CN107334952B - Ear acupoint sticking and acupuncture combined traditional Chinese medicine for treating phlegm-dampness accumulation type primary hypertension and application thereof - Google Patents

Ear acupoint sticking and acupuncture combined traditional Chinese medicine for treating phlegm-dampness accumulation type primary hypertension and application thereof Download PDF

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CN107334952B
CN107334952B CN201710581367.0A CN201710581367A CN107334952B CN 107334952 B CN107334952 B CN 107334952B CN 201710581367 A CN201710581367 A CN 201710581367A CN 107334952 B CN107334952 B CN 107334952B
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李颖
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Shanghai Jing'an Traditional Chinese Medicine Hospital
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
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Abstract

The invention relates to a combination of ear acupoint pressure application and acupuncture for treating phlegm-dampness accumulation type primary hypertension, wherein the traditional Chinese medicine is prepared from the following raw material medicines: gastrodia elata, prepared pinellia ternate, uncaria, concha haliotidis, ligusticum wallichii, medicinal cyathula root, poria cocos, raw bighead atractylodes rhizome, scutellaria baicalensis, pericarpium citri reticulatae and raw liquorice. Its advantages are: the traditional Chinese medicine composition has the advantages of obvious clinical effect, blood pressure reduction of about 30mg basically, easy acceptance by patients, satisfaction of more than 90%, naturalness, no toxicity and suitability for long-term administration, supplement of each medicine, stable maintenance of the blood pressure in a normal range during administration, generally below 135%, basically no side effect, little harm to human bodies, reduction of drug resistance of the organisms and enhancement of the metabolism function of the organisms.

Description

Ear acupoint sticking and acupuncture combined traditional Chinese medicine for treating phlegm-dampness accumulation type primary hypertension and application thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to an ear acupoint sticking and acupuncture combined traditional Chinese medicine for treating phlegm-dampness accumulation type primary hypertension and application thereof.
Background
The traditional Chinese medicine has a long history, forms a unique theoretical thought and a syndrome differentiation treatment method different from the modern medicine through continuous accumulation and development, and has the characteristics of simplicity, convenience, cheapness and excellence. It includes internal medicine treatment and external non-medicine treatment, and focuses on the overall view, and the application of the therapeutic mode according with syndrome differentiation and treatment of individual patient is well accepted by patient, and more meets the requirements of modern medical development. The ear acupoint pressure application and acupuncture are combined with the traditional Chinese medicine to treat the phlegm-dampness accumulation type essential hypertension, and a traditional Chinese medicine comprehensive treatment mode of 'combination of acupuncture and medicine' and 'treatment by both internal and external methods' is explored. The comprehensive treatment of the traditional Chinese medicine is conducted by selecting reasonable traditional Chinese medicine treatment technology and method according to the specific conditions of patients in different stages of diseases under the guidance of the 'universe-human-in-one' and 'overall view' theories of the traditional Chinese medicine, and the overall advantages of the traditional Chinese medicine treatment can be furthest exerted, so that the clinical curative effect and the satisfaction degree of patients are improved. Phlegm-dampness accumulation type essential hypertension belongs to a common clinical disease, and in Danxi Xin Fa & dizziness, there is cloud which is 'no phlegm but no dizziness', phlegm-dampness runs through the whole disease process, and the clinical treatment takes spleen strengthening and phlegm reducing as the main treatment principle. On the basis of the original pure traditional Chinese medicine treatment, the comprehensive traditional Chinese medicine treatment is explored to improve the clinical curative effect and improve the medical experience of a patient.
Essential hypertension belongs to the disease name of modern medicine, and can be classified into dizziness, headache, liver wind and the like in the traditional Chinese medicine according to the symptoms of dizziness, headache and the like which are clinically common. Ancient sages about the etiology and pathogenesis of vertigo are not related to wind, phlegm, stasis, deficiency, excess and the like. Zhang Zhongjing proposed the theory of vertigo caused by phlegm-fluid retention in jin Kui Yao L ü e, phlegm-fluid retention cough syndrome and Ju Zhi, which is the first to suggest the pathogenesis of phlegm-turbidity and suggests the treatment of ze Xie Tang and Xiao ban Xia Tang. Based on the theory of Zhang Zhong Jing Tan Yin, Zhu Danxi puts forward the theory of "no phlegm and no dizziness" and stresses that the person with damp phlegm should be treated with Erchen decoction. In modern clinic, the primary hypertension patients are mostly accompanied by diseases such as hyperlipidemia, hyperglycemia, high blood viscosity and the like, and the disease course is generally longer. It is often related to senile and body failure, improper diet, emotional distress and malnutrition. The generation and development of the above factors will not damage qi, blood and body fluids, and then produce phlegm-turbidity, so the syndrome of phlegm-dampness accumulation is usually seen in clinic. Even Donghui applied to the modified gallbladder warming decoction for treating 60 cases of essential hypertension with phlegm-dampness accumulation is superior to the western medicine applied to the treatment of both the traditional Chinese medicine syndrome curative effect and the blood pressure curative effect. The application of Zhumei and the like in syndrome-based medicine is to carry out systematic evaluation on the random control test literature of the pinellia ternate, rhizoma atractylodis macrocephalae and rhizoma gastrodiae decoction for treating the phlegm-dampness accumulation type essential hypertension, and the result shows that the pinellia ternate, rhizoma atractylodis macrocephalae and rhizoma gastrodiae decoction can enhance the blood pressure reducing effect and improve the traditional Chinese medicine syndrome. Clinical researches show that the traditional Chinese medicine composition in the embodiment 6 is combined with a hypotensor to treat the phlegm-dampness accumulation type essential hypertension, the clinical curative effect is superior to that of pure western medicine treatment, and the traditional Chinese medicine composition has a function of reducing uric acid.
Essential hypertension is one of the risk factors causing cardiovascular and cerebrovascular severe diseases such as stroke and myocardial infarction. At present, the clinical treatment of essential hypertension mainly comprises drug therapy, and symptoms such as dizziness, head distension and the like accompanied by patients and blood pressure fluctuation along with the change of seasons and air temperatures are difficult points of clinical medication. The comprehensive treatment of traditional Chinese medicine is a treatment method for comprehensively applying internal treatment and external treatment of traditional Chinese medicine, and reflects the flexibility and diversity of traditional Chinese medicine treatment. It is clinically established that acupuncture can stabilize the blood pressure of patients with essential hypertension. The chronic disease of essential hypertension of mild or moderate phlegm-dampness accumulation type can be treated by needling the acupoints of Yinlingquan (bilateral), Zusanli (bilateral), Zhongwan and Fenglong (bilateral), which has advantages over the simple application of western medicines in improving the hospitalization feeling and the quality of life of the patient. Li Ting and so on apply auricular point paste pressure to combine with hypotensor to treat primary hypertension to obtain certain clinical curative effect. Wei Si Ning and the like are used for treating auricular points of patients with liver-fire hyperactivity type, phlegm-dampness accumulation type, yin deficiency and yang hyperactivity type and yin-yang deficiency type primary hypertension, and the results are as follows: the blood pressure of the patients with hyperactivity of liver fire and yin deficiency and yang hyperactivity is remarkably reduced. The von hong acupuncture and moxibustion and ear acupoint sticking pressure are used for treating primary hypertension with syndrome of excessive phlegm-dampness complicated with obesity, and have the effects of lowering blood pressure and reducing quality. The Su Bao and the like can effectively control the blood pressure level of community essential hypertension patients and simultaneously reduce the incidence rate of complications by applying comprehensive intervention of oral antihypertensive drugs, ear acupoint sticking pressure, ginkgo leaf tea infusion and the like. Based on western medicine antihypertensive drugs, the traditional Chinese medicine oral administration and acupuncture are added to treat the senile essential hypertension, and the result shows that the long-term antihypertensive effect is obvious, and the traditional Chinese medicine has the effect of continuously relieving the clinical symptoms of patients.
Chinese patent document CN103751203A discloses a pharmaceutical composition for treating essential hypertension and its application, the pharmaceutical composition comprises the following raw materials: wolfberry polysaccharide component-II, wolfberry polysaccharide component-III, friedelin-3 beta-alcohol, astragalus polysaccharide component Al and leonurus glycoside A. Chinese patent document CN102526470A discloses a pharmaceutical composition for treating essential hypertension, which is prepared from the following active ingredients in parts by weight: 10-15 parts of chrysanthemum, 10-15 parts of mulberry leaf, 12-16 parts of earthworm, 12-16 parts of scutellaria baicalensis, 12-16 parts of radix scrophulariae, 18-22 parts of salvia miltiorrhiza, 12-16 parts of radix rehmanniae, 10-15 parts of radix paeoniae alba, 8-12 parts of radix ophiopogonis, 18-22 parts of radix angelicae pubescentis and 12-16 parts of herba cirsii jeponici, but the application of the auricular point patch pressure and acupuncture combined traditional Chinese medicine for treating phlegm-dampness accumulation type primary hypertension and the application thereof are not reported at present.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating primary hypertension in the type of excessive phlegm-dampness by combining ear acupoint sticking and acupuncture aiming at the defects in the prior art.
The invention further aims to provide the traditional Chinese medicine composition for treating the phlegm-dampness accumulation type primary hypertension.
Another object of the present invention is to provide the use of a Chinese medicinal composition.
In order to achieve the purpose, the invention adopts the technical scheme that: a traditional Chinese medicine composition for treating phlegm-dampness accumulation type primary hypertension is prepared from the following raw material medicines in parts by weight: 7-11 parts of gastrodia elata, 7-11 parts of prepared pinellia ternate, 12-18 parts of uncaria (after-treatment), 12-18 parts of concha haliotidis, 16-20 parts of ligusticum wallichii, 12-18 parts of medicinal cyathula root, 12-18 parts of poria cocos, 7-11 parts of raw bighead atractylodes rhizome, 10-14 parts of scutellaria baicalensis, 10-14 parts of dried orange peel and 2-4 parts of raw liquorice.
The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 9 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 15 parts of uncaria (placed later), 15 parts of concha haliotidis (placed first), 18 parts of ligusticum wallichii, 15 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 12 parts of dried orange peel and 3 parts of raw liquorice.
In order to realize the second purpose, the invention adopts the technical scheme that: a traditional Chinese medicine composition for treating phlegm-dampness accumulation type primary hypertension is prepared from the following raw material medicines in parts by weight: 13-17 parts of gastrodia elata, 8-12 parts of ligusticum wallichii, 15-25 parts of medicinal cyathula root, 8-12 parts of poria cocos, 10-14 parts of dried orange peel, 8-12 parts of angelica sinensis, 13-17 parts of salvia miltiorrhiza, 8-12 parts of schisandra chinensis, 4-6 parts of radix ophiopogonis, 15-20 parts of andrographis paniculata and 4-6 parts of ginkgo.
The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 14-16 parts of gastrodia elata, 9-11 parts of ligusticum wallichii, 18-22 parts of medicinal cyathula root, 9-11 parts of poria cocos, 11-13 parts of dried orange peel, 9-11 parts of angelica sinensis, 14-16 parts of salvia miltiorrhiza, 9-11 parts of schisandra chinensis, 4.5-5.5 parts of radix ophiopogonis, 16-20 parts of andrographis paniculata and 4.5-5.5 parts of ginkgo.
The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15 parts of gastrodia elata, 10 parts of ligusticum wallichii, 20 parts of medicinal cyathula root, 10 parts of poria cocos, 12 parts of dried orange peel, 10 parts of angelica sinensis, 15 parts of salvia miltiorrhiza, 10 parts of schisandra chinensis, 5 parts of radix ophiopogonis, 18 parts of andrographis paniculata and 5 parts of ginkgo.
In order to achieve the third object, the invention adopts the technical scheme that: the traditional Chinese medicine composition is applied to preparing a medicine for treating phlegm-dampness accumulation type primary hypertension.
The dosage form of the medicine is granules, capsules, tablets, pills or oral liquid.
The invention has the advantages that:
1. the traditional Chinese medicine composition has remarkable clinical effect, the blood pressure reduction is basically about 30mg, the traditional Chinese medicine composition is easily accepted by patients, and the satisfaction degree is over 90 percent.
2. The traditional Chinese medicine composition is natural and non-toxic, is suitable for long-term administration, the medicines supplement each other, and the blood pressure is stably maintained in a normal range during administration, generally below 135.
3. The traditional Chinese medicine composition disclosed by the invention basically has no side effect, causes little harm to a human body, and can reduce the drug resistance of an organism and enhance the metabolism function of the organism.
Detailed Description
The following examples are provided to illustrate specific embodiments of the present invention.
The invention provides a combination of ear acupoint pressure application and acupuncture for treating phlegm-dampness accumulation type primary hypertension, wherein the traditional Chinese medicine is prepared from the following raw material medicines in parts by weight: 7-11 parts of gastrodia elata, 7-11 parts of prepared pinellia ternate, 12-18 parts of uncaria (after-treatment), 12-18 parts of concha haliotidis, 16-20 parts of ligusticum wallichii, 12-18 parts of medicinal cyathula root, 12-18 parts of poria cocos, 7-11 parts of raw bighead atractylodes rhizome, 10-14 parts of scutellaria baicalensis, 10-14 parts of dried orange peel and 2-4 parts of raw liquorice.
Example 1 Chinese medicinal composition
7 parts of gastrodia elata, 11 parts of prepared pinellia ternate, 12 parts of uncaria, 12 parts of concha haliotidis, 16 parts of ligusticum wallichii, 16 parts of medicinal cyathula root, 12 parts of poria cocos, 7 parts of raw bighead atractylodes rhizome, 10 parts of scutellaria baicalensis, 10 parts of pericarpium citri reticulatae and 2 parts of raw liquorice.
Example 2 Chinese medicinal composition
8 parts of gastrodia elata, 10 parts of prepared pinellia ternate, 13 parts of uncaria, 13 parts of concha haliotidis, 17 parts of ligusticum wallichii, 15 parts of medicinal cyathula root, 13 parts of poria cocos, 8 parts of raw bighead atractylodes rhizome, 11 parts of scutellaria baicalensis, 11 parts of pericarpium citri reticulatae and 2.5 parts of raw liquorice.
Example 3 Chinese medicinal composition
9 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 14 parts of uncaria, 14 parts of concha haliotidis, 18 parts of ligusticum wallichii, 14 parts of medicinal cyathula root, 14 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 12 parts of pericarpium citri reticulatae and 3 parts of raw liquorice.
Example 4 Chinese medicinal composition one
10 parts of gastrodia elata, 8 parts of prepared pinellia ternate, 15 parts of uncaria, 15 parts of concha haliotidis, 19 parts of ligusticum wallichii, 13 parts of medicinal cyathula root, 15 parts of poria cocos, 10 parts of raw bighead atractylodes rhizome, 13 parts of scutellaria baicalensis, 13 parts of pericarpium citri reticulatae and 3.5 parts of raw liquorice.
Example 5 Chinese medicinal composition one
11 parts of gastrodia elata, 7 parts of prepared pinellia ternate, 16 parts of uncaria, 16 parts of concha haliotidis, 20 parts of ligusticum wallichii, 12 parts of medicinal cyathula root, 16 parts of poria cocos, 11 parts of raw bighead atractylodes rhizome, 14 parts of scutellaria baicalensis, 14 parts of pericarpium citri reticulatae and 4 parts of raw liquorice.
Example 6 Chinese medicinal composition
9 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 15 parts of uncaria, 15 parts of concha haliotidis, 18 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 12 parts of pericarpium citri reticulatae and 3 parts of raw liquorice.
Example 7 Chinese medicinal composition
9 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 15 parts of uncaria, 15 parts of concha haliotidis, 18 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 12 parts of pericarpium citri reticulatae and 3 parts of raw liquorice.
Example 8 Chinese medicinal composition one
11 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 17 parts of uncaria, 15 parts of concha haliotidis, 18 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 12 parts of pericarpium citri reticulatae and 3 parts of raw liquorice.
Example 9 Chinese medicinal composition one
11 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 18 parts of uncaria, 15 parts of concha haliotidis, 18 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 12 parts of pericarpium citri reticulatae and 2 parts of raw liquorice.
Example 10 Chinese medicinal composition one
8 parts of gastrodia elata, 8 parts of prepared pinellia ternate, 14 parts of uncaria, 15 parts of concha haliotidis, 18 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 14 parts of pericarpium citri reticulatae and 3 parts of raw liquorice.
Example 11 Chinese medicinal composition one
9 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 17 parts of uncaria, 15 parts of concha haliotidis, 18 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 13 parts of pericarpium citri reticulatae and 3 parts of raw liquorice.
Example 12 Chinese medicinal composition
9 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 17 parts of uncaria, 17 parts of concha haliotidis, 16 parts of ligusticum wallichii, 13 parts of medicinal cyathula root, 13 parts of poria cocos, 7 parts of raw bighead atractylodes rhizome, 11 parts of scutellaria baicalensis, 12 parts of pericarpium citri reticulatae and 3 parts of raw liquorice.
EXAMPLE 13 preparation of Chinese medicinal composition I
The conventional preparation method of the sealed package liquid medicine is adopted, namely, the traditional Chinese medicine composition in any one of the embodiments 1 to 12 is put into a decocting machine to prepare 150ml of sealed package liquid medicine.
EXAMPLE 14 clinical trial
1 data and method
1.1 case selection
1.1.1 diagnostic criteria
The western medicine diagnosis meets the diagnosis standard of essential hypertension in the Chinese hypertension prevention and treatment guideline 2010. The diagnosis of syndrome in traditional Chinese medicine refers to the guidelines of clinical research on new Chinese medicines, and syndrome differentiation is caused by excessive phlegm-dampness.
1.1.2 inclusion criteria
The diagnosis standard of western medicine diagnosis and traditional Chinese medicine syndrome of primary hypertension is met; age 18-75 years old, male and female; the blood pressure value is not up to the standard after taking the antihypertensive drug.
1.1.3 exclusion criteria
Those under 18 years of age or over 75 years of age; pregnant or lactating women; secondary hypertension; patients with serious primary diseases and mental diseases such as heart, brain, liver, kidney and hematopoietic system; allergic constitution and people allergic to various drugs.
1.2 general data
All 367 patients are outpatients of the department of traditional Chinese medicine comprehensive treatment of cardiovascular diseases in our hospital and are randomly divided into 2 groups. 192, male 90, female 102 treatment groups; age 45-74 years, mean (57.46 ± 0.86) years; combined coronary heart disease 11 cases, cerebrovascular accident 3 cases, type 2 diabetes 5 cases, coronary heart disease and cerebrovascular accident 4 cases, coronary heart disease and type 2 diabetes 4 cases. Control group 175, male 82, female 93; age 46-75 years, mean (58.60 ± 0.85) years; combined coronary heart disease 12 cases, cerebrovascular accident 3 cases, type 2 diabetes 5 cases, coronary heart disease and cerebrovascular accident 7 cases, coronary heart disease and type 2 diabetes 6 cases. The comparison of 2 general data has no statistical significance (P <0.05) and is comparable.
1.3 methods of treatment
The 2 groups are all treated by internal medicine conventional treatment, including blood pressure reduction, blood sugar reduction, anticoagulation and the like.
1.3.1 control group
The medicine comprises the following components: 9 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 15 parts of uncaria, 15 parts of concha haliotidis, 18 parts of ligusticum wallichii, 15 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 12 parts of pericarpium citri reticulatae and 3 parts of raw liquorice. The daily dose of the decoction is 1 dose, and the decoction is prepared into sealed package of 2 bags of 150ml per bag and taken 1 bag in the morning and at night.
1.3.2 treatment groups
Ear acupoint sticking and acupuncture treatment is added on the basis of the treatment of the control group. And (3) ear acupoint selection: the depression channel (the dorsal aspect of the auricle, the sulcus running from the upper to the lower), the liver (the posterior aspect of the stomach and duodenum), and the kidney (the inferior border of the lower crus of the antihelix, the point of the small intestine). The physician's left hand holds the auricle with the finger and the right hand grasps the auricular magnetic beads with forceps. And (3) aligning the magnetic beads to the acupuncture points, clinging to the acupuncture points, pressing the magnetic beads on the acupuncture points, and slightly kneading and pressing for 1-2 min. Pressing 3-6 acupoints every time, 2-3 times daily. Acupuncture point selection: sanyinjiao (on the medial aspect of the calf, 3 cun above the medial malleolus, posterior to the medial border of the tibia), rerun (on the medial aspect of the calf, 2 cun above the straight Taixi, in front of the Achilles tendon), Taixi (on the posterior aspect of the medial malleolus, in the depression between the medial malleolus and the Achilles tendon), and Taichong (on the dorsal aspect of the foot, in the depression posterior aspect of the 1 st metatarsal gap). Using Huatuo brand disposable aseptic acupuncture needle (0.25X 0.25mm), applying Pingbu Pingtui method, and keeping the needle for 20 min.
1.3.3 courses of treatment
All 2 groups were treated 3 times per week for 4 weeks.
1.4 Observation index
Observing the blood pressure change before and after treatment. Secondly, according to the description of the syndrome of excessive phlegm-dampness in the guideline of clinical research of new traditional Chinese medicines, the integral of the syndrome of traditional Chinese medicine is recorded, and the clinical symptoms such as dizziness, headache, head wrapping, chest distress, vomiting phlegm and saliva, palpitation, insomnia, pale mouth, poor appetite, swollen tongue with greasy coating, slippery pulse and the like are respectively counted according to the non-weight, light weight, middle weight and heavy weight for 0, 2, 4 and 6. Respectively evaluating 10 aspects of improving main symptoms, service attitudes and technical levels of doctors and nurses, convenience, comfort level and total treatment value of comprehensive treatment, environment and identification of a consulting room, paying attention to protection of patient privacy and the like, respectively calculating 4 grades of satisfaction, more satisfaction, general satisfaction and dissatisfaction, respectively calculating 10, 8, 6 and 4 grades of the total grades, and then grading the total grades to serve as a comparison basis of 2 groups of satisfaction degrees. And (3) satisfaction: the total score is 80 minutes (excluding) to 100 minutes (including); the method is more satisfactory: total score of 60 (excluding) to 80 (inclusive); in general: a total of 40 minutes (excluding) to 60 minutes (including); dissatisfaction: the total min is ≦ 40 min. Fourthly, recording adverse reactions of patients during treatment. And counting the total satisfaction rate by satisfaction + relatively satisfaction.
1.5 Standard of curative effects of the traditional Chinese medicine syndrome
The effect is shown: clinical symptoms and physical signs are obviously improved, and the traditional Chinese medicine syndrome integral is reduced by more than or equal to 70%; the method has the following advantages: the clinical symptoms and physical signs are improved, and the traditional Chinese medicine syndrome integral is reduced by 30-70 percent (containing 30 percent); and (4) invalidation: clinical symptoms and physical signs are not obviously improved or even aggravated, and the traditional Chinese medicine syndrome integral is reduced by less than 30 percent.
1.6 therapeutic Standard of blood pressure
The effect is shown: the diastolic pressure drops by more than 10mmHg (1mmHg ═ 0.133kPa) and reaches the normal range or the diastolic pressure has not dropped to the normal range, but has dropped to more than 20 mmHg; the method has the following advantages: the diastolic pressure is reduced by less than 10mmHg, but has reached the normal range or is reduced by 10-19mmHg before the diastolic pressure, but still has not reached the normal range or is reduced by more than 30mmHg before the systolic pressure; and (4) invalidation: the above standard is not met.
1.7 statistical methods
Statistical processing is carried out on the data by using an SPSS21.0 statistical analysis system, and the mean value is +/-standard deviation
Figure BDA0001352379720000072
Representing a value belonging to a normal distribution, using a repeated measurement test; expressing the numerical value belonging to the abnormal distribution by using a median form, and applying an nonparametric rank sum test; the grade data is checked with nonparametric rank sum.
2 results
2.12 the syndrome curative effects of the traditional Chinese medicines are compared (see Table 1)
TABLE 12 comparative examples of the therapeutic effects of the syndrome of traditional Chinese medicine
Group of n Show effect Is effective Invalidation The total effective rate%
Treatment group 192 123 65 4 97.92*
Control group 175 28 101 46 73.71
P <0.05 compared to control group
As can be seen from Table 1, the comparison and difference of the total effective rates of the 2 groups has statistical significance (P <0.05), and the curative effect of the traditional Chinese medicine syndrome in the treatment group is better than that in the control group.
2.22 group blood pressure curative effect comparison (see Table 2)
TABLE 22 comparative examples of blood pressure therapeutic effect
Figure BDA0001352379720000071
Figure BDA0001352379720000081
P <0.05 compared to control group
As can be seen from Table 2, the comparison of the differences of the total effective rates of the 2 groups is statistically significant (P <0.05), and the curative effect of the blood pressure of the treated group is better than that of the control group.
2.32 before and after treatment, the integration of traditional Chinese medicine syndromes is compared (see Table 3)
In Table 32, the syndrome integrals of TCM are compared before and after treatment,
Figure BDA0001352379720000082
Figure BDA0001352379720000083
compared with the control group, the compound of the formula,*P<0.05; the comparison is carried out in the group,P<0.05
as can be seen from Table 3, the reduction of the syndrome integral of TCM was statistically different in the 2 groups after treatment, and the treated group was better than the control group.
2.42 group comparison of blood pressure before and after treatment (see Table 4)
TABLE 42 group comparison of blood pressure before and after treatment
Figure BDA0001352379720000084
Figure BDA0001352379720000085
Compared with the control group, the compound of the formula,*P<0.05; the comparison is carried out in the group,P<0.05 As can be seen from Table 4, after treatment, the reductions in systolic and diastolic blood pressure were statistically different in the 2 groups, and the reductions in systolic and diastolic blood pressure were better in the treated group than in the control group.
Group 2.52 satisfaction comparisons (see table 5).
TABLE 52 comparative examples of satisfaction
Group of n Satisfaction Is more satisfactory In general Is not satisfied with The total satisfaction rate%
Treatment group 192 163 16 13 0 93.23*
Control group 175 83 75 17 0 90.29
P <0.05 compared to control group
As can be seen from Table 5, the comparison of the differences in the total satisfaction rates of the 2 groups was statistically significant (P <0.05), and the satisfaction of the treated group was superior to that of the control group.
2.62 adverse events
No obvious adverse reactions such as bleeding and rash were observed in group 2.
The traditional Chinese medicine comprehensively treats the primary hypertension with excessive phlegm-dampness, and the curative effect of the traditional Chinese medicine on the syndrome and the blood pressure is superior to that of the traditional Chinese medicine only. Meanwhile, the satisfaction degree of the patients in the treatment group is superior to that of the patients in the control group, which shows that the patients are satisfied with the improvement of the main symptoms of the patients and the convenience and comfort degree of the technical level and the comprehensive treatment of the medical staff. In conclusion, the ear acupoint pressure application and acupuncture combined with the traditional Chinese medicine for treating the phlegm-dampness accumulation type essential hypertension has a remarkable clinical effect, is easily accepted by patients, and is worth popularizing to the basic community service center.
Example 15 Chinese medicinal composition II
15 parts of gastrodia elata, 10 parts of ligusticum wallichii, 20 parts of medicinal cyathula root, 10 parts of poria cocos, 12 parts of dried orange peel, 10 parts of angelica sinensis, 15 parts of salvia miltiorrhiza, 10 parts of schisandra chinensis, 5 parts of radix ophiopogonis, 18 parts of andrographis paniculata and 5 parts of ginkgo.
Example 16 Chinese medicinal composition II
14 parts of gastrodia elata, 11 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 11 parts of poria cocos, 11 parts of dried orange peel, 9 parts of angelica sinensis, 14 parts of salvia miltiorrhiza, 11 parts of schisandra chinensis, 4.5 parts of radix ophiopogonis, 16 parts of andrographis paniculata and 4.5 parts of ginkgo.
Example 17 Chinese medicinal composition II
16 parts of gastrodia elata, 9 parts of ligusticum wallichii, 22 parts of medicinal cyathula root, 9 parts of poria cocos, 13 parts of dried orange peel, 11 parts of angelica, 16 parts of salvia miltiorrhiza, 9 parts of schisandra chinensis, 5.5 parts of radix ophiopogonis, 20 parts of andrographis paniculata and 5.5 parts of ginkgo.
EXAMPLE 18 Chinese medicinal composition II
13 parts of gastrodia elata, 12 parts of ligusticum wallichii, 15 parts of medicinal cyathula root, 12 parts of poria cocos, 10 parts of dried orange peel, 12 parts of angelica sinensis, 13 parts of salvia miltiorrhiza, 12 parts of schisandra chinensis, 4 parts of radix ophiopogonis, 20 parts of andrographis paniculata and 4 parts of ginkgo.
EXAMPLE 19 Chinese medicinal composition II
17 parts of gastrodia elata, 8 parts of ligusticum wallichii, 25 parts of medicinal cyathula root, 8 parts of poria cocos, 14 parts of dried orange peel, 8 parts of angelica sinensis, 17 parts of salvia miltiorrhiza, 8 parts of schisandra chinensis, 6 parts of radix ophiopogonis, 15 parts of andrographis paniculata and 6 parts of ginkgo.
EXAMPLE 20 preparation of Chinese medicinal composition two
The method of any one of embodiments 15-19, wherein the decoction is obtained by decocting the Chinese medicinal composition in water.
EXAMPLE 21 preparation of Chinese medicinal composition two
Any of the Chinese medicinal compositions of examples 15-19 can be prepared into any dosage form, such as granules, capsules, tablets, pills, oral liquids, and the like, by conventional preparation means.
Example 22 animal experiments
1. Selection of laboratory animals
New Zealand white rabbits (male) with the weight of 2.45 + -0.59 kg are selected for 90 rabbits.
2. Experimental methods
2.1 animal model creation
Experimental animals were randomly divided into two groups, 10 normal control groups, 80 model groups, and high-sugar, high-salt feed. The high-sugar feed contains 75% of sugar, 12% of fat and 13% of protein according to caloric calculation, and drinking 1.5% of NaCL solution (prepared by ionized water) is unlimited. The normal control group is fed with common feed, sugar accounts for 50% of the total calorie, deionized water is drunk, the quantity is unlimited, and the total calories of the two groups are similar. Meanwhile, the dwelling environment of the model group is humid, the humidity is 85-90%, and the temperature is 18-20 ℃.
2.2 raising for 8 weeks, then carrying out experiments, fasting and water deprivation for 12 hours before the experiments, and measuring the blood pressure by a rabbit blood pressure measuring method after weighing. Under the quiet condition of rabbits, the average value of the rabbit is measured every five minutes, and the model group is determined to be a model when the systolic pressure (SBP) is more than or equal to 140mmHg and the diastolic pressure (DBP) is more than or equal to 90mmHg simultaneously causes obesity, the weight is obviously increased, the patients suffer from anorexia, sleepiness, laziness, no drinking water and stool shapelessness.
2.3 randomly dividing the 90 molded rabbits into a blank control group, a treatment group I, a treatment group II, a treatment group III, a treatment group IV, a control group I, a control group II, a control group III, a control group IV and 10 rabbits in each group, feeding common feed after molding, and drinking deionized water.
2.31 blank control group: feeding with common feed, and drinking deionized water.
2.32 treatment group one: feeding with common feed, adding deionized water, and infusing with 20ml medicinal liquid prepared from Chinese medicinal composition. The formula of the traditional Chinese medicine composition (example 17): 16 parts of gastrodia elata, 9 parts of ligusticum wallichii, 22 parts of medicinal cyathula root, 9 parts of poria cocos, 13 parts of dried orange peel, 11 parts of angelica, 16 parts of salvia miltiorrhiza, 9 parts of schisandra chinensis, 5.5 parts of radix ophiopogonis, 20 parts of andrographis paniculata and 5.5 parts of ginkgo.
2.33 treatment group two: feeding with common feed, adding deionized water, and infusing with 20ml medicinal liquid prepared from Chinese medicinal composition. The formula of the traditional Chinese medicine composition (example 16): 14 parts of gastrodia elata, 11 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 11 parts of poria cocos, 11 parts of dried orange peel, 9 parts of angelica sinensis, 14 parts of salvia miltiorrhiza, 11 parts of schisandra chinensis, 4.5 parts of radix ophiopogonis, 16 parts of andrographis paniculata and 4.5 parts of ginkgo.
2.34 treatment group three: feeding with common feed, adding deionized water, and infusing with 20ml medicinal liquid prepared from Chinese medicinal composition. The formula of the traditional Chinese medicine composition (example 15): 15 parts of gastrodia elata, 10 parts of ligusticum wallichii, 20 parts of medicinal cyathula root, 10 parts of poria cocos, 12 parts of dried orange peel, 10 parts of angelica sinensis, 15 parts of salvia miltiorrhiza, 10 parts of schisandra chinensis, 5 parts of radix ophiopogonis, 18 parts of andrographis paniculata and 5 parts of ginkgo.
2.35 treatment group four: feeding with common feed, adding deionized water, and infusing with 20ml medicinal liquid prepared from Chinese medicinal composition. The formula of the traditional Chinese medicine composition (example 18): 13 parts of gastrodia elata, 12 parts of ligusticum wallichii, 15 parts of medicinal cyathula root, 12 parts of poria cocos, 10 parts of dried orange peel, 12 parts of angelica sinensis, 13 parts of salvia miltiorrhiza, 12 parts of schisandra chinensis, 4 parts of radix ophiopogonis, 20 parts of andrographis paniculata and 4 parts of ginkgo.
2.36 control group one: feeding with common feed, adding deionized water, and infusing with 20ml medicinal liquid prepared from Chinese medicinal composition. The formula of the traditional Chinese medicine composition comprises: 15 parts of gastrodia elata, 10 parts of ligusticum wallichii, 20 parts of medicinal cyathula root, 10 parts of poria cocos and 12 parts of dried orange peel.
2.37 control group two: feeding with common feed, adding deionized water, and infusing with 20ml medicinal liquid prepared from Chinese medicinal composition. The formula of the traditional Chinese medicine composition comprises: 9 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 15 parts of uncaria, 15 parts of concha haliotidis, 18 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 12 parts of pericarpium citri reticulatae and 3 parts of raw liquorice.
2.38 control group three: feeding with common feed, adding deionized water, and infusing with 20ml medicinal liquid prepared from Chinese medicinal composition. The formula of the traditional Chinese medicine composition comprises: 9 parts of gastrodia elata, 9 parts of prepared pinellia ternate, 15 parts of uncaria, 15 parts of concha haliotidis, 18 parts of ligusticum wallichii, 18 parts of medicinal cyathula root, 15 parts of poria cocos, 9 parts of raw bighead atractylodes rhizome, 12 parts of scutellaria baicalensis, 12 parts of pericarpium citri reticulatae, 3 parts of raw liquorice, 10 parts of angelica sinensis, 15 parts of salvia miltiorrhiza, 10 parts of schisandra chinensis, 5 parts of radix ophiopogonis, 18 parts of andrographis paniculata and 5 parts of ginkgo.
2.39 control group four: feeding with common feed, adding deionized water, and infusing with 20ml medicinal liquid prepared from Chinese medicinal composition. The formula of the traditional Chinese medicine composition comprises: 10 parts of angelica, 15 parts of salvia miltiorrhiza, 10 parts of schisandra chinensis, 5 parts of radix ophiopogonis, 18 parts of andrographis paniculata, 5 parts of ginkgo and 5 parts of chrysanthemum.
After the treatment of more than 2.4 months, the blood pressure and various symptoms of the rabbits are retested.
3. Statistical method
The results are expressed as means plus minus standard deviation
Figure BDA0001352379720000111
The analysis was checked with t.
4. Results
TABLE 6 improvement of symptoms in each group
Figure BDA0001352379720000112
Note: the improvement of various symptoms is not improved in the blank control group, and the improvement effect of the treatment group III is best
TABLE 7 improvement of symptoms in each group
Figure BDA0001352379720000113
Figure BDA0001352379720000121
TABLE 8 comparison of blood pressure after treatment
n SBP(mmHg)
Blank control group 10 172.167±4.895
Treatment group one 10 120.369±4.235
Treatment group two 10 118.253±2.364
Treatment group III 10 112.258±3.365
Treatment group four 10 115.833±6.559
Control group one 10 135.167±4.855
Control group two 10 138.697±5.247
Control group III 10 139.123±6.544
Control group IV 10 140.325±5.321
In conclusion, it can be seen that the blood pressure reduction of the example group is obvious, the comparison ratio is good, and the curative effect of the treatment group is the best.
EXAMPLE 23 clinical trial
1 data and method
1.1 case selection
1.1.1 inclusion criteria
The diagnosis of the symptoms of the traditional Chinese medicine refers to the guiding principle of clinical research of new traditional Chinese medicines, and the syndrome differentiation belongs to the patients with excessive phlegm-dampness; the Western diagnosis standard refers to the 2010 Chinese guideline for hypertension prevention and treatment (the third edition), and meets the hypertension of grade 2 (moderate).
1.1.2 exclusion criteria
Refer to the guideline for clinical research of new Chinese medicine.
1.1.3 case sources and groupings
All cases were patients in the cardiology department of traditional Chinese medicine hospitals in the quiet zone of Shanghai city from 12 months to 2016 and 9 months in 2015. The treatment group I, the treatment group II and the control group are randomly divided into 30 cases respectively, and the total number of the treatment group I, the treatment group II and the control group is 90 cases. The sex, age and course of disease of each group are statistically treated, have no statistical significance (P >0.10) and are comparable.
1.2 methods of treatment
Control group: levamlodipine besylate tablet 2.5mg, is orally taken, 2.5mg each time, 1 time daily.
Treatment group one: the traditional Chinese medicine composition provided by the embodiment 15 of the invention is taken on the basis of treatment of a control group, the total amount of traditional Chinese medicines is 132g, and the traditional Chinese medicine composition is taken orally 1 dose per day and is divided into two times.
Treatment group two: the traditional Chinese medicine composition disclosed in the embodiment 6 of the invention is taken on the basis of the treatment of the control group, and the application is the same as that of the treatment group I.
Treatment results were counted 4 weeks after treatment in all groups.
1.3 Observation index
Measuring blood pressure: the specific measurement and calculation methods of blood pressure refer to the method for measuring blood pressure in 2010 Chinese hypertension control guidelines (third edition), and the measured blood pressure values of treatment weeks 0 and 4 are recorded respectively.
1.4 therapeutic efficacy assessment criteria
Blood pressure curative effect judgment standard: refer to the guidance principle of clinical research of new Chinese medicine in 2002. The effect is shown: the diastolic pressure is reduced by more than 10mmHg and reaches the normal range or the diastolic pressure is not reduced to the normal range but is reduced to more than 20 mmHg; the method has the following advantages: the diastolic pressure is reduced by less than 10mmHg, but has reached the normal range or is reduced by 10-19mmHg before the diastolic pressure, but still has not reached the normal range or is reduced by more than 30mmHg before the systolic pressure; and (4) invalidation: those which do not meet the above standards.
2 results
And evaluating and comparing the curative effect of the three groups of blood pressure.
TABLE 9 comparative examples of evaluation of post-treatment (4-week) blood pressure efficacy of six groups
Group of n (number of cases) Show effect Is effective Invalidation Total effective%
Treatment group one 30 20 10 0 100
Treatment group two 30 10 17 3 90
Control group 30 6 18 6 80
As can be seen from table 9, the total effective rate of the blood pressure therapeutic effect of the treatment group is better than that of the control group compared with the control group, wherein the effect of the treatment group is the most significant, and the difference is significant (P < 0.05).
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims (3)

1. The traditional Chinese medicine composition for treating phlegm-dampness accumulation type primary hypertension is characterized by being prepared from the following raw material medicines in parts by weight: 15 parts of gastrodia elata, 10 parts of ligusticum wallichii, 20 parts of medicinal cyathula root, 10 parts of poria cocos, 12 parts of dried orange peel, 10 parts of angelica sinensis, 15 parts of salvia miltiorrhiza, 10 parts of schisandra chinensis, 5 parts of radix ophiopogonis, 18 parts of andrographis paniculata and 5 parts of ginkgo.
2. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for treating phlegm-dampness accumulation type primary hypertension.
3. The use of claim 2, wherein the pharmaceutical dosage form is a granule, a capsule, a tablet, a pill, or an oral liquid.
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