CN116808162A - Traditional Chinese medicine composition for preventing and treating ventricular premature contraction due to stagnation of gallbladder and phlegm and application thereof - Google Patents
Traditional Chinese medicine composition for preventing and treating ventricular premature contraction due to stagnation of gallbladder and phlegm and application thereof Download PDFInfo
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Abstract
The application provides a traditional Chinese medicine composition for preventing and treating ventricular premature contraction due to stagnation of gallbladder and phlegm disturbance, which is prepared from the following raw materials in parts by weight: 6-12 parts of bupleurum, 6-12 parts of scutellaria baicalensis, 6-12 parts of immature bitter orange, 6-12 parts of bamboo shavings, 3-7 parts of ginger, 4-8 parts of Chinese date, 10-20 parts of codonopsis pilosula, 4-8 parts of polygala tenuifolia, 6-12 parts of dried orange peel, 6-12 parts of pinellia ternate, 6-12 parts of rhizoma acori graminei, 6-12 parts of cassia twig, 10-20 parts of poria cocos, 20-40 parts of pig iron, 20-40 parts of fossil fragments, 20-40 parts of oyster and 3-7 parts of liquorice. The application also provides application of the traditional Chinese medicine composition. The advantages are that: the Chinese medicinal composition has effects of relieving shaoyang, promoting qi circulation, nourishing middle energizer, regulating qi movement of the triple energizer, regulating qi-flowing, eliminating phlegm, tranquilizing, and stopping palpitation.
Description
Technical Field
The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for preventing and treating ventricular premature contraction due to stagnation of gallbladder and phlegm disturbance and application thereof.
Background
Ventricular extra-systole (Premature Ventricular Contraction, PVC) is one of the common clinical arrhythmias, and can cause symptoms such as palpitation, chest distress, shortness of breath, hypodynamia, dizziness and the like. Its main pathogenesis is premature depolarization of heart muscle originating in the heart chamber due to an automatic enhancement, triggering of activity or reentry. ARIC studies indicate that PVC is present in more than 6% of the population and that the incidence of PVC increases with age. The risk of combining ischemic cardiomyopathy, cardiac insufficiency, sudden cardiac death and total cause death in PVC patients is higher. Neither drug treatment nor surgical treatment achieves ideal effects, and an effective comprehensive treatment strategy is not yet available.
PVC belongs to the category of palpitations in traditional Chinese medicine. It is usually caused by exogenous internal injury, fatigue due to food consumption, and seven emotions. Palpitation is caused by deficiency of essence, deficiency of body, and malnutrition of heart. Heart vessels are blocked by pathogenic factors from the exterior or by phlegm turbidity and blood stasis, and palpitations occur. The traditional Chinese medicine starts from the whole body, and the treatment is based on syndrome differentiation, so that the PVC frequency of patients can be reduced, and the clinical symptoms of the patients can be improved.
The modern Chinese and Western medicine combined journal, 2021, 30 (34), 3814-3817 discloses the application of "ChaiQin WenDan tranquillizing prescription" based on "He Fang Jie" in palpitation disease, and the prescription contains bupleurum root, scutellaria root, rhizoma Pinelliae Preparata, pig iron, ginger, jujube, licorice root, etc. Some of the drugs of the traditional Chinese medicine composition disclosed by the application are the same as the drugs disclosed in the article, and also are different. The article also does not disclose the pharmaceutical composition in full and the amounts are not disclosed.
Chinese patent document CN: 202011210079.2A Chinese medicinal composition for treating ventricular arrhythmia, and its preparation method and application are disclosed, and it comprises the following raw materials (by weight portion): radix Glycyrrhizae Preparata, ramulus Cinnamomi, radix Ophiopogonis, radix rehmanniae, radix Codonopsis, saviae Miltiorrhizae radix, radix scrophulariae, radix Sophorae Flavescentis, bulbus Lilii, cortex Albiziae, magnetitum, fluoritum, radix Dichroae and rhizoma et radix Valerianae. The results prove that the traditional Chinese medicine composition can effectively reduce the frequency of the ventricular arrhythmia attacks in a patient for 24 hours, can relieve symptoms of palpitation and chest distress, can delay disease progression, improves the life quality of the patient, and has no side effect.
Such traditional Chinese medicine compositions for treating premature ventricular contractions have many but more or less disadvantages, such as excessive medicine taste, difficult material acquisition, high price, insignificant medicine effect, poor treatment effect and the like. Therefore, a traditional Chinese medicine composition which has obvious effect of preventing and treating the ventricular premature contraction caused by the stagnation of the gallbladder and the phlegm disturbance, has moderate medicinal taste and is convenient to prepare is needed.
Disclosure of Invention
The application aims at providing a traditional Chinese medicine composition for preventing and treating premature ventricular contractions, aiming at the defects in the prior art.
It is a further object of the present application to provide a use of the above medicament.
In order to achieve the first object, the application adopts the following technical scheme:
a traditional Chinese medicine composition for preventing and treating premature ventricular contractions is prepared from the following raw materials in parts by weight: 6-12 parts of bupleurum, 6-12 parts of scutellaria baicalensis, 6-12 parts of immature bitter orange, 6-12 parts of bamboo shavings, 3-7 parts of ginger, 4-8 parts of Chinese date, 10-20 parts of codonopsis pilosula, 4-8 parts of polygala tenuifolia, 6-12 parts of dried orange peel, 6-12 parts of pinellia ternate, 6-12 parts of rhizoma acori graminei, 6-12 parts of cassia twig, 10-20 parts of poria cocos, 20-40 parts of pig iron, 20-40 parts of fossil fragments, 20-40 parts of oyster and 3-7 parts of liquorice.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8-10 parts of radix bupleuri, 8-10 parts of radix scutellariae, 8-10 parts of immature bitter orange, 8-10 parts of bamboo shavings, 3-7 parts of ginger, 5-7 parts of Chinese date, 13-17 parts of radix codonopsitis, 5-7 parts of polygala tenuifolia, 8-10 parts of dried orange peel, 8-10 parts of pinellia ternate, 8-10 parts of rhizoma acori graminei, 8-10 parts of cassia twig, 13-17 parts of poria cocos, 25-35 parts of pig iron, 25-35 parts of fossil fragments, 25-35 parts of oyster and 3-5 parts of liquorice.
More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9 parts of bupleurum, 9 parts of scutellaria baicalensis, 9 parts of immature bitter orange, 9 parts of bamboo shavings, 3 parts of ginger, 6 parts of jujube, 15 parts of codonopsis pilosula, 6 parts of polygala tenuifolia, 9 parts of dried orange peel, 9 parts of pinellia ternate, 9 parts of rhizoma acori graminei, 9 parts of cassia twig, 15 parts of poria cocos, 30 parts of pig iron, 30 parts of fossil fragments, 30 parts of oyster and 3 parts of liquorice.
Preferably, the traditional Chinese medicine composition is in the form of granules, tablets, capsules, oral liquid, mixture or syrup.
In order to achieve the second purpose, the application adopts the following technical scheme:
the application of the traditional Chinese medicine composition in preparing medicines for preventing and treating premature ventricular contractions.
Preferably, the ventricular extra-systole is a ventricular extra-systole with stagnation of the gallbladder and phlegm.
The application has the advantages that:
1. the traditional Chinese medicine composition achieves the effects of harmonizing shaoyang, pivotally activating qi-flowing, reinforcing middle energizer, mediating triple energizer qi-flowing, regulating qi-flowing, resolving phlegm, soothing nerves and stopping palpitation.
2. Clinical experiments prove that the traditional Chinese medicine composition can obviously reduce the number of times of ventricular premature contraction, improve heart rate variability, improve traditional Chinese medicine symptoms of patients and the like.
Detailed Description
The application is further described below in conjunction with the detailed description. It is to be understood that these examples are illustrative of the present application and are not intended to limit the scope of the present application. Further, it is understood that various changes and modifications of the present application may be made by those skilled in the art after reading the description of the present application, and such equivalents are intended to fall within the scope of the application as defined in the appended claims.
Example 1 Chinese medicinal composition for preventing and treating premature ventricular contraction due to stagnation of gallbladder and phlegm
9 parts of bupleurum, 9 parts of scutellaria baicalensis, 9 parts of immature bitter orange, 9 parts of bamboo shavings, 3 parts of ginger, 6 parts of jujube, 15 parts of codonopsis pilosula, 6 parts of polygala tenuifolia, 9 parts of dried orange peel, 9 parts of pinellia ternate, 9 parts of rhizoma acori graminei, 9 parts of cassia twig, 15 parts of poria cocos, 30 parts of pig iron, 30 parts of fossil fragments, 30 parts of oyster and 3 parts of liquorice.
Example 2 Chinese medicinal composition for preventing and treating premature ventricular contraction due to stagnation of gallbladder and phlegm
8 parts of radix bupleuri, 9 parts of radix scutellariae, 10 parts of immature bitter orange, 6 parts of bamboo shavings, 7 parts of ginger, 6 parts of jujube, 13 parts of radix codonopsis pilosulae, 7 parts of polygala tenuifolia, 6 parts of dried orange peel, 12 parts of pinellia ternate, 9 parts of rhizoma acori graminei, 8 parts of cassia twig, 17 parts of poria cocos, 20 parts of pig iron, 40 parts of fossil fragments, 30 parts of oyster and 3 parts of liquorice.
Example 3 Chinese medicinal composition (III) for preventing and treating premature ventricular contractions due to stagnation of gallbladder and phlegm
8 parts of bupleurum, 10 parts of scutellaria baicalensis, 6 parts of immature bitter orange, 12 parts of bamboo shavings, 3 parts of ginger, 5 parts of jujube, 17 parts of codonopsis pilosula, 4 parts of polygala tenuifolia, 12 parts of dried orange peel, 9 parts of pinellia ternate, 8 parts of rhizoma acori graminei, 10 parts of cassia twig, 10 parts of poria cocos, 40 parts of pig iron, 30 parts of fossil fragments, 25 parts of oyster and 5 parts of liquorice.
Example 4 Chinese medicinal composition for preventing and treating premature ventricular contraction due to stagnation of gallbladder and phlegm
10 parts of bupleurum, 6 parts of scutellaria baicalensis, 12 parts of immature bitter orange, 9 parts of bamboo shavings, 3 parts of ginger, 7 parts of jujube, 10 parts of codonopsis pilosula, 8 parts of polygala tenuifolia, 9 parts of dried orange peel, 8 parts of pinellia ternate, 10 parts of rhizoma acori graminei, 6 parts of cassia twig, 20 parts of poria cocos, 30 parts of pig iron, 25 parts of fossil fragments, 35 parts of oyster and 3 parts of liquorice.
Example 5 Chinese medicinal composition for preventing and treating premature ventricular contraction due to stagnation of gallbladder and phlegm
6 parts of bupleurum, 12 parts of scutellaria baicalensis, 9 parts of immature bitter orange, 8 parts of bamboo shavings, 5 parts of ginger, 4 parts of jujube, 20 parts of codonopsis pilosula, 6 parts of polygala tenuifolia, 8 parts of dried orange peel, 10 parts of pinellia ternate, 6 parts of rhizoma acori graminei, 12 parts of cassia twig, 15 parts of poria cocos, 25 parts of pig iron, 35 parts of fossil fragments, 20 parts of oyster and 7 parts of liquorice.
Example 6 Chinese medicinal composition for preventing and treating premature ventricular contraction due to stagnation of gallbladder and phlegm
12 parts of bupleurum, 9 parts of scutellaria baicalensis, 8 parts of immature bitter orange, 10 parts of bamboo shavings, 3 parts of ginger, 8 parts of jujube, 15 parts of codonopsis pilosula, 5 parts of polygala tenuifolia, 10 parts of dried orange peel, 6 parts of pinellia ternate, 12 parts of rhizoma acori graminei, 9 parts of cassia twig, 13 parts of poria cocos, 35 parts of pig iron, 20 parts of fossil fragments, 40 parts of oyster and 3 parts of liquorice.
Example 7 Chinese medicinal composition for preventing and treating premature ventricular contraction due to stagnation of gallbladder and phlegm
9 parts of bupleurum, 10 parts of scutellaria baicalensis, 6 parts of immature bitter orange, 12 parts of bamboo shavings, 3 parts of ginger, 5 parts of jujube, 17 parts of codonopsis pilosula, 4 parts of polygala tenuifolia, 12 parts of dried orange peel, 9 parts of pinellia ternate, 8 parts of rhizoma acori graminei, 10 parts of cassia twig, 10 parts of poria cocos, 40 parts of pig iron, 30 parts of fossil fragments, 25 parts of oyster and 5 parts of liquorice.
Example 8 Chinese medicinal composition (eight) for preventing and treating premature ventricular contractions due to stagnation of gallbladder and phlegm
8 parts of radix bupleuri, 6 parts of radix scutellariae, 12 parts of immature bitter orange, 9 parts of bamboo shavings, 3 parts of ginger, 7 parts of jujube, 10 parts of radix codonopsis pilosulae, 8 parts of polygala tenuifolia, 9 parts of dried orange peel, 8 parts of pinellia ternate, 10 parts of rhizoma acori graminei, 6 parts of cassia twig, 20 parts of poria cocos, 30 parts of pig iron, 25 parts of fossil fragments, 35 parts of oyster and 3 parts of liquorice.
Example 9 Chinese medicinal composition for preventing and treating premature ventricular contraction due to stagnation of gallbladder and phlegm
10 parts of bupleurum, 12 parts of scutellaria baicalensis, 9 parts of immature bitter orange, 8 parts of bamboo shavings, 5 parts of ginger, 4 parts of jujube, 20 parts of codonopsis pilosula, 6 parts of polygala tenuifolia, 8 parts of dried orange peel, 10 parts of pinellia ternate, 6 parts of rhizoma acori graminei, 12 parts of cassia twig, 15 parts of poria cocos, 25 parts of pig iron, 35 parts of fossil fragments, 20 parts of oyster and 7 parts of liquorice.
Example 10 Chinese medicinal composition for preventing and treating premature ventricular contraction due to stagnation of gallbladder and phlegm
6 parts of bupleurum, 9 parts of scutellaria baicalensis, 8 parts of immature bitter orange, 10 parts of bamboo shavings, 3 parts of ginger, 8 parts of jujube, 15 parts of codonopsis pilosula, 5 parts of polygala tenuifolia, 10 parts of dried orange peel, 6 parts of pinellia ternate, 12 parts of rhizoma acori graminei, 9 parts of cassia twig, 13 parts of poria cocos, 35 parts of pig iron, 20 parts of fossil fragments, 40 parts of oyster and 3 parts of liquorice.
Example 11 Chinese medicinal composition for preventing and treating premature ventricular contraction due to stagnation of gallbladder and phlegm (eleven)
12 parts of bupleurum, 9 parts of scutellaria baicalensis, 10 parts of immature bitter orange, 6 parts of bamboo shavings, 7 parts of ginger, 6 parts of jujube, 13 parts of codonopsis pilosula, 7 parts of polygala tenuifolia, 6 parts of dried orange peel, 12 parts of pinellia ternate, 9 parts of rhizoma acori graminei, 8 parts of cassia twig, 17 parts of poria cocos, 20 parts of pig iron, 40 parts of fossil fragments, 30 parts of oyster and 3 parts of liquorice.
EXAMPLE 12 preparation of pharmaceutical granules for preventing and treating premature ventricular contractions due to stagnation of gallbladder and phlegm
Taking the medicine in any one of the embodiments 1-11, adding 8-10 times of water, decocting for 3 hours, and filtering out the medicine juice. Adding 10 times of water, decocting for 2.5 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 2 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical auxiliary materials, granulating, drying, finishing to obtain 20 parts of granules, and subpackaging to 10 parts per bag.
EXAMPLE 13 preparation of tablets/capsules for preventing and treating premature ventricular contractions due to stagnation of gallbladder and phlegm
Taking the medicine in any one of the embodiments 1-11, adding 9-11 times of water, decocting for 2-3.5 hours, and filtering out the medicine juice. Adding 9 times of water, decocting for 2.5 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule.
EXAMPLE 14 preparation of mixture/oral liquid/syrup for preventing and treating gallbladder stagnation and phlegm disturbance
Taking the medicine in any one of the embodiments 1-11, adding 8-11 times of water, decocting for 3 hours, and filtering out the medicine juice. Adding 8 times of water, decocting for 3 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3.5 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical adjuvants, and making into mixture, oral liquid or syrup
Example 15 clinical trials
1. Patient data
The diagnosis of 86 PVC patients with symptoms of the stagnation of the gallbladder and the phlegm disturbance by combining the Yueyang traditional Chinese medicine and Western medicine affiliated to Shanghai traditional Chinese medicine university with the clinic and hospitalization department in 2020 to 2021, the total study time is 2 months.
2. Standard of
2.1 diagnostic criteria for chinese medicine: reference is made to the "guidelines for clinical study of New Chinese medicine" and the ninth edition "diagnosis of Chinese medicine", published by the national science and technology Press in 2002.
(1) Main symptoms are as follows: palpitation, chest distress and shortness of breath;
(2) Secondary symptoms: insomnia, dizziness, bitter taste, low emotion, irritability, panic, nausea, vomiting and tinnitus;
(3) Tongue pulse: a red tongue with yellow and greasy coating or a slippery and greasy coating, and a deep and thready pulse with a substitution of knots or a wiry and slippery pulse.
Wherein, at least one main symptom is provided, at least three secondary symptoms are provided, and the symptoms can be diagnosed as the symptoms of the stagnation of the gallbladder and the phlegm disturbance by combining tongue pulse of a patient.
2.2 Western diagnostic criteria: reference is made to the guidelines for clinical practice for ventricular arrhythmia patient management and sudden cardiac death, published by the American society of cardiology, united states Cardiology, 2017.
(1) ECG performance:
(1) QRS waves occur in advance, without preceding or correlating P-waves;
(2) QRS morphology is greatly deformed, the time limit is more than 0.12 seconds, and the direction of the T wave is opposite to the main direction of QRS;
(3) often complete decompensation.
(2) The PVC classification standard is referred to the Down classification standard proposed by Bernard Down et al 1971, see Table 1.
TABLE 1 ventricular extra-systole Low grading criteria
2.3 inclusion criteria
(1) Low grade pre-ventricular systole patients at grade 2-4A;
(2) The traditional Chinese medicine is a patient with symptoms of the stagnation of the gallbladder and the phlegm disturbance;
(3) Age is more than or equal to 18 years old and less than or equal to 80 years old;
(4) Understanding, agreeing to participate in the study and signing informed consent.
2.4 exclusion criteria
(1) Severe cardiovascular diseases such as variable angina pectoris, poor hypertension control, hypotension, chronic arrhythmia, etc.;
(2) Heart failure (NYHA class iii-iv, EF < 45%);
(3) Allergy to the drugs used in the study;
(4) Serious primary diseases of various systems;
(5) A person with thyroid dysfunction;
(6) Patients with severe mental disorders;
(7) Pregnant or lactating women.
2.5 criteria for reject and drop
(1) Misdischarge and misreception;
(2) Compliance is poor;
(3) Incomplete medical record data;
(4) Self-exit;
(5) Other researchers considered unsuitable to continue with the present investigator.
2.6 stop criteria
(1) The researcher judges that the laboratory detection value cannot be continuously tested due to adverse events or abnormalities;
(2) The subject voluntarily withdraws from the test;
(3) Violating the regimen (subject not meeting inclusion criteria; not being able to comply with the requirements of the regimen; not being able to comply with the requirements of the medication, etc.);
(4) Other researchers considered it unsuitable to continue taking the drug or considered it difficult to continue the trial.
3. Therapeutic method
(1) Control group: metoprolol succinate sustained release tablet (alsiricon pharmaceutical limited) specification: 47.5mg×7 tablets/cassette; the administration method comprises the following steps: the initial dose of the metoprolol succinate sustained release tablet is generally 23.75mg, and the metoprolol succinate sustained release tablet is orally taken once a day, and the dose is adjusted according to the actual conditions (such as blood pressure, heart rate and the like) of a subject. The treatment course is 1 course of treatment for 4 weeks, and the total treatment course is 2 courses of treatment.
(2) Test group: the traditional Chinese medicine composition (9 g of bupleurum, 9g of scutellaria baicalensis, 9g of immature bitter orange, 9g of bamboo shavings, 3g of ginger, 6g of Chinese date, 15g of codonopsis pilosula, 6g of polygala tenuifolia, 9g of dried orange peel, 9g of pinellia ternate, 9g of grassleaf sweelflag rhizome, 9g of cassia twig, 15g of poria cocos, 30g of pig iron, 30g of dragon bone, 30g of oyster and 3g of liquorice) comprises the following components. The decoction method is as follows: decocting with water 200ml twice daily, and orally taking. The treatment course is 1 course of treatment for 4 weeks, and the total treatment course is 2 courses of treatment.
4. Statistical treatment
The study used SPSS V26.0 for data processing. And adopting t-test when the measurement data accords with normal distribution and variance uniformity. Non-parametric testing is used for metrology data that does not meet normal distribution (or variance skew). The ranking data are described in terms of ranking scores and the group comparisons are tested using the Kruskal-Wallis rank sum test. The difference of P is less than or equal to 0.05, which has statistical significance.
5. Observation index
(1) The main observation indexes are as follows: dynamic electrocardiogram curative effect comparison before treatment (baseline D0) of patients and after 8 weeks of treatment, and integral change of Chinese medicine symptoms;
(2) Safety index: including blood routine, liver function, kidney function, and electrolytes.
6. Standard of
6.1 efficacy evaluation criteria
(1) Holter: the therapeutic effect judging standard refers to the guidelines of clinical research on cardiovascular system medicines.
(1) Clinical cure: the PVC times disappear or are reduced by more than 90 percent or the low classification is improved by 2 grades;
(2) the method is effective: PVC times are reduced by 50% or more or the low classification is improved by 1 level;
(3) invalidation: not reaching an effective level.
6.2 integral evaluation of symptoms in TCM
Referring to the guidelines of clinical research on new traditional Chinese medicines, the total integral is calculated according to the grading and quantifying table of the symptoms of the traditional Chinese medicine, wherein the scores are 0, 1, 2 and 3 according to different degrees.
Clinical cure: clinical symptoms and signs disappear or disappear basically, and the symptom integral is reduced by more than or equal to 95 percent;
(1) the effect is shown: the clinical symptoms and signs are obviously improved, and the symptom integral is reduced by more than or equal to 70 percent compared with the prior symptom integral;
(2) the method is effective: the clinical symptoms and signs are improved, and the symptom integral is reduced by more than or equal to 30 percent compared with the prior symptom integral;
(3) invalidation: no obvious improvement of clinical symptoms and signs, and a reduction of symptom score of <30% compared with the prior symptoms.
Nimodipine method [ (total pre-treatment integral-total post-treatment integral)/total pre-treatment integral ] ×100% was used.
7. Results
7.1 comparison of 24 hour PVC times for two groups of patients
The PVC times of the test group (Z= -5.579, P < 0.05) and the control group (Z= -3.882, P < 0.05) are reduced to a certain extent after 24 hours of treatment compared with those before treatment; the inter-group comparison showed that the number of PVC times was lower for the 24 hour post-treatment test group than for the control group (z= -1.995, p=0.046), see table 2.
Table 2 comparison of PVC times
7.2 Electrocardiogram efficacy comparison of two groups of patients
The test group clinically cures 10 cases, 22 cases with effectiveness and 9 cases with ineffective cases, and the effective rate is 78.05%; the control group clinically cures 4 cases, effectively 18 cases and ineffective 20 cases, and the effective rate is 52.38%. The test group was more efficient than the control group (z=94.472, p < 0.05), see table 3.
TABLE 3 comparative dynamic electrocardiographic efficacy before and after treatment [ n (%) ]
7.3 comparison of heart rate variability (Heart Rate Variability, HRV) of two groups of patients
In-group comparison, the total standard deviation (Standard Diviation of Normal to Normal Intervals, SDNN) of the normal sinus RR interval of the test group after treatment is higher than that before treatment, the difference has statistical significance (P is less than 0.05), and the control group has no statistical difference before and after treatment. Inter-group comparison, post-treatment test group SDNN was higher than control group, and differences were statistically significant (f=2.429, p=0.017), see table 4.
Table 4 comparison of heart rate variability for two groups of patients before and after treatment
7.4 comparison of the integral of symptoms in TCM before and after treatment of two groups of patients
In-group comparison, the integral of symptoms in both groups of traditional Chinese medicine after treatment is reduced (P < 0.001) compared with that before treatment; compared to the group, the post-treatment test group had a lower symptom score than the control group (wald2=5.807, p=0.016).
The symptom score comparison of the traditional Chinese medicine in the two groups of patients at different time points shows that: there was a statistical difference between the different times (wald2=347.384, p < 0.001). The results of the pairwise comparison show that the two time points after treatment have significant statistical differences compared with those before treatment, which suggests that the improvement effect of the traditional Chinese medicine composition provided by the application on the integral of the traditional Chinese medicine symptoms of the patients can be observed from the 4 th week, and the integral of the traditional Chinese medicine symptoms of the patients in the test group is reduced along with the extension of time, and the integral of the traditional Chinese medicine symptoms is shown in Table 5.
Table 5 comparison of the integral of symptoms in TCM before and after treatment in two groups of patients
7.5 comparison of the rate of decrease of the integral of the symptoms of a single symptom in two groups of patients
The two groups of patients were compared in single integral, and the experimental group was lower in palpitation (z= -3.094, p=0.001), chest distress (z= -3.150, p=0.002), insomnia (z= -2.601, p=0.009), bitter taste (z= -1.972, p=0.046), depressed mood (z= -2.652, p=0.010), irritability (z= -2.470, p=0.013), panic (z= -2.270, p=0.024), tinnitus (z= -2.773, p=0.005) than the control group, see table 6.
Table 6 comparison of the rate of decrease in the integral of the symptoms of a single symptom in two groups of patients [ n (%) ]
7.6 comparison of two groups of patient safety indicators
The two sets of safety indicators include blood routine (RBC, HB, WBC, PLT), liver function (ALT, AST), kidney function (Cr), electrolyte (K + 、Na + 、Cl - ) No obvious difference before and after treatment (P)>0.05). The traditional Chinese medicine composition has no abnormal conditions of blood convention, liver function, kidney function and electrolyte before and after treatment, and has no adverse events such as liver injury, kidney injury and the like, and the safety of the traditional Chinese medicine composition is indicated as shown in Table 7.
Table 7 comparison of two patient safety metrics
The foregoing is merely a preferred embodiment of the present application, and it should be noted that modifications and additions may be made to those skilled in the art without departing from the method of the present application, which modifications and additions are also to be considered as within the scope of the present application.
Claims (6)
1. The traditional Chinese medicine composition for preventing and treating premature ventricular contractions is characterized by being prepared from the following raw materials in parts by weight: 6-12 parts of bupleurum, 6-12 parts of scutellaria baicalensis, 6-12 parts of immature bitter orange, 6-12 parts of bamboo shavings, 3-7 parts of ginger, 4-8 parts of Chinese date, 10-20 parts of codonopsis pilosula, 4-8 parts of polygala tenuifolia, 6-12 parts of dried orange peel, 6-12 parts of pinellia ternate, 6-12 parts of rhizoma acori graminei, 6-12 parts of cassia twig, 10-20 parts of poria cocos, 20-40 parts of pig iron, 20-40 parts of fossil fragments, 20-40 parts of oyster and 3-7 parts of liquorice.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 8-10 parts of radix bupleuri, 8-10 parts of radix scutellariae, 8-10 parts of immature bitter orange, 8-10 parts of bamboo shavings, 3-7 parts of ginger, 5-7 parts of Chinese date, 13-17 parts of radix codonopsitis, 5-7 parts of polygala tenuifolia, 8-10 parts of dried orange peel, 8-10 parts of pinellia ternate, 8-10 parts of rhizoma acori graminei, 8-10 parts of cassia twig, 13-17 parts of poria cocos, 25-35 parts of pig iron, 25-35 parts of fossil fragments, 25-35 parts of oyster and 3-5 parts of liquorice.
3. The traditional Chinese medicine composition according to claim 2, which is characterized by being prepared from the following raw materials in parts by weight: 9 parts of bupleurum, 9 parts of scutellaria baicalensis, 9 parts of immature bitter orange, 9 parts of bamboo shavings, 3 parts of ginger, 6 parts of jujube, 15 parts of codonopsis pilosula, 6 parts of polygala tenuifolia, 9 parts of dried orange peel, 9 parts of pinellia ternate, 9 parts of rhizoma acori graminei, 9 parts of cassia twig, 15 parts of poria cocos, 30 parts of pig iron, 30 parts of fossil fragments, 30 parts of oyster and 3 parts of liquorice.
4. A Chinese medicinal composition according to claims 1-3, wherein the dosage form of the Chinese medicinal composition is granule, tablet, capsule, oral liquid, mixture or syrup.
5. Use of a Chinese medicinal composition according to any one of claims 1-3 for the preparation of a medicament for the prevention and treatment of premature ventricular contractions.
6. The use according to claim 5, wherein the extra-ventricular contractions are extra-ventricular contractions due to stagnation of the gallbladder and phlegm.
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