CN108578510A - A kind of drug for treating slow arrhythmia - Google Patents
A kind of drug for treating slow arrhythmia Download PDFInfo
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- CN108578510A CN108578510A CN201810852307.2A CN201810852307A CN108578510A CN 108578510 A CN108578510 A CN 108578510A CN 201810852307 A CN201810852307 A CN 201810852307A CN 108578510 A CN108578510 A CN 108578510A
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- slow arrhythmia
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Abstract
The present invention relates to a kind of drug for treating slow arrhythmia, which is made of effective ingredient and medically acceptable excipient, wherein the effective ingredient is made of the bulk pharmaceutical chemicals of following weight percent:Herba Epimedii 23~28%, Chinese cassia tree 9~11%, Radix Astragali 18~22%, Schisandra chinensis 14~17%, rhodiola root 9~11%, Radix Notoginseng 9~11%, dried orange peel 9~11%.Common granule, capsule or tablet can be made in drug of the present invention according to a conventional method.According to clinical verification, treatment slow arrhythmia of the present invention curative effect of medication is notable and without any adverse reactions and toxic side effect.
Description
Technical field
The present invention relates to medicinal preparations, and in particular to contains the treatment Retarder theory rhythm of the heart mistake for not determining structure from plant
Normal Chinese medicine preparation
Background technology
Slow arrhythmia is clinical common arrhythmia cordis.Arrhythmia cordis can by coronary heart disease, hypertensive cardiopathy,
Heart failure, a variety of diseases such as vital myocarditis, hypothyroidism, vegetative nerve functional disturbance cause.It is clinically
Activity palpitation is not peaceful in the minds of often showing as, and feels and beats in the heart, is panic-stricken, cannot be autonomous, in paroxysmal or lasts more than, with chest
Bored, shortness of breath and fatigue, even ambition pain, syndrome characterized by dyspnea limb cold sweat goes out, syncope.Belong to Chinese medicine " palpitaition " scope.With rhythm of life is fast,
Operating pressure is big, psychological stress is strong, such as adds that habits of smoking and alcohol drinking are more, factor is lacked in physical exertion, leads to arrhythmia cordis gradually year
Lightization, the incidence of the arrhythmia cordis such as slow arrhythmia are in dramatically increase trend.It is put into practice from Present clinical, the Retarder theory heart
It restrains that not normal pathogenesis is mostly in the majority with the deficiency of yang, deficiency of vital energy person, often shows as based on void, the heart kidney yang gas of simulataneous insufficiency and excessive loses
Empty, the stagnant obstructed syndrome of the heart arteries and veins stasis of blood, disease feature can be summarized as void, the stasis of blood, phlegm.Therefore it is living to be placed on QI invigorating temperature sun more for the emphasis for the treatment of
In terms of blood.
The common palpitaition of clinical manifestation, weak, dizzy, uncomfortable in chest, angina pectoris, the expiratory dyspnea of slow arrhythmia are even dizzy
It faints.Currently, including drug and non-drug therapy for the total therapeutic strategy of slow arrhythmia.The main needle of non-drug therapy
Arrhythmia cordis that is invalid to drug therapy, breaking out frequently or serious haemodynamics adverse consequences can be caused, such as RF ablation, peace
Pacemaker etc. is filled, it is costly, and there is stringent indication and contraindication, to most of slow arrhythmia patients
And be not suitable for, it is exactly that RF ablation is postoperative to cause bradycardia because having done to have many patients.Therefore in the period of considerably long in
Drug therapy is still the treatment main line of slow arrhythmia.But the anti-slow arrhythmia of several classes of current Clinical practice
There is common deficiencies for drug, first, curative effect is not good enough, second is that inducing the hair of new arrhythmia cordis when treatment arrhythmia cordis again
It is raw.
Europe and the U.S. consume more than 600 hundred million dollars of traditional herbal medicines every year at present, and the world is more elsewhere, especially exists
Far Eastern country.Therefore, antiarrhythmic Chinese medicine is studied, not only there are extensive market prospects at home, it is interior at the international level
With the very big market space.But since form of Chinese drug is not fixed, pharmacological research is not illustrated deeply, takes not convenient equal limit
The performance of its advantage is made.The anti-slow arrhythmia Chinese patent drug that further research and development curative effect is stablized, will become future
The therapeutic new hot spot of one period cardiovascular drugs.
Still lack the good effect drug for the treatment of slow arrhythmia at present, in contrast, Chinese medicine effect is generally preferred over Western medicine,
And it is small with toxic side effect, it is suitble to take for a long time, advantage at low cost.The Chinese medicine of the disease is treated at present mostly with QI invigorating Warming Yang and promoting blood circulation
Based on drug, as Chinese ephedra, asarum, monkshood, Radix Codonopsis, sealwort, Radix Salviae Miltiorrhizae, datura flower, ginseng, Chinese cassia tree, pilose antler, borneol, muscone,
Radix Notoginseng, safflower, rhizoma nardostachyos, Radix Ophiopogonis, cassia twig, santal, the dried venom of toads, jujube etc., and to have effects that the drug of QI invigorating Warming Yang and promoting blood circulation is
The compound and its preparation of main composition, such as heart treasure pill, Shen Song Yang Xin Capsule etc..Since said medicine is with the dry strong drug of temperature compensation
It is main, for quite a few and folder yin deficiency syndrome person, easy to produce malaise symptoms.Therefore, pools of traditional Chinese medicine is excavated, is innovated and perfect
Slow arrhythmia therapy theory, finds the treatment more efficiently Chinese medicine preparation of slow arrhythmia, not only has higher
Learning value, and wide market can obtain good social and economic effects.
Invention content
The purpose of the present invention is to provide a kind of drug of new treatment slow arrhythmia, which can effectively change
Kind symptom, treatment slow arrhythmia are significant in efficacy.
The present invention realizes that the technical solution of above-mentioned purpose is:
A kind of drug for treating slow arrhythmia, the drug is by effective ingredient and medically acceptable excipient group
At wherein the effective ingredient is made of the bulk pharmaceutical chemicals of following weight percent:
Herba Epimedii 23~28%, Chinese cassia tree 9~11%, Radix Astragali 18~22%, Schisandra chinensis 14~17%, rhodiola root 9~11%,
Radix Notoginseng 9~11%, dried orange peel 9~11%.
Drug of the present invention, wherein the optimum proportioning of the bulk pharmaceutical chemicals is:
Herba Epimedii 25%, Chinese cassia tree 10%, Radix Astragali 20%, Schisandra chinensis 15%, rhodiola root 10%, Radix Notoginseng 10%, dried orange peel 10%.
The drug for the treatment of slow arrhythmia of the present invention, is made by following methods:
(1) Radix Notoginseng is taken, it is the circumfluence distillation 3 times of 70% ethyl alcohol to add 8 times of amount volumetric concentrations, 1.5 hours every time, collects and closes
And alcohol extract, filtration, decompression filtrate recycling ethanol is simultaneously concentrated into medicinal extract, spare;
(2) it takes remaining bulk pharmaceutical chemicals to add water to cook 3 times, is fried by intense fire after boiling for the first time 30 minutes, force after boiling for the second time
Fire is decocted 1 hour, is fried by intense fire after boiling for the third time 1.5 hours, collecting decoction, is filtered, filtrate decompression is concentrated into medicinal extract, spare;
(3) medicinal extract obtained by step (1) and (2) is collectively disposed in baking oven, dry cream is baked at 75 DEG C, be ground into thin
Powder;
(4) it takes the fine powder obtained by step (3) that suitable acceptable excipient of medicine is added, is made according to a conventional method often
Solid oral agent.
Above-mentioned common solid oral agent, be according to a conventional method made of granule, capsule or tablet.
Drug of the present invention is equipped with Radix Astragali, Schisandra chinensis, rhodiola root, Radix Notoginseng, dried orange peel using Herba Epimedii, Chinese cassia tree as main ingredient
It is made.Wherein, Herba Epimedii, Chinese cassia tree temperature compensation heart kidney, rouse oneself yang-energy be monarch drug in a prescription;It is aided with Radix Astragali, Schisandra chinensis benefiting qi and nourishing yin nourishing heart is reinforced
Monarch drug in a prescription QI invigorating calming heart, then with rhodiola root, monarch drug in a prescription is promoting blood circulation and removing blood stasis promotes blood circulation for Radix Notoginseng auxiliary, the two is combined into ministerial drug;With dried orange peel qi-regulating
Phlegm, coordinating the drug actions of a prescription are to make medicine.Full side's temperature compensation heart kidney, supplementing qi and nourishing yin, blood circulation and channel invigorating, stagnation resolvation is without hindering just, and temperature compensation is without impairment of yin.
Drug of the present invention can effectively treat nervous palpitaition caused by slow arrhythmia, syncope, shortness of breath, tired, chest
The symptoms such as bored pectoralgia, and the objective indicators such as average ventricular rate, average heart rate, most slow heart rate and most fast heart rate that can improve patient,
And without apparent toxic side effect.
Drug therapy of the present invention is slow to be shown up to the clinical study results more than 3 years to 246 slow arrhythmia patients
Chronic arrhythmia cordis tool has a better effect, and reaches 85.19% according to the electrocardiogram ventricular rate efficacy evaluation total effective rate that is averaged, presses
Reach 93.83% according to Chinese medicine syndrome integral efficacy evaluation total effective rate.Invention drug to the therapeutic effect of slow arrhythmia,
Can be observed by following clinical cases is further confirmed.
The relevant criterion of 1 clinical experimental study
1.1 diagnostic criteria
(1) Western medicine diagnostic criteria:Sick sinus syndrome, atrioventricular block, brady-tachy arrhythmia syndrome diagnosis, with reference to the U.S.
Cardiology can defined I class pacemaker indication;(2) tcm diagnosis standard:According to《New Chinese medicine guideline of clinical investigations
Standard (second volume)》It is formulated about palpitaition, sick sinus syndrome related guidance principle.
1.2 inclusion criteria
(1) voluntary participation, informed consent;(2) meet Western medicine diagnostic criteria, while meeting the following conditions:24 hours total hearts
Number of fighting is less than 80000 times, but more than 70000 times;There is ventricular asystole < 3s or patients with atrial fibrillation ventricular asystole in sinus rhythm patient
< 5s;I Aminophyline of atrioventricular conduction time < 300ms;(3) meet tcm diagnosis standard;(4) age 18~85
Year;(5) it does not take or has withdrawn drug influential on arrhythmia cordis 2 weeks, include negative chronotropic, negativity conduction and the influence heart
The drug of flesh energetic supersession.
1.3 exclusion criteria
(1) age is less than 18 years old or is more than 85 years old;(2) controlling of blood pressure is bad, i.e. and systolic pressure >=160mmHg or diastolic pressure >=
100mmHg;(3) diabetes do not control, fasting blood-glucose >=7.0mmol/L, postprandial 2 hours blood glucose >=11.0mmol/L, and be saccharified blood
Hemoglobin concentration >=7.5%;(4) there are serious hepatic and kidney function obstacle persons such as with active hepatitis, alcoholic liver whole latter stage, liver cancer
The diseases patient such as late period, uremia;There is the laboratory examination abnormal index of clinical meaning:Liver transaminases, alkaline phosphatase before selected
The indexs such as enzyme, bilirubin are higher than 3 times of normal upper limit, and plasma albumin is less than 30g/L, and serum creatinine is higher than normal value, and blood potassium is less than
3.5mmol/L is higher than 5.5mmol/L;(5) other systems disease is suffered from, in fact it could happen that serious to damage or have mental act abnormal
Person, if cirrhotic patients with portal hypertension is likely to occur massive hemorrhage of gastrointestinal tract, hepatic encephalopathy, the Systemic Lupus Activity phase may go out
Existing heart, kidney or nervous system damage;(6) it currently indulges in excessive drinking or takes drugs, or screening in first 5 years has alcohol or drug indiscriminate
Use history;(7) gestation or women breast-feeding their children, Women of Childbearing Age (do not take sterilization measure or non-menopausal women, impasse to be defined as stopping
It is more than 1 year through the time) the preceding urine HCG negative findings that obtain must be selected in exclude gestation;(8) other are participated in (in 2 months) in the recent period to face
Bed development test but the person of dropping by the wayside withdraw other Chinese medicines not up to 2 weeks persons;(9) there is serious cardiovascular and cerebrovascular disease within nearly 6 months
And damage non-recuperator;(10) secondary slow arrhythmia caused by the other reasons such as drug or electrolyte disturbance;
(11) pacemaker person;(12) height or third degree A-V block or other severe arrhythmias induce aase's syndrome
Person;(13) medication cannot be adhered to as required or refuses signature informed consent form person.
1.4 subjects' falls off
(1) case that falls off judges:Filled in subject's informed consent form and by screening enrolled patient, no matter because
For when which kind of reason (voluntarily exiting, compliance is poor, lost to follow-up etc.), as long as the subject that the defined observation period does not complete,
It is the case that falls off.If the case to fall off there are data after the treatment of baseline, index the effect of last time can be carried over to
It is final as a result, for statistical analysis;(2) processing for the case that falls off:For the subject to fall off, phone, electronics can be taken
The modes such as mail, visit to the parents of schoolchildren or young workers contact subject.Inquire reason, the as far as possible index of the assessment in completion scheme.Fall off the disease of patient
The data of the CRF tables of people will put on record preservation, so as to FAS set analysis after the test.
1.5 subjects reject
(1) standard be included in and excluded for entering group and having violated scheme of case, should not be random enrolled;(2) subject is not
Obey enter at random group or it is random after do not take medicine or drug administration (10% total experiment dosage);(3) midway
The other Chinese patent drugs to affect the treatment with safety evaluatio are used;(4) after entering group at random, not any treatment data.
1.6 testing the standard stopped
(1) serious safety problem has occurred in test, it should stop experiment immediately;(2) medicine is found during experiment
Object does not have clinical value, is effectively treated in order to avoid delaying subject, it should stop experiment;(3) researcher test into
Find that scheme has significant error or severe deviations have occurred in scheme implementation process during exhibition;(4) sponsor tested
Because the reasons such as funds, management stop experiment;(5) National Drug Administration orders because of cause specific and stops to test.
2 clinical datas and research method
2.1 research method
(1) research and design:This experiment uses randomized controlled trial.(2) method of randomization:It is random using district's groups, parallel right
According to method table of random number is generated according to the case load of distribution and ratio by SAS softwares.(3) it is included in case source:
All subjects, which come from, to go to a doctor in Guangzhou Hospital of Southern Medical University, Guang Zhounan in December, 2016 in January, 2013-
The square hospitals of traditional Chinese and western medicine of medical university simultaneously meet the (reference of slow arrhythmia diagnostic criteria《Modern heart clinical practice》With
《Clinical electrocardiography》The diagnostic criteria of bradycardia arrhythmia cordis,《New Chinese medicine guideline of clinical investigations standard》System
Outpatient service calmly), inpatient.
2.2 therapeutic scheme
Clinical test according to《Declaration of Helsinki》Principle and drug clinical trial quality management practices
(Goodclinicalpractice, GCP) requires to carry out.Tranquil heart rate is counted daily 1 time;It has an electro-cardiogram weekly 1 time;Observation is complete
Dynamic electrocardiogram after portion patient treats 8 weeks and before treatment Fig. 1 times, compares pretherapy and post-treatment curative effect.
(1) trial drug:
1. treatment group:Treat the granule that medication is following embodiments 1, each 15g, warm boiled water.3 times a day, even
Continuous medication 8 weeks.
2. heart treasure pill group:Using the heart treasure pill (Chinese medicines quasi-word Z44O21843) produced by Guangdong Xin Bao drugmakers, every
60mg.Give heart treasure pill 5 (300mg) every time, 3 times a day, warm water is taken after mixing it with water, and is continuously taken 8 weeks.
3. complex group:Using conventional compound medication, Radix Notoginseng total glucosides tablet (Daphne Pharmaceutical (Group) Co., Ltd.Yunnan) is given
Each 100mg, 10 tablets each time, (Community in Baiyunshan, Guangzhou Pharmaceutical Group share is limited for Inosine tablets for compound danshen dripping pills (Tianjin day scholar's power)
Company's White Cloud Mountain pharmacy head factory) 0.2 gram every time, three times a day, warm water delivery service.
Spicy food is avoided during medication, avoids spirits.It is as a treatment course with 8 weeks.It participates in withdrawing it from clinical test the last week
Its antiarrhymic.It is discontinued and checks in latter week.
(2) drug combination provides:The Chinese medicine and Chinese patent drug of other treatment arrhythmia cordis are forbidden to use during experiment, or to controlling
Treat the influential Chinese medicine of arrhythmia cordis curative effect and Chinese patent drug.It is constant with the treatment of other diseases.For complication such as diabetes,
Hypertension, dyslipidemia, heart failure, hypotensive shock etc. should give anti symptom treatment according to associated guideline.All drug combinations are all
Must be recorded in detail in original record (patient medical history/inpatient cases) and CRF, including medicine title, per total daily dose,
Slurry pump, is discontinued the date at medication Start Date.
2.3 observation index
(1) Population demographic indicators associated:Gender, age, date of birth, nationality, height, weight.Remember before importing database
Record information above.
(2) general clinical data:Present illness history (including the course of disease, medicining condition etc.), medical history, medication history, allergies, suction
Cigarette and situation etc. of drinking.Information above is recorded before importing database.
(3) endpoint (curative effect index):Average ventricular rate efficacy evaluation:With reference to the national combination of Chinese tradiational and Western medicine in 1979
Prevention and treatment of coronary heart disease, angina pectoris, arrhythmia cordis research forum《The common arrhythmia cordis cause of disease, severity and curative effect reference standard》
It formulates.It is effective:Clinical symptoms are obviously improved or disappear substantially, and heart rate increases by 10 beats/min of > or more;Effectively:Clinical symptom relief,
Heart rate increases to be mitigated up to 5 beats/min or more or electrocardio diagram conductive impairment;In vain:Clinical symptoms increase without improvement, heart rate less than 5
Beat/min, electrocardiogram is identical before relatively treating or conductive impairment aggravates.
(4) secondary efficacy index:Tcm syndrome curative effect:It is indicated using tcm syndrome element integration method.1. clinical recovery:It is former
There are symptom, sign to disappear substantially, total mark reduces >=90%;2. effective:Original symptom, sign largely disappear or obviously subtract
Gently, total mark reduces >=70%, < 90%;3. effectively:Original symptom, sign mitigate before relatively treating, and total mark reduces >=30%,
< 70%;4. invalid:Without improvement, total mark reduces < 30% for original symptom, sign.
(5) safety detection:1. vital sign:Including:(heart rate, body temperature, breathing, blood pressure), needs under rest state
It measures, blood pressure measurement uniformly takes seat blood pressure.Baseline 0 day, medication ± 7 days the 8th week, be discontinued after ± 7 days the 4th week.2. physique is examined
It looks into:Only record positive sign.Especially whether there is or not the performances such as blutpunkte, ecchymosis for record body surface.Baseline 0 day, medication ± 7 days the 12nd week,
± 7 days the 4th week after drug withdrawal.3. laboratory examination:Blood routine, routine urinalysis, just routine;Glutamic-pyruvic transaminase, glutamic-oxalacetic transaminease;Blood urine
Plain nitrogen, blood uric acid, serum creatinine, glomerular filtration rate;Coagulation function;Troponin;Blood fat situation;Hs-CRP feelings
Condition.4. Adverse event monitoring:Overall process monitoring is tested, is recorded in detail at any time
2.4 statistical analysis
Test data uses SAS9.3 statistical softwares for statistical analysis and mapping:1. describing the metering money in baseline characteristic
Material selects mean, standard deviation, median, quartile spacing.The number of cases and percentage of all kinds of generations of enumeration data are described.Between group
Compare, measurement data is using the side such as variance analysis, paired t-test, Kruskal-Wallis H inspections, Wilcoxon rank sum tests
Method;Enumeration data accurately examined using Fisher, Chi-square Test etc., and ranked data are examined using Kruskal-Wallis H.
3 results
3.1 are included in case
From on January 4th, 2013 until 30 days December in 2016, which screens altogether 246 patients, is randomly divided into 3
Group, every group 82.Fall off 4 cases altogether, wherein 2 are complex group, treatment group and each 1 of heart treasure pill group.Finally have 242 by
Examination person's qualification enters statistical analysis.Male 122 in 242 subjects, women 120, minimal ages 40 years old, max age
84 years old.Sinus bradycardia has 110, and sick sinus syndrome has 68, and atrial fibrillation has 64 with long pause.
3.2 Baseline Data
The data of subject's baseline are shown in Table 1.Wherein the average age for the treatment of group is 61.32 years old, the average year of heart treasure pill group
Age is 61.45 years old, and the average age of complex group is 60.89 years old.The crowd of hypertension occupies 43.21% in treatment group, heart treasure pill
Group occupies 45.68%, and complex group occupies 45.00% (p>0.05).Diabetic occupies 25.93% in treatment group, and the heart is precious
Occupy 24.69% in ball group, 23.75% (p is occupied in control group>0.05).Hyperlipidemia patient occupies in No. 2 groups of calming heart
20.99%, occupy 19.75% in heart treasure pill group, 18.75% (p is occupied in complex group>0.05).The height of three groups of patients in group,
Weight, systolic pressure, diastolic pressure, resting heart rate, drug combination, medical history are consistent, no difference of science of statistics (p>0.05).
1 subject's Baseline Data project of table
3.3 Syndrome Differentiation of Traditional Chinese Medicine features and elements of TCM syndromes
Syndrome Differentiation of Traditional Chinese Medicine belongs to based on void more, actual situation holds miscellaneous card under the arm.Wherein more than four one-tenth more than patient's Chinese medical discrimination category
Yang-energy virtual loss, remaining is followed successively by the cards types such as deficiency of both qi and yin, qi deficiency to blood stasis and the resistance of blood stasis phlegm.Three groups of each card type distributions are almost the same,
No difference of science of statistics (p>0.05), TCM Syndrome Type distribution situation is shown in Table 2.Nervous, syncope, shortness of breath, tired, chest uncomfortable in chest in view of palpitaition
Bitterly, six indexs of pulse condition have leading meaning on the tcm diagnosis of slow arrhythmia, it is thus determined that its Chinese medicine primary symptom is demonstrate,proved
Waiting element is:Palpitaition is nervous, syncope, shortness of breath, tired, feeling of oppression and pain in the chest, pulse condition, by light 3 points, in 6 points, weigh 9 and divide scoring, each primary symptom
Integral estimation standard is shown in Table 3.In view of spontaneous perspiration, night sweat, aversion to cold and cold limbs, six poor, complexion, tongue picture indexs are received in the mistake of the Retarder theory rhythm of the heart
Also there is important references value, it is thus determined that its Chinese medicine minor symptom elements of TCM syndromes is on normal tcm diagnosis:Spontaneous perspiration, night sweat, chilly
Limb is cold, receives poor, complexion, tongue picture, by light 1 point, in 2 points, weigh 3 scoring, each minor symptom integral estimation standard divided to be shown in Table 4.
2 slow arrhythmia TCM Syndrome Type distribution situation of table compares
Group | Number of cases | Yang-energy virtual loss example (%) | Deficiency of both qi and yin example (%) | Qi deficiency to blood stasis example (%) | Blood stasis phlegm hinders example (%) |
Treatment group | 81 | 36(44.44) | 18(22.22) | 14(17.28) | 13(16.05) |
Heart treasure pill group | 81 | 35(43.21) | 18(22.22) | 14(17.28) | 14(17.28) |
Complex group | 80 | 34(42.50) | 17(21.25) | 15(18.75) | 14(17.50) |
The 3 slow arrhythmia tcm syndrome element primary symptom table of integrals of table
The 4 slow arrhythmia tcm syndrome element primary symptom table of integrals of table
The effect of 3.4 pairs of ventricular rates
According to average ventricular rate curative effect determinate standard, effective 44 for the treatment of group, effective 25, invalid 12, total effective rate
It is 85.19%;Effective 34 of heart treasure pill group, effective 19, invalid 28, total effective rate 65.43%;Complex group effective 14
Example, effective 19, invalid 47, total effective rate 41.25%.Treatment group, heart treasure pill group total effective rate are apparently higher than complex group
(p < 0.01), and treatment group's total effective rate is apparently higher than heart treasure pill group (p < 0.01), and statistical result is shown in Table 5.Treatment group, the heart
The pretherapy and post-treatment 24 hours ventricular rates of treasure pill group compare, most slow heart rate, most fast heart rate and the significant difference of average ventricular rate
(p < 0.01) prompts drug of the present invention and heart treasure pill that the average ventricular rate of slow arrhythmia patient, the most slow heart can be improved
Rate and most fast heart rate, and treatment group is better than heart treasure pill group (p < 0.01), shows that curative effect of medication of the present invention is best.Complex group is controlled
It treats forward backward averaging ventricular rate and also slightly improves (p < 0.05), but is little to most slow heart rate, most fast Heart rate influences, statistical result is shown in
Table 6.
5 treatment group of table is compared with the effect of other group treatment slow arrhythmias are averaged ventricular rate
Group | Number of cases | Effective example (%) | Effective example (%) | Invalid example (%) | Total effective rate |
Treatment group | 81 | 44(54.32) | 25(30.86) | 12(14.81) | 85.19%**▲▲ |
Heart treasure pill group | 81 | 34(41.98) | 19(23.46) | 28(34.57) | 65.43%** |
Complex group | 80 | 14(17.50) | 19(23.75) | 47(58.75) | 41.25% |
Note:* expressions are compared with complex group, p < 0.01;▲▲It indicates compared with heart treasure pill, p < 0.01.
6 treatment group of table is compared with the effect of other organize pretherapy and post-treatment ventricular rates
Note:△It indicates compared with before treatment, p < 0.05,△△It indicates compared with before treatment, p < 0.01.
The effect of 3.5 pairs of tcm syndromes
According to Chinese medicine syndrome integral curative effect determinate standard, clinical recovery 30 after treatment group's treatment, effective 29, effective 17
Example, invalid 5, total effective rate 93.83%;Clinical recovery 20 after the treatment of heart treasure pill group, effective 22, effective 18, nothing
Effect 21, total effective rate 74.07%;Clinical recovery 12 after complex group treatment, effective 14, effective 15, invalid 39,
Total effective rate is 51.25%.Treatment group, heart treasure pill group total effective rate are apparently higher than complex group (p < 0.01), and treatment group is total
Effective percentage is apparently higher than heart treasure pill group, and two groups are compared p < 0.01, and statistical result is shown in Table 7.Pretherapy and post-treatment Chinese medicine syndrome integral ratio
Compared with through statistical test, treatment group, the pretherapy and post-treatment Chinese medicine syndrome integral of heart treasure pill group have difference (the p < of statistical significance
0.01), prompt drug of the present invention and heart treasure pill that can improve the tcm clinical practice syndrome of patient, statistical result is shown in Table 8.
7 treatment group of table is compared with the effect of other groups treat slow arrhythmia tcm syndromes
Note:* expressions are compared with complex group, p < 0.01;▲▲Treatment group is indicated compared with heart treasure pill, p < 0.01.
The variation of 8 pretherapy and post-treatment each group Chinese medicine syndrome integral of table is compared (x ± s)
Note:△It indicates compared with before treatment, p < 0.05,△△It indicates compared with before treatment, p < 0.01.
The effect of 3.6 pairs of each card types, is analyzed
The curative effect basis equalization in each card type for the treatment of group, in each card type group total effective rate 84.62% to 97.22% it
Between, illustrate that drug of the present invention can play preferable curative effect for each card type of slow arrhythmia, statistical result is shown in Table 9.And
It is the most notable with yang-energy deficiency curative effect in each card type of heart treasure pill group, secondly it is Qi deficiency blood stasis type, total effective rate is respectively
97.14% and 78.57%.Type of deficiency of both QI and YIN total effective rate is 33.33%, illustrates heart treasure pill to yang-energy deficiency, qi deficiency to blood stasis
Type therapeutic effect is preferable, and then curative effect religion is poor to type of deficiency of both QI and YIN, and statistical result is shown in Table 10.Then with qi deficiency to blood stasis in complex group
It is preferable with blood stasis phlegm retention curative effect, and it is poor to yang-energy virtual loss, type of deficiency of both QI and YIN curative effect, and statistical result is shown in Table 11.
The effect of each TCM Syndrome Type of 9 treatment group of table, compares
TCM Syndrome Type | Number of cases | Example of fully recovering (%) | Effective example (%) | Effective example (%) | Invalid example (%) | Total effective rate |
Yang-energy virtual loss | 36 | 17(47.22) | 15(41.67) | 3(8.33) | 1(2.78) | 97.22% |
Deficiency of both qi and yin | 18 | 7(38.89) | 5(27.78) | 5(27.78) | 1(5.56) | 94.44% |
Qi deficiency to blood stasis | 14 | 4(28.57) | 4(28.57) | 5(35.71) | 1(7.14) | 92.86% |
Blood stasis phlegm hinders | 13 | 2(15.38) | 5(38.46) | 4(30.77) | 2(15.38) | 84.62% |
It is total | 81 | 30(37.04) | 29(35.80) | 17(20.99) | 5(6.17) | 93.83% |
The effect of each TCM Syndrome Type of 10 heart treasure pill group of table, compares
Note:The * p < 0.05 compared with yang-energy virtual loss, * * p < 0.01;Compared with deficiency of both qi and yin△△P < 0.01.
The effect of each TCM Syndrome Type of 11 complex group of table, compares
TCM Syndrome Type | Number of cases | Example of fully recovering (%) | Effective example (%) | Effective example (%) | Invalid example (%) | Total effective rate |
Yang-energy virtual loss | 34 | 2(5.88) | 2(5.88) | 3(8.82) | 27(79.41) | 20.59%△ |
Deficiency of both qi and yin | 17 | 2(11.76) | 2(11.76) | 3(16.64) | 10(58.82) | 41.18%* |
Qi deficiency to blood stasis | 15 | 3(20.00) | 5(33.33) | 6(40.00) | 1(6.67) | 93.33%**△ |
Blood stasis phlegm hinders | 14 | 5(35.71) | 5(35.71) | 3(21.43) | 1(7.14) | 92.86%**△ |
It is total | 80 | 12(17.50) | 14(17.50) | 15(23.75) | 39(48.75 | 51.25% |
Note:The * p < 0.05 compared with yang-energy virtual loss, * * p < 0.01;Compared with deficiency of both qi and yin△P < 0.05,△△P < 0.01.
The effect of 3.7 pairs of elements of TCM syndromes, is analyzed
By comparing the variation of pretherapy and post-treatment primary symptom elements of TCM syndromes, palpitaition is nervous, syncope, shortness of breath, tired, feeling of oppression and pain in the chest,
Six indexs of pulse condition, treatment group and heart treasure pill group have clear improvement (p < 0.01 or p < 0.05), and treatment group's elements of TCM syndromes
Improve and more write (p < 0.01), complex group, which only has part elements of TCM syndromes, to be improved.Prompt illustrates drug and the heart treasure pill of the present invention to slow
The primary symptom elements of TCM syndromes of chronic arrhythmia cordis is significantly improved, and invention drug improvement result is more notable, and statistical result is shown in Table
12。
The pretherapy and post-treatment primary symptom elements of TCM syndromes variation of 12 each group of table is compared
Note:△It indicates compared with before treatment, p < 0.05,△△It indicates compared with before treatment, p < 0.01.
By to pretherapy and post-treatment minor symptom elements of TCM syndromes variation compare, treatment group to minor symptom spontaneous perspiration, night sweat, aversion to cold and cold limbs, receive
The syndromes whole element such as difference, complexion, tongue picture has clear improvement (p < 0.01), and heart treasure pill group is then to spontaneous perspiration, aversion to cold and cold limbs, face
Color, tongue picture four indices have improvement, complex group then only to improve to complexion elements of TCM syndromes.Illustrate that drug of the present invention wants minor symptom syndrome
The improvement result of element is notable, and statistical result is shown in Table 13.
The pretherapy and post-treatment minor symptom elements of TCM syndromes variation of 13 each group of table is compared
Note:△It indicates compared with before treatment, p < 0.05,△△It indicates compared with before treatment, p < 0.01.
3.8 safety indexes are observed and evaluation
Over the course for the treatment of and during follow-up, three groups of subjects have no dizziness, Nausea and vomiting, agitation, expiratory dyspnea etc.
Serious adverse reaction, periodically to blood urine, just the number of lab index such as three big routine, hepatic and renal function, coagulation functions carries out observation point
Analysis, does not find apparent exception.In Adverse event monitoring, no adverse events occur.
4. discussing
4.1 Syndrome Differentiation of Traditional Chinese Medicine features and elements of TCM syndromes
Slow arrhythmia appears in weak or high year people or insufficiency of natural endowment, the innate deficiency of YANG in the body or year high gate of vitality mostly
Fire declines, and void, the disease feature of phlegm, the stasis of blood is presented easily from the moonization in perverse trend.Void is mainly the deficiency of yang, the deficiency of vital energy, and real is mainly blood stasis phlegm
Resistance.Our observation is that Syndrome Differentiation of Traditional Chinese Medicine belongs to based on void more, actual situation holds miscellaneous card under the arm.Wherein more than four one-tenth more than patient's Chinese medicine
Dialectical category yang-energy virtual loss, remaining is followed successively by the cards types such as deficiency of both qi and yin, qi deficiency to blood stasis and the resistance of blood stasis phlegm.Therefore the Retarder theory rhythm of the heart is lost
Normal treatment, should by temperature compensation heart kidney, rouse oneself yang-energy headed by be engaged in.In conjunction with previous clinical practice and long-term clinical observation, table
Bright slow arrhythmia is in the majority with the deficiency of yang, deficiency of vital energy person, often shows as based on void, the heart kidney yang gas virtual loss of simulataneous insufficiency and excessive, the heart
The stagnant obstructed syndrome of the arteries and veins stasis of blood, disease feature can be summarized as void, the stasis of blood, phlegm.The tcm clinical practice disease of comprehensive analysis slow arrhythmia
Card feature, in view of palpitaition, six nervous, syncope, shortness of breath, tired, feeling of oppression and pain in the chest, pulse condition indexs are in slow arrhythmia
There is leading meaning, it is thus determined that its Chinese medicine primary symptom elements of TCM syndromes is in doctor's diagnosis:Palpitaition is nervous, syncope, shortness of breath, tired, chest
Bored pectoralgia, pulse condition.In view of spontaneous perspiration, night sweat, aversion to cold and cold limbs, six poor, complexion, tongue picture indexs are received in slow arrhythmia
Also there is important references value, it is thus determined that its Chinese medicine minor symptom elements of TCM syndromes is in doctor's diagnosis:Spontaneous perspiration, aversion to cold and cold limbs, is received night sweat
Difference, complexion, tongue picture.
The influence of 4.2 pairs of slow arrhythmia hearts rate
Heart treasure pill is the Chinese patent drug of clinical treatment slow arrhythmia generally acknowledged in recent decades, by Guangdong heart treasured pharmacy
Company produce (Chinese medicines quasi-word Z44O21843), by datura flower, ginseng, Chinese cassia tree, monkshood, pilose antler, borneol, muscone, Radix Notoginseng,
Nine herbal medicine such as dried venom of toads forms, and has the effect of temperature compensation heart kidney, benefiting qi and supporting yang, blood circulation and channel invigorating.Be mainly used for treat heart-kidney yang deficiency,
Chronic cardiac insufficiency caused by heart arteries and veins stasis blocking, bradycardia, sick sinus syndrome and ischemic caused by sinus node dysfunction
Angina pectoris caused by heart disease and electrocardiogram ischemic lesions.Clinical test proves, compares according to average ventricular rate curative effect, and the heart is precious
Ball treatment slow arrhythmia truly has curative effect, total effective rate 65.43%, hence it is evident that total higher than by compound danshen dripping pills and Radix Notoginseng
The 41.25% of the complex group of glycosides piece and Inosine tablets composition, but heart treasure pill temperature compensation effect is had a surplus, supplementing qi and nourishing yin and work promoting blood circulation and removing blood stasis
With deficiency, thus it is clinically somewhat limited, also influence the performance of whole curative effect.Drug of the present invention is by seven taste Chinese medicine groups
At using Herba Epimedii, Chinese cassia tree temperature compensation heart kidney, rousing oneself yang-energy as monarch drug in a prescription;With Radix Astragali, Schisandra chinensis benefiting qi and nourishing yin nourishing heart, rhodiola root, Radix Notoginseng
It is promoting blood circulation and removing blood stasis to promote blood circulation as ministerial drug;It is to make medicine with dried orange peel regulating qi-flowing for eliminating phlegm, coordinating the drug actions of a prescription.All medicine phases 5, gather altogether temperature compensation heart kidney, QI invigorating support
The effect of the moon, blood circulation and channel invigorating.According to average ventricular rate curative effect determinate standard, drug total effective rate of the present invention is 85.19%, remote high
In 65.43% (p < 0.01) of heart treasure pill.The flat of slow arrhythmia patient can be improved in invention drug and heart treasure pill simultaneously
Equal heart rate, most slow heart rate and most fast heart rate, and it is especially best with invention curative effect of medication.
The influence of 4.3 pairs of tcm syndromes and element
According to Chinese medicine syndrome integral curative effect determinate standard, treatment group's total effective rate is 93.83%, heart treasure pill group total effective rate
It is 74.07%, complex group total effective rate is 51.25%.Treatment group, heart treasure pill group curative effect are apparently higher than complex group (p < 0.01),
And treatment group's curative effect is apparently higher than heart treasure pill group (p < 0.01) again.And compared by pretherapy and post-treatment Chinese medicine syndrome integral, it carries
The tcm clinical practice syndrome of patient can be improved by showing invention medicine and heart treasure pill.In terms of heart treasure pill improves the tcm clinical practice syndrome of patient,
It is the most notable with yang-energy deficiency curative effect, it is secondly Qi deficiency blood stasis type, poor is type of deficiency of both QI and YIN, illustrates that heart treasure pill loses yang-energy
Deficiency, Qi deficiency blood stasis type therapeutic effect are preferable, and then curative effect religion is poor to type of deficiency of both QI and YIN.And curative effect is basic in each card type for the treatment of group
Equilibrium, total effective rate illustrates that invention medicine is each for slow arrhythmia between 84.62% to 97.22% in each card type group
Card type can play preferable curative effect, be suitable for the treatment of the slow arrhythmia of each TCM Syndrome Type.
By analyzing the effect of elements of TCM syndromes, in terms of primary symptom elements of TCM syndromes, invention medicine is nervous, dizzy to improving palpitaition
Faint, shortness of breath, tired, feeling of oppression and pain in the chest, pulse condition six indexs effect it is notable, heart treasure pill group also has improvement result, illustrates invention drug
The primary symptom elements of TCM syndromes of slow arrhythmia is significantly improved with heart treasure pill.In terms of minor symptom elements of TCM syndromes, hair
Bright drug has clear improvement to minor symptom spontaneous perspiration, night sweat, aversion to cold and cold limbs, the syndromes such as poor, complexion, tongue picture of receiving, and heart treasure pill is then to certainly
Sweat, aversion to cold and cold limbs, complexion, tongue picture four indices have improvement, and complex group then only improves complexion elements of TCM syndromes, and drug of the present invention
It is more notable to the minor symptom syndrome improvement result of slow arrhythmia.
5, conclusion
Drug of the present invention can effectively treat slow arrhythmia, improve the tcm syndrome of slow arrhythmia, press
According to generally acknowledged curative effect standard, with control group drug heart treasure pill and Radix Notoginseng total glucosides tablet, compound danshen dripping pills, Inosine tablets drug combination
The effect of compare, otherness have significant (P < 0.01), illustrate drug therapy slow arrhythmia curative effect of the present invention
Significantly.In addition, during clinical observation, do not find that drug of the present invention has any bad toxicity, shows that this drug is one
Safe and effective preparation.
Specific implementation mode
Embodiment 1 (granule)
1, prescription:Herba Epimedii 2500g, Chinese cassia tree 1000g, Radix Astragali 2000g, Schisandra chinensis 1500g, rhodiola root 1000g, Radix Notoginseng
1000g, dried orange peel 1000g.
2, preparation method:
(1) Radix Notoginseng is taken, adds 8 times of 70% alcohol heat reflux of amount to extract 3 times, 1.5 hours every time, collects and merge alcohol extract, filter
It crosses, decompression filtrate recycling ethanol is simultaneously concentrated into the medicinal extract that relative density is 1.10 at 60 DEG C, spare;
(2) remaining bulk pharmaceutical chemicals outside Radix Notoginseng are removed, are added water to cook 3 times, are fried by intense fire after boiling for the first time 30 minutes, second
It fries by intense fire 1 hour, is fried by intense fire after boiling for the third time 1.5 hours, collecting decoction after boiling, filtered, filtrate decompression is concentrated into 80 DEG C
The medicinal extract that relative density is 1.25, it is spare;
(3) medicinal extract obtained by step (1) (2) is collectively disposed in baking oven, dry cream is baked at 75 DEG C, be ground into thin
Powder;
(4) it takes the fine powder obtained by step (3) that appropriate dextrin and starch is added to 1000g, adds water and particle is made, then
Dry, whole grain is distributed into 15g/ packets (including often dry powder drug about 7.8g).
Embodiment 2 (granule)
1, prescription:Herba Epimedii 2600g, Chinese cassia tree 900g, Radix Astragali 2200g, Schisandra chinensis 1400g, rhodiola root 1100g, Radix Notoginseng
900g, dried orange peel 900g.
2, preparation method:
Granule is made according to method described in embodiment 1.
Embodiment 3 (granule)
1, prescription:Herba Epimedii 2500g, Chinese cassia tree 900g, Radix Astragali 2200g, Schisandra chinensis 1700g, rhodiola root 900g, Radix Notoginseng
900g, dried orange peel 900g.
2, preparation method:
Granule is made according to method described in embodiment 1.
Embodiment 4 (granule)
1, prescription:Herba Epimedii 2800g, Chinese cassia tree 1100g, Radix Astragali 1800g, Schisandra chinensis 1400g, rhodiola root 900g, Radix Notoginseng
900g, dried orange peel 1100g.
2, preparation method:
Granule is made according to method described in embodiment 1.
Embodiment 5 (capsule)
The drug granule that embodiment 1 is prepared into is packed into gelatine capsule, capsule is made.
Embodiment 5 (tablet)
Tablet is made using conventional method tabletting in the drug granule that embodiment 1 is prepared into.
Claims (4)
1. a kind of drug for treating slow arrhythmia, the drug is by effective ingredient and medically acceptable excipient group
At wherein the effective ingredient is made of the bulk pharmaceutical chemicals of following weight percent:Herba Epimedii 23~28%, Chinese cassia tree 9~11%,
Radix Astragali 18~22%, Schisandra chinensis 14~17%, rhodiola root 9~11%, Radix Notoginseng 9~11%, dried orange peel 9~11%.
2. a kind of drug for treating slow arrhythmia according to claim 1, which is characterized in that it is described it is effective at
Part is made of the bulk pharmaceutical chemicals of following weight percent:Herba Epimedii 25%, Chinese cassia tree 10%, Radix Astragali 20%, Schisandra chinensis 15%, rhodiola root
10%, Radix Notoginseng 10%, dried orange peel 10%.
3. a kind of drug for treating slow arrhythmia according to claim 1 or 2, which is characterized in that the medicine
Object is prepared by following methods:
(1) Radix Notoginseng is taken, adds 8 times of 70% alcohol heat reflux of amount to extract 3 times, 1.5 hours every time, collects and merge alcohol extract, filter, filter
Liquid is recovered under reduced pressure ethyl alcohol and is concentrated into medicinal extract, spare;
(2) remaining bulk pharmaceutical chemicals outside Radix Notoginseng are removed, are added water to cook 3 times, fries by intense fire after boiling for the first time 30 minutes, boils for the second time
After fry by intense fire 1 hour, fried by intense fire after boiling for the third time 1.5 hours, collecting decoction, filter, filtrate decompression is concentrated into medicinal extract, standby
With;
(3) medicinal extract obtained by step (1) and (2) is collectively disposed in baking oven, bakes dry cream at 75 DEG C, is ground into fine powder;
(4) it takes the fine powder obtained by step (3) that suitable acceptable excipient of medicine is added, is made according to a conventional method common
Solid oral agent.
4. a kind of drug for treating slow arrhythmia according to claim 3, which is characterized in that the solid port
It is granule, capsule or tablet to take agent.
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