Rong ** reporter Yin Han Doctor Daily
In my 31 years of clinical career, the youngest patient I have treated is in his 20s. ”Professor Xu Qiuxia, Department of Cardiology, The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine"It was a young taxi driver who suddenly fainted while driving and was taken to the hospital by ambulance. After electrocardiogram and related examinations, acute myocardial infarction was confirmed. Fortunately, due to the timely delivery to the hospital, the patient was able to recover from critical condition after emergency percutaneous coronary intervention** (PCI). ”
Professor Xu Qiuxia said that in fact, with the rapid development of China's economy, the lives of the people have undergone tremendous changes - high-salt, high-fat diet, increased work pressure, and reduced ...... exerciseThe accumulation of various unhealthy lifestyles has increased the number of people with hypertension and diabetes, which are the high-risk factors for coronary heart disease, and are also the main reasons for the incidence of acute myocardial infarction to increase year by year, and show a younger trend, which seriously affects the life and health of the Chinese people. Professor Xu Qiuxia emphasized that the prevention and treatment of myocardial infarction is urgent.
Recently,The results of the National Key R&D Program "Research on the Intervention of the Cardiovascular Event Chain with the Guidance System of Context Theory".It was held in Beijing, one of the sub-topics of the study"Myocardial protection study of myocardial infarction in China Tongxinluo**" (CTS-AMI study).Published Oct. 24 in the Journal of the American Medical Association (JAMA) [IF 120.]7] Published a blockbuster, confirming that Tongxinluo can significantly improve the prognosis of patients with acute myocardial infarction. At the meeting, Professor Xu Qiuxia, one of the participants of the CTS-AMI study, was invited by Physician Daily to conduct an interview on the current status of diagnosis and treatment of acute myocardial infarction, her thoughts on the research, and the research results and significance of CTS-AMI.
"For more than 20 years, the series of studies on Tongxinluo has strengthened the determination of the clinical use of traditional Chinese medicine for coronary heart disease".
At present, PCI is one of the most effective means of acute myocardial infarction in clinical practice, which can reduce the complications of myocardial infarction, effectively improve cardiac function, shorten the length of hospitalization, and reduce the disability rate and mortality rate by opening the occluded blood vessels and rebuilding blood vessels. However, patients may still face clinical challenges such as no myocardial reflow and bleeding after surgery. Professor Xu Qiuxia pointed out that after PCI, aspirin and clopidogrel dual antiplatelet ** are also required. At the same time, the patient's blood pressure and heart function also need long-term medication control.
As a treasure of traditional medicine in China, traditional Chinese medicine has unique advantages in the prevention and treatment of cardiovascular diseases. With the development of medical technology and the advancement of pharmaceutical technology in recent years, traditional Chinese medicine plays an increasingly important role in the clinical development of coronary heart disease. However, Professor Xu Qiuxia also admitted that because of the lack of objective clinical evidence, even in the affiliated hospital of the University of Chinese Medicine, cardiologists were once skeptical of coronary heart disease in traditional Chinese medicine. Professor Xu Qiuxia pointed out that, in fact, it is the Tongxinluo series of studies that justify the name of traditional Chinese medicine, from basic research to "enleat" trials to "capital" researchIn the past 20 years, a series of studies have confirmed the good efficacy and safety of Tongxinluo in coronary heart disease**, and strengthened the determination of clinicians to use traditional Chinese medicine to improve the prognosis of patients.
According to Professor Xu Qiuxia, basic research has shown that Tongxinluo Capsule can resist the infiltration of inflammatory cells, protect the integrity of microvascular endothelial cells and microvessels in the reflow area, reduce the expression of myocardial inflammatory factors, and reduce the area of myocardial non-reflow and myocardial infarction.
byProfessor Yang Yuejin of Fuwai Hospital, Chinese Academy of Medical SciencesLed by the development"Evidence-based medical study of myocardial reflow after intervention in the prevention and treatment of acute myocardial infarction with Tongxinluo capsule**" (Enleat trial).It was confirmed that the addition of Tongxinluo Capsule on the basis of conventional Western medicine** can significantly improve myocardial blood perfusion, increase the rate of complete regression of ST segment of 24-hour ECG by 20%, and significantly reduce the incidence of myocardial reflow without reflow366%。At 180 days, compared with the control group, Tongxinluo Capsule could significantly improve myocardial blood perfusion, reduce the size of myocardial infarction, and improve cardiac function. The efficacy and safety of Tongxinluo** myocardial reflow without reflow have been preliminarily demonstrated.
byAcademician Zhang Yun of Qilu Hospital of Shandong UniversityLed by the development"A Multicenter, Randomized, Double-blind, Placebo Parallel-Controlled Study of the Application of Tongxinluo Capsule for the Intervention of Carotid Artery Plaque" (Capital Study).The results showed that Tongxinluo Capsule could delay the progression of carotid intima-media thickness (IMT), plaque area and vascular remodeling, delay the time of first occurrence of major cardiovascular events, and reduce the incidence of major cardiovascular events, especially the incidence of unstable angina.
On the basis of the above series of studies, in order to further evaluate the effectiveness and safety of Tongxinluo, Professor Yang Yuejin led the "China Tongxinluo** Myocardial Protection Study in Acute Myocardial Infarction (CTS-AMI)". A total of 124 STEMI patients from Chinese mainland hospitals with onset within 24 hours were included. All patients were randomized in a 1:1 ratio to Tongxinluo and placebo for 12 months** (loading dose 2.)08g, maintenance dose 104 g, 3 times a day). The primary endpoint of the study was 30-day major adverse cardiovascular and cerebrovascular events (MACCES), including cardiovascular death, myocardial reinfarction, emergency coronary revascularization, and stroke.
In 2018, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, where Professor Xu Qiuxia works, participated in the CTS-AMI study as one of the clinical centers.
Evidence-based research is involved, from skepticism to acceptance, to the "propagandist" of traditional Chinese medicine
The road to evidence-based research on Chinese medicine is full of twists and turns. Professor Xu Qiuxia recalled that in the initial enrollment stage, many patients did not know enough about the clinical research project, and the medical staff needed to patiently explain them one by one. "At that time, a patient learned that he was going to be enrolled in a clinical trial of traditional Chinese medicine, and immediately showed rejection. He said, 'There is no data on this drug yet, so I won't use it as a test for you!'No matter how the medical staff explained, it didn't help. Professor Xu Qiuxia smiled and talked about the fact that she was still a friend of this patient, a patient who had already been enrolled. He said: "After I joined the group, I feel that the effect is quite good, you still listen to the director, and participate in the research first." ”
Under the "testimony of the friend", the patient was suspiciously enrolled in the group (after unblinding, he knew that he was enrolled in the Tongxinluo group). In less than a week after taking the drug, he felt that the symptoms of chest tightness and breathlessness had improved significantly compared with before, and his sleep quality was also better. "The patients were very happy and their attitudes towards participating in the study changed completely. Professor Xu Qiuxia said that after the one-year follow-up, the patient came to the hospital for follow-up and told me that he felt that the effect of Tongxinluo was very good, and he had been eating it after the follow-up.
Professor Xu Qiuxia said that in fact, many patients believe in traditional Chinese medicine deep down, as the quintessence of traditional Chinese medicine, traditional Chinese medicine has been prosperous for thousands of years. When there was no Western medicine, stents, and PCI technology, my ancestors used traditional Chinese medicine to save the lives of countless patients with cardiovascular diseases - and this is the truth I often tell patients. "For patients, the reason is reasonable, and the efficacy is experienced, and compliance is naturally improved. Many enrolled patients recommended Tongxinluo capsules to other patients: "I use this medicine very well, you see I'm alive and kicking now, isn't it?."You eat too!Professor Xu Qiuxia said that from skepticism to gladly acceptance, and then to the "propagandist" of traditional Chinese medicine, in fact, there are many such examples in clinical practice.
Professor Xu Qiuxia pointed out that in addition to the support of previous evidence-based medical evidence,In clinical application, the team led by her also truly felt the significant advantages of Tongxinluo Capsule in improving myocardial perfusion, preventing the formation and redevelopment of heart failure, and improving the rehospitalization rate and mortality rate of patients with myocardial infarction.
Tongxinluo significantly reduced adverse cardiovascular and cerebrovascular events, climbed to the top of JAMA, and went international
Through the joint efforts of 124 clinical centers across the country, on August 12, 2022, the CTS-AMI study ushered in the moment of unblinding.
The results of the study showed that compared to the placebo group, ...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%.In addition, the complication rate of acute myocardial infarction (STEMI) with severe ST-segment elevation at 30 days was lower in the Tongxinluo group than in the placebo group. At one year of follow-up, Tongxinluo could still continuously reduce the risk of adverse cardiovascular and cerebrovascular events by 36%, cardiovascular death by 27%, and again myocardial infarction by 74%. There were no significant differences in the incidence of stroke at 30 days, major bleeding at 30 days and 1 year, all-cause mortality at 1 year, or stent thrombosis within 24 hours at 24 hours, and the incidence of adverse events was generally similar between the two groups. It provides an effective ** drug to improve the long-term prognosis of acute myocardial infarction.
Such a result means that in the ** of acute myocardial infarction, Tongxinluo capsule will undoubtedly have a place. Professor Xu Qiuxia said, "Only evidence-based medical evidence can convince everyone." CTS-AMI research has greatly enhanced the confidence of the academic community in the use of traditional Chinese medicine ** acute myocardial infarction, and more and more Western medical physicians have added Tongxinluo capsule on the basis of STEMI guideline standards to solve the clinical problem of myocardial reflux. The CTS-AMI study not only provides clinicians with a better choice, so that more patients with acute myocardial infarction can benefit, but also provides a new impetus for promoting the integrity and innovation of traditional Chinese medicine, inheritance and development. ”
In November 2022, the CTS-AMI study was featured in the Breakthrough Research Presentation Session of the American Heart Association Annual Meeting (AHA 2022).In October this year, the results of the CTS-AMI study were published in the Journal of the American Medical Association (JAMA), a top international medical journal.
This is a milestone achievement in the process of Chinese medicine going global. Professor Xu Qiuxia pointed out that the lack of evidence from modern evidence-based medical research is a major factor that seriously hinders the introduction of traditional Chinese medicine to the world. The CTS-AMI study meets the highest international standards of evidence-based medicine, and uses internationally recognized evidence-based medicine methods to "explain and explain" the efficacy of traditional Chinese medicine, which enhances the status of traditional Chinese medicine in the international medical community and accumulates experience and sets an example for more evidence-based research in traditional Chinese medicine.
The road is tortuous, but the future is bright. Tongxinluo evidence-based medical research has proved the superior efficacy of Tongxinluo Capsule in coronary heart disease**, and its improvement of international problems such as stabilizing plaques and improving the prognosis of myocardial infarction has enhanced the world's confidence in traditional Chinese medicine. "The CTS-AMI study is the first multicenter, randomized, double-blind, placebo-controlled hard endpoint study to evaluate the efficacy and safety of traditional Chinese medicine, which has created a path of innovation and development for the clinical application of Tongxinluo capsule and the internationalization of traditional Chinese medicine, and provided useful reference for promoting the construction and development of the discipline system of traditional Chinese medicine." ”
It is believed that with the joint efforts of experts in the fields of traditional Chinese medicine and Western medicine in China, the modern and innovative development of traditional Chinese medicine will surely bring more benefits to patients. For the future development of traditional Chinese medicine, Professor Xu Qiuxia said with great expectations.