CN115590941A - Traditional Chinese medicine composition and application thereof in preparation of medicine for treating acute ischemic stroke - Google Patents
Traditional Chinese medicine composition and application thereof in preparation of medicine for treating acute ischemic stroke Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition and application thereof in preparing a medicine for treating acute ischemic stroke. 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 the melastoma dodecandrum and the pinellia ternate as monarch drugs, takes the exocarpium citri rubrum, the ligusticum wallichii and the panax notoginseng as auxiliary drugs, has the functions of promoting blood circulation, reducing phlegm and dredging collaterals, and achieves the effects of reducing phlegm and removing blood stasis, and inducing resuscitation and restoring consciousness by combining the whole formula; 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 function of patients, improving the independent life capacity 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 preparation of a medicine for treating acute ischemic cerebral apoplexy.
Background
The cerebral apoplexy is the main cause of death of Chinese people, the death of the cerebral apoplexy accounts for one third of the world, and becomes the first disabling disease species in China, and the ischemic cerebral apoplexy accounts for 69.6 percent of all patients with the cerebral apoplexy. With the advance of the aging process of the population in China, the reduction of the disability rate and the death rate of cerebral apoplexy faces a great challenge.
The pathological nature of AIS is that intravascular thrombosis causes ischemic damage and even necrosis of the brain tissue in its innervated area. Therefore, the AIS patients within the time window are treated by direct recanalization through thrombolysis, vascular intervention thrombus extraction and the like clinically, and good prognosis is obtained, but the measures for recanalization of blood vessels of the AIS patients outside the time window are quite limited. Normative stroke management can reduce post-stroke complications, but damage to ischemic brain tissue and neuronal death cannot be completely avoided.
The mechanism of neuronal damage caused by ischemia is complex, mainly characterized by excitotoxicity, calcium overload, and oxidative stress in the early stage, and neuroinflammation and apoptosis in the later stage. Therefore, the multi-target intervention can be carried out through different action mechanisms of the medicine, and a new treatment idea is provided for the treatment of the stroke. The ischemic brain tissue initiates neuroinflammation by inducing inflammatory factors such as TNF-alpha, IL-1 beta, IL-6 and the like, thereby promoting the destruction of blood brain barrier, causing edema, hemorrhage and the like of nerve cells, and aggravating the apoptosis of neuron cells. Therefore, the damage to ischemic tissues of stroke patients can be reduced by reducing local inflammatory factors (such as TNF-alpha, IL-1 beta, IL-6 and the like). Therefore, the key points of promoting the recovery of the stroke nerve function are to recover the hypoxia injury of ischemic tissues and inhibit the release of inflammatory mediators in the early stage of AIS and reduce local inflammation.
For example, the application of the Chinese patent application with the publication number of CN103989696A discloses the application of the baohuoside I in preparing the medicine for preventing and treating the cerebral arterial thrombosis, and the research shows that the baohuoside I has the protection effect on a Lipopolysaccharide (LPS) lateral ventricle injection induced AD-like rat model, and the mechanism of the baohuoside I is related to the over-expression of the baohuoside I in inhibiting inflammatory factor cyclooxygenase 2 (COX-2), interleukin 1 beta (IL-1 beta), inducible nitric oxide synthase iNOS and the like induced by the LPS.
The exploration and development of more medicaments with therapeutic action on the acute ischemic stroke have important significance.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition and application thereof in preparing a medicine for treating acute ischemic stroke.
In order to achieve the purpose, the technical scheme of the invention is as follows:
a 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 AIS belongs to the categories of 'apoplexy', 'wind bias', 'body bias' and the like in traditional Chinese medicine, pathological factors are not wind-fire phlegm stasis, congenital deficiency, spleen failure and transportation caused by improper diet or excessive desire, dampness accumulation and phlegm generation, wind-phlegm upper disturbance and internal resistance, collateral channel fleeing, upper obstruction and orifice clearing, and skin numbness and hand-foot numbness are seen; the symptoms of hemiplegia, slurred speech, facial distortion, etc. are caused by the deficiency of the meridians, pathogenic wind in the body and obstruction of qi and blood.
The research of the invention finds that the apoplexy patients are mostly suffered from phlegm-stasis orifices obstruction, and the apoplexy is caused by obstruction of qi and blood circulation, phlegm-stasis accumulation and blood vessel obstruction. Therefore, the melastoma dodecandrum and the pinellia ternate are used as monarch drugs, the exocarpium citri rubrum, the ligusticum wallichii and the pseudo-ginseng are used as auxiliary drugs, the blood circulation promoting, phlegm eliminating and collaterals dredging are performed, the rhizoma acori graminei, the radix curcumae and the polygala tenuifolia are used for restoring consciousness and inducing resuscitation, and the effects of reducing phlegm and removing blood stasis and inducing resuscitation are achieved together; when the traditional Chinese medicine composition is used for treating AIS patients with phlegm stagnation and orifice obstruction, the Chinese medicine symptom score is obviously lower than that of a conventional treatment group after 2 weeks of continuous treatment.
Meanwhile, the traditional Chinese medicine composition is researched and found to reduce the 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, so that the nerve function rehabilitation of patients is promoted, the life independence ability after stroke is improved, the prognosis of AIS patients is finally improved, the positive effect on reducing disability rate is achieved, and the clinical popularization is worthy of being realized.
Based on the above, the invention also provides application of the traditional Chinese medicine composition in preparation of a medicine for treating acute ischemic stroke, and preferably, the acute ischemic stroke is phlegm stagnation type acute ischemic stroke.
Meanwhile, the invention also provides application of the traditional Chinese medicine composition in preparing medicines for treating neuroinflammation.
Preferably, the traditional Chinese medicine composition comprises, by mass, 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.
Compared with the prior art, the invention has the beneficial effects that:
(1) The traditional Chinese medicine composition takes the melastoma dodecandrum and the pinellia ternate as monarch drugs, is supplemented with the exocarpium citri rubrum, the ligusticum wallichii and the panax notoginseng for promoting blood circulation, reducing phlegm and dredging collaterals, and the rhizoma acori graminei, the radix curcumae and the polygala tenuifolia for restoring consciousness and inducing resuscitation; when the traditional Chinese medicine composition is used for treating the phlegm stasis type AIS patients, the Chinese medicine symptom integral after 2 weeks of continuous treatment is obviously lower than that of the conventional treatment group.
(2) The traditional Chinese medicine composition can relieve the 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 nerve function rehabilitation of patients, improving the independent life capacity 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 chart of the modified Rakin scale scores of AIS patients on day 90 after treatment with the traditional Chinese medicine composition of the present invention;
wherein the modified Rankin scale scores in the range of 0 to 6, with no symptoms (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), death (score 6).
Detailed Description
The technical scheme of the invention is further explained in detail by combining 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 measurement data is in mean plus or minus standard deviationShowing that the independent sample T test is adopted for comparison among groups; the non-normally distributed data is represented by a median (quartile) [ M (P25, P75)]In this case, the inter-group comparison was performed by the independent sample nonparametric test count data in cases (%) and the inter-group comparison was performed by the X2 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 were: (1) compliance with AIS diagnostic criteria [8]; (2) The dialectical type of the traditional Chinese medicine is phlegm stagnation and orifices obstruction syndrome (3) the age is 35-90 years; (4) The patient can see the disease within 72 hours and has no symptom of neurologic deficit after the first stroke or the previous stroke; (5) National Institute of Health Stroke Scale (NIHSS): 4-24 min; (5) And (4) when the patient is admitted, the patient signs an informed consent by himself or family members by improving a Rakin scale (the score of the improved Rakin scale is 0-6, the higher the score is, the more serious the disability is), and the number is more than or equal to 2 (6) (7). The study strictly executes the clinical trial study specification of the hospital, and is executed after being approved by the ethical committee of the hospital.
Exclusion criteria: (1) patients with severe liver and kidney failure (2) are not prescribed to take the medicine, and (3) patients with allergy or severe allergic constitution.
212 AIS patients are selected from the patients who are hospitalized in neurology department of the department of Chinese medicine of Lishui city and have the disease incidence within 72 hours during the period of 1 month to 1 month of 2022 in 2020. The patients in the group were divided into 106 treatment groups and 106 control groups by a random table. Some patients can not insist on taking and quit, and other patients lose visits after discharge, and 193 effective data are finally recovered, wherein 95 patients in a treatment group and 98 patients in a control group. Treatment groups: 60 men and 35 women, the age being 36-90 years. Control group: 59 men and 39 women, age 39-90 years old. The two groups have no statistical significance (P > 0.05) and are comparable in terms of onset age, gender, complications, NIHSS score and TOAST typing (see Table 1).
TABLE 1 comparison of baseline data for two groups of patients
Note: a is chi-square test; b is the Z value; c is a T value; smoking is defined to be more than or equal to 10 cigarettes/day, and smoking lasts for more than 3 years.
2. Medical treatment
Wherein, the patients in the control group are subjected to standard cerebral apoplexy treatments, including platelet aggregation resistance, lipid lowering, plaque stabilizing and the like, and the treatment course is 14 days; the treatment group takes the Chinese medicinal composition decoction of the invention, and the preparation method of the decoction comprises the following steps: 20g of melastoma dodecandrum lour, 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 twice a day by adding water and decocting to 400ml, and the treatment course is 14 days.
3. Serum inflammatory factor level determination
Before treatment and after 14 days of treatment, venous blood is drawn with an empty stomach, within 30 minutes after blood drawing, the blood is placed at 3000r/min for centrifugation for 15min, supernatant liquid is taken, and the expression levels of three inflammatory factors, namely TNF-alpha, IL-1 beta and IL-6, are measured by using an enzyme-linked immunosorbent assay monitoring method. The results are shown in Table 2.
TABLE 2 comparison of inflammatory factor levels before and after treatment in two groups of patients
As can be seen from Table 2, the expression levels of TNF-alpha, IL-1 beta and IL-6 in the serum of the two groups of patients were not statistically different before treatment; after 2 weeks of treatment, there was a decrease in serum inflammatory factors in both groups, with the decrease in serum inflammatory factors being greater in the treated group and statistically different from the control group (P < 0.05).
4. Evaluation of therapeutic effects
(1) Integral of Chinese medicine syndrome
Assigning scores to Chinese medicine symptoms of patients according to scoring standard of Chinese medicine new drug clinical research guiding principle, wherein the main contents comprise 7 items of hemiplegia, limb numbness, dysphasia, mouth and tongue deflection, flushed complexion, dysphoria with smothery sensation in chest, palms and soles, weakness, short breath and the like, and the scores are assigned according to the severity of the symptoms, namely none score (0 score), mild score (1 score), moderate score (2 score) and severe score (3 score); the analysis results are shown in Table 3.
TABLE 3 comparison of Chinese medicine syndrome integrals before and after treatment of two groups of patients(minute)
As can be seen from table 3, there was no statistical difference in the traditional Chinese medicine syndrome scores of the two groups of patients before treatment, 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 traditional Chinese medicine symptom integral reduction range of the treatment group is greatly different from that of the conventional treatment group, and the difference has statistical significance (P is less than 0.05); the traditional Chinese medicine composition can improve the prognosis of AIS patients.
(2) Modified Rakin Scale score on day 90
Statistics were performed on the scores of the modified Rakin scale at day 90 after treatment in both groups of patients and are shown in FIG. 1.
As can be seen from FIG. 1, the number of independent life functions (0-2 points on the modified Rakin scale) obtained in the treated group was significantly better than that obtained in the control group in the overall score distribution (OR: 1.43% by 95% CL1.04-1.98P-straw bundle of 0.05.
(3) Improved Rakin scale score, NIHSS score and safety index
The modified Rakin scale score, the NIHSS score and various safety indexes of the two groups of patients after two weeks of treatment are counted, and the observation results are shown in a table 4.
TABLE 4 modified Rakin Scale score, NIHSS score, and safety index statistics
Note: a is chi fang inspection; b, the theoretical frequency is less than 5, and a continuity correction value is adopted. seich is symptomatic intracranial hemorrhage.
As can be seen from Table 4, after 14 days of treatment, the number of independent life functions (0-2 points of the modified Rakin scale) and the reduction range of the NIHSS score are both better than those of the control group (P < 0.05); whereas the treatment group did not increase the rate of symptomatic bleeding nor the rate of 90 days death of patients in terms of safety index, there was no statistical difference between the two groups (P > 0.05).
The research of the embodiment discovers that the treatment effect of the traditional Chinese medicine composition provided by the invention on the patients suffering from AIS within 72 hours is better than that of the conventional treatment group, and the tissue damage of brain tissues in anoxia and ischemia can be reduced by inhibiting the release of inflammatory factors such as TNF-alpha, IL-1 beta, IL-6 and the like, so that the nerve function rehabilitation of the patients is promoted, the independent life capacity after stroke is improved, the prognosis of the patients suffering from AIS is finally improved, a positive effect on reduction of disability rate is achieved, and the traditional Chinese medicine composition is worthy of clinical popularization.
Claims (5)
1. A traditional Chinese medicine composition is characterized by comprising, 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 as claimed in claim 1, which comprises, by mass, 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 the Chinese medicinal composition of claim 1 or 2 in the preparation of a medicament for the treatment of acute ischemic stroke.
4. The use of the Chinese medicinal composition of claim 3 in the preparation of a medicament for treating acute ischemic stroke, wherein the acute ischemic stroke is phlegm stagnation type acute ischemic stroke.
5. The use of the Chinese medicinal composition of claim 1 or 2 in the preparation of a medicament for the treatment of neuroinflammation.
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