Traditional Chinese medicine composition for treating gastroesophageal reflux disease related dental erosion as well as pharmaceutical preparation and application of traditional Chinese medicine composition

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating gastroesophageal reflux disease related dental erosion, which is prepared from the following raw material medicines in parts by weight: 15 to 30 parts of sword bean, 10 to 15 parts of folium eriobotryae, 15 to 30 parts of concha meretricis seu cyclinae, 15 to 30 parts of spiral shell, 10 to 15 parts of solanum septemlobum bunge, 5 to 10 parts of bunge cherry root, 1 to 5 parts of rhizoma nardostachyos, 1 to 3 parts of fructus piperis longi, 10 to 15 parts of herba taxilli and 3 to 6 parts of liquorice root. The traditional Chinese medicine composition formula disclosed by the invention has the effects of calming adverse-rising energy, harmonizing stomach, relieving acid and protecting teeth, and is remarkable in curative effect when being used for gastroesophageal reflux disease related dental erosion. Pharmacodynamic experiments prove that the traditional Chinese medicine composition can effectively improve the basic corrosive wear condition of teeth, regulate the pH value of saliva, improve related respiratory system symptoms and inhibit reflux, achieves the purpose of treating gastroesophageal reflux disease related dental erosion, has a definite clinical curative effect, does not have obvious adverse reaction, and has a remarkable new medicine conversion application prospect.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating gastroesophageal reflux disease-related dental erosion, and a pharmaceutical preparation and application thereof. Background Art

[0002] Gastroesophageal reflux disease (GERD) is a common digestive system disease. Its main cause is the reflux of acidic gastric juice in the stomach into the esophagus, causing damage to the esophageal mucosa and inflammation. GERD-related dental erosion (DE) is a common complication of GERD. It refers to the lesions in which the tooth surface is eroded and worn due to long-term exposure to gastric acid, resulting in damage to the tooth texture, discoloration of the tooth surface, exposure of dentin, involvement of specific parts, dry mouth and thick tongue coating. Studies have shown that the incidence of DE in adult GERD patients ranges from 5% to 47.5%. Worldwide, approximately 30-50% of deciduous teeth and 20-45% of permanent teeth are affected by DE. The severity of DE is positively correlated with the frequency and duration of GERD. Therefore, the main clinical treatments are proton pump inhibitors, H 2 Receptor antagonists and other anti-reflux treatments are the main treatments. However, although anti-reflux drug treatment can relieve symptoms, it is difficult to cure the erosion and wear of teeth, and the effect is not long-lasting and prone to recurrence. There is currently no optimal treatment plan.

[0003] There is no consensus on DE in traditional Chinese medicine. Combined with its clinical symptoms, it is often classified as "toothache". It is mostly caused by improper diet, emotional depression, excessive thinking, etc., which leads to gastric qi reflux, inducing the contents of the stomach and duodenum to invade the epigastrium and harm the oral cavity. The acidic gastric juice burns the teeth, and the symptoms include toothache and tooth damage. Because the lung and stomach are related, the stomach's failure to descend can induce the lung's failure to clear and purify. In addition, the gastric juice's upward invasion also affects the pharynx, and common lung-related symptoms such as cough, sputum, hoarseness, pharyngeal pain, and foreign body sensation in the pharynx. Therefore, although the location of the disease is in the mouth and pharynx, its symptoms are in the lungs and its root is in the stomach. Because teeth are the remains of bones, and bones are dominated by the kidneys, the density of teeth depends on the sufficient kidney essence to nourish bones and produce marrow, so its root is in the kidneys. In summary, gastric qi reflux and gastric failure to descend are its basic pathogenesis, and lung failure to clear and purify, kidney essence failure, acid erosion and tooth burning are its important pathogenesis.

[0004] Although the multi-pathway, multi-target and multi-level therapeutic effects of traditional Chinese medicine are effective in treating GERD-related symptoms, there is no traditional Chinese medicine composition scheme for treating DE using the above-mentioned etiology and pathogenesis in the prior art. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicine composition for treating gastroesophageal reflux disease-related tooth erosion (hereinafter referred to as Tooth Erosion Ling Fang) and its pharmaceutical preparation and application. The present invention is the first solution to improve GERD-related DE symptoms by utilizing the advantages of traditional Chinese medicine, and has the characteristics of few side effects and high safety.

[0006] The first aspect of the present invention provides a Chinese medicine composition for treating gastroesophageal reflux disease-related dental erosion, which is composed of the following raw materials in parts by weight:

[0007] 15-30 parts of sword bean, 10-15 parts of loquat leaves, 15-30 parts of sea clam shells, 15-30 parts of white snail shells, 10-15 parts of Shuyangquan, 5-10 parts of Yu Li root, 1-5 parts of Nardostachys grandiflora, 1-3 parts of Piper longum, 10-15 parts of mistletoe, and 3-6 parts of liquorice.

[0008] Furthermore, the Chinese medicine composition for treating gastroesophageal reflux disease-related dental erosion is composed of the following raw materials in parts by weight:

[0009] 20-30 parts of sword bean, 12-15 parts of loquat leaves, 20-30 parts of sea clam shells, 20-30 parts of white snail shells, 12-15 parts of Shuyangquan, 8-10 parts of Yu Li root, 3-5 parts of Nardostachys grandiflora, 2-3 parts of Piper longum, 12-15 parts of mistletoe, and 4-6 parts of liquorice.

[0010] Furthermore, the Chinese medicine composition for treating gastroesophageal reflux disease-related dental erosion is composed of the following raw materials in parts by weight:

[0011] 30 parts of sword bean, 15 parts of loquat leaves, 30 parts of sea clam shells, 30 parts of white snail shells, 15 parts of Shuyangquan, 10 parts of Yu Li Radix, 5 parts of Nardostachys grandiflora, 3 parts of Piper longum, 15 parts of Taxillus chinensis, and 6 parts of Radix Glycyrrhizae.

[0012] The second aspect of the present invention provides a pharmaceutical preparation having the above-mentioned Chinese medicine composition for treating GERD-related dental erosion as an active ingredient, wherein the pharmaceutical preparation is prepared into a commonly used dosage form in pharmacy by conventional preparation methods in the art.

[0013] Furthermore, the dosage form of the pharmaceutical preparation is decoction, tablet, capsule, granule, pill, oral liquid or syrup.

[0014] Furthermore, the preparation method of the pharmaceutical preparation is as follows: take the raw materials according to weight, mix them according to proportion, add 6 times the total amount of the medicinal materials in water, soak for half an hour, boil them quickly over high heat, boil them over low heat until the amount of water is 2 times the amount of the medicinal materials, and pour out the decoction. Add 4 times the total amount of the medicinal materials in water again, boil them over low heat until the amount of water is 2 times the amount of the medicinal materials, pour out the decoction, combine the decoctions, filter, and combine the medicinal liquids.

[0015] Furthermore, the pharmaceutical preparation also includes pharmaceutically acceptable excipients.

[0016] The third aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for preventing or treating gastroesophageal reflux disease-related dental erosion.

[0017] The fourth aspect of the present invention provides a use of the pharmaceutical preparation as described above in the preparation of a drug for preventing or treating gastroesophageal reflux disease-related dental erosion.

[0018] The dosage of the present invention is a therapeutically effective amount, for example, about 1 g / kg body weight to about 1.5 g / kg body weight per day. The general medication period is 2-8 months, preferably 3-6 months. Of course, the medication period also needs to consider the route of administration and the patient's health status, which are all within the skill range of skilled physicians.

[0019] In addition, the Chinese medicine composition of the present invention can be used as the sole active ingredient to prevent or treat gastroesophageal reflux disease-related tooth erosion, and can also be used together with other therapeutic agents, such as proton pump inhibitors or H 2 Receptor antagonists, etc.

[0020] Traditional Chinese medicine does not have a related disease name for gastroesophageal reflux disease-related tooth erosion. It can be diagnosed as "toothache" based on its clinical symptoms. DE disease is located in the mouth and pharynx, with the lungs as the sign, the stomach as the base, and the kidneys as the root. The pathological mechanism is complex.

[0021] This prescription uses sword bean and loquat leaf as the main medicines to reduce adverse reactions and harmonize the stomach, sea clam shell and white snail shell as the assistant medicines to reduce acid and relieve pain, Shuyangquan, Yu Li root, Nardostachys grandiflora, Piper longum, and Viscum album as the adjuvant medicines to protect the teeth, relieve pain, benefit the kidneys and strengthen the teeth, and licorice as the guiding medicine to harmonize the various medicines.

[0022] The properties, flavors, meridians and functions of the various drugs in the prescription of the present invention, as well as their commonly used weights are as follows:

[0023] Sword bean: sweet, warm. It enters the stomach and kidney meridians, reduces adverse effects and stops vomiting, warms the kidney and helps yang. It is used for hiccups and vomiting caused by deficiency and cold in the middle jiao, and for low back pain caused by kidney deficiency. It has the effect of sweetness, warmth and helping yang. Common dosage: 10-30 grams.

[0024] Loquat leaf: bitter, slightly cold. Enters the lung and stomach meridians. Good at clearing the lungs and relieving cough, lowering adverse qi and stopping vomiting. Can treat lung heat cough, qi reverse wheezing, dry heat cough and wheezing, stomach heat vomiting, hiccups, etc. Common dosage: 5-25 grams.

[0025] Sea clam shell (calcined): cold in nature, salty in taste; enters the lung and stomach meridians; has the effects of clearing the lungs and resolving phlegm, softening and dispersing lumps, absorbing moisture and healing sores, and is mainly used to treat lung heat, thick phlegm, difficulty in coughing, coughing and asthma, stomach pain and heartburn, etc. Common dosage: 10-30 grams.

[0026] White snail shell: sweet, mild and flat. It can dissipate phlegm, soothe the stomach, heal sores, reduce acid and relieve pain. It is mainly used to treat hot phlegm cough, nausea and vomiting acid, scrofula ulcer, burns and other symptoms. Common dosage: 10-30 grams.

[0027] Shuyangquan: sweet, cold, toxic, mainly enters the liver and stomach meridians. Good at dispelling wind and heat, removing dampness and relieving pain. Mainly used for toothache, rheumatic pain, cold, scrofula. Common dosage: 10-15 grams.

[0028] Prunus mume root: bitter, slightly sour, cool. Enters the spleen and large intestine meridians. Good at regulating qi and relieving pain. Indications: pain caused by qi stagnation and toothache. "Ben Jing": "It treats gingival swelling, tooth decay, and strong teeth." Common dosage: 5-15 grams.

[0029] Gansong: pungent, sweet and warm, belongs to the spleen and stomach meridians. It promotes qi and relieves pain, relieves depression and invigorates the spleen. It is used for abdominal distension and pain caused by cold stagnation and qi stagnation, loss of appetite; and chest tightness and abdominal distension caused by worrying about the spleen and qi stagnation. It is good for treating toothache. Common dosage: 10-15 grams.

[0030] Piper longum: pungent, hot. Enters the stomach and large intestine meridians. Good at warming the middle and relieving pain. Indications: swelling, pain, toothache, headache, etc. caused by internal fire and external cold. Common dosage: 1.5-3 grams.

[0031] Mulberry: bitter, sweet, neutral. Enters the liver and kidney meridians. Nourishes the liver and kidneys, strengthens the tendons and bones. Shennong's Herbal Classic says it "strengthens hair and teeth." Common dosage: 10-30 grams.

[0032] Licorice: sweet, neutral. It enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving pain, and harmonizing various medicines. Common dosage: 1.5-10 grams.

[0033] The advantages and beneficial effects of the present invention are:

[0034] 1. The Chinese medicine composition formula of the present invention, the Tooth Erosion Recipe, has the effects of lowering adverse qi, harmonizing the stomach, reducing acid and protecting teeth. It is one of the series of prescriptions of the "tong", "hua", "xuan" and "ping" diagnosis and treatment system of spleen and stomach diseases in the Chen Cunren Academic Thought Research Base of the Ding's Internal Medicine School of Shanghai School of Traditional Chinese Medicine. It embodies the "plain, light and smart" and "pure, correct and gentle" medication method of Menghe. It is used for tooth erosion associated with gastroesophageal reflux disease with remarkable efficacy. The sword bean in the prescription is good at lowering adverse qi and benefiting the kidney, and can be used as the root treatment of the pathogenesis. The loquat leaf is good at clearing the lung qi, harmonizing the stomach and lowering adverse qi, and can focus on the treatment of the symptoms of the pathogenesis. They are all monarch drugs, specializing in lowering adverse qi. The sea clam shell and the white snail shell are better at reducing acid and pain, calming and lowering adverse qi, and can control the source of adverse qi such as gastric juice, and are all minister drugs. Shuyangquan is good at removing toothache caused by rheumatism, Yuligen is good at toothache caused by qi stagnation, Gansong is good at toothache caused by cold stagnation and qi stagnation, and Piper longum is good at toothache caused by cold and heat. They are all tested medicines for toothache to remove tooth erosion. In addition, mistletoe helps the main medicine to nourish the kidney and strengthen the teeth. The five medicines are used as adjuvants. Licorice is used to harmonize the medicines. The combination of the medicines can play the role of descending adverse qi, harmonizing the stomach, controlling acid and protecting teeth, so that the lung qi can be purged, the kidney qi can be strengthened, the stomach qi can be descended, the stomach acid can be restrained, and the teeth can be nourished, and all symptoms can be eliminated.

[0035] 2. The Chinese medicine composition formula of the present invention has been verified by pharmacodynamic experiments to be able to effectively improve the basic corrosive wear of teeth, regulate the pH value of saliva, improve related respiratory system symptoms, inhibit reflux, and achieve the purpose of treating gastroesophageal reflux DE. It has a positive clinical efficacy and no obvious adverse reactions. It has significant prospects for new drug transformation and application.

[0036] 3. In the Chinese medicine formula of the present invention, the ratio and preparation method of the Chinese medicine raw materials are obtained through a large number of experimental comparisons and screenings, and have the advantages of good efficacy and significant effects. DETAILED DESCRIPTION

[0037] The specific implementation methods provided by the present invention are described in detail below in conjunction with the examples. The experimental methods in the following examples that do not specify specific conditions are usually carried out under conventional conditions or under conditions recommended by the manufacturer. Unless otherwise specified, the medicinal materials used in the embodiments of the present invention can be obtained from a Chinese medicinal material sales company. Unless otherwise specified, the obtained medicinal materials are all Chinese medicinal material slices. The slices can be obtained from the sales company or processed after being obtained.

[0038] Embodiment 1: Chinese medicine composition of the present invention

[0039] 15 parts of sword bean, 10 parts of loquat leaves, 15 parts of sea clam shells, 15 parts of white snail shells, 10 parts of Shuyangquan, 5 parts of Yu Li Radix, 1 part of Nardostachys grandiflora, 1 part of Piper longum, 10 parts of Taxillus chinensis, and 3 parts of Licorice.

[0040] Embodiment 2: Chinese medicine composition of the present invention

[0041] 20 parts of sword bean, 12 parts of loquat leaves, 20 parts of sea clam shells, 20 parts of white snail shells, 12 parts of Shuyangquan, 8 parts of Yuli Radix, 3 parts of Nardostachys grandiflora, 2 parts of Piper longum, 12 parts of parasitic herb, and 4 parts of liquorice.

[0042] Embodiment 3: Chinese medicine composition of the present invention

[0043] 25 parts of sword bean, 14 parts of loquat leaves, 25 parts of sea clam shells, 25 parts of white snail shells, 14 parts of Shuyangquan, 9 parts of Yu Li Radix, 4 parts of Nardostachys grandiflora, 3 parts of Piper longum, 14 parts of parasitic loranthus, and 5 parts of liquorice.

[0044] Embodiment 4: Chinese medicine composition of the present invention

[0045] 30 parts of sword bean, 15 parts of loquat leaves, 30 parts of sea clam shells, 30 parts of white snail shells, 15 parts of Shuyangquan, 10 parts of Yu Li Radix, 5 parts of Nardostachys grandiflora, 3 parts of Piper longum, 15 parts of Taxillus chinensis, and 6 parts of Radix Glycyrrhizae.

[0046] Example 5: Preparation of the Chinese medicine composition decoction of the present invention

[0047] Take the raw materials, mix them according to the proportion, add 6 times the total amount of the medicinal materials in water, soak for half an hour, boil over high heat, boil over low heat until the amount of water is 2 times the amount of the medicinal materials, pour out the decoction. Add 4 times the total amount of the medicinal materials in water again, boil over low heat until the amount of water is 2 times the amount of the medicinal materials, pour out the decoction, combine the decoctions, filter, and combine the medicinal liquids.

[0048] Example 6: Preparation of Chinese medicine composition tablets / capsules of the present invention

[0049] Weigh each Chinese medicine raw material according to weight proportion, grind it into powder, decoct it, and concentrate it under reduced pressure to obtain an extract, dry and crush the extract into granules, add pharmaceutical excipients, and press it into tablets or fill it into capsules.

[0050] Example 7: Preparation of the Chinese medicine composition granules of the present invention

[0051] Weigh each Chinese medicine raw material according to weight proportion, grind it into powder, decoct it, and concentrate it under reduced pressure to obtain an extract, which is then dried and crushed to prepare granules.

[0052] Example 8: Preparation of the Chinese medicine composition pills / oral liquid / syrup of the present invention

[0053] Weigh each Chinese medicine raw material according to the weight ratio, grind it into powder, decoct it, take the supernatant, and concentrate it into a thick extract; add appropriate pharmaceutical excipients (such as white sugar, honey, benzopropionic acid or ethylparaben) to make pills, oral liquid or syrup.

[0054] Example 9: Clinical trial of the Chinese medicine composition of the present invention

[0055] 1. Experimental Materials and Methods

[0056] 1.1 Case source:

[0057] The data were selected from 68 patients who visited the gastroesophageal reflux disease specialist clinic / expert clinic / general clinic / gastroenterology ward of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from January 2021 to December 2023. All research subjects filled out and signed informed consent forms in accordance with the requirements of ethical review.

[0058] 1.2 Inclusion criteria:

[0059] (1) Aged 18-75 years old;

[0060] (2) having GERD-related symptoms;

[0061] (3) Underwent esophageal and gastrointestinal examinations (gastroscopy, esophageal 24-hour pH test, esophageal manometry, etc.), and at least one result showed the presence of pathological reflux;

[0062] (4) No other serious systemic diseases;

[0063] (5) The subject had at least 20 teeth in the mouth, excluding the third molars.

[0064] 1.3 Exclusion criteria:

[0065] (1) Diseases that cause reflux of gastrointestinal contents, such as long-term alcoholism, anorexia, bulimia nervosa, vomiting neurasthenia, and long-term vomiting during pregnancy;

[0066] (2) Long-term nocturnal bruxism, excessive consumption of acidic foods and drugs, and long-term exposure to an acidic environment;

[0067] (3) taking drugs that reduce saliva secretion, including antidepressants, diuretics, and anesthetics;

[0068] (4) Tetracycline-induced teeth, dental fluorosis, and orthodontic treatment is in progress;

[0069] (5) Suffering from diseases that can cause obvious oral changes, such as dry mouth syndrome, sialolithiasis, other salivary gland inflammation or maxillofacial tumors;

[0070] (6) There are other obvious pathogenic factors that can cause erosion.

[0071] 1.4 Treatment methods:

[0072] Treatment group: The decoction of the present invention (prepared by the method of Examples 4 and 5) was administered, 1 dose per day, twice a day, morning and evening, for 12 consecutive weeks.

[0073] Control group: Omeprazole capsules (manufacturer: Hainan Hailing Chemical Pharmaceutical Co., Ltd.; approval number: National Medicine Standard H10920092; specification: 28 capsules / bottle) 20 mg each time, twice a day, orally, for 12 weeks.

[0074] 1.5 Observation indicators:

[0075] 1.5.1 Basic Corrosive Wear Inspection Scoring

[0076] The risk of DE in each patient was assessed using the Basic Erosive Wear Examination (BEWE) score, which examined the buccal (B), palatal (P) / lingual (L), and occlusal (O) / incisal (I) surfaces of all teeth and recorded the maximum score in each quintile. All values ​​were summed to obtain the final score. Erosive wear is graded as follows: 0 (no tooth erosion); 1 (beginning wear of the surface texture); 2 (obvious loss, hard tissue loss <50% of the surface area); 3 (hard tissue loss ≥50% of the surface area). The BEWE score quantifies the severity of DE as follows: 0-3 (none); 4-8 (low); 9-13 (moderate); >13 (high).

[0077] 1.5.2 Determination of saliva pH by electrode method

[0078] Before the collection, the subjects fasted and did not drink water for at least 30 minutes. During the collection, the subjects cleaned their mouths with sterile water and collected the secreted saliva to prevent the saliva from being affected by the outside world. About 1-2 ml of saliva was collected per person using a sterile container, and then the pH electrode was inserted into the saliva sample to ensure that the electrode covered enough saliva liquid surface, and the measured saliva pH value was recorded.

[0079] 1.5.3 Clinical symptom score

[0080] The clinical symptoms of the subjects were evaluated before and every two weeks after treatment according to the relevant standards of the Guiding Principles for Clinical Research of New Chinese Medicines. The symptoms were divided into four levels (0, I, II, III) according to the severity of the symptoms, with scores of 0, 1, 2, and 3. Because the clinical symptoms of DE are closely related to respiratory symptoms, the efficacy of the five main clinical symptoms of cough, sputum, hoarseness, pharyngeal pain, and foreign body sensation in the pharynx was mainly compared.

[0081] 1.5.4 Clinical Effectiveness

[0082] Combined with the score in 1.5.3, the efficacy evaluation criteria are as follows: cured: symptoms disappear, and the symptom score decreases by 95% or more; markedly effective: symptoms basically disappear, although there are occasional symptoms but they disappear quickly, and the symptom score decreases by 70% or more; effective: symptoms do not disappear, but are alleviated compared to before, and the symptom score decreases by 30% or more; ineffective: symptoms do not disappear, the degree of symptom does not decrease, and the symptom score decreases by less than 30%. [Note: The calculation formula is: (pre-treatment score - post-treatment score) / pre-treatment score * 100%].

[0083] 1.5.5GERD Q-scale score

[0084] The GerdQ questionnaire is the simplest and most effective tool for diagnosing and evaluating GERD. It can evaluate the impact of GERD on the patient's quality of life and the efficacy of the treatment. The scale evaluates the patient's positive symptoms, negative symptoms, and positive effects based on the frequency of symptoms within a week. There are 6 questions in total, and the maximum total score after adding up is 18 points. A GerdQ score of 8 or more indicates a GERD diagnosis, and the scores of the last two items greater than or equal to 3 indicate that GERD affects the quality of life. The evaluation is done once before and after treatment.

[0085] 1.6 Research Results:

[0086] A total of 68 DE subjects were recruited in this trial and randomly assigned at a ratio of 1:1. During the treatment period, 6 subjects were lost to follow-up, with a loss rate of ≈8.82%<10%, which met the dropout criteria. A total of 62 subjects actually completed follow-up, including 32 in the treatment group and 30 in the control group.

[0087] 2. Experimental results

[0088] 2.1 Comparison of BEWE scores between the two groups

[0089] There was no significant difference in BEWE scores between the Chinese medicine group and the Western medicine group before treatment (P>0.05), so they can be compared. Compared with the group before treatment, both groups had significant effects in improving BEWE scores, but the difference in the Chinese medicine group was more significant (Chinese medicine group P<0.001, Western medicine group P<0.05). Compared with the Western medicine group after treatment, the Chinese medicine group had more prominent efficacy, and the difference was statistically significant (P<0.05), that is, the Chinese medicine group was better than the Western medicine group in improving the BEWE scores of patients.

[0090] Table 1 Comparison of BEWE scores between the two groups after treatment

[0091]

[0092] Note: Compared with the treatment within the same group, * P<0.05, ** P<0.01; compared with the intergroup after treatment, #P<0.05, ## P<0.01.

[0093] 2.2 Comparison of saliva pH between the two groups of patients

[0094] There was no significant difference in saliva pH value between the Chinese medicine group and the Western medicine group before treatment (P>0.05), so the comparison was possible. There was a significant difference in saliva pH value between the Chinese medicine group after treatment and before treatment (P<0.001); there was no significant difference between the Western medicine group after treatment and before treatment (P>0.05). The comparison between the two groups after treatment showed that the difference was statistically significant (P<0.05), that is, the Chinese medicine group was better than the Western medicine group in improving the oral acid-base level of patients.

[0095] Table 2 Comparison of saliva pH values ​​between the two groups after treatment

[0096]

[0097] Note: Compared with the treatment within the same group, * P<0.05, ** P<0.01; compared with the intergroup after treatment, # P<0.05, # P<0.01.

[0098] 2.3 Comparison of clinical symptom scores between the two groups

[0099] Compared with the treatment of this group, the Chinese medicine group showed improvement in cough, sputum, hoarseness, pharyngeal pain, and foreign body sensation in the pharynx, and the difference was statistically significant (P < 0.05); the Western medicine group did not show significant improvement in the above symptoms (P > 0.05). Compared with the Western medicine group, the Chinese medicine group had a better effect in improving the respiratory system-related symptoms caused by GERD, and the difference was statistically significant (P < 0.05).

[0100] Table 3 Comparison of clinical symptom efficacy between the two groups [P50 (P25, P75)]

[0101]

[0102] Note: Compared with the treatment within the same group, * P<0.05, ** P<0.01; compared with the intergroup after treatment, # P<0.05, ## P<0.01.

[0103] 2.4 Comparison of clinical efficacy between the two groups of patients

[0104] Compared with the control group, the total effective rate of TCM clinical efficacy in the observation group was 90.6% (29 / 32), significantly higher than that in the control group (40.0% (12 / 30), with a statistically significant difference (χ 2 =25.009, P<0.05).

[0105] Table 4 Comparison of clinical efficacy between the two groups [cases (%)]

[0106]

[0107] 2.5 Comparison of GerdQ scores between the two groups

[0108] Before treatment, the Gerd Q scales of the two groups were compared. Because they did not meet the normal distribution, a non-parametric test was performed, and Z = -0.891, P = 0.373, the difference was not statistically significant (P>0.05), and the comparison was possible. After testing, the GerdQ score of the Chinese medicine group was significantly different from that before treatment (P<0.001); the GerdQ score of the Western medicine group was significantly different from that before treatment (P<0.05). The GerdQ scores of the Chinese medicine group and the Western medicine group were compared before and after treatment. After non-parametric test, there was no statistically significant difference (P>0.05).

[0109] Table 5 Comparison of GerdQ scale scores between the two groups after treatment [P50 (P25, P75)]

[0110]

[0111] Note: Z 1 , P 1 is the result of intra-group comparison; Z 2 , P 2 The results are compared between groups; * P<0.05, ** P<0.01; compared with the intergroup after treatment, # P<0.05, ## P<0.01.

[0112] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the embodiments. Those skilled in the art may make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A Chinese medicine composition for treating gastroesophageal reflux disease-related dental erosion, characterized in that: The invention is composed of the following raw materials in parts by weight: 15-30 parts of sword bean, 10-15 parts of loquat leaf, 15-30 parts of sea clam shell, 15-30 parts of white snail shell, 10-15 parts of Shuyangquan, 5-10 parts of Yu Li root, 1-5 parts of Nardostachys grandiflora, 1-3 parts of Piper longum, 10-15 parts of mistletoe and 3-6 parts of liquorice.

2. The Chinese medicine composition for treating gastroesophageal reflux disease-related dental erosion according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 20-30 parts of sword bean, 12-15 parts of loquat leaf, 20-30 parts of sea clam shell, 20-30 parts of white snail shell, 12-15 parts of Shuyangquan, 8-10 parts of Yu Li root, 3-5 parts of Nardostachys grandiflora, 2-3 parts of Piper longum, 12-15 parts of mistletoe and 4-6 parts of liquorice.

3. The Chinese medicine composition for treating gastroesophageal reflux disease-related dental erosion according to claim 1, characterized in that: The medicine is composed of the following raw materials in parts by weight: 30 parts of sword bean, 15 parts of loquat leaf, 30 parts of sea clam shell, 30 parts of white snail shell, 15 parts of Shuyangquan, 10 parts of Yu Li root, 5 parts of Nardostachys grandiflora, 3 parts of Piper longum, 15 parts of Viscum album and 6 parts of Licorice.

4. A pharmaceutical preparation using the Chinese medicine composition for treating gastroesophageal reflux disease-related dental erosion as claimed in any one of claims 1 to 3 as an active ingredient, characterized in that: The pharmaceutical preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

5. The pharmaceutical preparation according to claim 4, characterized in that The dosage form of the pharmaceutical preparation is decoction, tablet, capsule, granule, pill, oral liquid or syrup.

6. The pharmaceutical preparation according to claim 4, characterized in that The preparation method of the pharmaceutical preparation is as follows: take the raw materials according to weight, mix them according to proportion, add 6 times the total amount of the medicinal materials in water, soak for half an hour, boil them quickly over high heat, boil them over low heat until the amount of water is 2 times the amount of the medicinal materials, and pour out the decoction. Add 4 times the total amount of the medicinal materials in water again, boil them over low heat until the amount of water is 2 times the amount of the medicinal materials, pour out the decoction, combine the decoctions, filter, and combine the medicinal liquids.

7. The pharmaceutical preparation according to claim 4, characterized in that The pharmaceutical preparation also includes pharmaceutically acceptable excipients.

8. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for preventing or treating gastroesophageal reflux disease-related dental erosion.

9. Use of the pharmaceutical preparation according to any one of claims 4 to 7 in the preparation of a drug for preventing or treating gastroesophageal reflux disease-related dental erosion.

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