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Guanxinning for Residual Inflammation of Stable Coronary Artery Disease: A Pilot Randomized Controlled Trial
Tielong Chen1, Jianwu Zheng1, Cheng Bao1
1Department of Cardiology, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People's Republic of China.
Insights
Guanxinning tablets reduced residual inflammation risk (RIR) in stable coronary artery disease (SCAD) patients on standard therapy. This treatment showed significant improvements in inflammation markers and cardiovascular health indicators with good safety.
Area of Science:
- Cardiology
- Pharmacology
- Inflammation Research
Background:
- Stable coronary artery disease (SCAD) patients face persistent cardiovascular risk despite standard treatments like statins.
- Residual inflammation risk (RIR) is a key contributor to this ongoing risk in SCAD patients.
- Guanxinning is being investigated as an adjunct therapy to mitigate RIR.
Purpose of the Study:
- To evaluate the efficacy of Guanxinning in reducing RIR in SCAD patients receiving standard atherosclerotic cardiovascular disease (ASCVD) therapy.
- To assess the impact of Guanxinning on inflammation markers, endothelial function, lipid profiles, and clinical symptoms.
Main Methods:
- A prospective, randomized, single-blind study involving 50 SCAD patients on standard ASCVD treatment.
- Patients were randomized to receive either Guanxinning tablets (4 tablets, thrice daily) or a placebo for 12 weeks.
- Primary outcomes included changes in inflammatory markers: IL-2, IL-4, IL-6, TNF-α, and hs-CRP.
Main Results:
- Guanxinning significantly decreased IL-2, IL-6, TNF-α, and hs-CRP levels compared to the control group (P < 0.05).
- Improvements were observed in endothelial function markers (VEGF, NO, PPAR-γ), lipid profiles (Tch, LDL-C), and angina/TCM syndrome scores.
- No significant differences were found in IL-4, triglycerides, carotid intima-media thickness, or safety parameters (blood counts, liver/kidney function, bleeding).
Conclusions:
- Adding Guanxinning to standard ASCVD therapy effectively reduces RIR in SCAD patients.
- The treatment demonstrated significant benefits in inflammatory markers, endothelial function, and clinical symptoms.
- Guanxinning exhibited a favorable safety profile in this patient cohort.
Background:
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.
Methods:
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).
Results:
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).
Conclusion:
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.
