Coronary heart disease is one of the most common cardiovascular diseases in the clinic, according to the "China Cardiovascular Disease Report 2018", China's current cardiovascular disease patients are about 290 million, of which about 11 million patients with coronary heart disease, cardiovascular disease diagnosis and treatment has become a major public health problem. For the treatment of coronary heart disease, traditional Chinese medicine has played an important role, but it should be noted that there are currently hundreds of proprietary Chinese medicines used for the treatment of coronary heart disease, and how to "reasonably select and standardize the use" of these proprietary Chinese medicines still lacks the normative guidance of the guidelines.
In view of this, the State Administration of Traditional Chinese Medicine has set up a standardization project of "Guidelines for the Clinical Application of Proprietary Chinese Medicines for the Treatment of Dominant Diseases", which is undertaken by the China Association of Chinese Medicines, and the experts and scholars such as Academician Zhang Boli of the Chinese Academy of Engineering and Tianjin University of Traditional Chinese Medicine, and Academician Chen Keji of the Chinese Academy of Sciences and Xiyuan Hospital of the Chinese Academy of Chinese Medical Sciences constitute the standardization project team of the guidelines. The "Guidelines for the Clinical Application of Proprietary Chinese Medicines in the Treatment of Coronary Heart Disease" is led by the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Fuwai Hospital of the Chinese Academy of Medical Sciences and Xiyuan Hospital of the Chinese Academy of Chinese Medical Sciences, and organized the clinical experts of traditional Chinese medicine, clinical experts of Western medicine, experts of guideline research methodology and pharmacy experts to form a guideline writing research group, review working group and consulting expert group (see the end of the article for the list of core experts), and according to the World Health Organization (WHO) guidelines, the "Guidelines for the Clinical Application of Proprietary Chinese Medicines in the Treatment of Coronary Heart Disease (2020 Edition)" was formulated in accordance with the Guidelines of the World Health Organization (WHO) (hereinafter referred to as the "Guide"). Among them, the aromatic wentong drug musk baoxin pill has won the "strong recommendation" of the guidelines in the treatment of five major clinical problems such as coronary heart disease stability angina, unstable angina, acute myocardial infarction, peri-interventional surgery period, and acute onset of angina.
<h1 class="pgc-h-arrow-right" data-track="6" > with evidence-based evidence as the cornerstone, the Guidelines guide the normative application of musk heart pills in the treatment of coronary heart disease</h1>
On the basis of the combination of "dialectical treatment" and "evidence-based research", the Guidelines follow the principle of "evidence-based first, consensus as a supplement, and experience as a lesson", refer to the best evidence in Chinese and English, sort out and standardize the application of proprietary Chinese medicine in the treatment of coronary heart disease, and have important reference value for guiding Western medical specialists, general practitioners, Traditional Chinese medicine physicians and clinical pharmacists in the treatment of patients with coronary heart disease.
Musk Baoxin Pills has the clinical effect of aromatic warm passage, qi relieving pain, and strengthening the heart, and has a definite effect on the treatment and symptom relief of patients with coronary heart disease who have evidence of stagnant blood stasis (chest and stasis, purple lips, purple or dark red tongue). At present, the specific recommendations and evidence of the Guidelines for musk pills are summarized as follows:
l Stable angina (evidence of stagnant blood stasis): It is recommended to add musk heart pills (1B) to the conventional treatment of Western medicine.
The Guidelines included 21 randomized controlled trials (RCTs) of musk pills, and the results of the relevant meta-analysis showed that the use of musk pills in combination with conventional treatment of Western medicine was better than conventional treatment in Western medicine, and musk pills could reduce the incidence of cardiovascular events, reduce the number of angina attacks, and improve TCM symptoms.
Unstable angina (evidence of stagnant blood stasis): It is recommended to add musk heart pills (1B) to the conventional treatment of Western medicine.
The Guidelines included 43 LACTs of Musk Heart Pills, and the results of the relevant meta-analysis showed that the use of Musk Pills in combination with conventional treatment of Western medicine was superior to conventional treatment in Western medicine, and Musk Pills could reduce the incidence of cardiovascular events, reduce the number of angina attacks, improve ECG efficacy, and shorten the duration of angina.
Acute myocardial infarction (evidence of stagnant blood stasis): It is recommended to add musk heart pills (1B) to the conventional treatment of Western medicine.
The Guidelines included 23 articles on musk heart pills RCT, and the relevant meta-analysis results showed that the use of musk pills in combination with western medicine routine treatment was better than western medicine conventional treatment, and musk heart pills could reduce the incidence of cardiovascular events, shorten the peak pullback time of creatine kinase isoenzyme MB (CK-MB) and reduce the inflammatory factor high-sensitivity C-reactive protein (hs-CRP).
Peri-interventional surgical period (evidence of stagnant blood stasis): It is recommended to add musk heart pills (1C) to the conventional treatment of Western medicine.
The Guidelines included 8 articles of musk heart-saving pills RCT, and the relevant meta-analysis results showed that the use of musk heart pills in combination with western medicine routine treatment was superior to western medicine conventional treatment, and musk heart pills reduced the incidence of cardiovascular events, improved left ventricular ejection fraction (LVEF), lowered myocardial troponin T (cTNT) or myocardial troponin I (cTNI), and reduced inflammatory factor C-reactive protein (CRP) or hs-CRP.
Acute onset of angina: Musk Heart Pills (1C) are recommended.
The "Guidelines" included 7 musk heart pills RCT, the relevant meta-analysis results showed that the use of musk pills alone and nitrates are similar to the efficacy of nitrates, musk pills can quickly alleviate chest pain symptoms, short onset time, improve ECG efficacy.
Based on previous well-researched evidence, the Guidelines give musk pills a "strong recommendation" for the treatment of five clinical problems of coronary heart disease, which means that clinicians should recommend musk pills for almost all patients who meet the symptoms.
<h1 class="pgc-h-arrow-right" data-track="48" > unprecedented, musk baoxin pill MUST research "ten years to grind a sword"</h1>
Traditional Chinese medicine has accumulated a lot of clinical experience in the diagnosis and treatment of coronary heart disease, and in recent years, the emergence of more and more evidence-based evidence has further confirmed the clinical efficacy and safety of traditional Chinese medicine, and this "Guideline" is based on this evidence-based evidence. However, as stated in the limitations of the Guidelines, although the current reference studies are all RCT studies, these RCT studies have many shortcomings in design, development, statistics, etc., and the quality of the studies is generally low.
As one of the representatives of the inheritance and innovation of traditional Chinese medicine in China, Musk Baoxin Pill has always been at the forefront of the modernization and internationalization of traditional Chinese medicine, and has embarked on a solid path of evidence-based development. In 2011, Academician Ge Junbo of Zhongshan Hospital affiliated to Fudan University and Professor Fan Weihu of Huashan Hospital affiliated to Fudan University led a large-scale evidence-based study of musk baoxin pills in line with international norms - THE MUST study. The study, which lasted for ten years, scientifically evaluated the efficacy, safety and incidence of long-term cardiovascular and cerebrovascular events in the treatment of patients with chronic stable coronary heart disease, and the results of the study were published in the Chinese Medical Journal in January 2021, which became a landmark study in the evidence-based journey of traditional Chinese medicine.
Overview of the MUST study
The MUST study was a multicenter, randomized, double-blind, placebo-controlled Phase IV clinical trial, all endpoint events were independently reviewed by the endpoint event review committee led by Academician Chen Keji, covering 22 provinces, municipalities directly under the central government and autonomous regions across the country, with a total of 97 tertiary hospitals participating, including a total of 2673 patients with stable coronary artery disease (CAD), completed 8 follow-up visits, lasted 24 months, and the observation indicators covered the "hard endpoint" major cardiovascular adverse events (MACE) and " The soft endpoint is the Seattle Angina Scale (SAQ), which has been registered for clinical trials in China and the United States.
RESULTS OF THE MUST STUDY
In terms of the main endpoint MACE, the incidence of MACE after 2 years of treatment in the experimental group (musk heart pills combined with standard therapy) and the control group (placebo combined standard therapy) was 1.9% and 2.6%, respectively. Among them, the K-M curve was gradually separated after 18 months, and the incidence of MACE in the experimental group was reduced by 26.9% compared with the control group at 24 months, which suggested the characteristics of the long-term effect of musk heart pills and provided strong support for the long-term treatment of coronary heart disease by musk heart pills. In addition, subgroup analysis showed that the application of musk heart pills to women and BMI < 24 kg/m2 populations significantly reduced the risk of MACE events, confirming that musk heart pills benefited more in women and BMI < 24 kg/m2 populations.
In terms of secondary endpoint SAQ, studies have shown that long-term use of musk pills can significantly improve the stability of angina and the frequency of attacks, and confirmed that musk pills can effectively alleviate patient symptoms and significantly improve the quality of life of patients.
In terms of safety endpoints, studies confirmed that the incidence of liver and kidney function and metabolism-related adverse events related to long-term use of musk pills was comparable to that of the control group, and confirmed that the long-term application of musk pills was safe.
<h1 class="pgc-h-arrow-right" data-track="51" > summary</h1>
As a national treasure, Chinese medicine has played an important role in the diagnosis and treatment of cardiovascular diseases. However, due to the differences in the culture and diagnosis and treatment concepts of traditional Chinese and Western medicine, allowing clinicians to use traditional Chinese medicine in a standardized manner and allowing the world to recognize the value of traditional Chinese medicine has always been the direction of continuous exploration and progress of scholars in the industry, and the formulation of the "Guidelines for the Clinical Application of Proprietary Chinese Medicine in the Treatment of Coronary Heart Disease (2020 Edition)" can be described as "born at the right time and naturally completed". Among them, the musk heart pills that have obtained "strong recommendation" in the treatment of coronary heart disease stability angina, unstable angina, acute myocardial infarction, peri-interventional surgery period, and acute onset of angina will continue the success of MUST research and effectively take the road of modernization and international development of evidence-based development of traditional Chinese medicine.
Professor Li Gongxin
Research group of "Guidelines for the Clinical Application of Proprietary Chinese Medicines in the Treatment of Coronary Heart Disease"
Author:
Professor Mao Jingyuan, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Professor Wu Yongjian, Fuwai Hospital, Chinese Academy of Medical Sciences
Professor Shi Dazhuo, Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Judge:
Academician Zhang Boli of the Chinese Academy of Engineering and Tianjin University of Traditional Chinese Medicine
Academician Chen Keji of Xiyuan Hospital, Chinese Academy of Sciences and China Academy of Chinese Medical Sciences
Academician Gao Runlin of the Chinese Academy of Engineering and Fuwai Hospital of the Chinese Academy of Medical Sciences
Working Group:
Xiaolong Wang (Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine), Wang Xianliang (First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine), Wang Xian (Dongzhimen Hospital of Beijing University of Chinese Medicine), Deng Yue (Affiliated Hospital of Changchun University of Chinese Medicine), Liu Zhongyong (Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine), Liu Hongxu (Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University), An Dongqing (Xinjiang Medical University), Zhu Mingjun (First Affiliated Hospital of Henan University of Chinese Medicine), Bi Yingfei (First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine), Junhua Zhang (Tianjin University of Traditional Chinese Medicine), Qian Lin (Dongzhimen Hospital of Beijing University of Chinese Medicine), Yazhu Hou (First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine), Haiming Shi (Huashan Hospital Affiliated to Fudan University), Siyuan Hu (First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine), Zhiqiang Zhao (First Affiliated Hospital of Tianjin University of Chinese Medicine), Ruyu Yuan (Second Hospital of Tianjin Medical University), Dai Xiaohua (Affiliated Hospital of Anhui University of Traditional Chinese Medicine)