Tongluo Drugs for the Clinical Treatment of Cardiovascular Diseases(一)

   "From Shijiazhuang, Changsha, Nanjing, Hangzhou to Changchun, the 4C Conference, founded by the Chinese Medical Association and the Chinese Society of Cardiology (CSC) in 2019, has always adhered to the original aspiration, integrated the collective wisdom of cardiovascular experts across the country, passed on cutting-edge information, discussed difficulties in the practice of cardiovascular disease prevention and treatment, and improved the level of diagnosis and treatment. Improved clinical outcomes and quality of life in cardiovascular patients." On May 12th, at the 5th Chinese Clinical Cardiovascular Congress (4C Meeting), Han Yaling, president of the Congress, member of CSC and academician of the General Hospital of the Northern Theater Command of the Chinese People's Liberation Army, pointed out that new technologies and methods in the field of cardiovascular medicine in China are changing with each passing day and new breakthroughs are being made. With the accumulation of evidence-based medicine evidence in China, The clinical diagnosis of cardiovascular disease is more accurate and the curative effect is more reliable.

                                               Academician Han Yaling

    In recent years, Tongluo intervention has carried out a series of studies in the fields of anti-atherosclerosis (AS), prevention and treatment of acute myocardial infarction (AMI) and made very important research breakthroughs. At this 4C conference, Academician Zhang Yun from Chinese Academy of Engineering and Qilu Hospital of Shandong University reviewed the program design and research results of Tongxinluo CAPITAL, and Professor Yang Yuejin from Fuwei Hospital of Chinese Academy of Medical Sciences made a systematic introduction of a series of basic and clinical studies on the prevention and treatment of AMI myocardial non-reperfusion injury with Tongxinluo Capsule. Tongxinluo Capsule related content has brought a lot of thinking and enlightenment to the clinic, and achieved a major breakthrough of Tongluo intervention in the prevention and treatment of cardiovascular diseases. Here are the highlights of the report.

Academician Zhang Yun: CAPITAL opens a new chapter in TCM research, Tongxinluo provides evidence of anti-atherosclerosis in China

                                                         Academician Zhang Yun

       Accumulation of short step, thousands of miles, Tongxinluo anti-AS evidence-based research for more than 20 years of scientific research

   AS the pathological basis of cardiovascular and cerebrovascular diseases, atherosclerosis (AS) has become the first cause of death worldwide. AS the cornerstone of anti-AS therapy, statins are effective in primary and secondary prevention of atherosclerotic cardiovascular events. However, there is a residual risk of cardiovascular events in a subset of patients at high risk for atherosclerotic cardiovascular disease (ASCVD), even with high-intensity statin therapy. The level of LDL-C decreased by only 6% after doubling the statin dose, and long-term high-dose statin treatment resulted in new diabetes mellitus, myopathy/myolysis, hemorrhagic stroke, liver function impairment and other adverse effects. Therefore, it is imperative to find safe and effective new drugs against AS.

   As early as 1996, Tongxinluo Capsule was approved by the State Food and Drug Administration for the treatment of angina pectoris and ischemic stroke, Zhang Yun said. Previous basic studies have found that Tongxinluo shrinks and stabilizes AS plaques through lipid-lowering, antioxidant and anti-inflammatory effects. In terms of clinical research, Professor Yang Yuejin completed the "Clinical Study on the Prevention and Treatment of Acute Myocardial Infarction without myocardial refluxing after interventional Therapy (ENLEAT test)", which showed that the addition of Tongxinluo capsule on the basis of conventional western medicine treatment significantly reduced the incidence of myocardial refluxing after myocardial infarction and reduced the area of myocardial infarction.

   Academical Zhang Yun emphasized that, in view of the lack of large-scale, multi-center clinical research evidence on the anti-AS effect of Tongxinluo Capsule at that time, a national "randomized, double-blind, placebo-controlled, multi-center clinical study on the application of Tongxinluo in the intervention of carotid artery plaque", referred to AS the CAPITAL study, was launched after the scientific development of the expert group.

   With unique ingenuity and foresight, CAPITAL research has achieved weighty results in accordance with clinical practice

   The primary observational endpoint of the CAPITAL study was the intergroup difference in the annual mean rate of change of carotid intima-media thickness (IMT) at 12 measurement sites in both carotid arteries after 24 months of medication. Secondary end points included maximum carotid plaque size, vascular remodeling index, lipid levels, high-sensitivity C-reactive protein, and the composite end point of the first major cardiovascular event 24 months after treatment.

   The main inclusion criteria of the CAPITAL study was the presence of non-calcified carotid plaque in ultrasound examination, and the underlying diseases and drug administration were not strictly restricted. Academician Zhang Yun introduced that a total of 1212 subjects from 35 clinical centers in 18 provinces were included in the CAPITAL study. All subjects were randomly divided into Tongxinluo group (N=607) and placebo group (N=605). More than 50% of patients in both groups had a history of hypertension at baseline, and about 20% had a history of diabetes. Before enrollment, most patients had received basic Western drug therapy (such as aspirin, statins, ACEI/ ARBs, calcium antagonists, etc.). "At the time of inclusion, patients were not excluded due to lack of treatment space that might have been caused by previous treatment, which was in line with clinical practice and medical ethics." Academician Zhang Yun stressed that the above drugs themselves will have an impact on IMT. Therefore, on the basis of Western medicine treatment, whether Tongxinluo capsule can further intervene in AS plaque changes is one of the major breakthroughs in this study.

endothelial and myocardial cells, to solve the international problem of no reflow

   The results of the study showed that although patients in both groups were receiving basic Western medicine treatment, IMT in the placebo group continued to increase, while that in the Tongxinluo group tended to decrease. At 24 months, the mean annual rate of IMT change in Tongxinluo group and placebo group was -0.00095mm (95%CI: -0.00330 ~ -0.00141) and 0.01312mm (95%CI: 0.01076 ~ 0.01548), respectively, and the difference was -0.01407 (95%CI: -0.01407). -0.01740 ~ -0.01073, P<0.001), there were significant differences.