CN115590941B - Traditional Chinese medicine composition and application thereof in preparation of acute ischemic cerebral apoplexy treatment medicine - Google Patents
Traditional Chinese medicine composition and application thereof in preparation of acute ischemic cerebral apoplexy treatment medicine Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition and application thereof in preparing medicines for treating acute ischemic cerebral apoplexy. The traditional Chinese medicine composition comprises, by mass, 15-25 parts of melastoma dodecandrum, 7-12 parts of pinellia ternate, 3-9 parts of exocarpium citri rubrum, 10-20 parts of radix curcumae, 9-15 parts of pseudo-ginseng, 9-15 parts of ligusticum wallichii, 5-15 parts of polygala tenuifolia and 9-15 parts of rhizoma acori graminei. The invention takes melastoma dodecandrum and pinellia ternate as monarch drugs, and is supplemented with exocarpium citri rubrum, ligusticum wallichii and pseudo-ginseng to activate blood, resolve phlegm and remove meridian obstruction, grassleaf sweelflag rhizome, radix curcumae and polygala tenuifolia are used for resuscitation, and the whole prescription is combined to play the roles of resolving phlegm, removing blood stasis, inducing resuscitation and restoring consciousness; the traditional Chinese medicine composition can relieve tissue damage of brain tissues in hypoxia and ischemia by inhibiting the release of inflammatory factors such as TNF-alpha, IL-1 beta, IL-6 and the like, thereby promoting the recovery of the nerve functions of patients, improving the life independence ability after stroke, finally improving the prognosis of AIS patients, playing a positive role in reducing disability rate, and being worthy of clinical popularization.
Description
Technical Field
The invention belongs to the technical field of cerebral apoplexy treatment, and particularly relates to a traditional Chinese medicine composition and application thereof in preparing a medicine for treating acute ischemic cerebral apoplexy.
Background
Cerebral apoplexy is a main cause of national death, and the cerebral death accounts for one third of the world, becomes the first disability disease of China, and ischemic cerebral apoplexy accounts for 69.6% of all cerebral patients. With the promotion of the aging process of the population in China, the reduction of the disability rate and the death rate of cerebral apoplexy will face significant challenges.
The pathological nature of AIS is that intravascular thrombosis causes ischemic damage or even necrosis of brain tissue in its dominant region. Therefore, the AIS patients in the time window are clinically treated by direct recanalization through thrombolysis, vascular intervention thrombolysis and the like and obtain good prognosis, but the AIS patients outside the time window have limited vascular recanalization measures. Canonical stroke management can reduce complications after stroke, but still cannot completely avoid damage to ischemic brain tissue and death of neurons.
The nerve cell injury mechanism caused by ischemia is complex, mainly including excitotoxicity, calcium overload and oxidative stress in the early stage and nerve inflammation and apoptosis in the later stage. Therefore, the multi-target intervention can be performed through different action mechanisms of the medicine, and a new treatment idea is provided for treating cerebral apoplexy. Ischemic brain tissue initiates neuroinflammation by inducing inflammatory factors such as TNF-alpha, IL-1 beta, IL-6 and the like, thereby promoting blood brain barrier destruction, causing edema, hemorrhage and the like of nerve cells, and aggravating apoptosis of the nerve cells. Therefore, reducing local inflammatory factors (such as TNF-alpha, IL-1 beta, IL-6, etc.) can reduce the damage to ischemic tissues of stroke patients. Thus, it can be seen that recovery of hypoxic damage of ischemic tissue and inhibition of release of inflammatory mediators at the early stage of AIS, and reduction of local inflammation are key to promoting recovery of stroke nerve function.
The application of baohuoside I in preparing medicine for preventing and treating ischemic cerebral apoplexy is disclosed in Chinese patent application No. CN103989696A, and the research shows that baohuoside I has protecting effect on LPS side ventricle injection induced AD rat model and the mechanism of the baohuoside I is related to the over expression of LPS induced inflammatory factor cyclooxygenase 2 (COX-2), interleukin 1 beta (IL-1 beta), inducible nitric oxide synthase iNOS, etc.
The research and development of more drugs with therapeutic effect on acute ischemic cerebral apoplexy are of great significance.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition and application thereof in preparing medicines for treating acute ischemic cerebral apoplexy.
In order to achieve the above purpose, the technical scheme of the invention is as follows:
a Chinese medicinal composition comprises (by weight parts) herba Melastomatis Dodecandri 15-25, rhizoma Pinelliae 7-12, exocarpium Citri rubrum 3-9, radix Curcumae 10-20, notoginseng radix 9-15, rhizoma Ligustici Chuanxiong 9-15, cortex et radix Polygalae 5-15, and rhizoma Acori Graminei 9-15.
AIS belongs to the categories of traditional Chinese medicine such as apoplexy, migraine, general deviation without using, pathological factors such as wind-fire phlegm stasis, congenital endowment deficiency, improper diet or excessive fatigue, spleen failing to transport, dampness accumulation and phlegm generation, wind phlegm disturbance and internal resistance, collaterals obstruction, upper obstruction and orifice clearing, so skin is not benefited, and hand and foot numbness are seen; the symptoms of hemiplegia, slurred speech, facial distortion and the like are caused by the deficiency of the collaterals and wind evil in the people with deficiency of qi and blood.
The invention researches show that the apoplexy patients are frequently caused by phlegm and blood stasis blocking orifice, and the apoplexy is often caused by qi and blood circulation obstruction, phlegm and blood stasis intertwined and blood vessel obstruction. Therefore, the invention takes the melastoma and the pinellia tuber as monarch drugs, and is supplemented with the exocarpium citri rubrum, the ligusticum wallichii and the pseudo-ginseng to activate blood, resolve phlegm and remove meridian obstruction, and the grassleaf sweelflag rhizome, the radix curcumae and the polygala tenuifolia are used together to achieve the effects of resolving phlegm, removing blood stasis and inducing resuscitation; the traditional Chinese medicine composition is used for treating the phlegm stagnation orifice blocking AIS patient, and the integral of the traditional Chinese medicine symptoms is obviously lower than that of the conventional treatment group after 2 weeks of continuous treatment.
Meanwhile, the invention also researches and discovers that the traditional Chinese medicine composition can relieve tissue damage of brain tissues in hypoxia and ischemia by inhibiting the release of inflammatory factors such as TNF-alpha, IL-1 beta, IL-6 and the like, thereby promoting the recovery of the nerve functions of patients, improving the independent ability of life after stroke, finally improving the prognosis of AIS patients, playing a positive role in reducing disability rate and being worthy of clinical popularization.
Based on the above, the invention also provides application of the traditional Chinese medicine composition in preparing medicines for treating acute ischemic cerebral apoplexy, and preferably, the acute ischemic cerebral apoplexy is phlegm stagnation orifice type acute ischemic cerebral apoplexy.
Meanwhile, the invention also provides application of the traditional Chinese medicine composition in preparing a medicament for treating neuroinflammation.
Preferably, the traditional Chinese medicine composition comprises 20 parts of melastoma, 9 parts of pinellia ternate, 6 parts of exocarpium citri rubrum, 15 parts of radix curcumae, 12 parts of pseudo-ginseng, 12 parts of ligusticum wallichii, 10 parts of polygala tenuifolia and 12 parts of rhizoma acori graminei in parts by weight.
Compared with the prior art, the invention has the beneficial effects that:
(1) The traditional Chinese medicine composition takes melastoma and pinellia ternate as monarch drugs, and is supplemented with exocarpium citri rubrum, ligusticum wallichii and pseudo-ginseng, which have the effects of activating blood, resolving phlegm and dredging collaterals, and grassleaf sweelflag rhizome, radix curcumae and polygala tenuifolia, which are used together, have the effects of resolving phlegm, removing blood stasis, inducing resuscitation and restoring consciousness; the traditional Chinese medicine composition is used for treating the phlegm stagnation orifice blocking AIS patient, and the integral of the traditional Chinese medicine symptoms is obviously lower than that of the conventional treatment group after 2 weeks of continuous treatment.
(2) The traditional Chinese medicine composition can relieve tissue damage of brain tissues in hypoxia and ischemia by inhibiting the release of inflammatory factors such as TNF-alpha, IL-1 beta, IL-6 and the like, thereby promoting the recovery of the nerve functions of patients, improving the independent ability of life after stroke, finally improving the prognosis of AIS patients, playing a positive role in reducing disability rate and being worthy of clinical popularization.
Drawings
Fig. 1 is a statistical graph of improved Rakin scale scores for AIS patients on day 90 after treatment with a traditional Chinese medicinal composition of the invention;
wherein the modified rank scale has a score ranging from 0 to 6, wherein there is no symptom (score 0), no clinically significant disability (score 1), mild disability (score 2), moderate disability (score 3), moderate severe disability (score 4), severe disability (score 5), and death (score 6).
Detailed Description
The technical scheme of the invention is further described in detail below with reference to the attached drawings and the detailed description.
In the embodiment of the invention, SPSS26.0 statistical software is adopted to process data, and normal distribution metering data is processed by mean ± standard deviationRepresenting that the comparison between groups adopts independent sample T test; the non-normally distributed metering data is distributed in median (quartile) [ M (P25, P75)]The inter-group comparisons are shown as independent sample nonparametric test count data in example (%), and the inter-group comparisons are shown as χ2 test. With P<A difference of 0.05 is statistically significant.
Example 1
1. Volunteer screening
Volunteers were screened for inclusion and exclusion criteria as follows:
inclusion criteria: (1) compliance with AIS diagnostic criteria [8]; (2) The dialectical type of traditional Chinese medicine is phlegm stasis orifice obstruction syndrome (3) with ages of 35-90 years; (4) The patient can visit the doctor within 72 hours after onset of the disease and has no symptom of neurological deficit after the first stroke or the past stroke; (5) National Institutes of Health Stroke Scale (NIHSS): 4-24 minutes; (5) The improved Rakin scale (the score of the improved Rakin scale is 0-6 points, the higher the score is, the more serious the disability is), the more than or equal to 2 points (6) (7) of the patient himself or herself or the family members sign an informed consent. The study was performed strictly in accordance with the clinical trial study specifications, approved by the ethical committee of the hospital.
Exclusion criteria: after the patients (1) with severe liver and kidney failure (2) are taken in, the patients (3) are not allergic to the medicine or are severely allergic in constitution.
During the period of 1 month 2020 to 1 month 2022, the department of neurology in hospital in Lishui city was selected for hospitalization according to the inclusion and exclusion criteria described above and 212 AIS patients developed within 72 hours. Patients entered into the group were divided into 106 treatment groups and 106 control groups using a random table. Some patients can not stay taking and exit, and other patients lose visit after discharge, and 193 cases of effective data are finally recovered, wherein 95 cases of treatment groups and 98 cases of control groups are treated. Treatment group: 60 men and 35 women, ages 36-90. Control group: 59 men and 39 women, ages 39-90. The two groups were compared in terms of age of onset, sex, complications, NIHSS score, TOAST typing, etc., the differences were not statistically significant (P > 0.05), and were comparable (see table 1).
Table 1 comparison of baseline data for two groups of patients
Note that: a is chi-square test; b is a Z value; c is a T value; smoking is defined as smoking for more than 3 years with smoking definition not less than 10 cigarettes/day.
2. Drug treatment
Wherein, the control group patients are given standard treatment of cerebral apoplexy, including treatment such as platelet aggregation resistance, lipid-lowering and plaque-stabilizing, and the treatment course is 14 days; the treatment group takes the traditional Chinese medicine composition decoction, and the preparation method of the decoction comprises the following steps: 20g of melastoma dodecandrum, 9g of pinellia ternate, 6g of exocarpium citri rubrum, 15g of radix curcumae, 12g of pseudo-ginseng, 12g of ligusticum wallichii, 10g of polygala tenuifolia and 12g of rhizoma acori graminei are taken, decocted with water to 400ml, taken twice daily, and the treatment course is 14 days.
3. Serum inflammatory factor level determination
Venous blood is extracted on an empty stomach before treatment and after the treatment course is finished for 14 days respectively, the blood is placed at 3000r/min for centrifugation for 15min within 30 minutes after blood extraction, upper clear liquid is taken, and the expression levels of three inflammatory factors of TNF-alpha, IL-1 beta and IL-6 are measured by using an enzyme-linked immunosorbent assay. The detection results are shown in Table 2.
Table 2 comparison of inflammatory factor levels before and after treatment for two groups of patients
As can be seen from Table 2, there was no statistical difference in the levels of TNF- α, IL-1β, IL-6 expression in the serum of the two groups of patients prior to treatment; after 2 weeks of treatment, inflammatory factors were reduced in both groups, with greater reduction in inflammatory factors in the treated group serum and statistical differences (P < 0.05) compared to the control group.
4. Evaluation of efficacy
(1) Integral of Chinese medicine symptoms
According to the grading standard of the Chinese medicine clinical research guidelines of new Chinese medicine, the Chinese medicine symptoms of the patient are graded, the main contents comprise 7 items of hemiplegia, numbness of limbs, slurred speech, deviation of the mouth and tongue, flushing, dysphoria with feverish sensation in chest, hypodynamia, shortness of breath and the like, and the grading is respectively carried out according to the severity of the symptoms, namely no (0 grade), slight (1 grade), medium (2 grade) and severe (3 grade); the analysis results are shown in Table 3.
Table 3 comparison of the integral of symptoms of TCM before and after treatment of two groups of patients(divide)
As can be seen from table 3, there was no statistical difference in the integral of the symptoms of the traditional Chinese medicine before treatment for the two groups of patients, and after 1 week of treatment, there was no statistical difference in the two groups of patients although there was a slight difference; after 2 weeks of treatment, the magnitude of the decrease in the integral of symptoms in the treatment group was significantly different from that in the conventional treatment group, and the difference was statistically significant (P < 0.05); the traditional Chinese medicine composition disclosed by the invention can improve the prognosis of AIS patients.
(2) Day 90 modified Rakin scale score
The scores of the modified Rakin scale on day 90 after treatment were counted for two groups of patients and the statistical structure is shown in fig. 1.
As can be seen from FIG. 1, the number of cases of independent life function (0-2 minutes on the modified Rakin scale) obtained by the treatment group is significantly better than that of the control group (OR: 1.43;95% Cl1.04 to 1.98; P < 0.05) on the overall score distribution.
(3) Improved Rakin scale score, NIHSS score and security index
The improved Rakin scale score, NIHSS score and various safety metrics were counted for two weeks after treatment for two groups of patients and the observations are shown in table 4.
Table 4 improved Rakin scale score, NIHSS score, and security index statistics
Note that: a is chi-square test; and b, theoretical frequency is smaller than 5, and a continuity correction value is adopted. The sICH is symptomatic intracranial hemorrhage.
As can be seen from table 4, after 14 days of treatment, the number of independent living functions (0-2 minutes of modified Rakin scale) and NIHSS score decrease amplitude were both superior to those of the control group (P < 0.05); in terms of safety, the treatment group neither increased the proportion of symptomatic bleeding nor the proportion of 90-day deaths in patients, and the two groups were not statistically different (P > 0.05).
According to the research of the embodiment, the treatment effect of the AIS patient is superior to that of the conventional treatment group when the AIS patient is administrated within 72 hours, and the composition can relieve the tissue injury of brain tissues in hypoxia and ischemia by inhibiting the release of inflammatory factors such as TNF-alpha, IL-1 beta, IL-6 and the like, so that the neurological function recovery of the patient is promoted, the life independence ability after stroke is improved, the prognosis of the AIS patient is improved finally, and the AIS treatment composition has a positive effect on reducing disability rate and is worthy of clinical popularization.
Claims (3)
1. The traditional Chinese medicine composition for treating phlegm stagnation orifice blocking type acute ischemic cerebral apoplexy is characterized by comprising the following active ingredients in parts by mass: 15-25 parts of melastoma dodecandrum, 7-12 parts of pinellia ternate, 3-9 parts of exocarpium citri rubrum, 10-20 parts of radix curcumae, 9-15 parts of pseudo-ginseng, 9-15 parts of ligusticum wallichii, 5-15 parts of polygala tenuifolia and 9-15 parts of rhizoma acori graminei.
2. The traditional Chinese medicine composition according to claim 1, wherein the active ingredients of the traditional Chinese medicine composition comprise the following raw materials in parts by weight: 20 parts of melastoma dodecandrum, 9 parts of pinellia ternate, 6 parts of exocarpium citri rubrum, 15 parts of radix curcumae, 12 parts of pseudo-ginseng, 12 parts of ligusticum wallichii, 10 parts of polygala tenuifolia and 12 parts of rhizoma acori graminei.
3. The use of a Chinese medicinal composition according to claim 1 or 2 in the preparation of a medicament for treating acute ischemic stroke with phlegm stagnation.
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