Recently, the 25th Southern Conference on Cardiovascular Diseases (SCC 2024), the first large-scale comprehensive conference in the field of cardiovascular diseases this year, was held in Guangzhou. Domestic academicians, authoritative experts, industry leaders, and grassroots rookies in the cardiovascular field conducted exchanges and in-depth communication on hot spots, difficulties, and key topics in the cardiovascular field, presenting a brilliant academic feast.
In the 28 years since Tongxinluo was launched in 1996, Professor Wu Yiling has led the team to adhere to the development and innovation of traditional Chinese medicine theory, and has carried out a series of drug research and development and a large number of modern evidence-based medical research, providing safe and effective new options for the treatment of cardiovascular diseases such as coronary heart disease, arrhythmia, and heart failure. Professor Zhang Minzhou, vice president of the Integrative Medicine Branch of the Chinese Medical Doctor Association and professor of Guangdong Provincial Hospital of Traditional Chinese Medicine, said that the research results obtained under the theory of network disease and its guidance are proud of the industry, especially in October 2023, the "Myocardial Protection Study on the Treatment of Acute Myocardial Infarction in China Tongxinluo" led by Professor Yang Yuejin of Fuwai Hospital of the Chinese Academy of Medical Sciences was published in the four major international medical journals "JAMA" The journal is a milestone of great significance in the modernization of traditional Chinese medicine, and it is also a major breakthrough in the research of evidence-based medicine of traditional Chinese medicine, which has taken a solid step for traditional Chinese medicine to go international.
At the "Summit Forum on the Research on the Intervention of the Cardiovascular Event Chain under the Guidance of Context Theory and Health Theory", Professor Zhang Minzhou, Professor Xu Dingli of Nanfang Hospital of Southern Medical University, Professor Zhang Gaoxing of Jiangmen Central Hospital and Professor Tan Hong of Guangdong Provincial People's Hospital co-chaired the forum, Professor Jia Zhenhua of Hebei Institute of Integrated Traditional Chinese and Western Medicine, Professor Yang Yuejin of Fuwai Hospital of Chinese Academy of Medical Sciences, Professor Qian Xiaoxian of the Third Affiliated Hospital of Sun Yat-sen University, Professor Hou Yuqing from Nanfang Hospital of Southern Medical University and Professor Zhou Shuxian from Sun Yat-sen Memorial Hospital of Sun Yat-sen University gave a detailed introduction to the progress and latest achievements of clinical research related to Tongxinluo, Ginseng Song and Qili Qiangxin under the guidance of the theory of network disease, and systematically demonstrated the important achievements made in the inheritance, innovation and transformation of the theoretical system of network disease. This article summarizes the highlights of the conference as follows for the benefit of readers.
Professor Jia Zhenhua: A number of breakthroughs have been made in the research on the chain of cardiovascular events guided by the theory of the vein theory
Professor Jia Zhenhua
At the meeting, Professor Jia Zhenhua gave an overall introduction to the National Key R&D Program "Research on the Intervention of the Cardiovascular Event Chain with the Guidance System of Contextual Theory and Health Theory". Professor Jia Zhenhua pointed out that cardiovascular diseases will develop in a chain pattern. Hypertension, hyperlipidemia, and hyperglycemia are recognized as high-risk factors for cardiovascular diseases in the world, and the "three highs" lead to vascular endothelial damage, cause atherosclerosis, rupture of vulnerable plaques, acute myocardial infarction, and arrhythmia after myocardial infarction occurs as the disease worsens, and finally heart failure and eventually death. The whole event chain is causally connected and progressively developed, and the sudden occurrence of cardiovascular events often causes serious consequences, so it is urgent to suppress the cardiovascular event chain.
Professor Jia Zhenhua said that there are still bottlenecks and problems in the treatment of cardiovascular diseases. Based on this, the project of "Research on the Chain of Cardiovascular Events Guided by the Theory of Vascular Intervention in the Context Theory" has conducted in-depth research on major diseases in five key links, including metabolic syndrome, vulnerable plaque, myocardial infarction, atrial fibrillation and heart failure, and has achieved a series of scientific research results.
This project proposes a new view of systematic intervention of "treating the root disease and preventing the disease", which is to prevent upstream factors, treat current lesions, and control downstream transmission, and reveal the pathogenesis transmission characteristics and medication rules of the system intervention in the cardiovascular event chain guided by the context theory.
In terms of evidence-based medical research, Professor Jia Zhenhua introduced that 889 cases of Jinlida on metabolic syndrome with impaired glucose tolerance showed that Jinlida can systematically intervene in multiple metabolic abnormalities, significantly reduce the risk of diabetes, and protect blood vessels to reduce the risk of cardiovascular events; 220 cases of Tongxinluo intervention in coronary artery fragile plaque clinical studies have shown that Tongxinluo can increase the thickness of plaque fiber caps, stabilize vulnerable plaques, improve the severity of angina, improve quality of life, and reduce the occurrence of events; 3797 cases of myocardial protection in the treatment of acute myocardial infarction by Tongxinluo (CTS-AMI study). ) is the first randomized controlled trial of proprietary Chinese medicine published in the journal JAMA, and the results show that Tongxinluo can significantly reduce the risk of major adverse cardiovascular and cerebrovascular events at 30 days by 36% and the risk of cardiovascular death by 30%. A clinical study of 920 patients with atrial fibrillation after radiofrequency ablation showed that Ginseng Song Yangxin could reduce the recurrence rate of atrial fibrillation and improve the quality of life within one year after ablation, and a clinical study of 3119 patients with the composite endpoint of chronic heart failure showed that Qili Yangxin could significantly improve the prognosis of patients with heart failure and reduce the risk of cardiovascular death and rehospitalization after heart failure deterioration.
Professor Jia Zhenhua said that sufficient evidence-based research not only supports the entry of traditional Chinese medicine into authoritative guidelines and consensus, but also promotes the construction of unified textbooks of traditional Chinese and Western medicine, national key laboratories and key clinical specialties. Since 2018, the theory of the pulse has been recommended by the guidelines or consensus for a total of 39 times, and the relevant research results have been highly praised. Based on the theory of network disease, the research organization and management norms have successfully made a major breakthrough in the chain of cardiovascular events intervened by the traditional Chinese medicine system, and have become a model for the research of integrated traditional Chinese and Western medicine.
Professor Xu Dingli pointed out that the research on the chain of cardiovascular events under the guidance of the theory of health and health has made a major breakthrough in the systematic intervention of cardiovascular event chain with traditional Chinese medicine, and has become a model of integrated traditional Chinese and Western medicine research. "Unlike Western doctors, the biggest feature of Chinese doctors is that they have the support of the medicine of their motherland. Therefore, we should vigorously give full play to the role and advantages of the integration of traditional Chinese and Western medicine in clinical work to bring more benefits to patients. ”
Prof. Yang Yuejin: The CTS-AMI study provides a model for evidence-based medicine research in traditional Chinese medicine
Professor Yang Yuejin
Acute myocardial infarction (AMI) is a common and fatal acute and critical illness in clinical practice. Professor Yang Yuejin pointed out that reperfusion therapy is the treatment of choice for AMI. However, even after the opening of the coronary artery and large vessels, 30%~37% of patients still have myocardial reflow without reflow. In addition, reperfusion injury may occur even if reperfusion is successful. Myocardial reflux and myocardial reperfusion injury are two major international problems, and new drugs or new treatment strategies are urgently needed to improve the treatment status.
In the prevention and treatment of myocardial reflow, a series of basic studies carried out by Professor Yang Yuejin have shown that Tongxinluo has a dual and two-way protective effect on the structure and function of microvascular endothelial cells and cardiomyocytes. In terms of clinical research, the clinical study (ENLEAT trial) of myocardial reflow after interventional treatment for the prevention and treatment of acute myocardial infarction by Tongxinluo showed that the addition of Tongxinluo on the basis of conventional western medicine treatment before and after PCI surgery can significantly reduce the amplitude of ST segment elevation, accelerate the rate of ST segment regression, reduce the incidence of ECG without reflow by 36.6%, reduce the area without reflow and infarction, and improve the left ventricular systolic function.
In order to further confirm the ability of Tongxinluo to improve the clinical outcome of patients with acute myocardial infarction. In 2019, Professor Yang Yuejin's team took the lead in carrying out the "Myocardial Protection Study on the Treatment of Acute Myocardial Infarction in China Tongxinluo" (referred to as the "CTS-AMI Study"). The CTS-AMI study is a randomized, double-blind, placebo-controlled, multicenter clinical study that included 3797 patients with ST-elevation myocardial infarction (STEMI) in 124 hospitals in mainland China, and finally 3777 patients were included in the main analysis. The results of the study showed that on the basis of the treatment recommended by the guidelines, the risk of major adverse cardiovascular and cerebrovascular events (MACCEs) at 30 days was significantly reduced by 36% and the risk of cardiovascular death by 30% in the Tongxinluo group was significantly reduced, and the risk of MACCEs was significantly reduced by 36% and the risk of cardiovascular death by 27% in the Tongxinluo group at 1 year of treatment.
In October 2023, the CTS-AMI research results were published in the top international medical journal "JAMA". Professor Yang Yuejin said that the CTS-AMI study provided AMI patients with the first innovative traditional Chinese medicine with dual protection against microvascular and myocardial reperfusion injury, which is one of the main mechanisms by which Tongxinluo can effectively improve clinical outcomes, provides an example for evidence-based medicine research of traditional Chinese medicine, takes a solid step forward for the internationalization of traditional Chinese medicine, and finds a combination point and effective path for the integration of traditional Chinese and Western medicine.
"Myocardial reflow without reflow and reperfusion injury are more harmful to patients undergoing interventional therapy, which can increase the risk of heart failure and arrhythmia in the future. Professor Zhang Gaoxing said that a series of studies have confirmed that Tongxinluo can effectively improve coronary microcirculation, thereby effectively reducing myocardial reflow and reperfusion injury, improving patients' clinical outcomes, and bringing more clinical benefits to patients.
Professor Hou Yuqing: The "Expert Consensus" of Tongxinluo was released, which effectively promoted the standardization of the prevention and treatment of coronary heart disease
Professor Hou Yuqing
Cardiovascular disease is the main cause of death among urban and rural residents in mainland China, and according to the China Cardiovascular Health and Disease Report 2022, it is estimated that there are 11.39 million patients with coronary heart disease in mainland China, and the mortality rate of coronary heart disease is still on the rise. Professor Hou Yuqing said that even after standard medical treatment and revascularization, patients with coronary heart disease still have a higher residual cardiovascular risk.
With the increasingly urgent health needs of mainland residents, the importance of traditional Chinese medicine in the treatment and prevention of diseases has become increasingly prominent, and it has played a very important role in the prevention and treatment of cardiovascular diseases. Professor Hou Yuqing introduced that Tongxinluo is a representative drug developed under the guidance of the theory of network disease for the treatment of ischemic cardiovascular and cerebrovascular diseases, diabetic microangiopathy and other diseases, which is composed of 12 traditional Chinese medicines such as ginseng, leeche, and whole scorpion, which has multiple effects such as lipid regulation, anticoagulation, anti-inflammatory, antioxidant, improving blood rheology, protecting vascular endothelium and stabilizing plaque. A series of previous basic and clinical studies have confirmed that Tongxinluo can further bring benefits to patients with coronary heart disease.
In order to further clarify the applicable population and evidence strength of Tongxinluo in the treatment of coronary heart disease, and better guide and give full play to the clinical application value of Tongxinluo in patients with coronary heart disease, the "Chinese Expert Consensus on the Clinical Application of Tongxinluo in the Prevention and Treatment of Coronary Heart Disease" (hereinafter referred to as the "Consensus") jointly written by 47 authoritative experts in the cardiovascular field in mainland China was recently released.
The "Consensus" covers 9 disease types and patient groups, including acute coronary syndrome, chronic coronary syndrome, coronary heart disease after interventional treatment, coronary heart disease combined with cerebrovascular disease, and carotid arteriosclerosis, and recommends the use of Tongxinluo in the treatment of 9 types of coronary heart disease. Tongxinluo has been recommended by 8 Class I experts and 9 Class A evidence recommendations in the prevention and treatment of primary and secondary levels, and is the first innovative Chinese medicine to receive Class I/A recommendations in acute coronary syndrome.
"In the field of coronary heart disease treatment, despite the great efforts made by clinicians, the rehospitalization rate of coronary heart disease, especially the mortality rate of acute myocardial infarction, is still high, which is related to complex factors such as untimely reperfusion and microangiopathy. Professor Zhang Gaoxing emphasized that Tongxinluo has a unique mechanism of action with multiple targets in the treatment of coronary heart disease, which can further improve the coronary microcirculation function on the basis of standard treatment, thereby improving the clinical prognosis of patients, and the release of the "consensus" provides a good "tool" for clinicians to treat coronary heart disease, and also brings a safe and effective drug for patients with coronary heart disease to improve efficacy and prognosis.
Professor Zhou Shuxian: Ginseng Song Yangxin reduces the risk of atrial fibrillation recurrence after ablation of persistent atrial fibrillation
Professor Chow Shuk-han
"The standardized prevalence of atrial fibrillation in adults in mainland China is 1.6%, and the incidence of atrial fibrillation is increasing with age. Professor Zhou Shuxian said that in recent years, the indications for catheter ablation of atrial fibrillation have gradually broadened, and the effect of maintaining sinus rhythm is better than that of anti-arrhythmic drugs (AADs), but for patients with persistent atrial fibrillation, the recurrence rate after catheter ablation is higher, and the short-term use of AADs after catheter ablation cannot improve the long-term success rate.
Ginseng Song Yangxin is an innovative drug for the treatment of arrhythmia developed under the guidance of the theory of network disease, which can not only inhibit cardiac multi-ion channels, but also have the regulatory effect of non-ion channels, and can block the pathogenesis of arrhythmia in multiple ways, links and targets. Previous studies have confirmed that ginseng song Yangxin has a definite curative effect in the treatment of non-organic premature ventricular contractions, organic premature ventricular contractions, atrial fibrillation, bradyarrhythmia, heart failure with premature ventricular contractions, and sinus bradycardia with premature ventricular contractions, which has opened up a new way of "integrated regulation, fast and slow treatment" of arrhythmia, and made up for the shortcomings of clinical drug treatment of arrhythmia.
In order to evaluate the effect of ginseng song Yangxin on the prognosis of patients with persistent atrial fibrillation (PerAF) radiofrequency ablation (RFCA), in 2019, the "multicenter, randomized, double-blind, placebo-controlled clinical study of ginseng song Yangxin capsule on the prognosis of patients with radiofrequency atrial fibrillation after radiofrequency ablation" (SS-AFRF) led by Professor Huang He of Wuhan University People's Hospital was launched in Chinese mainland.
The SS-AFRF study included 920 patients with PerAF treated with RFCA in 66 hospitals in mainland China and were randomly assigned to the experimental group and the control group in a 1:1 ratio. The primary endpoint of the study is the incidence of recurrent atrial tachyarrhythmias lasting ≥30 seconds after a blank period.
The results of the study showed that most patients discontinued class I or III AADs after a blank period. Ginseng Song Yangxin can significantly reduce the recurrence rate of atrial fibrillation in patients with PerAF after radiofrequency ablation of persistent atrial fibrillation, reduce the burden of atrial fibrillation at 3 months and 6 months after ablation, and improve the quality of life of patients. In addition, there was a trend of delaying the recurrence time of atrial fibrillation after radiofrequency ablation of persistent atrial fibrillation, and there were no significant differences in echocardiographic parameters, cardioversion, stroke incidence and adverse event rates between the two groups. "Long-term use of Ginseng Song Yangxin Capsule after ablation has a good safety profile. The results of this trial provide an innovative treatment strategy for the postoperative management of persistent atrial fibrillation radiofrequency ablation. Professor Zhou Shuxian said.
Professor Tan Hong said that the SS-AFRF study uses modern evidence-based medical research methods to explore the improvement of the prognosis of patients with atrial fibrillation, with rigorous study design and encouraging results, providing a safe and effective treatment option for patients with persistent atrial fibrillation after radiofrequency ablation.
Professor Qian Xiaoxian: Qili strengthens the heart to provide strong "Chinese evidence" for the treatment of chronic heart failure
Professor Chin Hsiao-yin
"Heart failure is a severe or advanced stage of a variety of heart diseases, with high mortality and rehospitalization rates. Professor Qian Xiaoxian said that the aging of the population in the mainland is intensifying, the incidence of chronic diseases such as coronary heart disease, hypertension, diabetes, and obesity is on the rise, and the improvement of medical standards has prolonged the survival of patients with heart diseases, which together have led to a continuous increase in the prevalence of heart failure in the mainland. In response to this current situation in mainland China, the "Guidelines for the Diagnosis and Treatment of Heart Failure in China 2024" (hereinafter referred to as the "Guidelines") jointly authored by the Heart Failure Group of the Cardiovascular Disease Branch of the Chinese Medical Association was officially released on March 24, 2024.
The guidelines are updated after 6 years on the basis of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018. It is worth noting that the traditional Chinese medicine Qili Qiangxin has once again been recommended by the Guidelines for the treatment of patients with heart failure with chronic reduced ejection fraction.
The guidelines point out that Qili cardiac may play a beneficial role in cardiovascular by improving oxidative stress, anti-cardiac maladaptive hypertrophy, cardiomyocyte apoptosis, and pro-inflammatory and pro-fibrotic pathways. For patients with HFrEF who have received standard anti-heart failure therapy recommended by the guidelines, the combination of Qili Qiangxin for 12 weeks can significantly reduce the level of NT-proBNP, improve the NYHA cardiac function class, cardiovascular composite endpoint events (death, cardiopulmonary resuscitation for cardiac arrest, admission to hospital for heart failure, need for intravenous medication for heart failure exacerbation, abandonment of treatment in patients with stroke and heart failure exacerbation), 6-minute walking distance, and quality of life.
In terms of clinical research, in 2018, the team led by Professor Li Xinli from the First Affiliated Hospital of Nanjing Medical University launched the "Evaluation Study of Qili Qiangxin Capsule on Composite Endpoint Events of Chronic Heart Failure (QUEST Study)". The primary endpoints of the study were cardiovascular mortality and rehospitalization with heart failure exacerbation.
The results of the QUEST study were presented at the 2023 European Society of Cardiology Congress (ESC). The results of the study showed that compared with the placebo group, Qili strong heart significantly reduced the risk of composite endpoint events (the composite endpoint of cardiovascular death and heart failure worsening rehospitalization) by 22%, and significantly reduced the risk of heart failure deterioration rehospitalization by 24% and cardiovascular death by 17%, respectively.
Professor Zhang Minzhou pointed out that in recent years, with the continuous development and progress of medical technology, especially with the deepening of the research of traditional Chinese medicine with multiple mechanisms of action represented by Qili Qiangxin, the mortality rate of heart failure has shown a downward trend. In the future, it is expected that more strong evidence-based medical evidence will be published to provide strong support for the clinical treatment of heart failure.
brief summary
Professor Zhang Minzhou said that traditional Chinese medicine has a multi-target mechanism of action, taking into account both efficacy and safety. In recent years, with the continuous deepening of research, strong evidence-based research results have been released, which has attracted much attention for TCM treatment. The announcement of the CTS-AMI research results is undoubtedly a milestone event in the entire field of traditional Chinese medicine, marking the beginning of traditional Chinese medicine treatment to the international stage.
In 2019, the project "Construction of the Theory of Traditional Chinese Medicine and Its Guidance for the Prevention and Treatment of Microvascular Lesions", which focuses on the research related to Tongxinluo, Ginseng Song and Qiluo Strengthening the Heart, won the first prize of the National Science and Technology Progress Award, and it was also the only first prize of the National Science and Technology Progress Award in the field of medicine and health in mainland China that year. In December 2023, at the 6th Qihuang Forum hosted by the China Association of Traditional Chinese Medicine, the landmark scientific and technological achievements of traditional Chinese medicine in the new era (2012-2022) were released, and the project of "Construction of Chinese Medicine Context Theory to Promote the Prevention and Treatment of Microvascular Lesions" ranked first in the first major category of "the formation of new theories and new disciplines of traditional Chinese medicine".
It is expected that more rigorous and standardized research on traditional Chinese medicine will be carried out in the future, so as to provide strong evidence-based support for the clinical application of traditional Chinese medicine on a global scale, convey the unique voice of Chinese treatment to the world, and demonstrate the unique charm of traditional Chinese medicine treatment.