Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)

1. Research Background Coronary microvascular disease (MVD) is a clinical syndrome refers to laboratory evidence of exertional angina or myocardial ischemia caused by structural and/or functional abnormalities of precoronary arterioles and arterioles under the influence of multiple pathogenic factors.. The main symptoms of patients with coronary microvascular disease are exertion-related chest pain attacks. It is difficult to distinguish patients with coronary microvascular disease from patients with severe coronary stenosis based on symptoms alone. However, the following clinical characteristics suggest that patients have coronary microvascular disease. It is more likely. First of all, it is more common in women, accounting for about 56%-79% of patients with coronary microvascular disease. However, most female patients with coronary microvascular disease have their first symptoms after menopause, which is no different from traditional female coronary heart disease patients. Secondly, most of the symptoms are induced by exertion, but it is not uncommon to have patients with silent chest pain. There are fewer patients with coronary microvascular disease who simply present with silent chest pain. Impaired coronary dilatation, increased sympathetic stimulation and sensitivity, and exercise-mediated coronary constriction can lead to the development of coronary microvascular dysfunction and reduced coronary flow reserve. Long-term recurrent angina pectoris attacks affect the patient's quality of life. Patients with significantly reduced coronary blood flow reserve or myocardial perfusion reserve, especially female patients, may have a higher incidence of adverse cardiovascular events.

Regarding drug treatment, traditional anti-ischemic treatment methods are currently recommended, including β- blockers, calcium ion antagonists and nitrates. If symptoms persist, other drugs include angiotensin-converting enzyme inhibitors, statins, ivabradine , ranolazine , and estrogen drugs. However, there is no specific clinical drug treatment. Basic and clinical studies of the traditional Chinese medicine Compound Danshen Dripping Pill have found that it can improve vascular endothelial function and relieve angina pectoris, and is widely used in clinical practice. However, its effect on coronary reserve function and angina pectoris in coronary microvascular disease needs further clinical research to confirm. 2. Study drug The main drug studied in this study is Compound Danshen Dripping Pill. Compound Danshen Dripping Pills (Compound Danshen Dripping Pills, produced by Tasly Holding Group Co., Ltd.) is a compound traditional Chinese medicine preparation composed of Salvia miltiorrhiza, Panax notoginseng, and Borneol. In 1994, it was approved as a drug for the treatment of coronary heart disease and angina pectoris. It has good clinical efficacy and has It has the characteristics of fast onset, low toxicity, small adverse reactions and high safety.

The active ingredients of compound Danshen dripping pills are water-soluble phenolic acids such as salvia miltiorrhiza and Panax notoginseng saponins. During the preparation process, borneol and auxiliary materials are added, and a highly dispersed solid dispersion is made through a specific process. The active ingredients of the drug have high purity, are evenly dispersed, and can be quickly absorbed through the mucous membrane. The dripping pills have good solid dispersion effect. The principle is to melt the drug ingredients and matrix into a solid solution, and the active ingredients of the drug are in the molecular state or in extremely fine form. The crystalline state is highly uniformly dispersed in the matrix, with fast drug dissolution and higher bioavailability. It can be taken sublingually and can quickly relieve angina pectoris and chest tightness.

Compound Danshen Dripping Pill has achieved a full-process quality control method from medicinal materials, intermediates to preparations (GAP-GEP-GMP) through the multi-factor fingerprint quality control system of compound oral Chinese medicine preparations, further improving the full-process quality control system of Compound Danshen Dripping Pill , after testing and analyzing nearly 200 batches of Compound Salvia Miltiorrhizae Dropping Pills Extract and Compound Salvia Miltiorrhizae Dropping Pills, the similarity is over 90%, and the quality of the products is stable between batches. It has been confirmed through the toxicology study of Compound Danshen Dripping Pill and the clinical use of hundreds of millions of people: it has no toxicity, few adverse reactions, and is safe and reliable for long-term use.

As a Chinese patent medicine for the treatment of stable angina pectoris, Compound Danshen Dripping Pill are included in Category A of the 2018 National Essential Drugs Catalog and the 2019 National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue. Under the name of "Compound Danshen Dripping Pill", it has been written into more than 20 national medical guidelines or consensus, 15 of which involve the cardiovascular field, including "Guidelines for Rational Medication in Coronary Heart Disease (2nd Edition)", "Acute Myocardial Medication "Guidelines for the Diagnosis and Treatment of Infarction by Integrated Traditional Chinese and Western Medicine", "Chinese Expert Recommendations on the Clinical Application of Compound Danshen Dripping Pill", "Expert Consensus on the Diagnosis and Treatment of Atherosclerosis by Integrated Traditional Chinese and Western Medicine", etc.