CN113209218B

CN113209218B - Traditional Chinese medicine composition for treating ventricular premature beat of children and application thereof

Info

Publication number: CN113209218B
Application number: CN202110107297.1A
Authority: CN
Inventors: 姜永红; 肖臻; 赵鹏军; 周冬雪; 陈一柳
Original assignee: Longhua Hospital Affiliated to Shanghai University of TCM
Current assignee: Longhua Hospital Affiliated to Shanghai University of TCM
Priority date: 2021-01-19
Filing date: 2021-01-27
Publication date: 2022-02-25
Anticipated expiration: 2041-01-27
Also published as: CN113209218A

Abstract

The invention discloses a traditional Chinese medicine composition for treating children ventricular premature beat, which is prepared from the following raw material medicines in parts by weight: 3-6 parts of cassia twig, 3-6 parts of honey-fried licorice root, 9-15 parts of dragon bone, 9-15 parts of oyster, 6-9 parts of radix pseudostellariae, 6-9 parts of radix ophiopogonis, 6-9 parts of scutellaria baicalensis, 3-6 parts of schisandra chinensis, 6-12 parts of nardostachyos root and rhizome and 6-15 parts of pericarpium trichosanthis. The Chinese medicinal composition is mixed with pharmaceutically acceptable medicinal adjuvants and made into tablet, pill, granule, powder, unguent, powder, injection, aqua or injection. The traditional Chinese medicine composition has proper compatibility, has the effects of tonifying yin and yang, soothing nerves and stopping palpitation, can be used for treating the ventricular premature beat of children, can effectively reduce the frequency of the ventricular premature beat, and can improve symptoms such as chest distress, palpitation, hypodynamia, sweating, sleep, appetite, defecation and the like. The traditional Chinese medicine composition is prepared from pure traditional Chinese medicines, has no toxic or side effect, and is easily accepted by children patients and family members.

Description

Traditional Chinese medicine composition for treating ventricular premature beat of children and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating ventricular premature beat of children and application thereof.

Background

Ventricular premature beat is a more common arrhythmia disease in pediatrics, and the prevalence rate is about 1% -2%. Modern medicine believes that premature ventricular onset is associated with autonomic nerves of the heart, leading to premature depolarization of the heart muscle with increased sympathetic excitation and vagal tone, resulting in premature beats. Cardiac insufficiency, myocardial damage, long-term smoking and drinking, external stimulation, emotion and the like are common factors causing ventricular premature beat.

The ectopic site autodiscipline increase and the reentry activation of the ventricular premature beat are considered to be the main pathogenesis of the ventricular premature beat of children, and for the children patients who frequently suffer from premature beat and have the conjunctive beat, if the intervention is not carried out, malignant arrhythmia and cardiac organic diseases can be caused, and the health of the children patients is seriously damaged.

In recent years, the incidence of ventricular premature beats has been increasing clinically, and the incidence in children has also been increasing year by year, which may be related to factors such as changes in lifestyle and environment, and physical changes in humans. At present, most of ventricular arrhythmias of children are used in western medicine, the research of treating ventricular premature beats in traditional Chinese medicine is mostly concentrated on adults, and the literature of applying traditional Chinese medicine to children is rarely reported.

At present, modern medicine mainly treats ventricular premature beats of children without obvious organic damage by taking oral antiarrhythmic drugs, wherein the most commonly used first-line antiarrhythmic drugs, such as arrhythmia, are helpful in reducing the number of premature beats and relieving typical clinical symptoms, such as palpitation and chest distress, but gastrointestinal reactions such as nausea, vomiting and constipation and adverse reactions of nervous systems such as dizziness, headache, blurred vision and ataxia may occur after some children patients take the medicine, and related researches prove that the arrhythmia may also generate the effect of promoting arrhythmia. For patients who have no effective antiarrhythmic drug treatment, the western medicine will further use radiofrequency ablation. However, the technical requirements of the treatment are high, the curative effect is unstable, and certain side effects are caused, so that safe and effective antiarrhythmic drugs are urgently needed to be searched, and the treatment has extremely important significance particularly for children.

The traditional Chinese medicine has rich theory and clinical experience in the aspect of treating arrhythmia, particularly has the multi-target multi-channel regulation function, can ensure the long-term curative effect and reduce the occurrence of adverse reactions, and therefore has certain advantages in the aspect of treating ventricular premature beat.

The traditional Chinese medicine considers that the constitution of the children has the characteristic of 'young yin and yang'. Compared with adults, the infant has delicate viscera and inadequate body shape, which means that the infant is more susceptible to the influence of external environment and invasion of exogenous pathogenic factors. With the change of modern living environment and habits and the abuse of antibiotics, more children patients suffer from impairment of vital qi, even if the primordial yang is felled, and symptoms such as mental fatigue, hypodynamia, aversion to cold, cold limbs, inappetence and the like appear. The heart is yang in yang, which governs blood vessels of the whole body, and if heart yang fails, blood circulation is not smooth and the blood flow is not smooth; heart yang deficiency, malnutrition of heart spirit, easy floating and palpitation; chest yang deficiency may lead to chest distress, short breath, asthenia, and sigh. The department of pediatrics of our hospital as the inheritance base of Xushi pediatrics is inspired by the academic thought and experience of "warming yang" in clinical treatment and academic research. We find in long-term clinical observation that the infantile ventricular premature beat is mostly the syndrome of insecurity of heart-yang, so that the treatment idea of 'benefiting yin and strengthening yang' is provided, on one hand, the importance of yang qi on the growth and development of infants is emphasized, and on the other hand, the 'mutual root between yin and yang and the emphasis on compatibility' are required during treatment, so that the infantile pulse restoring decoction is formulated to treat the infantile ventricular premature beat.

Disclosure of Invention

Aiming at the defects of the traditional Chinese medicine in the aspect of treating the ventricular premature beat of the child and the defects in the prior art, the embodiment of the invention aims to provide the traditional Chinese medicine composition for treating the ventricular premature beat of the child, so as to reduce the incidence rate of the ventricular premature beat, effectively improve the clinical symptoms of the child with the ventricular premature beat and improve the life quality.

According to the embodiment, the traditional Chinese medicine composition for treating children ventricular premature beat is prepared from the following raw material medicines in parts by weight: 3-6 parts of cassia twig, 3-6 parts of honey-fried licorice root, 9-15 parts of dragon bone, 9-15 parts of oyster, 6-9 parts of radix pseudostellariae, 6-9 parts of radix ophiopogonis, 6-9 parts of scutellaria baicalensis, 3-6 parts of schisandra chinensis, 6-12 parts of nardostachyos root and rhizome and 6-15 parts of pericarpium trichosanthis.

According to one embodiment, the traditional Chinese medicine composition for treating children ventricular premature beat comprises the following raw material medicines in parts by weight: 3 parts of cassia twig, 3 parts of honey-fried licorice root, 9 parts of dragon bone, 9 parts of oyster, 6 parts of radix pseudostellariae, 6 parts of radix ophiopogonis, 6 parts of scutellaria baicalensis, 3 parts of schisandra chinensis, 6 parts of nardostachyos root and rhizome and 6 parts of pericarpium trichosanthis.

According to one embodiment, in the traditional Chinese medicine composition for treating ventricular premature contraction of children, the traditional Chinese medicine composition is mixed with pharmaceutically acceptable pharmaceutical excipients to be prepared into tablets, pills, granules, powder, paste, powder, injection, aqua or injection.

The preparation method of the traditional Chinese medicine composition is not special, and the 10 medicinal materials are respectively weighed according to the parts by weight by adopting a common method in the field and are decocted in water for taking once in the morning and at night.

Clinical research and application prove that the traditional Chinese medicine composition can effectively reduce the ventricular premature beat frequency, improve the clinical symptoms of children patients and improve the life quality of the children patients, has no toxic or side effect and good safety, and can be used for treating the ventricular premature beat of children.

In the traditional Chinese medicine composition, cassia twig and liquorice are used as monarch drugs to recover the qi of heart yang; mu Li and Long Gu are used to calm the restlessness. Ministerial drugs including radix pseudostellariae, radix ophiopogonis and schisandra chinensis, namely, tonifying one, clearing one, astringing the other, benefiting heart qi and nourishing heart yin; the adjuvant drugs of the scutellaria baicalensis, the trichosanthes bark and the nardostachys root, the radix et rhizoma nardostachyos, the radix scutellariae, the pericarpium trichosanthis, the rhizoma nardostachyos, the chest stuffiness relieving, the qi regulating and the phlegm eliminating. The whole formula is combined to play the efficacies of strengthening yang, benefiting yin, reducing phlegm and stabilizing palpitation.

The pharmacological effects of the traditional Chinese medicine composition are as follows: aiming at the pathogenesis characteristics of unconsolidation of heart yang of ventricular premature beat children and the physiological characteristics of young yin and young yang, the traditional Chinese medicine composition can benefit yin and strengthen yang, soothe nerves and fix palpitation to treat palpitation and even impairment of both yin and yang caused by unconsolidation of heart yang, and fundamentally pay attention to strengthen yang and simultaneously nourish yin to prevent impairment of both yin and yang.

The traditional Chinese medicine composition has proper compatibility, has the effects of tonifying yin and yang, soothing nerves and stopping palpitation, can be used for treating the ventricular premature beat of children, can effectively reduce the frequency of the ventricular premature beat, and can improve symptoms such as chest distress, palpitation, hypodynamia, sweating, sleep, appetite, defecation and the like. The traditional Chinese medicine composition is prepared from pure traditional Chinese medicines, has no toxic or side effect, and is easily accepted by children patients and family members.

Detailed Description

The invention will be further illustrated with reference to the following specific examples. These examples are to be construed as merely illustrative and not limitative of the remainder of the disclosure in any way whatsoever. After reading the description of the invention, one skilled in the art can make various changes and modifications to the invention, and such equivalent changes and modifications also fall into the scope of the invention defined by the claims.

In the following examples of the present invention, the experimental methods not specifically shown are all the experimental methods commonly used in the art.

In the following examples of the present invention, reagents not specifically shown are commercially available.

Example 1

Weighing 3g of cassia twig, 3g of honey-fried licorice root, 9g of dragon bone, 9g of oyster, 6g of radix pseudostellariae, 6g of radix ophiopogonis, 6g of scutellaria baicalensis, 3g of schisandra chinensis, 6g of rhizoma nardostachyos and 6g of pericarpium trichosanthis, and decocting the materials in water by a common method for later use.

Example 2

Weighing 3g of cassia twig, 3g of honey-fried licorice root, 9g of dragon bone, 9g of oyster, 6g of radix pseudostellariae, 6g of radix ophiopogonis, 6g of scutellaria baicalensis, 3g of schisandra chinensis, 6g of nardostachyos root and 6g of trichosanthes bark, and preparing the granules from Sichuan new green pharmaceutical science and technology development limited company.

Example 3

Weighing 3g of cassia twig, 3g of honey-fried licorice root, 12g of dragon bone, 12g of oyster, 9g of radix pseudostellariae, 9g of radix ophiopogonis, 9g of scutellaria baicalensis, 5g of schisandra chinensis, 9g of nardostachyos root and 9g of trichosanthes bark, and preparing the granules from Sichuan new green pharmaceutical science and technology development limited company.

Example 4

Weighing 5g of cassia twig, 5g of honey-fried licorice root, 15g of dragon bone, 15g of oyster, 9g of radix pseudostellariae, 9g of radix ophiopogonis, 12g of scutellaria baicalensis, 9g of schisandra chinensis, 6g of rhizoma nardostachyos and 12g of pericarpium trichosanthis, and decocting the materials in water by a common method for later use.

Experimental example-clinical observation of pediatric Fumai decoction for treating ventricular premature beat of children

1. Case selection

60 ventricular premature beat patients meeting the inclusion and exclusion standards in pediatrics of Longhua hospital affiliated to Shanghai medical university and medical school affiliated to Xinhua hospital of Shanghai transportation university from 2018 to 2019 in 7 months are selected, and after signing an informed consent, the ventricular premature beat patients are divided into a treatment group and a comparison group according to the ratio of 1:1 by adopting a random digital table method according to the group entering sequence, wherein each group comprises 30 cases.

1) Standard of Western diagnosis

The Western diagnostic standard for ventricular premature beat refers to 12-lead electrocardiogram, cardiac ultrasound and 24-hour electrocardiogram of ventricular arrhythmia Chinese expert consensus.

Standard for grading the severity of arrhythmia, the standard for grading the severity of arrhythmia refers to "guidelines for clinical research on new drugs in Chinese medicine (2 nd edition)") for monitoring and observation of electrocardiography. Mild: the patient has no obvious symptoms, and the average premature beat per minute is less than or equal to 5 times; medium: the average premature beat per minute is more than 5 times, or in a two-and-three-tone law; and (3) severe degree: multiple sources or more than 2 continuous premature beats, or R wave on T peak, or Q-T prolonged.

2) The traditional Chinese medicine syndrome standard is as follows: refer to the "clinical research guidelines for new Chinese medicine

Heart yang insecurity syndrome: the symptoms of palpitation, movement preference, chest distress, short breath, cold body and limbs, repeated cold, spontaneous perspiration, cool skin, pale complexion, inappetence, pale red tongue, white coating, deep and thready pulse or intermittent pulse.

3) Inclusion criteria

(1) The mild and moderate degree of the western medicine diagnosis standard and the traditional Chinese medicine syndrome differentiation standard of ventricular premature beat are met; (2) age 1-12 years, male and female; (3) the parents of the subjects sign informed consent and can cooperate with the therapists.

4) Exclusion criteria

(1) Other antiarrhythmic drugs are being taken; (2) with severe liver and kidney disease, organic heart disease, endocrine disease, hematologic and neurological disease; (3) those who are allergic to the test drugs; the doctor can easily make an interview missing according to the judgment.

5) Rejection, shedding and termination test standards:

(1) finding cases that do not meet inclusion criteria after inclusion; (2) if the drug is not administered according to the prescription, the curative effect cannot be judged or the data is not complete, which affects the judgment of the curative effect; (3) allergic reaction, serious adverse events and complications occur, and researchers judge that the testers should be stopped; (4) patients with other diseases during the test; cases with poor subject compliance.

2. Experimental methods

1) Chinese medicine

The granules prepared in the embodiment 3 (consisting of 3g of cassia twig, 3g of honey-fried licorice root, 9g of dragon bone, 9g of oyster, 6g of radix pseudostellariae, 6g of radix ophiopogonis, 6g of scutellaria baicalensis, 3g of schisandra chinensis, 6g of nardostachyos root and rhizome and 6g of snakegourd peel) are taken with water, the formula is prepared into granules by Sichuan new green pharmaceutical industry science and technology development limited company, and children patients less than 6 years old take half bags each time and 2 times a day; the medicine is taken by children older than 6 years old 1 bag each time, 2 times daily. Is administered after meal with warm water for 4 weeks.

2) Western medicine group

Oral cardioversion (manufactured by Shanghai Yixinfei pharmaceutical factory Co., Ltd., national drug standard: H31020492). The use method comprises the following steps: 5mg/kg. times, q8h oral administration, 4 consecutive weeks.

3) Observation index

1) 24-hour dynamic electrocardiogram, conventional 12-lead electrocardiogram, heart color ultrasound, myocardial zymogram and the like.

2) Traditional Chinese medicine syndrome integration: palpitation, chest distress, asthenia, sigh, spontaneous perspiration, diet, sleep, etc.

3) And (4) safety observation: blood convention, liver and kidney function, nausea, vomiting, abdominal pain, diarrhea, etc.

4) Criteria for evaluating therapeutic effects

The standard of curative effect of ventricular premature beat refers to dynamic electrocardiography. And counting the total number of ventricular premature beats before and after two groups of treatment by adopting a 24h dynamic electrocardiogram. Calculating the formula: the curative effect of ventricular premature beat is equal to the number of treated posterior ventricular premature beats/the number of treated anterior ventricular premature beats multiplied by 100%

The effect is shown: the curative effect index of the ventricular premature beat is less than or equal to 20 percent, and no relapse occurs after the medicine is stopped; the method has the following advantages: after the medicine is taken, the curative effect index of the ventricular premature beat is more than 20 percent and less than or equal to 50 percent, or the ventricular premature disappears during the treatment, and the patient relapses after the medicine is reduced or stopped, but the ventricular premature score is less than or equal to 20 percent. And (4) invalidation: after the medicine is taken, the curative effect index of the ventricular premature beat is more than 50 percent, even the curative effect index is increased, and the curative effect index is not changed after the dosage is adjusted.

5) Data analysis

Performing data statistical analysis by using SPSS 24.0 statistical software, and describing a person who accords with normal distribution in the measured data by using x +/-s; if the distribution is not in accordance with normal distribution, the median and the maximum and minimum values are used for description. Comparing the measured data between groups, and testing the data which accords with the normality by using two independent samples t; the measurement data and the counting data which do not conform to normal distribution are tested by non-parameter test; the rating data were tested by X2, and P < 0.05 indicated that the difference was statistically significant.

3. Results of the experiment

1) General data

The difference of the baseline data of the two groups of children patients in the aspects of sex, age, disease grade and the like has no statistical significance (P is more than 0.05), and the comparability of the treated numbers of the two groups is ensured.

2) The two groups of the ventricular premature treatment effects are compared in a table 1, and the two groups of the ventricular premature treatment effects have no significant difference.

3) The comparison of the number of premature beats in the two groups of children patients is shown in Table 2. After treatment, the ventricular premature times of the children patients in the traditional Chinese medicine and western medicine groups are reduced compared with those before treatment.

4) A comparison of the total integral of the syndrome before and after the two groups of treatments is shown in Table 3. After treatment, the traditional Chinese medicine syndrome integrals of the patients in the traditional Chinese medicine and western medicine groups are reduced compared with those before treatment, and the traditional Chinese medicine syndrome integrals after treatment of the traditional Chinese medicine groups are obviously lower than those of the patients in the western medicine groups.

5) The comparison of the single syndrome integrals is shown in tables 4, 5 and 6. Through treatment, all the traditional Chinese medicine symptoms after the treatment of the traditional Chinese medicine group are obviously improved compared with the symptoms before the treatment, the symptom score after the treatment of the western medicine group is obviously reduced only in the aspects of palpitation and chest distress compared with the symptoms before the treatment, the symptoms of the palpitation and the chest distress can be improved by the traditional Chinese medicine group and the western medicine group without obvious statistical difference, but the traditional Chinese medicine group is superior to the western medicine group in the aspects of improving shortness of breath, sigh, mental fatigue, hypodynamia, sleep, spontaneous perspiration, appetite and stool.

No serious arrhythmia appears in the two groups of patients during treatment, and the conventional blood and the liver and kidney function are not abnormal after treatment. After treatment, the western medicine group shows 4 cases of inappetence, 5 cases of nausea and 3 cases of diarrhea, which respectively account for 13.33%, 16.67% and 10.00% of the total number of people in the group, while the traditional Chinese medicine group does not show symptoms of inappetence, nausea, vomiting, abdominal pain, diarrhea and the like.

TABLE 1 curative effect comparison of two groups of ventricular premature beats [ n (%) ]

TABLE 2 comparison of ventricular premature beats counts in two groups (one/24 h)

TABLE 3 comparison of the integrals of two groups of syndromes

TABLE 4 comparison of the integral of each syndrome before and after treatment with the Chinese medicinal composition

TABLE 5 comparison of the score of each syndrome before and after treatment with the Western medicine group

TABLE 6 comparison of the various syndromes of TCM after treatment between groups

In conclusion, the traditional Chinese medicine composition can effectively reduce the number of ventricular premature beats and ensure the clinical curative effect, has no obvious side effect, and can better improve the life quality of children patients with ventricular premature beats.

Claims

1. A traditional Chinese medicine composition for treating children ventricular premature beat is characterized by being prepared from the following raw material medicines in parts by weight: 3-6 parts of cassia twig, 3-6 parts of honey-fried licorice root, 9-15 parts of dragon bone, 9-15 parts of oyster, 6-9 parts of radix pseudostellariae, 6-9 parts of radix ophiopogonis, 6-9 parts of scutellaria baicalensis, 3-6 parts of schisandra chinensis, 6-12 parts of nardostachyos root and rhizome and 6-15 parts of pericarpium trichosanthis.

2. The traditional Chinese medicine composition for treating children's ventricular premature beat according to claim 1, wherein the weight parts of the raw materials are respectively as follows: 3 parts of cassia twig, 3 parts of honey-fried licorice root, 9 parts of dragon bone, 9 parts of oyster, 6 parts of radix pseudostellariae, 6 parts of radix ophiopogonis, 6 parts of scutellaria baicalensis, 3 parts of schisandra chinensis, 6 parts of nardostachyos root and rhizome and 6 parts of pericarpium trichosanthis.

3. The traditional Chinese medicine composition for treating ventricular premature contraction of children as claimed in claim 1 or 2, wherein the traditional Chinese medicine composition is mixed with pharmaceutically acceptable pharmaceutical excipients to be prepared into tablets, pills, granules, powder, paste, powder or aqua.

4. Use of a Chinese medicinal composition according to claim 1, 2 or 3 for the preparation of a medicament for the treatment of ventricular premature contraction in children.