Traditional Chinese medicine composition for treating chest pain after coronary heart disease blood circulation reconstruction and preparation method, preparation and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating chest pain after coronary heart disease blood circulation reconstruction and a preparation method, a preparation and application thereof. The traditional Chinese medicine composition for treating chest pain after coronary heart disease blood circulation reconstruction is prepared from the following components in parts by weight: 20 to 40 parts of raw radix astragali seu hedysari, 10 to 20 parts of fructus trichosanthis, 5 to 15 parts of bulbus allii macrostemi, 5 to 15 parts of rhizoma chuanxiong, 10 to 20 parts of radix salviae miltiorrhizae, 2 to 6 parts of radix notoginseng powder, 3 to 10 parts of herba rhodiolae, 5 to 13 parts of lignum dalbergiae odoriferae, 5 to 15 parts of flos carthami and 5 to 15 parts of lumbricus. The traditional Chinese medicine composition has the effects of tonifying qi, dispersing blood stasis, promoting qi circulation, relieving pain, activating yang and removing stasis, and is mainly used for treating patients with chest stuffiness and pains caused by heart qi deficiency, blood stasis blocking collaterals, qi stagnation and phlegm stagnation and chest yang deficiency after coronary heart disease blood circulation reconstruction.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating chest pain after coronary heart disease revascularization surgery, and a preparation method, a preparation and an application thereof. Background Art

[0002] Currently, revascularization is the main treatment for coronary heart disease, but the incidence of coronary no reflow, in-stent restenosis (ISR) and other problems remains high, and the incidence of major adverse cardiac events within one year after surgery can reach 12%. Drug-coated balloon (DCB) is an emerging interventional treatment procedure that achieves dilation of diseased blood vessels through balloon expansion and local release of antiproliferative drugs. It is not inferior to stent implantation in improving patient prognosis, and can avoid foreign body implantation and shorten the use of dual antiplatelet therapy. It has become the first treatment choice for more and more patients. However, due to reasons such as vascular wall elastic retraction, the incidence of the composite endpoint (including all-cause death, myocardial infarction, and thrombosis in the target lesion) within three years after DCB treatment of ISR surgery can reach 20.3%. Therefore, the incidence of chest pain after revascularization is more than 50%.

[0003] Traditional Chinese medicine has the characteristics of multi-pathway and multi-target treatment and irreplaceable advantages in preventing and treating coronary heart disease. A systematic review of 27 clinical trials of traditional Chinese medicine for the treatment of coronary heart disease found that the treatment strategy of combining traditional Chinese medicine with Western medicine can reduce the risk of cardiovascular death in patients with myocardial infarction by about 27%, and the improvement rate of chest pain symptoms is more than 90%. The unique holistic and multi-link effects of traditional Chinese medicine can prevent the onset of angina pectoris in coronary heart disease, and embody the characteristics of multi-pathway and multi-target treatment and irreplaceable advantages in improving symptoms and prognosis and improving the quality of life.

[0004] Chinese invention patent publication number CN118477139A discloses the use of a Chinese medicine compound composition in the preparation of a drug for treating chest pain after coronary heart disease stent implantation. The Chinese medicine compound composition comprises, by weight, 9-60 parts of peach kernel, 6-50 parts of safflower, 10-60 parts of gardenia, 15-90 parts of salvia miltiorrhiza, 10-60 parts of cyperus rotundus, 15-90 parts of millettia reticulata, 15-90 parts of angelica sinensis, 8-50 parts of ligusticum chuanxiong, 15-90 parts of red peony root and 15-90 parts of codonopsis pilosula. The main components of the Chinese patent medicine include the above Chinese medicine compound composition. The invention relates to a volatile oil, an alcohol extract, a water extract and a pharmaceutically acceptable excipient of a Chinese medicine compound composition, wherein the volatile oil is the volatile oil extracted from the Chinese medicine compound composition by steam distillation; the alcohol extract is the extract obtained by extracting the volatile oil from the Chinese medicine compound composition by steam distillation and then subjecting the Chinese medicine compound composition to alcohol extraction; the water extract is the extract obtained by extracting the volatile oil from the Chinese medicine compound composition by steam distillation and alcohol extraction and then subjecting the Chinese medicine compound composition to water extraction. However, the composition prepared by the invention has a low efficacy in treating chest pain, and the preparation process is complicated and the cost is high.

[0005] In view of this, there is an urgent need in the art to develop a Chinese medicine composition and a preparation method thereof for treating chest pain after coronary heart disease revascularization surgery, which has a high cure rate, a simple preparation process and low cost. Summary of the invention

[0006] In view of the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating chest pain after coronary heart disease revascularization surgery, and a preparation method, a preparation and application thereof.

[0007] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0008] A traditional Chinese medicine composition for treating chest pain after coronary heart disease revascularization surgery comprises the following components in parts by weight: 20-40 parts of raw astragalus, 10-20 parts of trichosanthes, 5-15 parts of allium macrostemon, 5-15 parts of ligusticum chuanxiong, 10-20 parts of salvia miltiorrhiza, 2-6 parts of notoginseng powder, 3-10 parts of rhodiola rosea, 5-13 parts of dalbergia odorifera, 5-15 parts of safflower and 5-15 parts of earthworm.

[0009] Preferably, the following components are included in parts by weight: 25-35 parts of raw astragalus, 12-18 parts of trichosanthes, 8-12 parts of xiebai, 8-12 parts of chuanxiong, 12-18 parts of salvia miltiorrhiza, 3-5 parts of panax notoginseng powder, 5-7 parts of rhodiola rosea, 7-11 parts of dalbergia odorifera, 8-12 parts of safflower and 8-12 parts of earthworm.

[0010] More preferably, the composition comprises the following components by weight: 30 parts of raw astragalus, 15 parts of trichosanthes, 10 parts of zedoaria, 10 parts of ligusticum chuanxiong, 15 parts of salvia miltiorrhiza, 3 parts of notoginseng powder, 6 parts of rhodiola rosea, 9 parts of dalbergia odorifera, 10 parts of safflower and 10 parts of earthworm.

[0011] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps: decocting each medicinal material with water to obtain the composition.

[0012] The present invention also provides a traditional Chinese medicine preparation for treating chest pain after coronary heart disease revascularization surgery, comprising the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method and pharmaceutically acceptable excipients.

[0013] Preferably, the auxiliary material includes at least one of an emulsifier, a filler, a binder, a disintegrant, a colorant and a solubilizing agent.

[0014] More preferably, the excipient comprises at least one of lactose and aspartame.

[0015] Preferably, the preparation is in the form of pills, powders, powders, tablets, pastes, capsules, granules, oral liquids or decoctions.

[0016] More preferably, the preparation is in the form of pills, capsules, granules or decoction.

[0017] The present invention also provides a use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared by the above-mentioned preparation method or the above-mentioned Chinese medicine preparation in the preparation of a drug for treating chest pain after coronary heart disease revascularization surgery.

[0018] According to its common clinical manifestations, chest pain after revascularization for coronary heart disease can be classified as "chest pain and heart pain", which is a special type of chest pain and heart pain. Due to the trauma of surgery and postoperative restenosis, this type of chest pain usually lasts longer and occurs more frequently. The effect of Western medicine to relieve angina pectoris is not good, and the patient's pain cannot be relieved. It is mostly caused by insufficient heart qi after surgery, fatigue, qi and blood stasis, resulting in heart blood malnutrition, pain due to lack of nourishment; or yin and cold stagnation, or phlegm turbidity, or qi stagnation and blood stasis, etc., resulting in chest yang deficiency, heart meridian obstruction, blood stasis blocking the collaterals, and pain due to obstruction. Clinically, chest tightness, shortness of breath and paroxysmal chest pain are the symptoms. Its basic pathogenesis is deficiency of the root and excess of the superficial, with deficiency and excess mixed. The deficiency is mainly due to deficiency of viscera qi, blood, yin and yang, and the excess is due to qi stagnation, cold stagnation, phlegm turbidity, blood stasis, heat toxicity, and mutual trouble; the key pathogenesis is obstruction of the heart meridian, pain due to obstruction or pain due to lack of nourishment.

[0019] The Chinese medicine composition of the invention is mainly used to treat patients with chest obstruction and heart pain caused by deficiency of heart qi, blood stasis blocking collaterals, qi stagnation and phlegm obstruction and chest yang deficiency after revascularization of coronary heart disease.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] The Chinese medicine composition provided by the invention has the effects of invigorating qi and removing blood stasis, promoting qi flow and relieving pain, and removing phlegm and dispersing nodules.

[0022] The Chinese medicine composition provided by the present invention is mainly used to treat patients with chest pain caused by deficiency of heart qi, blood stasis blocking the collaterals, qi stagnation and phlegm obstruction and chest yang deficiency after coronary heart disease revascularization surgery. The symptoms include fullness and discomfort in the chest, or suffocation, or stabbing pain, or distending pain, or tenderness, or dullness and pain in the left back, frequent sighing, aggravation by fatigue, palpitations and shortness of breath, fatigue, pale and dark tongue or ecchymosis, and weak and thready pulse.

[0023] In the Chinese medicine composition provided by the present invention, Astragalus membranaceus is used to replenish the Qi of the heart and lungs, and to benefit the acquired foundation, and to benefit the five internal organs, and to nourish the spirit and stabilize the soul; Chuanxiong is pungent and fragrant, and is a blood Qi medicine, which can promote blood circulation and remove blood stasis, promote Qi circulation and relieve stagnation, and is good at promoting Qi circulation and activating blood circulation and relieving pain; Panax notoginseng is used to invigorate Qi and relieve blood stasis and relieve pain; the three medicines are used together, and invigorating Qi and activating blood circulation, and promoting Qi circulation and relieving pain are the main medicines. Salvia miltiorrhiza is good at passing, and is good at promoting blood circulation and removing blood stasis; Jiangxiang warms and relieves stagnation; Trichosanthes kirilowii clears heat and removes phlegm, widens the chest and disperses stagnation; Rhodiola rosea invigorates Qi and activates blood circulation, and relieves pain; the above four medicines are ministerial medicines to help Panax notoginseng and Chuanxiong invigorate the heart yang, and remove blood stasis and relieve pain. Safflower and earthworm clear the meridians, promote blood circulation and remove blood stasis, and help Panax notoginseng and Salvia miltiorrhiza to promote blood circulation and remove blood stasis; Xiebai is pungent, dispersing, warming and unblocking, and is good at dispersing the stagnation of yin and cold, and clearing the stagnation of chest yang, and is used together with Trichosanthes kirilowii to promote Qi circulation and remove stagnation and remove phlegm, and invigorate the heart yang. The combination of these medicines can achieve the effects of invigorating Qi and activating blood circulation, promoting Qi flow and relieving pain, and promoting yang and dispersing stagnation. DETAILED DESCRIPTION

[0024] It is worth noting that the raw materials used in the present invention are all common commercially available products.

[0025] Example 1

[0026] A traditional Chinese medicine composition (i.e., Xinshudan) for treating chest pain after coronary heart disease revascularization surgery, composed of the following components: 30g of raw astragalus, 15g of trichosanthes, 10g of allium macrostemon, 10g of ligusticum chuanxiong, 15g of salvia miltiorrhiza, 3g of notoginseng powder, 6g of rhodiola rosea, 9g of dalbergia odorifera, 10g of safflower and 10g of earthworm.

[0027] The preparation method of the above-mentioned Chinese medicine composition into granules is as follows:

[0028] (1) Add water to the medicinal materials except Panax notoginseng powder and decoct them twice, add 10 times the amount of water for the first time and 8 times the amount of water for the second time, decoct for 1 hour each time, combine the extracts, concentrate, and dry the concentrate in a microwave vacuum at 60°C. Then mix it with Panax notoginseng powder, crush it and pass it through a 60-mesh sieve to obtain a dry paste powder extract.

[0029] (2) The dry powder extract obtained in step (1) was mixed with lactose and aspartame in a mass ratio of 100:10:0.8, and passed through an 80-mesh sieve. The sieved material was placed in a three-dimensional motion mixer, which was turned on at a speed of 10 rpm and a mixing time of 5 min.

[0030] (3) The mixed materials are placed in a dry granulator for granulation, and the parameters are set as follows: feed speed 20 rpm / min, tableting speed 40 rpm / min, granulation speed 108 rpm / min, primary sieve plate aperture 5.0 mm, secondary sieve plate aperture 1.0 mm. All particles pass through a 60-mesh sieve, and particles and powders below 60 mesh are returned to the dry granulator for secondary granulation, until particles and powders below 60 mesh account for about 10% of the total particles.

[0031] (4) The sieved granules are packaged into 15 g / bag, and the difference in packaging volume is controlled within ±5%, thereby obtaining Xinshudan granules.

[0032] Example 2

[0033] A traditional Chinese medicine composition (i.e., Xinshudan) for treating chest pain after coronary heart disease revascularization surgery, composed of the following components: 20g of raw astragalus, 10g of trichosanthes, 6g of allium macrostemon, 6g of ligusticum chuanxiong, 10g of salvia miltiorrhiza, 3g of notoginseng powder, 3g of rhodiola rosea, 5g of dalbergia odorifera, 5g of safflower and 6g of earthworm.

[0034] The preparation method of the above-mentioned Chinese medicine composition into granules is the same as that in Example 1.

[0035] Example 3

[0036] A traditional Chinese medicine composition (i.e., Xinshudan) for treating chest pain after coronary heart disease revascularization surgery, composed of the following components: 40g of raw astragalus, 20g of trichosanthes, 15g of allium macrostemon, 15g of ligusticum chuanxiong, 20g of salvia miltiorrhiza, 6g of notoginseng powder, 10g of rhodiola rosea, 15g of dalbergia odorifera, 15g of safflower and 15g of earthworm.

[0037] The preparation method of the above-mentioned Chinese medicine composition into granules is the same as that in Example 1.

[0038] Test Example 1

[0039] The Xinshudan granules prepared in Example 1 were used to conduct a clinical study on the treatment of chest pain after coronary heart disease revascularization surgery.

[0040] 1. Research Methods

[0041] 1.1 Study design: A prospective, randomized controlled clinical study method was adopted.

[0042] 1.2 Research subjects:

[0043] 1.2.1 Western medicine diagnostic criteria

[0044] The diagnostic criteria for coronary heart disease were established based on the "Guidelines for the Diagnosis and Treatment of Chronic Stable Angina" issued by the Chinese Society of Cardiovascular Diseases and the Editorial Committee of the Chinese Journal of Cardiovascular Diseases in 2007. The severity classification of angina pectoris (I-IV) was based on the Canadian Cardiovascular Society (CCS).

[0045] Quantitative standard for grading angina pectoris symptoms: based on the number of angina pectoris occurrences, pain duration, and pain intensity, each is divided into 2 points for mild, 4 points for moderate, and 6 points for severe.

[0046] 1.2.2 Standards for TCM Syndrome Differentiation

[0047] With reference to the Technical Guidelines for Clinical Research on the Treatment of Stable Angina Pectoris in Coronary Heart Disease with Traditional Chinese Medicine and Natural Medicine, the syndrome of Qi deficiency and phlegm and blood stasis was selected as the observation syndrome type.

[0048] Syndrome differentiation criteria for Qi deficiency, blood stasis and phlegm obstruction syndrome: The main symptoms are chest pain, chest fullness and discomfort. Secondary symptoms are palpitations, shortness of breath, fatigue, frequent sighing, and dark purple complexion. Tongue: pale purple with ecchymosis; tongue coating: thin white coating. Pulse: weak and astringent. The main symptoms must be present, and at least two secondary symptoms must be present. Combined with tongue and pulse, a comprehensive analysis of the subject is performed to determine Qi deficiency and blood stasis syndrome as the observation syndrome type.

[0049] Quantitative scoring standard for TCM syndrome: The main symptoms are chest pain and chest tightness, with 2 points for mild, 4 points for moderate, and 6 points for severe. The secondary symptoms are palpitations, shortness of breath, fatigue, and frequent sighing, with 1 point for mild, 2 points for moderate, and 3 points for severe. The description of tongue and pulse is not scored.

[0050] 1.3 Inclusion and Exclusion Criteria

[0051] 1.3.1 Selection criteria (all of the following options must be met)

[0052] (1) Elective percutaneous coronary intervention (PCI) for more than two weeks;

[0053] (2) Meet the diagnostic criteria of chronic stable angina pectoris in Western medicine;

[0054] (3) Meet the TCM syndrome differentiation criteria for qi deficiency and blood stasis;

[0055] (4) Canadian Cardiovascular Society (CCS) angina pectoris grade I-III;

[0056] (5) The number of angina attacks was ≥2 times / week and ≤6 times / day;

[0057] (6) Those who have used beta-blockers in the past should use them regularly for more than 3 months;

[0058] (7) Patients aged between 18 and 70 years;

[0059] (8) The subjects participated voluntarily and signed the informed consent.

[0060] 1.3.2 Exclusion criteria (meet any of the following options)

[0061] (1) Patients with severe heart disease (unstable angina, severe arrhythmia, etc.) or severe cardiopulmonary insufficiency;

[0062] (2) poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after treatment);

[0063] (3) Patients with cardiac pacemakers;

[0064] (4) had severe ST segment depression during level 1 exercise testing in the past;

[0065] (5) Those who are planning to undergo CABG or PCI during the trial;

[0066] (6) Those who have been taking (and are currently taking and cannot stop taking) long-acting nitrate preparations for a long time;

[0067] (7) Patients with severe liver and kidney function damage (ALT, AST or TBIL>2 times the upper limit of normal reference value, or Cr>1.5 times the upper limit of normal reference value), severe primary diseases such as hematopoietic system diseases, and mental illness;

[0068] (8) Any other serious disease or condition such as malignant tumor;

[0069] (9) Pregnant or lactating women or those planning to become pregnant;

[0070] (10) Participated in other clinical research within the past 3 months;

[0071] (11) Patients with allergic constitution or allergic to known ingredients of the study drug.

[0072] 1.4 General Information and Dosage

[0073] 1.4.1 General information: A total of 396 patients with chest pain after PCI of coronary heart disease with qi deficiency and blood stasis, aged between 18 and 70 years old, who met the TCM differentiation criteria of qi deficiency and blood stasis and signed informed consent, were enrolled in the Department of Traditional Chinese Medicine of Fuwai Hospital. A total of 336 patients completed the trial, including 156 in the experimental group and 180 in the control group. There were no significant differences between the two groups in terms of gender, age, vital signs, and conventional western medicine treatment during the follow-up period (P>0.05).

[0074] 1.4.2 Trial drugs and methods of administration

[0075] (1) Both the control group and the experimental group received conventional western medicine treatment (i.e., enteric-coated aspirin tablets 100 mg / day, atorvastatin 20 mg / day, and clopidogrel 75 mg / day). The experimental group additionally took the Xinshudan granules prepared in Example 1, 15 g / time, twice / day.

[0076] (2) Treatment course: The treatment course of this trial is 8 weeks.

[0077] (3) Combined medication: Both groups of subjects took conventional Western medicine with unchanged usage and dosage. They could also use nitroglycerin tablets (0.5 mg / tablet, produced by Beijing Yimin Pharmaceutical Co., Ltd.) as emergency medicine.

[0078] (4) Prohibited medication: During the trial, no Chinese herbal medicines with blood-activating and blood-stasis-removing effects may be taken.

[0079] 1.5 Observation indicators

[0080] 1.5.1 Main efficacy indicators

[0081] Angina symptoms before treatment and 4 and 8 weeks after treatment: the number of angina attacks per week, the duration of each angina attack, and the angina pain intensity score.

[0082] 1.5.2 Secondary efficacy indicators

[0083] The rate of nitroglycerin withdrawal before treatment and 4 and 8 weeks after treatment; TCM syndrome score; Seattle Angina Scale score. Laboratory indicators before treatment and 8 weeks after treatment: blood lipids (TC, LDL-C, HDL-C, TG) and blood coagulation (PT, APTT, TT, FIB).

[0084] The Seattle Angina Scale score was based on the Seattle Angina Survey Scale, and the TCM syndrome score was based on the Guidelines for Clinical Research of New Chinese Medicines. Laboratory indicators before and after 8 weeks of treatment: blood lipids (TC, LDL-C, HDL-C, TG) and blood coagulation (PT, APTT, TT, FIB).

[0085] 1.5.3 Safety indicators

[0086] The incidence of adverse events and vital signs before and after treatment (resting blood pressure, body temperature, respiration, heart rate for 10 minutes); laboratory tests: routine blood tests (RBC, WBC, HGB, PLT), routine urine tests (LEU, ERY, PRO), routine stool tests + occult blood, liver function tests (ALT, AST, ALP, GGT, TBIl) and renal function tests (BUN, Cr), routine 12-lead electrocardiogram (including QTc).

[0087] 1.5.4 Criteria for determining efficacy

[0088] Evaluation criteria for the efficacy of angina pectoris symptoms: According to the angina pectoris symptom scoring method, the efficacy index (n) = (pre-test score - post-test score) / pre-test score × 100%. Among them, marked effect: n ≥ 70%; effective: 30% ≤ n < 70%; ineffective: 0 ≤ n < 30%; aggravation: n < 0.

[0089] The efficacy of nitroglycerin discontinuation and reduction is as follows: (1) Discontinuation: After treatment, there is no need to take nitroglycerin sublingually; (2) Reduction: After treatment, the daily nitroglycerin dosage is reduced by more than 50% compared with that before treatment; (3) No change: After treatment, the daily nitroglycerin dosage is reduced by less than 50% compared with that before treatment or the dosage is increased.

[0090] TCM syndrome efficacy standard: efficacy index (n) = (pre-test score - post-test score) / pre-test score

[0091] ×100%. Among them, markedly effective: n≥70%; effective: 30%≤n<70%; ineffective: 0≤n<30%; aggravated: n<0.

[0092] 1.6 Statistical methods

[0093] SAS 9.2 software was used for statistical analysis and processing. Count data were described by frequency (constituent ratio). The two groups were compared. The qualitative data were analyzed by chi-square test, Fisher's exact test, etc. Wilcoxon rank sum test was used according to CONSORT requirements to calculate the means and standard deviations of the main and secondary efficacy indicators of the experimental group and the control group before and after treatment. The measurement data were expressed as x±s. The comparison between the two groups, the subgroup analysis of different pathological types, and the comparison before and after treatment were in accordance with the normal distribution. The t test was used, and the Wilcoxon rank sum test was used if it did not conform to the normal distribution. P<0.05 was considered statistically significant.

[0094] 2. Research Results

[0095] 2.1 Analysis of the main efficacy of patients in the experimental group and the control group

[0096] The efficacy of the treatment was evaluated by the number of angina attacks, the duration of each angina pain, and the degree of pain at 4 and 8 weeks after treatment. As shown in Table 1, starting from the 4th week, the number of angina attacks and the duration of angina symptoms in the test group were significantly less than those in the control group, that is, as the medication time increased, the number of angina attacks in the test group gradually decreased, the duration of each angina attack gradually shortened, and the degree of pain was significantly alleviated, which was significantly different from the control group (P < 0.0001). As shown in Table 2, the total effective rate of the angina symptom efficacy test group was 90.38%, which was significantly higher than that of the control group (62.22%, P <

[0097] 0.0001).

[0098] Table 1 Comparison of total scores of angina symptoms between the two groups at different time points

[0099] time Control group (N=180) Experimental group (N=156) Before treatment 13.06±3.76 12.29±3.85 4 weeks of treatment 9.84±3.62 7.71±3.28 Before treatment - 4 weeks after treatment <![CDATA[3.58±2.71 * ]]> <![CDATA[5.69±1.91 *a ]]> 8 weeks of treatment 7.76±3.11 4.35±2.37 Before treatment - 8 weeks of treatment <![CDATA[5.01±2.97 * ]]> <![CDATA[8.41±2.42 *a ]]>

[0100] Note: Compared with before treatment within the same group, * Indicates P < 0.0001; compared with the control group, a Indicates P < 0.0001.

[0101] Table 2 Comparison of efficacy of angina pectoris symptoms between the two groups

[0102] Group Number of cases Significant effect efficient invalid Aggravation Total Effectiveness Control group 180 45(25.00％) 67(37.22％) 48(26.67％) 20(11.11％) 62.22％ Experimental Group 156 69(44.23％) 72(46.15％) 11(7.05％) 4(2.57％) <![CDATA[90.38% a ]]>

[0103] Note: Compared with the control group, a Indicates P < 0.0001.

[0104] 2.2 Secondary evaluation indicators

[0105] 2.2.1 Comparison of nitroglycerin usage between the experimental group and the control group

[0106] As shown in Table 3, the amount of nitroglycerin used in the experimental group after medication was significantly lower than that in the control group (P < 0.0001), and the amount of nitroglycerin used gradually decreased with the extension of medication time. The total effective rate of the experimental group was 91.03%, and the total effective rate of the control group was 53.31%, which was statistically significant (P < 0.0001).

[0107] Table 3 Nitroglycerin withdrawal rate before and after treatment and comparison between groups

[0108] Group Number of cases Stopping medication Reduction constant Total stop-and-reduction rate Control group 180 20(11.11％) 76(42.22％) 84(46.67％) 53.31％ Experimental Group 156 39(25.00％) 103(66.03％) 14(8.97％) <![CDATA[91.03% a ]]>

[0109] Note: Compared with the control group,a Indicates P < 0.0001.

[0110] 2.2.2 Analysis of TCM syndrome score data

[0111] Compared with before treatment, the TCM symptoms of both the experimental group and the control group were significantly improved at the 4th and 8th weeks after medication. As shown in Table 4, starting from the 4th week after medication, the improvement of TCM syndrome score in the experimental group was significantly better than that in the control group (P < 0.0001), and the difference was statistically significant. As shown in Table 5, the TCM syndrome efficacy rate of the experimental group was 91.03%, and the effective rate of the control group was 55%, which was statistically significant (P < 0.0001).

[0112] Table 4 Comparison of total scores of TCM symptoms between the two groups

[0113] time Control group (N=180) Experimental group (N=156) Before treatment 12.01±2.86 11.62±3.74 4 weeks of treatment 8.86±3.46 6.79±3.88 Before treatment - 4 weeks after treatment <![CDATA[3.38±3.41 * ]]> <![CDATA[5.69±1.62 *a ]]> 8 weeks of treatment 7.19±3.31 3.76±2.46 Before treatment - 8 weeks of treatment <![CDATA[5.01±2.97 * ]]> <![CDATA[7.70±2.10 *a ]]>

[0114] Note: Compared with before treatment within the same group, * Indicates P < 0.0001; compared with the control group, a Indicates P < 0.0001.

[0115] Table 5 Comparison of the efficacy of TCM symptoms between the two groups

[0116] Group Number of cases Significant effect efficient invalid Total Effectiveness Control group 180 30(16.67％) 69(38.33％) 81(45.00％) 55.00％ Experimental Group 156 81(51.92％) 61(39.11％) 14(8.97％) <![CDATA[91.03% a ]]>

[0117] Note: Compared with the control group, a Indicates P < 0.0001.

[0118] 2.2.3 Analysis of blood lipids and blood coagulation

[0119] There was no significant difference in blood lipid (TC, LDL-C, HDL-C, TG) and blood coagulation (PT, APTT, TT, FIB) levels between the two groups before and after treatment.

[0120] 2.3 Security Analysis

[0121] The safety analysis of this study included adverse events, as well as laboratory indicators of the two groups before and after medication, including blood, urine, stool routine, blood coagulation, liver function, kidney function, and electrocardiogram. There was no statistical difference in the incidence of adverse events related to the experiment between the experimental group and the control group, and there was no statistical difference in laboratory indicators such as blood, urine, stool routine between the experimental group and the control group (P>

[0122] 0.05).

[0123] 3. Discussion

[0124] Clinical studies have confirmed that Xinshudan has significant efficacy in treating chest pain after coronary heart disease revascularization, can significantly improve the angina symptoms of patients with chest pain after revascularization, reduce the use of nitroglycerin, and improve the quality of life of patients. After 4 and 8 weeks of treatment, the number of angina attacks and the duration of attacks in the experimental group gradually shortened with the extension of medication time, the pain level was significantly relieved, and the use of nitroglycerin was significantly reduced, which was significantly different from the control group. This shows that Xinshudan has significant efficacy in treating chest pain after coronary heart disease revascularization, and is one of the effective drugs for the clinical prevention and treatment of chest pain after coronary heart disease revascularization. At the same time, the results of this study also show that Xinshudan has no obvious adverse reactions and side effects and has high safety.

[0125] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating chest pain after coronary heart disease revascularization surgery, characterized in that: The invention comprises the following components by weight: 20-40 parts of raw astragalus, 10-20 parts of trichosanthes, 5-15 parts of allium macrostemon, 5-15 parts of ligusticum chuanxiong, 10-20 parts of salvia miltiorrhiza, 2-6 parts of notoginseng powder, 3-10 parts of rhodiola rosea, 5-13 parts of dalbergia odorifera, 5-15 parts of safflower and 5-15 parts of earthworm.

2. The Chinese medicine composition according to claim 1, characterized in that: Calculated by weight, the invention comprises the following components: 25-35 parts of raw astragalus, 12-18 parts of trichosanthes, 8-12 parts of xiebai, 8-12 parts of chuanxiong, 12-18 parts of salvia miltiorrhiza, 3-5 parts of notoginseng powder, 5-7 parts of rhodiola rosea, 7-11 parts of dalbergia odorifera, 8-12 parts of safflower and 8-12 parts of earthworm.

3. The Chinese medicine composition according to claim 2, characterized in that: The invention comprises the following components by weight: 30 parts of raw astragalus, 15 parts of trichosanthes, 10 parts of zedoariae, 10 parts of ligusticum chuanxiong, 15 parts of salvia miltiorrhiza, 3 parts of notoginseng powder, 6 parts of rhodiola rosea, 9 parts of dalbergia odorifera, 10 parts of safflower and 10 parts of earthworm.

4. A method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The method comprises the following steps: decocting various medicinal materials with water to obtain the product.

5. A Chinese medicine preparation for treating chest pain after coronary heart disease revascularization surgery, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to claim 4 and pharmaceutically acceptable excipients.

6. The Chinese medicine preparation according to claim 5, characterized in that: The auxiliary materials include at least one of an emulsifier, a filler, a binder, a disintegrant, a colorant and a solubilizing agent.

7. The Chinese medicine preparation according to claim 6, characterized in that: The auxiliary material includes at least one of lactose and aspartame.

8. The Chinese medicine preparation according to claim 5, characterized in that: The dosage form of the preparation is pill, powder, powder, tablet, paste, capsule, granule, oral liquid or decoction.

9. The Chinese medicine preparation according to claim 8, characterized in that: The preparation is in the form of pills, capsules, granules or decoction.

10. Use of the Chinese medicine composition according to any one of claims 1 to 3, or the Chinese medicine composition prepared by the preparation method according to claim 4, or the Chinese medicine preparation according to any one of claims 5 to 9 in the preparation of a drug for treating chest pain after coronary heart disease revascularization surgery.