) in the intervention group (all P<0.05). There was no significant difference in the triglyceride (TG) and carotid intima-media thickness between the two groups (P<0.05). Compared to the control group, there was no significant difference in the white blood cell line, liver and kidney function, anemia, and bleeding in the intervention group (all P<0.05).
The addition of Guanxinning tablets (4 tablets, thrice daily) to the standard treatment strategy for ASCVD was associated with a reduction in the RIR in patients with SCAD and demonstrated good safety.
尽管他汀类药物和其他药物在动脉粥样硬化性心血管疾病（ASCVD）二级预防中至关重要，但稳定型冠心病（SCAD）患者仍面临重大心血管风险，部分原因是存在残余炎症风险（RIR）。本研究旨在评估在标准ASCVD治疗方案中加用冠心宁是否能进一步减轻SCAD患者的RIR。
采用前瞻性、随机、单盲终点设计，将50例接受ASCVD标准化治疗策略的SCAD患者随机分为两组，分别服用冠心宁片（4片，每日3次）或不服用冠心宁片，并平均随访12周。主要结局指标为炎症相关指标的变化，包括白细胞介素-2（IL-2）、IL-4、IL-6、肿瘤坏死因子-α（TNF-α）和高敏C反应蛋白（hs-CRP）。
与对照组相比，干预组的IL-2、IL-6、TNF-α和hs-CRP水平显著降低（均P<0.05）。然而，两组间IL-4水平无显著差异（P>0.05）。与对照组相比，干预组的内皮功能相关指标（血管内皮生长因子（VEGF）、一氧化氮（NO）和过氧化物酶体增殖物激活受体-γ（PPAR-γ））、血脂谱（总胆固醇（Tch）、低密度脂蛋白胆固醇（LDL-C））以及胸痛相关评分（心绞痛和中医证候评分）也有显著改善（均P<0.05）。两组间甘油三酯（TG）和颈动脉内膜中层厚度无显著差异（P>0.05）。与对照组相比，干预组的白细胞系、肝肾功能、贫血及出血情况无显著差异（均P<0.05）。
在ASCVD标准治疗方案中加用冠心宁片（4片，每日3次）可降低SCAD患者的RIR，且安全性良好。
