Background. GXN tablets are composed of Danshen and Chuanxiong, with the functions of activating blood circulation, removing blood stasis, invigorating the pulse, and nourishing the heart, which are used for CHD patients with stable exertional angina Grade I or II (according to traditional Chinese medicine, it is a syndrome of heart and blood stasis with chest pain and dark purple lips and tongue). Clinical trials have shown satisfactory effects on coronary heart disease (CHD). 90.6% of Chinese patients with CHD use both Western medicine and Chinese medicine with the latter being thought to promote blood circulation and remove blood stasis. Some researchers doubt that the combination of Chinese medicine increases the risk of bleeding. The main objective of this study is to observe the safety of long-term use of Guanxinning (hereafter referred to as GXN) tablets combined with aspirin. Methods. The study population is patients with CHD after percutaneous coronary intervention (PCI). Randomization was performed for patients with stable CHD who received dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel or ticagrelor for more than 12 months and then switched to the treatment with aspirin alone for 1 month. This study includes a total of 3,595 subjects in 63 hospitals. The experimental group took aspirin orally (100 mg, 1 time/day) + GXN tablets (0–6 months: 4 tablets/time, 3 times/day; 7–12 months, 4 tablets/time, 2 times/day), and the control group received oral aspirin (100 mg, 1 time/day). Major observation indicators are the incidence of bleeding events, adverse events (AEs), and adverse reactions. The primary endpoint indicators are the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and the MACCE composite endpoint. Results. A total of 31 cases of symptomatic bleeding were found in the two groups, including 21 cases (0.98%) in the experimental group and 10 cases (0.86%) in the control group; the difference between the two groups was not statistically significant. There were 29 cases (1.35%) of bleeding not reaching BARC type 1 in the experimental group. No attention was paid to the laboratory indicators in the control group during the trial process, so the bleeding as a laboratory indicator between the two groups was not comparable. For BARC type 3–5 bleeding events, there were 3 cases in the experimental group (0.139%) and 2 cases in the control group (0.172%); the difference between the two groups was not statistically significant and not clinically significant. During the trial period, there were a total of 255 cases of adverse reactions in 208 subjects with an incidence of 6.57% (141/2146) in the experimental group and 5.77% (67/1161) in the control group, and the value was 0.5021; the difference between the two groups was not statistically significant. According to the analysis, the adverse reactions with a statistically significant difference between the two groups were gastrointestinal diseases, with the incidence in the experimental group being higher than that in the control group, and the main manifestations were gastrointestinal symptoms. There was no statistical difference in other types of adverse reactions between the two groups. In the trial period, there were 10 cases of serious adverse reactions, including 5 cases in the experimental group (5/2146, 0.23%) and 5 cases in the control group (5/ 1161, 0.43%), the value was 0.3351; the difference in the incidence between the two groups was not statistically significant. Conclusion. For CHD patients with heart-blood stasis syndrome, the combination of aspirin and GXN tablets in the experimental group did not increase the incidence of bleeding events, nor did it increase the risk of bleeding of types 3–5 defined by BARC. Except for the increase in gastrointestinal symptoms, there was no increase in other adverse reactions in the experimental group. This trial is registered with Registration no. ChiCTR-IIR-17010688.

Salvianolic acid B is the main active ingredient in salvianolate injection, which is produced by extracting danshen, the most commonly used Chinese herbal medicine for cardiovascular treatment. Clinically, salvianolate injection and aspirin are commonly combined to treat coronary heart diseases in patients with stable angina. To support clinical studies on drug-drug interactions (DDIs) between salvianolate injection and aspirin, a rapid and sensitive UPLC-MS/MS method for the simultaneous determination of aspirin (acetylsalicylic acid), its metabolite salicylic acid, and salvianolic acid B in human plasma was developed. The analytes and internal standard were extracted from the acidified plasma by liquid-liquid extraction with ethyl acetate and then separated by gradient elution with acetonitrile/0.5% formic acid in water on a C18 column. Salvianolic acid B, acetylsalicylic acid, and salicylic acid were quantified in multiple-reaction monitoring mode with negative ion electrospray ionization. The method was fully validated according to the current regulatory guidance for bioanalysis. Calibration curves in the range 5–6000 ng/mL, all with correlation coefficients greater than 0.99, were established using linear regression models for salvianolic acid B and acetylsalicylic acid and a quadratic model for salicylic acid. The validated method was successfully used to measure salvianolic acid B, acetylsalicylic acid, and salicylic acid concentrations in human plasma samples from 16 patients to observe the pharmacokinetic changes caused by DDIs.

Coronary heart disease (CHD) is a common cardiovascular disease accounting for 10–20% mortality by heart disease worldwide. The gold standard treatment to manage CHD is aspirin, which may prevent myocardial infarction and sudden death; however, long-term use of aspirin may increase its side effects. Currently, more and more clinicians are exploring different approaches to use the right combination of medicine to enhance the efficacy and reduce side effects. Salvianolate can significantly inhibit the aggregation and activation of platelets in patients with CHD; however, its optimum combination with western medicine is not established or supported by clinical trial results. This trial is a prospectively planned, open-labeled, parallel-grouped, single-centered clinical trial with aggregated pharmacodynamics-pharmacokinetics (PK-PD) data. All treatment courses will last for 10 days and blood sample will be acquired before administration on days 8, 9, and 10, and after administration at 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 12 h, and 24 h on day 10. This trial uses PK-PD modeling to provide a description of the concentration–effect relationship and an estimate of pharmacological potency of the medicine. The primary outcome will be changes in aspirin esterase and catechol-o-methyltransferase (COMT) activity at different blood concentrations to determine the PK-PD characteristics of the combination of salvianolate and aspirin, followed by analysis of the correlation between exposure level and pharmacodynamic index of the medicines. This trial will aim to evaluate the relationship between changes in the pharmacokinetics and therapeutic effect index in the combined use of salvianolate and aspirin. It also discusses the possible mechanism of medicine combination in the treatment for CHD and provides an experimental basis for a clinically rational medicine combination. ClinicalTrials.gov, NCT03306550 . Registered on 9 October 2017. ClinicalTrials.gov https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0007D8H&selectaction=Edit&uid=U0003QY8&ts=2&cx=oiuc9g

Background: The comorbidity burden of type 2 diabetes mellitus complicated with coronary heart disease is steadily increasing. However, there is a lack of systematic mapping of the research landscape, knowledge foundation, and emerging frontiers in this field. Methods: A systematic search of the Web of Science Core Collection, PubMed, and Scopus was conducted for literature published from April 2016 to April 2026. A series of tools, such as Origin Pro 2025, SCImago Graphica 1.0.55, VOSviewer 1.6.20, Bibliometrix R 4.6.0, and SciExplorer, were used to analyze annual trends, countries/regions, institutions, authors, journals, highly cited references, keyword co-occurrence, and thematic evolution. Results: A total of 8,390 publications were included, with annual output showing sustained growth. The United States and China emerged as the dominant contributors, and the United States displayed markedly higher international collaboration rates and greater citation impact per article. Institutions such as Harvard University and the University of Toronto anchored the core collaborative network. Cardiovascular Diabetology was identified as the most prolific journal. Highly cited documents predominantly comprised clinical guidelines and comprehensive reviews. Polygenic risk scores, machine learning applications, and the cardiovascular advantages of novel glucose-lowering agents are current research hotspots. Multi-omics investigations and integrated cardiometabolic multimorbidity management are gaining recognition as promising frontier directions. Conclusion: The past decade has witnessed a surge of research progress and innovation in this field. Capitalizing on the clinical translation of metabolomics, artificial intelligence-assisted decision-making, and integrated multimorbidity management represents a feasible pathway toward breakthrough research.