A Chinese medicine composition for preventing stenosis and occlusion after lower limb endovascular treatment and its preparation method

Abstract

The present invention discloses a traditional Chinese medicine composition for preventing stenosis and occlusion after endovascular treatment of lower limb blood vessels and a preparation method thereof. The traditional Chinese medicine composition comprises the following components in parts by weight: 6-10 parts of raw astragalus, 2-4 parts of cinnamon twig, 2-4 parts of white peony root, 2-4 parts of poria, 0.5-1.5 parts of wine-fermented rhubarb, 1-2 parts of peach kernel, 1-2 parts of sodium sulfate, 0.5-1.5 parts of magnolia bark, 2-4 parts of jujube, 1-2 parts of angelica, 1-2 parts of raw rehmannia root, 0.5-1 part of leech, 2-4 parts of thunbergii bulb, 3-5 parts of salvia miltiorrhiza, 0.5-1 part of horsefly, 1-2 parts of honeysuckle, 1-2 parts of forsythia, 2-4 parts of ginger, 1-2 parts of cyathula, 2-4 parts of roasted liquorice root, and 1-2 parts of barley sprout. The Chinese medicine composition of the present invention can invigorate qi and strengthen the spleen, eliminate dampness and resolve phlegm, remove blood stasis and dredge meridians, and harmonize the Ying and Wei. It can increase the oxygen partial pressure of the feet, improve microcirculation, and improve limb edema, thereby effectively preventing the occurrence of stenosis and occlusion after endovascular treatment of the lower limbs.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine formulas, and in particular to a traditional Chinese medicine composition for preventing stenosis and occlusion after intracavitary treatment of lower limb blood vessels and a preparation method thereof. Background Art

[0002] Lower limb arterial ischemic disease is a common and frequently occurring condition in peripheral vascular medicine, with diabetic lower limb arterial disease and lower limb occlusive arteriosclerosis being the most common. The "Guidelines for the Prevention and Treatment of Diabetic Foot in China (2019 Edition)" indicate that up to 60% of patients with type 2 diabetes suffer from lower limb arterial disease. Studies have shown that intermittent claudication due to limb ischemia occurs in approximately 10% of patients aged 70 and older. Some patients experience rest pain and even undergo amputation or even die. Limb arterial ischemia severely impacts patients' quality of life. Endovascular treatments for lower limb arteries (including lower limb artery balloon angioplasty or stenting, vascular volume reduction surgery, etc.) can significantly improve ischemic symptoms in the short term, but they carry the risk of restenosis and reocclusion. Data show that the restenosis rate of femoropopliteal arteries is as high as 40% to 50% one year after percutaneous transluminal angioplasty, compared to a relatively low restenosis rate of 20% to 40% one year after bare metal stent implantation. A meta-analysis showed that the average incidence of in-stent restenosis was approximately 41.7% six months after stent implantation, significantly impacting clinical efficacy. Drug-coated balloons can delay the occurrence of restenosis and reocclusion to a certain extent, but studies have shown that there is no significant difference in the target lesion revascularization rate between the drug-coated balloon group and the ordinary balloon group 36 months after surgery. At the same time, its efficacy in treating inflammatory lower limb arterial vascular diseases remains to be discussed.

[0003] Therefore, preventing restenosis and reocclusion after lower extremity arterial revascularization surgery has become a key focus of modern medical research. The inventors believe that Traditional Chinese Medicine, based on a holistic approach and using syndrome differentiation and treatment, can significantly improve the quality of life of patients with lower extremity arterial ischemic disease, complementing the shortcomings of Western medicine's lower extremity arterial vascular interventional treatments and achieving both symptomatic and root cause treatment. Summary of the Invention

[0004] In order to solve the above technical problems, the present invention provides a Chinese medicine composition for preventing stenosis and occlusion after intravascular treatment of lower limb blood vessels and a preparation method thereof.

[0005] In a first aspect, the present invention provides a traditional Chinese medicine composition for preventing stenosis and occlusion after intravascular treatment of lower limb blood vessels, which is achieved through the following technical solutions.

[0006] A traditional Chinese medicine composition for preventing stenosis and occlusion after intravascular treatment of lower limbs, comprising the following components in parts by weight: 6-10 parts of raw astragalus, 2-4 parts of cinnamon twig, 2-4 parts of white peony root, 2-4 parts of poria, 0.5-1.5 parts of wine-soaked rhubarb, 1-2 parts of peach kernel, 1-2 parts of sodium sulfate, 0.5-1.5 parts of magnolia bark, 2-4 parts of jujube, 1-2 parts of angelica, 1-2 parts of raw rehmannia, 0.5-1 part of leech, 2-4 parts of thunbergii bulb, 3-5 parts of salvia miltiorrhiza, 0.5-1 part of horsefly, 1-2 parts of honeysuckle, 1-2 parts of forsythia, 2-4 parts of ginger, 1-2 parts of cyathula, 2-4 parts of roasted liquorice, and 1-2 parts of barley sprout.

[0007] Preferably, a traditional Chinese medicine composition for preventing stenosis and occlusion after intravascular treatment of lower limb blood vessels is composed of the following components in parts by weight: 6 parts of raw astragalus, 2 parts of cinnamon twig, 2 parts of white peony root, 2 parts of Poria, 0.5 parts of wine rhubarb, 1 part of peach kernel, 1 part of Glauber's salt, 0.5 parts of Magnolia officinalis, 2 parts of jujube, 1 part of angelica, 1 part of raw rehmannia, 0.5 parts of leech, 2 parts of thunbergia thunbergii, 3 parts of salvia miltiorrhiza, 0.5 parts of horsefly, 1 part of honeysuckle, 1 part of forsythia, 2 parts of ginger, 1 part of Cyathula, 2 parts of roasted licorice, and 1 part of barley sprout.

[0008] The syndromes after endovascular treatment are qi deficiency and dampness stagnation, phlegm and blood stasis blocking the collaterals, and disharmony between the Ying and Wei. The Chinese medicine composition of the present invention uses raw astragalus as the main drug, which can replenish qi and reduce swelling, nourish the spleen and benefit the lungs. It can not only alleviate the symptoms caused by ischemia reperfusion after endovascular treatment, but also replenish the ancestral qi, penetrate the heart and lungs and promote blood circulation. Cinnamon twig can warm the meridians and promote yang, promote blood circulation and regulate the Ying. The combination of the two can replenish qi and promote yang, dispel cold and relieve arthritis. Peony root can disperse blood stasis and dredge the collaterals, nourish the liver and soften the tendons. When used together with cinnamon twig, one dispersing and one astringing, one warming and one cooling, the two complement each other, replenish without astringing the evil, and harmonize yin and yang. Angelica sinensis both nourishes and invigorates blood circulation. Combined with Astragalus membranaceus, it has the effects of replenishing Qi and generating blood. Astragalus membranaceus replenishes Qi and strengthens the exterior, strengthens the Wei and resists pathogens, and promotes blood circulation, thus unblocking the meridians. Angelica sinensis nourishes blood and works together to nourish and invigorate the body. The two herbs, one active and one defensive, work together to replenish Qi and generate blood, strengthen the body's defenses and expel toxins. This improves blood circulation in the lower limbs, promotes the establishment of collateral circulation, and alleviates clinical pain symptoms. Salvia miltiorrhiza invigorates and nourishes blood while also clearing away heat, similar to Siwu Decoction. Rhubarb, peach kernel, leech, and horsefly form Didang Decoction, which activates blood circulation and dispels stasis. Combined with cinnamon twig, Glauber's salt, and roasted licorice root, it forms Taohe Chengqi Decoction, which strengthens the dispersal of stagnant blood in the lower jiao. Magnolia officinalis promotes the descent of Qi and eliminates stagnation, further enhancing the effects of activating blood circulation and unblocking the meridians. Cinnamon twig, combined with white peony root, ginger, jujube, and roasted licorice root, forms Guizhi Decoction, harmonizing the Ying and Wei, warming Yang and unblocking the meridians. Fritillaria thunbergii is added to resolve phlegm and eliminate symptoms. Poria strengthens the spleen and eliminates dampness. Combined with cinnamon twig, peony root, and peach kernel to create Guizhi Fuling Wan, it dissolves blood stasis and promotes new blood, harmonizing qi and blood. Adding raw rehmannia root clears heat, nourishes yin, and promotes fluid production to prevent excessive blood-breaking and blood-stasis removal, while also clearing heat. Honeysuckle and forsythia clear heat and detoxify, opening the internal and external qi channels, allowing pathogens within the meridians to be cleared and transferred to the qi and qi regions for resolution. Rhizoma Cyathulae guides the downward movement of the herbs, dispelling blood stasis and promoting menstruation. Jiao Sanxian protects the spleen and stomach, preventing and treating stomach damage caused by blood circulation. The entire formula works together to invigorate qi and strengthen the spleen, eliminate dampness and resolve phlegm, dispel blood stasis and dredge the meridians, and harmonize the nutrient and defensive systems.

[0009] In a second aspect, the present invention provides a method for preparing a Chinese medicine composition for preventing stenosis and occlusion after intravascular treatment of lower limb blood vessels, which is achieved through the following technical solutions.

[0010] A method for preparing the above-mentioned Chinese medicine composition for preventing stenosis and occlusion after intraluminal treatment of lower limb blood vessels comprises the following steps:

[0011] S1. Weigh the specified amount of leeches and horseflies, grind them into powder or powder, and pass them through a 200-mesh sieve;

[0012] S2. Weigh the specified amount of jujube, cut it, and soak it with the remaining specified amount of raw materials for 30 to 60 minutes, add 3-4 times the amount of water, and boil it twice for 30 minutes each time;

[0013] S3. Take the leech and horsefly powder with the decoction obtained in step S2.

[0014] Optionally, in step S1, a specified amount of leeches and horseflies are directly soaked with other medicines and then boiled.

[0015] This application has the following beneficial effects.

[0016] The Chinese medicine composition of the present invention invigorates qi and strengthens the spleen, eliminates dampness and resolves phlegm, removes blood stasis and dredges the meridians, and harmonizes the Ying and Wei systems. It can increase the partial oxygen pressure in the feet, improve microcirculation, and alleviate limb edema, thereby effectively preventing the occurrence of stenosis and occlusion following endovascular treatment of lower extremity arteries. The Chinese medicine composition of the present invention has a scientific and rational formulation, exhibits excellent therapeutic effects, and can improve the quality of life of patients with lower extremity arterial ischemic disease. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a state diagram of the clinical treatment of Case 1 of the present invention;

[0018] Figure 2 This is a status diagram of the clinical treatment of Case 2 of the present invention. DETAILED DESCRIPTION

[0019] The present invention will be further described below with reference to the accompanying drawings and examples.

[0020] Example

[0021] A method for preparing the above-mentioned Chinese medicine composition for preventing stenosis and occlusion after intraluminal treatment of lower limb blood vessels comprises the following steps:

[0022] S1. Weigh 3g of leech and 3g of horsefly, grind into powder, and pass through a 200-mesh sieve;

[0023] S2. Weigh 15g of cut jujube, add 60g of raw astragalus, 15g of cinnamon twig, 15g of white peony root, 12g of Poria, 3g of wine-brewed rhubarb, 10g of peach kernel, 10g of sodium sulfate, 6g of Magnolia officinalis, 12g of Chinese angelica, 10g of raw rehmannia root, 12g of thunbergia thunbergii, 20g of salvia miltiorrhiza, 10g of honeysuckle, 10g of forsythia, 20g of ginger, 10g of Cyathula, 12g of roasted liquorice root, and 10g of barley sprout. Soak for 30 minutes, then add 4 times the amount of water and boil twice for 30 minutes each.

[0024] S3. Take the leech and horsefly powder with the decoction obtained in step S2.

[0025] Clinical efficacy

[0026] 1 Materials and Methods

[0027] 1.1 Clinical Data

[0028] Eighty-six patients with diabetic foot ulcers who underwent endovascular treatment at the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine between September 2020 and September 2022 were enrolled and randomly divided into two groups: a treatment group (n=43) and a control group (n=2). The age range of the control group patients was 54-75 years, with a mean age of 66.17±6.65 years. The age range of the treatment group patients was 39-75 years, with a mean age of 63.51±8.12 years. There were 31 males and 10 females in the control group; there were 32 males and 9 females in the treatment group. In the control group, 18 patients had a history of smoking, 11 had a history of drinking, accounting for 43.9% and 26.8%, respectively; 29 had a history of hypertension, and 21 had a history of coronary heart disease, accounting for 70.7% and 51.2%, respectively. In the treatment group, 19 had a history of smoking, 14 had a history of drinking, accounting for 46.3% and 34.1%, respectively; 28 had a history of hypertension, and 23 had a history of coronary heart disease, accounting for 68.3% and 56.1%, respectively. The general information of the two groups was analyzed and compared, and no statistically significant differences were found (P>0.05), indicating comparability. All patients were fully informed of the study and voluntarily signed consent forms to receive treatment. The study was reviewed and approved by the ethics committee (2019-021-01).

[0029] 1.2 Diagnostic criteria

[0030] The diagnostic criteria for type 2 diabetes are in accordance with the "Guidelines for the Prevention and Treatment of Type 2 Diabetic Foot in China (2017 Edition)" and include patients with significant limb ischemia. Patients who have not responded effectively to conventional treatment for more than 8 weeks and meet the indications for interventional therapy. The diagnostic criteria for Qi deficiency and phlegm stasis syndrome are established in accordance with the "Guidelines for the Diagnosis and Treatment of Common Diseases and Syndromes in Peripheral Vascular Disease" and the "Guidelines for the Diagnosis and Treatment of Diabetic Foot with Integrated Traditional Chinese Medicine Diseases and Syndromes."

[0031] Diagnostic criteria of TCM syndromes for Qi deficiency and phlegm stasis:

[0032] Main symptoms: Dry, flaky, thin, and cracked skin; thickened, deformed, and slow-growing toenails; hair loss; and muscle atrophy. Postoperative limb swelling, particularly in the ankles, with pain and tenderness. Weakness.

[0033] Secondary symptoms: Numbness and significant pain in the affected limb, especially at night; decreased or absent sensation in the foot skin; localized redness and swelling; intermittent claudication; fatigue; pale complexion; shortness of breath and laziness; pale, swollen tongue with a thin white coating; and a thready pulse.

[0034] 1.3 Inclusion criteria

[0035] ① Those who meet the diagnostic criteria for type 2 diabetic foot and meet Wagner grade 3-4 in the "Guidelines for the Prevention and Treatment of Type 2 Diabetic Foot in China (2019 Edition)", ABI < 0.5, and obvious limb ischemia.

[0036] ② Aged 18-80 years old, diagnosed with Qi deficiency and phlegm stasis according to Traditional Chinese Medicine.

[0037] ③HGB>90g / L, ALB>30g / L, and creatinine within the normal range.

[0038] ③ Those with ABI below 0.5 and who have undergone endovascular treatment of the lower limbs.

[0039] ④ Those who signed the informed consent form, voluntarily participated in this study, had good compliance, and were available for follow-up.

[0040] 1.4 Exclusion criteria

[0041] ① Patients with severe ischemia and infection in diabetic foot who are planning to undergo amputation; or patients with uncontrolled systemic infection.

[0042] ② Accompanied by malignant tumors, severe heart failure, severe lung, liver, and kidney failure.

[0043] ③Pregnant women or women preparing to become pregnant.

[0044] ④ Those who have had cardiovascular or cerebrovascular accidents recently.

[0045] ⑤ Those with mental disorders.

[0046] 2. Intervention plan

[0047] 2.1 Treatment methods

[0048] 2.1.1 Control Group: Routine diabetes and diabetic foot health education, diabetic diet, and foot ulcer care education. Basic medications: Routine control of blood sugar, blood lipids, and blood pressure, along with routine administration of medications for coronary artery dilation and nerve nutrition. Postoperatively, routine antiplatelet and anticoagulation therapy was administered with enteric-coated aspirin tablets (Bayer Healthcare Co., Ltd., National Medicine Approval No. J20130078) 100 mg, frequently, or clopidogrel bisulfate tablets 75 mg (Shenzhen Xinlitai Pharmaceutical Co., Ltd., National Medicine Approval No. H20120035), frequently, in combination with rivaroxaban (Bayer Healthcare Co., Ltd., National Medicine Approval No. J20180075) 2.5 mg, twice daily. Ulcers were treated with conventional dressing changes combining traditional Chinese and Western medicine.

[0049] 2.1.2 Treatment group: Based on the control group, patients were given Fangsai decoction during the perioperative period to invigorate qi and strengthen the spleen, resolve blood and remove blood stasis, resolve phlegm and dredge the meridians, and harmonize the Ying and Wei. The prescription consists of: raw astragalus 60g, cinnamon twig 15g, white peony root 15g, Poria 12g, wine-made rhubarb 3g, peach kernel 10g, sodium sulfate 10g, Magnolia officinalis 6g, Chinese angelica 12g, raw rehmannia glutinosa 10g, leech 3g, thunbergia thunbergii 12g, salvia miltiorrhiza 20g, horsefly 3g, honeysuckle 10g, forsythia suspensa 10g, Cyathula capitata 10g, roasted liquorice root 12g, barley sprout 10g, ginger 20g, jujube 15g (cut), provided by the pharmacy of the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, 200ml / bag, 1 dose / d, 1 bag taken warm in the morning and evening, for 2 weeks.

[0050] 2.2 Efficacy indicators

[0051] The efficacy evaluation criteria were based on the 2019 Chinese Expert Consensus on the Integrated Traditional Chinese and Western Medicine for the Prevention and Treatment of Diabetic Foot. Transcutaneous oxygen pressure and limb swelling were the primary efficacy indicators, with lower limb sensation and skin temperature as secondary efficacy indicators.

[0052] Limb swelling score: None, 0 points; below the ankle: 3 points; below the knee: 6 points; below the thigh: 9 points. Skin color: Normal, 1 point; Redness and swelling: 2 points; Dark redness: 3 points; Dark purple or gangrenous: 4 points. Skin temperature: Normal, 1 point; High: 2 points; Low: 3 points. Sensation: None, 1 point; Numbness / burning: 2 points; Burning / dressing change pain: 3 points; Nighttime resting pain: 4 points.

[0053] The efficacy was evaluated using the nimodipine method: cured: symptom score decreased by ≥90%, and clinical symptoms and signs disappeared or basically disappeared; markedly effective: symptom score decreased by ≥70% (90% > 90%), and clinical symptoms and signs were significantly improved; effective: symptom score decreased by ≥30% (70% > 70%), and clinical symptoms and signs were improved; ineffective: symptom score decreased by <30%, and clinical symptoms and signs did not change significantly.

[0054] 2.3 Comparison of Serum Inflammatory Factors: 4 mL of fasting venous blood was collected from both groups before and 2 weeks after treatment. The supernatant was centrifuged and placed in a refrigerator for analysis. Enzyme-linked immunosorbent assay (ELISA) was used to measure levels of inflammatory factors including IL-6, CRP, and TNF-α, following strict adherence to the kit instructions.

[0055] 2.4 Statistical methods

[0056] Statistical Analysis: Efficacy and safety were evaluated after treatment. SPSS 22.0 statistical software was used for analysis. Enumeration data were expressed as percentages (%) and subjected to chi-square tests. Measurement data were expressed as mean ± standard deviation and subjected to T tests, with an α = 0.05 level of significance.

[0057] 2.5 Security

[0058] Monitor the patient's vital signs (temperature, heart rate, respiration, blood pressure), blood routine, urine routine, liver function, kidney function, electrocardiogram, etc.

[0059] 3. Results:

[0060] 3.1 Comparison of transcutaneous oxygen partial pressure between the two groups

[0061] Preoperatively, the transcutaneous oxygen pressure in the control group was 18.78±4.74 mmHg, while that in the treatment group was 18.25±3.95 mmHg. There was no statistically significant difference between the two groups (P>0.05). Two weeks after surgery, the transcutaneous oxygen pressure in the control group was 32.17±4.39 mmHg, while that in the treatment group was 38.55±5.72 mmHg. There was a statistically significant difference between the two groups compared with the preoperative levels, and there was also a statistically significant difference between the two groups (P<0.05). This suggests that Fangsai decoction can increase the oxygen pressure in the foot and improve microcirculation.

[0062] Table 1. Comparison of transcutaneous oxygen partial pressure between the two groups (Mean±SD, mmHg)

[0063]

[0064] Note: Compared with preoperative period, *P<0.05; compared with control group, ▲ P<0.05

[0065] 3.2 Comparison of limb edema between the two groups

[0066] Preoperatively, the edema score in the control group was 3.23±1.14, while that in the treatment group was 3.54±3.95. There was no statistically significant difference between the two groups (P>0.05). Two weeks after surgery, the edema score in the control group was 1.17±0.44, while that in the treatment group was 0.55±0.12. There was a statistically significant difference between the two groups compared with the preoperative scores, and there was also a statistically significant difference between the two groups (P<0.05). This suggests that Fangsai decoction can improve limb edema.

[0067] Table 2. Comparison of edema between the two groups (Mean ± SD)

[0068]

[0069]

[0070] Note: Compared with preoperative period, *P<0.05; compared with control group, ▲ P<0.05

[0071] 3.3 Symptom score

[0072] Comparison of individual foot symptom scores between the two groups showed improvement after treatment. Effectiveness rates for skin color were 69.6% in the control group and 92.0% in the treatment group; skin temperature was 63.0% in the control group and 92.3% in the treatment group; and sensation was 68.4% in the control group and 75.0% in the treatment group. The effectiveness rates for each individual symptom were significantly higher in the treatment group than in the control group, indicating that Western medicine combined with Fangsai Decoction was superior to Western medicine alone. There were statistically significant differences in skin color and temperature before and after treatment (P < 0.05), but no significant difference in sensation improvement was observed (see Table 2).

[0073] Table 3 Comparison of single symptom scores between the two groups (cases)

[0074]

[0075] Note: Compared with the control group, ▲ P<0.05

[0076] 3.4 Comparison of clinical efficacy between the two groups of patients after treatment

[0077] Comparing the treatment effects of the two groups, the effective rate of the treatment group was higher than that of the control group, and the difference was significant (P=0.006, P<0.05), indicating that Western medicine combined with Fangsai Decoction is better than Western medicine alone, see Table 5.

[0078] Table 5 Comparison of clinical efficacy between the two groups before and after treatment

[0079]

[0080] Note: The rank sum test was used for comparison, and the difference was statistically significant when P < 0.05.

[0081] 3.5 Comparison of IL-6, TNF-α, and CRP levels between the two groups before and after treatment

[0082] The expression levels of inflammatory factors such as IL-6, TNF-α, and CRP showed a downward trend in both groups before and after treatment. Blood supply is a key factor in controlling infection and the expression of inflammatory factors. This study showed that the expression levels of IL-6, TNF-α, and CRP in the control and treatment groups after treatment were statistically significant compared with those before treatment (P < 0.05). The expression levels of inflammatory factors in the treatment group were significantly lower after treatment compared with those in the control group (P < 0.05). See Table 6.

[0083] Table 6. Comparison of IL-6, TNF-α, and CRP expression levels before and after treatment between the two groups (Mean ± SD)

[0084]

[0085] Note: Compared with the control group, ▲ P<0.05, ▲▲ P<0.01

[0086] 4. Typical clinical cases

[0087] Case 1: A 73-year-old man with a history of diabetes for over 20 years and hyperlipidemia and hypertension for 15 years. Five years prior, he underwent multiple superficial femoral artery stenting and anterior tibial artery balloon angioplasty for diabetic foot gangrene, followed by a right hemi-foot amputation. The wound healed after surgery. Two years prior, he underwent lower limb balloon angioplasty for a left foot ulcer, which healed after two months of combined Chinese and Western medicine treatment. After wound healing, the patient's lower extremities remained cold and numb, with no sweating and aversion to cold. His calf hair was sparse, and his foot and calf muscles were significantly atrophied. He was weak after activity, but his appetite and sleep were good, his bowel movements were normal, and his urination was regular. His tongue was dark, with a thick, greasy coating, and a thready, stringy pulse.

[0088] Syndrome type: Qi deficiency and dampness stagnation, phlegm and blood stasis blocking the meridians, disharmony between Ying and Wei

[0089] Treatment method: replenishing Qi and strengthening the spleen, resolving phlegm and removing blood stasis, and harmonizing Ying and Wei

[0090] Prescription: Example 1 prescription addition and subtraction

[0091] Take Chinese medicine orally intermittently for 3 to 4 months every year.

[0092] Over the past two years, the coldness and numbness of the lower limbs have been alleviated, and the symptoms have improved. Ultrasound showed that there was no obvious stenosis of the superficial femoral artery and no occlusion of the infrapopliteal artery (see Figure 1 ).

[0093] Case 2: A 63-year-old man had a history of diabetes for over 20 years, hyperlipidemia and hypertension for 10 years, and a smoking history of over 40 years. One year ago, he had undergone multiple superficial femoral artery stent implants and peroneal artery balloon angioplasty for diabetic foot gangrene, followed by a right anterior hemi-foot amputation. The wound ruptured again when it was close to healing. Considering reocclusion after endovascular treatment, he underwent another below-the-knee peroneal artery balloon angioplasty. The coldness and numbness of the left calf improved, he had no sweating and was afraid of cold. The hair on his calf was sparse, and the muscles of his foot and calf were atrophied compared to before. He was weak after activity, but his appetite and sleep were good, his bowel movements were normal, and his urination was normal. His tongue was dark, with a white coating, and his pulse was deep, thready, and weak.

[0094] Syndrome type: Qi deficiency and dampness stagnation, phlegm and blood stasis blocking the meridians, disharmony between Ying and Wei

[0095] Treatment method: replenishing Qi and strengthening the spleen, resolving phlegm and removing blood stasis, and harmonizing Ying and Wei

[0096] Prescription: Example 1 prescription addition and subtraction

[0097] Take Chinese medicine orally intermittently for 3 to 4 months.

[0098] Figure 2 Patient A suffered from diabetic foot gangrene. After amputation of the anterior hemifoot, the wound remained unhealed. He underwent balloon angioplasty of the superficial femoral artery and anterior tibial artery in his left lower limb. The anterior tibial artery was unobstructed after the procedure. He received routine medical interventions for basic medical conditions, including hypoglycemic, antihypertensive, and lipid-lowering measures, as well as routine surgical dressing changes and oral administration of traditional Chinese medicine. Figure 2 B is the patient who underwent endovascular treatment and debridement, including debridement of necrotic tissue and damaged bone; Figure 2 C: The patient's wound surface gradually heals; Figure 2 D is the patient's wound healed. After one year of follow-up, the wound healed well, the coldness and numbness of the lower limbs were relieved, and the symptoms improved. Ultrasound showed that the anterior tibial artery of the lower limb was mildly narrowed but not occluded, the foot temperature was normal, and there was no recurrence.

Claims

1. A Chinese medicine composition for preventing stenosis and occlusion after intravascular treatment of lower limb blood vessels, characterized in that: The invention is composed of the following components in parts by weight: 6-10 parts of raw astragalus, 2-4 parts of cinnamon twig, 2-4 parts of white peony root, 2-4 parts of poria, 0.5-1.5 parts of wine-soaked rhubarb, 1-2 parts of peach kernel, 1-2 parts of sodium sulfate, 0.5-1.5 parts of magnolia bark, 2-4 parts of jujube, 1-2 parts of angelica, 1-2 parts of raw rehmannia, 0.5-1 part of leech, 2-4 parts of thunbergia bulb, 3-5 parts of salvia miltiorrhiza, 0.5-1 part of horsefly, 1-2 parts of honeysuckle, 1-2 parts of forsythia, 2-4 parts of ginger, 1-2 parts of cyathula, 2-4 parts of roasted licorice, and 1-2 parts of barley sprout.

2. A Chinese medicine composition for preventing stenosis and occlusion after endovascular treatment of lower limb blood vessels according to claim 1, characterized in that: The invention is composed of the following components in parts by weight: 6 parts of raw astragalus, 2 parts of cinnamon twig, 2 parts of white peony root, 2 parts of poria, 0.5 parts of wine-soaked rhubarb, 1 part of peach kernel, 1 part of sodium sulfate, 0.5 parts of magnolia bark, 2 parts of jujube, 1 part of angelica, 1 part of raw rehmannia, 0.5 parts of leech, 2 parts of thunbergii bulb, 3 parts of salvia miltiorrhiza, 0.5 parts of horsefly, 1 part of honeysuckle, 1 part of forsythia, 2 parts of ginger, 1 part of cyathula, 3 parts of roasted licorice, and 1 part of barley sprout.

3. A method for preparing the Chinese medicine composition for preventing stenosis and occlusion after intravascular treatment of lower limb blood vessels according to claim 1 or 2, characterized in that: The following steps are involved: S1. Weigh the specified amount of leeches and horseflies, grind them into powder or powder, and pass them through a 200-mesh sieve; S2. Weigh the specified amount of jujube, cut it, and soak it with the remaining specified amount of raw materials for 30 to 60 minutes, add 3-4 times the amount of water, and boil it twice for 30 minutes each time; S3. Take the leech and horsefly powder with the decoction obtained in step S2.

4. The preparation method according to claim 3, wherein: Weigh a specified amount of leeches and horseflies and soak them directly with other medicines, then boil them.

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