A Chinese medicine external application package composition for reducing complications after transradial coronary intervention and its application

Abstract

The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine external application package composition and application for reducing complications after transradial coronary intervention. The composition of the present invention is composed of Lobelia chinensis, honeysuckle, earthworm, Rubescens rubescens, Scrophularia ningpoensis, Chinese angelica, Trillium gracile, Citrus aurantium, and liquorice. The above-mentioned medicines are used together to achieve the effects of clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, and promoting qi and relieving pain. The composition is closely related to the TCM pathogenesis of complications such as arterial occlusion and hand ischemia after transradial coronary intervention, which are caused by toxic invasion of collaterals and blood stasis. The composition can effectively reduce the incidence of arterial occlusion after transradial coronary intervention, alleviate the degree of palm swelling and hand ischemia symptoms after surgery, and reduce the degree of pain in the patient's postoperative wound site.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine external application bag composition and its application, which can reduce the incidence of arterial occlusion after transradial coronary intervention, alleviate postoperative palm swelling and hand ischemia symptoms, and reduce the pain level at the wound site after surgery. Background Art

[0002] Coronary atherosclerotic heart disease (CAD) is one of the most significant threats to human health, and coronary angiography is the gold standard for diagnosing CAD. Coronary angiography is an interventional diagnostic technique that uses imaging to determine the presence of coronary artery lesions, providing a reliable basis for the diagnosis, treatment, and research of CAD. This examination clearly demonstrates the presence, extent, and severity of coronary artery stenosis, making it the gold standard for diagnosing CAD.

[0003] Percutaneous radial artery access is the preferred interventional approach for coronary angiography. Radial artery occlusion is the main complication of percutaneous radial artery access. The guidelines for coronary intervention diagnosis and treatment have recommended the radial artery access as a Class I approach for coronary artery intervention diagnosis and treatment. As the preferred approach for coronary artery diagnosis and treatment, it is widely used in coronary angiography and coronary intervention. Radial artery occlusion is the main complication of percutaneous radial artery access. Although the vast majority of ischemic sites of radial artery occlusion are asymptomatic, it will hinder future ipsilateral transradial artery interventional treatment. It also hinders the choice of coronary artery bypass grafting. Therefore, the prevention of radial artery occlusion is very important in clinical practice and requires high attention.

[0004] Traditional Chinese Medicine (TCM) posits that the fundamental pathogenesis of radial artery occlusion can be summarized as follows: surgical trauma, pathogenic qi invading the collaterals, damaging the collaterals, causing qi and blood to stagnate, and obstructing circulation. This leads to toxic stasis, which in turn causes collateral stagnation. "Clearing heat and detoxifying, promoting blood circulation and removing stasis" are key preventative strategies. Currently, bandages are commonly used to apply pressure to hemostasis wounds, while there are few reports of applying pressure with traditional Chinese medicine external compresses. Furthermore, there are no reports of using traditional Chinese medicine external compresses based on the TCM principle of "detoxification and stasis removal" for percutaneous radial artery puncture, particularly for coronary angiography.

[0005] Modern medicine believes that the pathogenesis of radial artery occlusion may be the result of a combination of thrombosis, local inflammation leading to intimal hyperplasia, and radial artery spasm. One contributing factor to thrombosis is endothelial injury, endothelial dysfunction, and decreased arterial compliance during sheath placement in the radial artery, which accelerates vascular wall remodeling and promotes platelet activation and aggregation. Another contributing factor to thrombosis may be blood flow stagnation distal to the sheath tip, which is further exacerbated by the use of a sheath that exceeds the radial artery lumen diameter. When the sheath / radial artery ratio is greater than 1, radial artery blood flow can decrease by up to 13%, while when the S / A ratio is less than 1, the average decrease is 4%. Intimal hyperplasia of the radial artery is caused by the migration of smooth muscle cells into the endothelium following sheath insertion, which increases in intima-media thickness and may contribute to radial artery occlusion. Therefore, antithrombotic, anti-inflammatory, and spasm prevention strategies are important strategies for preventing postoperative complications. Summary of the Invention

[0006] The present invention provides a traditional Chinese medicine external application package composition for reducing complications after transradial coronary intervention. The composition has the effects of clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, and promoting qi and relieving pain. The composition is intended to reduce the incidence of arterial occlusion after transradial coronary intervention, alleviate postoperative hand ischemia symptoms and palm swelling, and reduce the pain level at the wound site after surgery.

[0007] To this end, the present invention provides a traditional Chinese medicine external compress composition for reducing the incidence of arterial occlusion after transradial coronary intervention, alleviating postoperative hand ischemia symptoms and palm swelling, and reducing the pain level at the patient's postoperative wound site. The composition comprises, by weight: 22-38 parts of Lobelia chinensis, 23-44 parts of Honeysuckle; 13-28 parts of Eupolyphaga sinensis, 9-22 parts of Rabdosia rubescens, 10-21 parts of Scrophularia ningpoensis; 10-19 parts of Chinese Angelica sinensis, 15-26 parts of Trillium gracile; 10-21 parts of Citrus aurantium, and 5-15 parts of Licorice.

[0008] Preferably, the Chinese medicine external application package composition for reducing the incidence of arterial occlusion after transradial coronary intervention, relieving postoperative hand ischemia symptoms and palm swelling, and reducing the pain level at the patient's postoperative wound site is composed of the following components in parts by weight: 30 parts of Lobelia chinensis, 30 parts of Honeysuckle; 20 parts of Eupolyphaga sinensis, 15 parts of Rubescens rubescens, 15 parts of Scrophularia ningpoensis, 20 parts of Angelica sinensis, 20 parts of Psoralea corylifolia, 15 parts of Citrus aurantium, and 10 parts of Licorice.

[0009] The present invention further provides a method for preparing a Chinese medicine external compress composition that reduces the incidence of arterial occlusion after transradial coronary intervention, alleviates postoperative hand ischemia symptoms and palm swelling, and reduces the pain level at the patient's postoperative wound site, including significantly reducing the incidence of arterial occlusion after transradial coronary intervention, and statistical analysis shows that the differences are statistically significant (P<0.05). BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0011] Figure 1 This is a schematic diagram demonstrating the use of the Chinese medicine external application bag after coronary intervention in an embodiment of the present application. DETAILED DESCRIPTION

[0012] Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative work shall fall within the scope of protection of the present invention.

[0013] The raw materials of the Chinese medicine composition include the following raw materials in parts by weight: 30 parts of Lobelia chinensis, 30 parts of honeysuckle, 20 parts of Eupolyphaga sinensis, 15 parts of Rubescens rubescens, 15 parts of Scrophularia ningpoensis, 20 parts of Angelica sinensis, 20 parts of Trillium gracile, 15 parts of Citrus aurantium, and 10 parts of Licorice.

[0014] After the medicine is dried, it is crushed, filtered through a 150-200 mesh sieve, and divided into gauze filter bags (3g / bag) for later use. Before use, heat it in a microwave for 10 seconds.

[0015] After clinical trials, good beneficial technical effects have been achieved. The relevant experimental data are as follows:

[0016] 1. Case Selection

[0017] (1) Source of subjects

[0018] The subjects of this study were 700 patients who underwent coronary angiography at the Traditional Chinese Medicine Hospital of Pidu District, Chengdu.

[0019] (2) Indications for coronary angiography (refer to "Interventional Cardiology (2nd Edition)" published by People's Medical Publishing House in 2012) ① For diagnostic purposes. a. Patients suspected of coronary heart disease but unable to be diagnosed by non-invasive examinations; b. Patients without symptoms but with a significantly positive exercise test, especially those with a positive exercise radionuclide myocardial perfusion scan or accompanied by exercise-induced left ventricular dysfunction; c. Patients resuscitated from primary cardiac arrest; d. Patients with atypical chest pain, non-invasive examinations suggesting or suspected myocardial ischemia, who are difficult to diagnose clinically and have poor treatment effects. ② For guiding the treatment of coronary heart disease. ③ For use before non-coronary heart surgery. a. Valvular disease; b. Congenital heart disease; c. Hypertrophic cardiomyopathy.

[0020] (3) Inclusion criteria

[0021] ① Meet the indications for coronary angiography; ② Agree to undergo coronary angiography via the right radial artery for the first time; ③ Age 18-85 years old; ④ Positive MAT test; ⑤ Sign the informed consent form and voluntarily participate in this study.

[0022] (4) Exclusion criteria

[0023] ① Negative MAT test; ② Use of 6F or larger catheter during surgery; ③ Insufficient coagulation function, severe infection, kidney, brain, or nervous system disease; ④ Recent right upper limb trauma or fracture; ⑤ Puncture is not smooth, and the puncture is repeated 2 or more times; ⑥ The patient has abnormal consciousness and comprehension ability and cannot cooperate.

[0024] (5) Test termination criteria

[0025] ① Severe adverse reactions occur during the study and the subjects are not suitable to continue participating in the study; ② Severe complications or worsening of the condition occur during the study and emergency measures are required; ③ The subjects request to withdraw from the clinical study midway; ④ The patients are uncooperative and refuse to comply with treatment, and repeated explanations by the clinicians are ineffective.

[0026] (6) Removal and shedding standards

[0027] ① Those who did not meet the inclusion criteria and were mistakenly included; ② Those who were not treated according to the prescribed plan; ③ Those who had serious adverse reactions or complications and were not suitable for further treatment and had the trial discontinued; ④ Those who refused to continue participating in the trial due to personal or family reasons; ⑤ Those who were not followed up on time.

[0028] 2. Clinical Trial Design

[0029] (1) Grouping method

[0030] The patients were divided into groups using a random number table: experimental group: Chinese medicine combination hot pack hemostasis group; control group: traditional pressure bandage hemostasis group.

[0031] (1) Surgery and hemostasis methods

[0032] All patients underwent radial artery coronary intervention using the Seldinger technique. An experienced interventionalist was assigned to perform the procedure, using a Terumo 6F radial artery sheath. Sterilization and draping were performed. The radial artery was punctured 1-3 cm proximal to the radial styloid process, where the pulse was most pronounced. After local anesthesia, the needle was inserted at a 30-45° angle. After blood returned, the radial artery was punctured and the posterior vessel wall was penetrated. The inner and outer guidewires were withdrawn until blood returned, and a 0.025" hydrophilic-coated guidewire was introduced. The skin was incised, the needle was withdrawn, and a 6F arterial sheath was inserted. A bolus of heparin sodium 50 U / kg, verapamil 5 mg, and nitroglycerin 100 μg was administered. Postoperatively, different hemostatic methods were administered according to the different treatment groups.

[0033] Control group (traditional pressure bandage hemostasis group): non-blocking blood flow compression hemostasis method (refer to the 2019 "International Consensus on the Best Prevention of Radial Artery Occlusion after Transradial Artery Interventional Diagnosis and Treatment"). After the operation, press to stop bleeding for 5 minutes; fold four layers of sterile gauze into 3 cm long and 1.5 cm wide, covering the intravascular opening at the puncture point; then fold the sterile gauze into a hard square with a length of 3 cm, a width of 1.5 cm, and a height of 1 cm, and place it directly above the sterile gauze; wrap a 5 cm elastic self-adhesive bandage with pressure four times, with a pressure of about -10 mmHg of the radial artery systolic pressure. Loosen one circle after 1 hour, loosen two circles after 2 hours, and loosen the last circle after 4 hours. Wrap it again without pressure and change the dressing on the second day; immobilize the right wrist for 6 hours after the operation.

[0034] Experimental Group (TCM Hemostatic Pack): Patients applied pressure to stop bleeding for 5 minutes after surgery. Sterile gauze was folded into four layers, 3 cm long and 1.5 cm wide, and placed over the puncture site. A 3 cm long, 1.5 cm wide, and 1 cm high TCM Hemostatic Pack was placed directly over the sterile gauze. Four wraps of a 5 cm elastic self-adhesive bandage were applied with pressure, applying a pressure equivalent to approximately -10 mmHg of radial artery systolic pressure. One wrap was loosened every hour, two wraps after two hours, and the final wrap was loosened after four hours. The bandage was then rewound without pressure and changed the next day. The right wrist was immobilized for 6 hours after surgery.

[0035] 3. Observation indicators

[0036] (1) Incidence of radial artery occlusion

[0037] Color Doppler ultrasound was used to assess the patency of the radial artery 48 hours after surgery. If the right radial artery blood flow was absent, it indicated arterial occlusion, and patients with radial artery occlusion were recorded.

[0038] (2) Evaluation of palm swelling

[0039] The degree of palmar swelling was evaluated 24 hours after surgery and classified into mild, moderate, and severe.

[0040] Mild swelling: The recorder's comparative assessment found that the palm of the operated hand was slightly swollen compared to the unaffected side; the patient felt only mild discomfort in the operated hand, which was slightly swollen compared to the unaffected side and was tolerable.

[0041] Moderate swelling: The recorder's comparative assessment found that the palm of the operated side was significantly swollen compared to the healthy side; the patient felt obvious swelling in the palm of the operated side, accompanied by pain and numbness, which was difficult to endure.

[0042] Severe swelling: The recorder's assessment reveals abnormal swelling of the operated palm compared to the unaffected palm. The patient perceives the operated palm as abnormally swollen and painful, with significant numbness in the fingertips, which is unbearable. The degree of palm swelling should be considered, considering both the volume comparison of the two palms and the patient's own perception of the degree of swelling on the operated side. The degree of palm swelling throughout the entire hemostasis process should be assessed after device removal.

[0043] (3) Pain score

[0044] Six hours after surgery, the visual analogue score (VAS) was used. A scale of 0 on the left indicates no pain, while a scale of 10 on the right indicates severe, unbearable pain. Patients rated their arm pain based on their current pain level. No pain was scored as 0, mild pain as 1-3, moderate pain as 4-6, and severe pain as 7-10.

[0045] (4) Modified Allen test to evaluate hand ischemia

[0046] The modified Allen test is used to evaluate hand ischemia after surgery. The patient clenches his hands and raises his arms while the operator compresses the patient's radial and ulnar arteries to block blood flow. After maintaining compression for 30 seconds, the patient maintains the raised hand posture and opens his palm. Under normal circumstances, the patient's palm should still be white at this time. The operator continues to compress the radial artery while releasing the ulnar artery and observing the change in color of the patient's palm. Record the time it takes for the patient's white palm to quickly become red or return to normal color. If the patient's white palm quickly becomes red or returns to normal color within 10 seconds, it means that the modified Allen test is positive, and there is good collateral circulation between the ulnar and radial arteries. If the patient's palm is still white within 10 seconds, it means that the modified Allen test is negative, and the palm collateral circulation is poor.

[0047] 4. Statistical Methods

[0048] SPSS 25.0 software was used to analyze statistical data. Enumeration data were analyzed using the chi-square test, measurement data were expressed as mean (X) ± standard deviation (S), and the t-test was used. Rank data were analyzed using the rank sum test. The statistical significance level was set at α = 0.05. A P > 0.05 indicated no statistical difference between the groups tested, and a P < 0.05 indicated a statistical difference between the groups tested.

[0049] 5. Result Evaluation

[0050] A total of 700 patients were enrolled in this study, with 350 in the control group and 350 in the experimental group. During the study, 21 patients in the experimental group and 27 patients in the control group dropped out and did not complete the final evaluation. The number of valid cases in the two groups was 329 and 323, respectively.

[0051] (1) Incidence of radial artery occlusion

[0052] Table 1. Comparison of the incidence of radial artery occlusion

[0053]

[0054] (2) Palm swelling

[0055] Table 2. Comparison of palm swelling

[0056]

[0057] (3) Comparison of pain levels

[0058] Table 3. Comparison of pain levels

[0059]

[0060] (4) Modified Allen test to evaluate the degree of hand ischemia

[0061] Table 4. Comparison of hand ischemia severity

[0062]

[0063]

[0064] After comparison, the incidence of postoperative radial artery occlusion, palm swelling, pain and hand ischemia in the experimental group (TCM composition hot-an bag hemostasis group) were significantly lower than those in the control group. After statistical analysis, the differences were statistically significant (P<0.05).

[0065] The above is a description of the embodiments of the present invention. Through the above description of the disclosed embodiments, professionals in the field can implement or use the present invention. Various modifications to these embodiments will be obvious to professionals in the field.

[0066] The general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention will not be limited to the embodiments shown herein, but should be accorded the widest scope consistent with the principles and novelties disclosed herein.

Claims

1. A Chinese medicine external application composition for reducing complications after transradial coronary intervention, characterized in that: The invention is composed of the following components in parts by weight: 30 parts of lobelia chinensis, 30 parts of honeysuckle, 20 parts of earthworm, 15 parts of rubescens, 15 parts of Scrophularia ningpoensis, 20 parts of angelica, 20 parts of trillium, 15 parts of green peel and 10 parts of liquorice.

2. A method for preparing the Chinese medicine external application composition for reducing complications after transradial coronary intervention according to claim 1, characterized in that: The preparation method comprises the following steps: drying and crushing lobelia chinensis, honeysuckle, earthworm, rubescens, figwort, angelica, trillium, green peel and liquorice, filtering through a 150-200 mesh sieve, and then packing the powder into gauze filter bags with a capacity of 3 g per bag for standby use, and heating the powder in a microwave oven for 10 seconds before use.

3. Use of the Chinese medicine composition according to claim 1 in the preparation of a medicament for reducing complications after transradial coronary intervention.

Images