CN115702925B - Traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof - Google Patents
Traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: fructus Aurantii Immaturus, parched Atractylodis rhizoma, arecae semen, radix et rhizoma Rhei, rhizoma Pinelliae, rhizoma Zingiberis recens, semen Persicae, and radix Codonopsis. The traditional Chinese medicine composition has no obvious adverse reaction, is safe and reliable, has good medication safety, ensures strict formula of the traditional Chinese medicine composition by selecting the formula components and controlling the addition amount of the formula components, effectively treats diabetic gastroparesis, improves core symptoms such as nausea, vomiting, postprandial satiety, early satiety, abdominal distention and the like, and has a certain regulating effect on blood sugar.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines. More particularly relates to a traditional Chinese medicine composition for treating diabetic gastroparesis and application thereof.
Background
Diabetes gastroparesis (diabetic gastroparesis, DGP) is one of the common complications of diabetes, is a symptom group mainly characterized by mechanical obstruction and delayed solid gastric emptying, common symptoms include nausea, vomiting, abdominal distension, early satiety, inappetence, frequent nausea and vomiting, easy electrolyte disturbance, dehydration and other physical problems caused by serious symptoms, is similar to the 'distention syndrome' of traditional Chinese medicine, and the symptoms of deficiency of spleen and stomach, weak transportation and transformation, qi stagnation, damp turbidity or food stagnation caused by ascending and descending, and qi stagnation are mainly marked by the pathological basis of the symptoms, and qi deficiency often causes qi stagnation and blood stasis, stasis complex and deficiency promotion, and malignant circulation, and belongs to the symptoms of principal deficiency and principal excess. In recent years, DGP has been increasing with the increasing incidence of diabetes, and it has been reported that among these diabetics, DGP has an incidence of up to 50%, and this disease not only brings great pain to the patient, but also affects the control of blood sugar, and places a heavy burden on society and home, so that importance on diabetic gastroparesis should be increased.
At present, western medicines mainly adopt gastric motility promoting medicines such as erythromycin, metoclopramide, domperidone and the like in the drug treatment of DGP, and certain limitations may exist in the use, which are related to low bioavailability of the first pass effect, and partial patients may cause related adverse reactions, so that the control of blood sugar and the treatment of digestive tract symptoms are difficult to take into account in the treatment, and long-term satisfactory curative effects are lacking. On the one hand, hyperglycemia and partial hypoglycemic agents themselves have the effect of disrupting gastric emptying and reducing the effect of the stomach on gastric motility enhancing agents such as erythromycin; on the other hand, for the patients with serious illness, frequent nausea and vomiting make the blood sugar difficult to control, and dangerous conditions are extremely easy to occur. Patterson D et al (Patterson D, abell T, rothstein R, koch K, barnett J.A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroarea. Am J gastroentenol. 1999May;94 (5): 1230-4) selected 98 persons for treatment of diabetic gastroparesis with domperidone and gastric reset, and studies showed that domperidone and gastric reset were effective in treating the disease, but produced adverse effects on the central nervous system, side effects of gastric reset were more severe and common, and 49% of patients admitted to have somnolence after taking gastric reset for 4 weeks, with 33% of patients being aware of reduced mental sensitivity. For patients with severe gastroparesis of diabetes, the conventional medicines are used for treating poor effects, and other optional treatment modes are limited, such as gastric electrical stimulation, surgical treatment, endoscopic botulinum injection and the like, however, the treatment modes have surgical adverse reactions such as infection, malnutrition and the like. Abell T et al (Abell T, mccalum R, hocking M, koch K, abrahamsson H, leblanc I, lindberg G, konturek J, nowak T, quigley EM, tougas G, stark baum W.gamic electrical stimulation for medically refractory gammaraservice.2003 Aug;125 (2): 421-8) treat 33 patients with gastric electrical stimulation protocol, and after 1 month treatment, the efficacy was better, the vomiting frequency was significantly reduced, but 5 cases were infected.
Therefore, how to perform effective therapeutic intervention on DGP patients remains a medical challenge to be solved.
Disclosure of Invention
The first aim of the invention is to provide a traditional Chinese medicine composition for treating diabetic gastroparesis, which can effectively treat and relieve symptoms of diabetic gastroparesis (specific symptoms include nausea, vomiting, abdominal distension, early satiety and inappetence).
The second aim of the invention is to provide an application of the traditional Chinese medicine composition in preparing a medicine for treating diabetic gastroparesis.
In order to achieve the first object, the present invention adopts the following technical scheme:
the invention provides a traditional Chinese medicine composition for treating diabetic gastroparesis, which is prepared from the following raw materials in parts by weight: fructus Aurantii Immaturus, parched Atractylodis rhizoma, arecae semen, radix et rhizoma Rhei, rhizoma Pinelliae, rhizoma Zingiberis recens, semen Persicae, and radix Codonopsis.
According to the invention, through selection of formula components and control of the addition amount of the formula components, the Chinese medicinal preparation can effectively treat diabetic gastroparesis, improve core symptoms such as nausea, vomiting, postprandial satiety, early satiation, abdominal distension and the like, and clinical accumulation practices show that the addition of peach kernels and rheum officinale can increase blood circulation and remove meridian obstruction, and has an effect on treating diabetic gastroparesis venation stasis.
Further, 10-15 parts of immature bitter orange, 10-20 parts of stir-fried bighead atractylodes rhizome, 3-6 parts of betel nut, 3-6 parts of wine rheum officinale, 6-9 parts of pinellia ternate, 6-12 parts of ginger, 3-6 parts of peach kernels and 10-20 parts of radix codonopsis pilosulae.
Further, the formula of each raw material is as follows:
12-15 parts of immature bitter orange, 12-18 parts of stir-fried bighead atractylodes rhizome, 3-6 parts of betel nut, 3-6 parts of wine rheum officinale, 6-9 parts of pinellia ternate, 9-12 parts of ginger, 3-6 parts of peach kernel and 12-18 parts of radix codonopsis pilosulae.
Within the range of the proportion, the traditional Chinese medicine composition can achieve the purpose of treating diabetic gastroparesis. For convenient blending and use, the inventor further prefers the following raw material medicine proportioning modes, and the curative effects of the raw material medicines are determined:
(1) 15g of immature bitter orange, 15g of stir-fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine rheum officinale, 9g of pinellia ternate, 10g of ginger, 6g of peach kernel and 15g of radix codonopsis pilosulae;
(2) 12g of immature bitter orange, 20g of stir-fried bighead atractylodes rhizome, 3g of betel nut, 3g of wine rheum officinale, 6g of pinellia ternate, 10g of ginger, 6g of peach kernel and 20g of radix codonopsis pilosulae;
(3) 10g of immature bitter orange, 15g of stir-fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine rheum officinale, 9g of pinellia ternate, 6g of ginger, 6g of peach kernel and 18g of radix codonopsis pilosulae.
The mechanism of the traditional Chinese medicine is as follows:
immature bitter orange: bitter, pungent and cold in nature, it is mainly indicated for spleen, stomach and liver meridians, removing accumulation and stagnation, especially for diarrhea and gastric excess, opening and resolving hard lumps, so it is indicated for middle-jiao to treat blood system, treat fullness in the abdomen and umbilicus, resolve phlegm and nodule, dispel water and stop food, remove accumulation of food, break chest, relieve constipation and block. If skin is itchy, it can not nourish the skin surface due to blood stasis in the middle energizer, and if eating is poor, it can not be transformed due to spleen stagnation, it is also indicated for Xin Sangu purgation. This is called qi-flowing in blood system.
White atractylodes rhizome: invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, suppressing sweating, preventing miscarriage, removing dampness, invigorating dryness, regulating middle warmer, invigorating qi, warming spleen and stomach, eliminating dampness in spleen and stomach, removing stomach heat, strengthening spleen and stomach, promoting diet, quenching thirst, and preventing miscarriage. The active ingredients of the composition have strong excitation effect on the gastrocnemius muscle strips, can promote gastrointestinal propulsion, and have obvious gastric emptying and small intestine propulsion functions.
Betel nut: killing parasites, removing food retention, reducing qi-flowing stagnation, promoting the hydration of the body.
Wine rheum officinale: clearing heat toxin of upper-jiao blood, and can be used for treating conjunctival congestion, pharyngeal swelling, and gingival swelling and pain.
Pinellia ternate: dry dampness and resolve phlegm, reduce adverse flow of qi and arrest vomiting, relieve distension and fullness and dissipate nodulation. Can be used for treating excessive phlegm, cough and asthma, phlegm retention, dizziness, wind phlegm vertigo, phlegm syncope headache, emesis, regurgitation, chest and gastric fullness, globus hystericus, and carbuncle.
Ginger: induce sweat to relieve exterior syndrome, warm middle energizer and arrest vomiting, warm lung and relieve cough, relieve toxicity of fish and crab, and relieve toxicity of drugs. Is suitable for treating wind-cold type common cold, headache, phlegm retention, cough and vomiting due to stomach cold; when the ginger Shang Yin is used for treating ice and snow, water dampness and cold invasion, the blood circulation can be improved, and cold evil can be dispersed.
Peach kernel: has effects of promoting blood circulation, removing blood stasis, loosening bowel to relieve constipation, relieving cough and asthma, and can be used for treating amenorrhea dysmenorrhea, abdominal mass, pulmonary abscess, acute appendicitis, traumatic injury, constipation due to intestinal dryness, cough and asthma.
Radix codonopsis pilosulae: sweet, flat, middle-jiao invigorating, qi invigorating, stomach regulating, salivation promoting, phlegm eliminating, and cough relieving. Can be used for treating spleen deficiency, anorexia, loose stool, limb weakness, palpitation, short breath, dry mouth, spontaneous perspiration, rectocele, and yin stiffness. The effective components can play a role in resisting gastric mucosal injury by increasing the gastric wall combined mucus content.
The recipe has the effects of strengthening spleen, promoting qi, promoting blood circulation and freeing viscera, the recipe has bitter orange, has the effect of relieving diarrhea and settling, the bighead atractylodes rhizome is sweet and bitter with warm fragrance, the two herbs have the effects of invigorating spleen and removing fullness, and tonifying and reducing, and tonifying without retention. Hammer tablet and radix et rhizoma Rhei preparata for promoting circulation of qi and relieving constipation, and rhizoma Pinelliae preparata and rhizoma Zingiberis recens for lowering adverse qi and relieving vomit, and semen Persicae for promoting blood circulation and removing blood stasis, and loosening bowel to relieve constipation. The codonopsis pilosula is added for tonifying qi, strengthening spleen and promoting the production of body fluid, so that pathogenic factors are eliminated without hurting the body resistance, and the medicines are used together to strengthen the spleen, promote qi circulation, promote blood circulation, dredge the viscera and restore gastrointestinal motility.
In use, the traditional Chinese medicine composition can be decocted with water according to the traditional usage of the prescription, taken as soup, or refined with water or other proper solvents, and made into various solid preparations such as tablets, granules, capsules and the like according to the conventional preparation process.
In order to achieve the second purpose, the invention provides application of the traditional Chinese medicine composition in preparing medicines for treating diabetic gastroparesis.
The beneficial effects of the invention are as follows:
the invention is a clinical study for treating severe diabetic gastroparesis by using pure traditional Chinese medicine decoction, and the traditional Chinese medicine composition has strict formula, effectively treats diabetic gastroparesis, improves core symptoms such as nausea, vomiting, postprandial satiety, early satiety, abdominal distention and the like, has a certain regulation effect on blood sugar, has no adverse reaction for patients during the administration period, and has good administration safety by selecting the formula components and controlling the addition amount of the formula components.
Detailed Description
In order to more clearly illustrate the present invention, the present invention will be further described with reference to preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and that this invention is not limited to the details given herein.
Example 1
Basic prescription: 15g of immature bitter orange, 15g of stir-fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine rheum officinale, 9g of pinellia ternate, 10g of ginger, 6g of peach kernel and 15g of radix codonopsis pilosulae.
The preparation method comprises the steps of grabbing the raw materials according to the prescription, adding water for decoction for 2 times, each time for 1h, filtering, and combining the decoctions.
Example 2
Basic prescription: 12g of immature bitter orange, 20g of stir-fried bighead atractylodes rhizome, 3g of betel nut, 3g of wine rheum officinale, 6g of pinellia ternate, 10g of ginger, 6g of peach kernel and 20g of radix codonopsis pilosulae.
The preparation method comprises the steps of grabbing the raw materials according to the prescription, adding water for decoction for 2 times, each time for 1h, filtering, and combining the decoctions.
Example 3
Basic prescription: 10g of immature bitter orange, 15g of stir-fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine rheum officinale, 9g of pinellia ternate, 6g of ginger, 6g of peach kernel and 18g of radix codonopsis pilosulae.
The preparation method comprises the steps of grabbing the raw materials according to the prescription, adding water for decoction for 2 times, each time for 1h, filtering, and combining the decoctions.
Clinical efficacy experiment
1 subject of study
1.1 general data
Based on a clinical electronic medical record database of Guangan hospitals of Chinese traditional Chinese medical college, 45 patients with medical treatment are selected from 1 st 2006 to 10 th 1 nd 2012 according to inclusion standards.
1.2 diagnostic criteria
Western diagnostic criteria: referring to the guidelines for clinical management of gastroparesis published in 2013 by the American gastroenterology institute (ACG), in combination with a history of diabetes, the following criteria are established: (1) a history of diabetes; (2) has symptoms of gastroparesis; (3) removing outlet obstruction caused by pylorus organic lesions; (4) delay in gastric emptying is confirmed.
Traditional Chinese medicine dialectical standard: the differentiation standard is formulated by referring to 199edition "Chinese traditional medicine society diabetes professional committee diabetes traditional Chinese medicine diagnosis reference standard" and 2002 edition "Chinese traditional medicine New medicine clinical study guiding principle (trial), and the symptoms belong to liver-stomach disharmony and phlegm-dampness middle-resistance (with liver-stomach disharmony and phlegm-dampness middle-resistance differentiation standard).
Liver-stomach disharmony: (1) distending pain in the stomach or pain in the hypochondrium; (2) frequent belching; (3) noisy pantothenic acid; (4) pale red tongue with thin and white or thick coating; (5) the pulse is wiry. Two diagnosable items are provided.
Phlegm-dampness retention: (1) gastric and abdominal distention and fullness; (2) poor appetite and anorexia; (3) dry and bitter taste; (4) nausea and vomiting; (5) urine is short yellow; (6) the pulse is slippery. The diagnosis can be realized by two items.
1.3 inclusion criteria
(1) Definitively diagnosing Diabetic Gastroparesis (DGP) > 1 year; (2) conventional drug therapies such as antiemetics and prokinetic drugs are difficult to treat; (3) the index of the main symptoms of Gastroparesis (GCSI) nausea/emesis score is more than or equal to 3.5.
1.4 exclusion criteria
Patients who are not re-diagnosed after initial diagnosis; patients who cannot call back; patients treated by other interventions (e.g. gastric electrical stimulation, new drugs); patients with primary eating or swallowing disorders include ruminant syndrome, cardiogenic vomiting and periodic vomiting syndrome, or active malignancy.
2 treatment regimen
2.1 modes of treatment
The original basic treatment is maintained, and the selected patients take the decoction prepared in the example 1, 1 dose per day, 400ml of decoction is orally taken in the morning and evening for 2 times.
2.2 treatment cycle
The treatment course is 3 months, and 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks are set for one follow-up.
3 observation index
And (5) reviewing general data of the patient from the clinical electronic medical record, and grading the patient. The index of the main symptoms of Gastroparesis (GCSI), which is classified into 0 to 56 grades in total, is used to evaluate the symptoms of gastroparesis. Wherein, the groups are carried out according to three score scales (nausea/vomiting, postprandial satiety/early satiety, abdominal distension), and the total score of GCSI is counted, and the severity of gastroparesis symptoms is taken as a main index for evaluating the curative effect of the traditional Chinese medicine.
Results of the study
4.1 improvement of nausea/vomiting symptoms
Table 1 shows the change in the score scale for nausea/vomiting symptoms.
Table 1 change in the score scale for nausea/vomiting symptoms
As can be seen from Table 1, the scores of symptoms of Chinese medicine are compared before and after treatment, and the symptoms of nausea and vomiting are obviously improved compared with those before treatment, wherein the symptoms of nausea and vomiting have very obvious statistical difference (P < 0.01).
4.2 postprandial satiety/early satiety symptomatic improvement
Table 2 shows the change in postprandial satiety/early satiety symptom score scale
TABLE 2 post-prandial satiety/early satiety symptom score scale variation
As can be seen from table 2, the symptoms of the traditional Chinese medicine are compared before and after treatment, the postprandial satiety/early satiety has very significant statistical difference (P < 0.01), and the symptoms of postprandial satiety/early satiety and the like are obviously improved compared with those before treatment.
4.3 improvement of symptoms of abdominal distension
Table 3 shows the change of the scoring scale for symptoms of abdominal distension
TABLE 3 variation of scoring scale for abdominal distension symptoms
As can be seen from table 3, the scores of the symptoms of the traditional Chinese medicine are compared before and after treatment, and the symptoms of abdominal distension have very significant statistical difference (P < 0.01) after treatment for 4 weeks, so that the symptoms of abdominal distension are obviously improved compared with those before treatment.
4.4 symptomatic improvement of Gastroparesis (GCSI)
Table 4 shows the total score change for Gastroparesis (GCSI)
TABLE 4 GCSI total score change for gastroparesis
As can be seen from table 4, the symptoms of Gastroparesis (GCSI) were significantly statistically different (P < 0.01) compared to the scores of the symptoms of the traditional Chinese medicine before and after the treatment, and the symptoms of Gastroparesis (GCSI) were significantly improved compared to those before the treatment.
4.5 conditions for improving fasting blood glucose levels
Table 5 shows changes in fasting blood glucose levels
TABLE 5 variation of fasting blood glucose levels
As can be seen from Table 5, the Chinese medicine symptom scores were compared before and after the treatment, and there was no statistical difference (P > 0.05) in the comparison before and after the treatment of fasting blood glucose levels.
4.5 Security analysis
All patients have no adverse reaction in the treatment process, and various safety indexes such as blood convention, urine convention, stool convention, electrocardiogram, liver function, kidney function and the like have no obvious change before and after treatment.
The research results show that the traditional Chinese medicine composition provided by the invention has obvious improvement on the conditions of treating the diabetic gastroparesis patients, has obvious improvement on core symptoms such as nausea, vomiting, postprandial satiety, early satiety, abdominal distension and the like, has a certain regulation effect on blood sugar, has the average time of obvious improvement on symptoms of 19.6 days, has no adverse reaction on the patients during the administration period, and has good administration safety.
It should be understood that the foregoing examples of the present invention are provided merely for clearly illustrating the present invention and are not intended to limit the embodiments of the present invention, and that various other changes and modifications may be made therein by one skilled in the art without departing from the spirit and scope of the present invention as defined by the appended claims.
Claims (7)
1. A traditional Chinese medicine composition for treating diabetic gastroparesis is characterized in that the formula of each raw material is as follows: 10-15 parts of immature bitter orange, 10-20 parts of stir-fried bighead atractylodes rhizome, 3-6 parts of betel nut, 3-6 parts of wine rheum officinale, 6-9 parts of pinellia ternate, 6-12 parts of ginger, 3-6 parts of peach kernel and 10-20 parts of radix codonopsis pilosulae.
2. The traditional Chinese medicine composition according to claim 1, wherein the formula of each raw material is:
12-15 parts of immature bitter orange, 12-18 parts of stir-fried bighead atractylodes rhizome, 3-6 parts of betel nut, 3-6 parts of wine rheum officinale, 6-9 parts of pinellia ternate, 9-12 parts of ginger, 3-6 parts of peach kernel and 12-18 parts of radix codonopsis pilosulae.
3. The traditional Chinese medicine composition according to claim 1, wherein the formula of each raw material is:
15g of immature bitter orange, 15g of stir-fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine rheum officinale, 9g of pinellia ternate, 10g of ginger, 6g of peach kernel and 15g of radix codonopsis pilosulae.
4. The traditional Chinese medicine composition according to claim 1, wherein the formula of each raw material is: 12g of immature bitter orange, 20g of stir-fried bighead atractylodes rhizome, 3g of betel nut, 3g of wine rheum officinale, 6g of pinellia ternate, 10g of ginger, 6g of peach kernel and 20g of radix codonopsis pilosulae.
5. The traditional Chinese medicine composition according to claim 1, wherein the formula of each raw material is: 10g of immature bitter orange, 15g of stir-fried bighead atractylodes rhizome, 6g of betel nut, 6g of wine rheum officinale, 9g of pinellia ternate, 6g of ginger, 6g of peach kernel and 18g of radix codonopsis pilosulae.
6. The use of a Chinese medicinal composition according to any one of claims 1 to 5 in the preparation of a medicament for treating diabetic gastroparesis.
7. The use according to claim 6, wherein the pharmaceutical dosage form comprises a decoction, a granule, a capsule, a tablet, a powder, a pill or an oral liquid.
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| CN104162129A (en) * | 2014-07-31 | 2014-11-26 | 南阳市宛城区第一人民医院 | Traditional Chinese medicine for treating diabetic gastroparesis |
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| CN108143875A (en) * | 2016-12-06 | 2018-06-12 | 北京中医药大学东方医院 | A kind of Chinese medicine composition for treating diabetic gastroparesis and preparation method thereof |
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| KR20070032375A (en) * | 2004-07-14 | 2007-03-21 | 노파르티스 아게 | Combination of DPP-IV Inhibitors and Compounds Modulating 5-HT3 and/or 5-HT4 Receptors |
| CN104162129A (en) * | 2014-07-31 | 2014-11-26 | 南阳市宛城区第一人民医院 | Traditional Chinese medicine for treating diabetic gastroparesis |
| CN104623499A (en) * | 2015-01-21 | 2015-05-20 | 三峡大学 | Traditional Chinese medicine preparation for assisting acupuncture treatment of diabetic gastroparesis and preparation method and applications thereof |
| CN108143875A (en) * | 2016-12-06 | 2018-06-12 | 北京中医药大学东方医院 | A kind of Chinese medicine composition for treating diabetic gastroparesis and preparation method thereof |
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