CN115501275B - Traditional Chinese medicine composition for treating subdural hematoma and application thereof - Google Patents
Traditional Chinese medicine composition for treating subdural hematoma and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating subdural hematoma and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 30-60 parts of motherwort herb, 9-20 parts of peach kernel, 9-20 parts of safflower and 3-6 parts of leech. The Chinese medicinal composition can be prepared into any oral preparation according to a conventional Chinese medicinal preparation method. In order to facilitate dispensing and avoid decoction, each Chinese medicinal material (such as Chinese medicinal decoction pieces) can be replaced by commercially available Chinese medicinal granule with equivalent crude drug amount, and the Chinese medicinal granule of each Chinese medicinal material can be directly mixed. It is administered by soaking in boiled water. Clinical researches prove that the recipe can promote the absorption of the subdural hematoma, improve the neurological deficit symptom of a patient, improve the life quality of the patient, reduce the recurrence, reduce the operation risk and the economic burden of the patient, become the beneficial choice of a small amount of acute/subacute subdural hematoma patients with chronic subdural hematoma and stable illness state, especially the aged chronic subdural hematoma patients, and has great economic benefit and social benefit.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating subdural hematoma and application thereof.
Background
Subdural hematomas (subdural hematoma, SDH) are hematomas that occur between the cerebral cortex and the dura mater after a craniocerebral injury, and are common secondary lesions to craniocerebral injury with a incidence of about 5%, accounting for about 40% of intracranial hematomas. The incidence rate of acute SDH is up to 70%, subacute accounts for about 5%, the two diseases are urgent, and the prognosis is poor. Chronic subdural hematomas (chronic subdural hematoma, CSDH) are a common neurosurgical disease, accounting for about 10% of intracranial hematomas, accounting for 25% of subdural hematomas, and are mainly found in older people with a prevalence of about 8.2-14.0/100,000, with an average age of 76.8 years. Chronic diseases such as hypertension, coronary heart disease, cerebrovascular disease and the like are often combined with old patients, often have the history of taking antiplatelet medicines such as long-term aspirin, and the risk of bleeding causes incapacity of drilling drainage operation or high operation risk, and serious complications and even death (the death rate is up to 32 percent) can be generated. Although drilling drainage is the first treatment method for treating the disease, the recurrence rate after operation is high, which can reach about 5% -30%, and the operation rate is 29%, even the repeated recurrence has to be subjected to multiple operation treatments or the interventional embolism treatment of the medial artery of the focus side dura mater. With the global approach to the aging society and the wide use of anticoagulant and antiplatelet aggregation drugs, there is a clear trend to increase the incidence of CSDH, which is necessary to enhance the drug therapy study of this disease.
At present, no medicine treatment method with definite curative effect and good prognosis exists in CSDH. The small doses of atorvastatin calcium (20 mg/d) completed by the scholars in China taken for 8 weeks of treatment of RCT of CSDH showed that the decrease in hematoma volume of atorvastatin treatment was significantly higher than that of placebo control group, but 17.3% of patients were still diverted to surgical treatment during treatment due to increased hematoma volume and/or exacerbation of neurological dysfunction. Furthermore, the effect of atorvastatin calcium on the prognosis of CSDH is not yet clear. A small dose of dexamethasone is recommended to treat patients with poor efficacy of atorvastatin calcium alone in combination with atorvastatin calcium. But recent uk RCT studies found that the incidence of good results was lower in dexamethasone group patients than in placebo control group at 6 months of group entry.
From the perspective of traditional Chinese medicine, the aged brain collaterals are damaged and ruptured due to head trauma and impact, the collateral damage overflows and stays in the cavity to form hematoma, which is the external cause of CSDH. The old brain is gradually eliminated, the marrow is eliminated, the cavity is large, the old has deficiency of upper qi and cannot nourish the brain, the inventor considers that the occurrence of CSDH of the old is caused by external force, kidney deficiency and qi deficiency are internal factors, qi deficiency promotes weakness, and blood circulation is unsmooth, thus being the physiological basis for the old to form blood stasis. Head trauma is one of the most common causes of CSDH, the head is impacted or swayed severely, the brain channels and collaterals are damaged, and blood flowing away from the channels and collaterals becomes blood stasis, which is both a pathogenic factor and a pathological product. "jin Kui Yao Lv Yuan (the key of gold) cloud: the adverse blood condition is water, and the theory of blood syndrome also states cloud: "stagnant blood turns into water, edema is also a blood disease and water, and" blood syndrome theory, sweat blood "indicates that: the blood is not separated from water, so that the blood is treated, the water is treated, and the blood stasis internal resistance causes abnormal body fluid distribution and metabolism, abnormal accumulation of water, blood stasis and water retention and hematoma formation. The traditional report literature for treating CSDH by traditional Chinese medicine is not many, and in recent years, the traditional Chinese medicine is reported to be applied to treating CSDH by combining traditional Chinese medicine compound with western medicine conventional treatment, combining traditional Chinese medicine compound with drilling drainage, and the like, so that a certain curative effect is achieved, but the number of patients treated by single traditional Chinese medicine is less, and the curative effect of the medicine is not clear. Therefore, drug therapy with definite curative effect, good prognosis and low cost for screening CSDH or acute/subacute CSDH with stable disease condition becomes a clinical problem to be solved urgently.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating subdural hematoma.
The invention provides a traditional Chinese medicine composition for treating subdural hematoma, which is prepared from the following raw materials in parts by mass: 30-60 parts of motherwort herb, 9-20 parts of peach kernel, 9-20 parts of safflower and 3-6 parts of leech.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 30-45 parts of motherwort herb, 9-15 parts of peach kernel, 9-15 parts of safflower and 3-6 parts of leech.
More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 30 parts of motherwort herb, 9-12 parts of peach kernel, 9-12 parts of safflower and 3-5 parts of leech.
Specifically, the traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 30 parts of motherwort herb, 9 parts of peach kernel, 9 parts of safflower and 5 parts of leech;
or the traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 30 parts of motherwort herb, 12 parts of peach kernel, 12 parts of safflower and 3 parts of leech;
the traditional Chinese medicine composition provided by the invention is prepared from the raw materials in parts by mass as the proportion, and can be increased or reduced according to the corresponding proportion during production, for example, the mass production can be carried out in kilograms or tons, the small-scale production can be carried out in grams, the weight can be increased or reduced, and the mass proportion of the raw materials among the components is unchanged.
The traditional Chinese medicine composition provided by the invention can be prepared into any oral preparation according to a conventional traditional Chinese medicine preparation method. For example: the water decoction (decoction) of the traditional Chinese medicine composition can be obtained by mixing the traditional Chinese medicinal materials, decocting in water, filtering after decoction, collecting filtrate, repeating decoction for 2 times, and mixing the filtrates.
Wherein the ratio of the total mass of the Chinese medicinal materials to the mass of water is 1 (8-10), and the specific water adding amount can be determined according to the mass of the medicinal materials.
In order to facilitate dispensing and avoid decoction, each Chinese medicinal material (such as Chinese medicinal decoction pieces) can be replaced by commercially available Chinese medicinal granule with equivalent crude drug amount, and the Chinese medicinal granule of each Chinese medicinal material can be directly mixed. It is administered by soaking in boiled water.
The Chinese medicine prescription granule is powder or granule prepared by leaching soluble effective components of single Chinese medicine decoction pieces according to the extraction method of Chinese medicine preparation by selecting proper solvent and procedure, concentrating and drying. Single-component quantitative packaging is carried out, and the medicine is provided for the patients to follow the doctor's advice and evidence following prescription and is blended into the patients according to the regulated dose for direct administration. The traditional Chinese medicine formula granule is a full-component extract of traditional decoction pieces, has the clinical curative effect equivalent to that of the decoction pieces, has corresponding preparation requirements and quality control standards, and has obvious advantages in stability, controllability and the like compared with the traditional Chinese medicine decoction piece mixed decoction liquid.
Besides the two methods, the single medicines (such as Chinese medicinal decoction pieces) in the Chinese medicinal composition can be replaced by main component extracts corresponding to the same crude drugs of the medicines, and the main component extracts of the single medicines are mixed to prepare a solution, so that similar curative effects can be obtained after oral administration.
Meanwhile, the medicine for treating subdural hematoma prepared by taking the traditional Chinese medicine composition provided by the invention as an active ingredient also belongs to the protection scope of the invention.
The pharmaceutical composition can be prepared directly or after adding pharmaceutically acceptable auxiliary materials, and can be prepared into any pharmaceutically acceptable dosage form. Taking oral preparations as examples, the preparation comprises: decoction, granule, capsule, tablet, oral liquid, powder, pill, dripping pill, sustained and controlled release preparation, oral liquid, mixture and syrup. The medicaments of the various formulations can be prepared according to the conventional method in the pharmaceutical field.
The invention also protects the application of the traditional Chinese medicine composition in preparing a medicine for treating subdural hematoma.
The Chinese medicinal composition has the effects of promoting blood circulation, regulating menstruation, promoting urination, reducing swelling, clearing heat and detoxicating, promoting urination, resisting oxidation, improving heart and kidney functions and the like, and the motherwort is reused to exert the effects of promoting blood circulation and promoting diuresis; the peach kernel is bitter and sweet, calms, returns to heart, liver and large intestine meridians, can promote blood circulation to remove blood stasis, moisten intestine to relieve constipation, relieve cough and asthma, and is pungent and warm in safflower, and returns to heart and liver meridians, can promote blood circulation to dredge meridians, remove blood stasis and relieve pain, and the two mutually have the functions of promoting blood circulation to remove blood stasis; leeches are salty and bitter, calm, enter liver meridian, break blood and promote menstruation, remove blood stasis and eliminate mass, zhang Xichun praise leeches on "break blood stasis without damaging new blood". The four medicines in the whole formula are combined, so that the aims of promoting blood circulation to remove blood stasis, inducing diuresis to alleviate edema, promoting the absorption of subdural hematoma, improving the nerve defect symptoms of patients, improving the life quality of the patients and reducing recurrence are fulfilled.
Detailed Description
The invention will be further illustrated with reference to the following specific examples, but the invention is not limited to the following examples. The methods are conventional methods unless otherwise specified. The starting materials are available from published commercial sources unless otherwise specified.
Example 1 preparation of Chinese medicinal composition granules for treating subdural hematoma
1. Prescription composition:
30 parts of motherwort herb, 12 parts of peach kernel, 12 parts of safflower and 3 parts of leech.
2. The preparation method comprises the following steps:
weighing traditional Chinese medicine formula granules of the medicinal materials corresponding to the medicinal materials according to the prescription, namely, taking traditional Chinese medicine formula granules corresponding to decoction pieces of 30g of motherwort, 12g of peach kernel, 12g of safflower and 3g of leech, wherein 1 dose per day is divided into 2 bags, and the traditional Chinese medicine formula granules are taken twice in the morning and the evening.
And directly mixing the traditional Chinese medicine formula granules to obtain the traditional Chinese medicine composition granules.
Example 2 clinical efficacy data of Chinese medicinal composition granule for treating chronic subdural hematoma
1. Method of
1.1 general data from 9 months 2020 to 9 months 2021, were included in 30 cases of chronic subdural hematoma patients who were treated in the department of medical science outpatient in Beijing Tiantan Hospital affiliated to the university of capital medical science, of which 26 cases for men, 4 cases for women, ages 23-88, average ages 65.00.+ -. 2.67, 26 cases above 50, and 4 cases below 50.
1.2 treatment regimen: the traditional Chinese medicine granule is prepared and provided by Beijing Kang Rentang Co, takes 1 dose of traditional Chinese medicine formula granule corresponding to decoction pieces of 30g of motherwort, 12g of peach kernel, 12g of safflower and 3g of leech, and is divided into 2 bags per day, is taken with boiled water, and is taken twice in the morning and evening. The medicine is taken for 3 months.
1.3 efficacy evaluation index:
(1) Hematoma absorption evaluation: the head CT is rechecked monthly, the maximum bleeding plane thickness of hematoma and the center line deviation degree are measured, and the hematoma absorption condition is estimated;
(2) Evaluation of neurological deficit in patients: carrying out Markwalder nerve function grading (MGS) grading on each month, and evaluating the improvement condition of the nerve function defect of the patient;
(3) Evaluation of the ability of patients to live daily: the barchel scale was scored monthly to evaluate improvement in the patients' ability to survive daily.
1.4 statistical treatment: data analysis was performed using SPSS 25.0 software. The measurement data is expressed by mean + -SE, the comparison among multiple groups adopts repeated measurement single factor analysis of variance, and the treatment effect evaluation before and after treatment adopts paired t test or nonparametric test according to the normal analysis result. P <0.05 is statistically significant for the differences.
2. Results
2.1 hematoma changes
The thickness of the hematoma maximum bleeding plane of a patient at a baseline (before treatment) is 0.80-6.00 cm, the median is 2.10cm, the average is 2.09+/-0.18 cm, the median is 0.00-3.80 cm, the average is 0.70cm, the average is 0.93+/-0.16 cm, and the thickness is obviously reduced (P=0.000) compared with the thickness before treatment; the centerline shift of the patient at baseline was 0.00-1.10cm, median 0.00cm, mean 0.30+ -0.07 cm, 0.00-0.70 cm after treatment, mean 0.00cm, mean 0.11+ -0.04 cm, significantly decreased after treatment compared to before treatment (p=0.003).
2.2 patient neurological function and daily Capacity Change
By repeated measurement of analysis of variance, compared with a baseline, the Markwalder nerve function of the patient is obviously reduced (P= 0.014,0.000,0.000) 1 month, 2 months and 3 months after graded administration, and the nerve function of the patient is obviously improved after treatment by the blood activating and diuresis promoting prescription; the barchel scale score showed no significant statistical difference from baseline at 1 month post-dose (p=0.070), and significantly improved lifestyle at 2 months and 3 months post-dose compared to baseline (p= 0.022,0.017).
2.3. Follow-up recurrence
Through clinic and telephone follow-up, the follow-up time is 0.5-1.5 years after stopping the medicine, and 30 patients have no recurrence.
The beneficial effects of the invention are as follows: the inventor provides that the core pathogenesis of the subdural hematoma is blood stasis and water retention through combing relevant traditional Chinese medicine documents and a large number of clinical practices, and the blood stasis and water retention is the basic treatment principle, so that the traditional Chinese medicine composition is formed, and satisfactory curative effects are obtained in clinical application, and are accepted by neurosurgery staff. Clinical researches prove that the recipe can promote the absorption of the subdural hematoma, improve the neurological deficit symptom of a patient, improve the life quality of the patient, reduce the recurrence, reduce the operation risk and the economic burden of the patient, become a beneficial choice for a small amount of acute/subacute subdural hematoma patients with chronic subdural hematoma and stable illness, especially for senile chronic subdural hematoma, and has great economic benefit and social benefit.
Claims (5)
1. A traditional Chinese medicine composition for treating subdural hematoma is prepared from the following raw materials in parts by mass: 30 parts of motherwort herb, 12 parts of peach kernel, 12 parts of safflower and 3 parts of leech.
2. A medicament for treating subdural hematoma, the active ingredient of which is the traditional Chinese medicine composition of claim 1.
3. A decoction-free granule for treating subdural hematoma, which is characterized in that: the decoction-free granules are prepared from the traditional Chinese medicine composition of claim 1.
4. A method for preparing the decoction-free granules according to claim 3, comprising the following steps: mixing herba Leonuri, semen Persicae, carthami flos, and Hirudo at a ratio of the materials.
5. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for treating subdural hematoma.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105582099A (en) * | 2014-10-21 | 2016-05-18 | 王新军 | Formula for removing blood stasis |
| CN111407849A (en) * | 2020-04-13 | 2020-07-14 | 陕西中医药大学附属医院 | Traditional Chinese medicine formula for treating chronic subdural hematoma and preparation method thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105582099A (en) * | 2014-10-21 | 2016-05-18 | 王新军 | Formula for removing blood stasis |
| CN111407849A (en) * | 2020-04-13 | 2020-07-14 | 陕西中医药大学附属医院 | Traditional Chinese medicine formula for treating chronic subdural hematoma and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 中医药在慢性硬膜下血肿临床治疗中的应用;樊永平等;《中华中医药杂志(原中国医药学报)》;第37卷(第9期);第5240-5243页 * |
| 樊永平辨证治疗老年人慢性硬膜下血肿的用药经验;关瑞熙等;《中华中医药杂志(原中国医药学报)》;第35卷(第3期);第1292-1295页，尤其是第1292页摘要、第1294页左栏第4段、第1295页右栏倒数第1段、第1294页倒数第2段 * |
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