Traditional Chinese medicine composition for preventing and treating liver cirrhosis, esophageal and gastric varicosity rupture bleeding and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for preventing and treating liver cirrhosis esophageal and gastric varicosity rupture bleeding. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 28-32 parts of astragalus membranaceus, 13-17 parts of radix rehmanniae recen, 7-11 parts of cooked rheum officinale, 13-17 parts of scutellaria baicalensis, 7-11 parts of coptis chinensis, 7-11 parts of fried peach kernels, 4-8 parts of ground beetles, 13-17 parts of turtle shells and 13-17 parts of thunberg fritillary bulbs. The invention further provides application of the traditional Chinese medicine composition. Compared with single application of western medicine sequential treatment (endoscope and carvedilol), the traditional Chinese medicine composition disclosed by the invention has the advantage that the rebleeding occurrence rate and the case fatality rate of a liver cirrhosis EGVB patient can be obviously reduced by matching with the western medicine sequential treatment (endoscope and carvedilol). The invention can be used for researching and developing new target drugs for treating liver cirrhosis, liver cirrhosis portal hypertension and liver cirrhosis esophageal gastric rupture bleeding (EGVB), and can be used for treating liver cirrhosis, portal hypertension and EGVB caused by various causes.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for preventing and treating esophageal and gastric varicose vein bleeding caused by liver cirrhosis and its application. Background Art

[0002] Esophagogastric variceal bleeding (EGVB) is a serious clinical consequence of cirrhosis and portal hypertension (PH), and is one of the most severe decompensated events in cirrhosis. The annual incidence of a first bleeding event is approximately 10% to 15%, with a mortality rate as high as 12% to 22%. In recent decades, rapid advances in endoscopic and interventional treatments have significantly improved the survival rate of patients with EGVB, but rebleeding remains a serious clinical event. After successful treatment of acute esophagogastric variceal bleeding, without secondary prevention, the rebleeding rate within 1 year is approximately 60%, with a mortality rate as high as 33%. However, the fundamental cause of esophageal and gastric variceal bleeding is portal hypertension caused by cirrhosis, which obstructs portal venous return. First-line preventive measures, primarily non-selective beta-blockers combined with endoscopic intervention, are unable to fundamentally alter this obstructed portal venous return. Interventional treatments, such as transjugular intrahepatic portosystemic shunts, not only cause surgical trauma but also often lead to serious complications such as hepatic encephalopathy and liver damage. Furthermore, modern medicine currently lacks treatments that can effectively improve the pathological basis of cirrhosis and portal hypertension. Therefore, seeking more effective secondary prevention options is crucial for preventing rebleeding and reducing complications.

[0003] Chinese patent document CN 105194554A discloses a method for preparing a traditional Chinese medicine composition for preventing and treating esophageal variceal bleeding in patients with cirrhosis. Based on the characteristics of traditional Chinese medicine and the pathology of cirrhosis, the present invention not only formulates a scientific formula but also selects a suitable method for preparation. The composition boasts the efficacy of invigorating qi and activating blood circulation, dissolving blood stasis, and relieving symptoms. It has significant efficacy for treating symptoms of esophageal varices in cirrhosis, such as liver pain, jaundice, ascites, spider bead nevus, liver palmar erythema, ecchymoses on the edges of the tongue, and splenomegaly, with an efficacy rate exceeding 95%. Patients with esophageal variceal bleeding in cirrhosis who consistently take the composition will not experience recurrence of bleeding. The composition not only significantly reduces portal and esophageal venous pressure, improves esophageal varices, and prevents bleeding, but also improves liver fibrosis, reduces resistance in the intrahepatic and portosystemic collateral vessels, and simultaneously enhances the body's resistance and strengthens the body's body, achieving the goal of treating the primary disease.

[0004] Chinese patent document CN 105031023A discloses a Chinese medicine composition for treating portal hypertension in cirrhosis. The Chinese medicine composition is composed of the following Chinese medicines in parts by weight: 8-16 parts of Ginkgo Biloba Root, 5-13 parts of White Nine-Knot Herba, 5-13 parts of White Peony Root, 4-8 parts of Pteris Psoralea Corylifolia, 8-16 parts of Dog Bell, 4-8 parts of Elephanthifolia, 4-8 parts of Artemisia absinthium, 5-13 parts of Artemisia dwarfis, 6-14 parts of Artemisia dwarfis, 6-14 parts of Artemisia argyi, 6-14 parts of White Haired Snake, 6-14 parts of Herba Eupatorii, and 4-8 parts of Licorice. The Chinese medicine composition of the present invention is used in combination to relieve damp-heat toxicity, remove blood stasis and unclog the meridians, and harmonize qi and blood, promoting liver function and nourishing the liver, attacking and tonifying, and playing the role of invigorating qi, detoxifying and unblocking the meridians. It has the effects of significantly alleviating symptoms and signs, protecting the liver, reducing enzyme levels, and lowering portal vein pressure, and has a definite therapeutic effect without obvious toxic and side effects.

[0005] However, there is no report on a Chinese medicine composition for preventing and treating esophageal and gastric varicose vein bleeding in cirrhosis of the liver that is practical, highly compliant, safe and effective, and its application. Summary of the Invention

[0006] The purpose of the present invention is to provide a Chinese medicine composition for preventing and treating esophageal and gastric varicose vein bleeding caused by liver cirrhosis and its application in view of the deficiencies in the prior art.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for preventing and treating esophageal and gastric varicose bleeding caused by cirrhosis of the liver, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 28-32 parts of astragalus, 13-17 parts of raw rehmannia, 7-11 parts of cooked rhubarb, 13-17 parts of scutellaria, 7-11 parts of coptis, 7-11 parts of stir-fried peach kernel, 4-8 parts of earthworm, 13-17 parts of turtle shell, and 13-17 parts of thunbergia thunbergii.

[0008] As a preferred example, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 29-31 parts of astragalus, 14-16 parts of raw rehmannia, 8-10 parts of cooked rhubarb, 14-16 parts of scutellaria, 8-10 parts of coptis, 8-10 parts of stir-fried peach kernel, 5-7 parts of earthworm, 14-16 parts of turtle shell, and 14-16 parts of thunbergia thunbergii.

[0009] As a preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 30 parts of Astragalus, 15 parts of Rehmannia, 9 parts of Rhubarb, 15 parts of Scutellaria, 9 parts of Coptis, 9 parts of stir-fried peach kernel, 6 parts of Eupolyphaga, 15 parts of Carapace of Turtle, and 15 parts of Fritillaria thunbergii.

[0010] As a preferred example, the pharmaceutical composition is prepared as an oral preparation based on the raw material drug according to a conventional method; or is prepared as a common oral preparation by adding pharmaceutically acceptable excipients.

[0011] As a preferred example, the oral preparation is a powder, tablet, granule, capsule, oral liquid, injection, or the above dosage forms of the original formula extract.

[0012] In a second aspect, the present invention provides the use of a traditional Chinese medicine composition in the preparation of a drug for preventing and treating esophageal and gastric varicose bleeding caused by liver cirrhosis, and for treating liver cirrhosis, portal hypertension, and EGVB.

[0013] As a preferred example, the TCM pathogenesis of the cirrhosis, portal hypertension and EGVB is deficiency of vital energy and blood stasis, and the liver function grade is Child A-C.

[0014] In a third aspect, the present invention provides a pharmaceutical composition for preventing and treating esophageal and gastric varicose bleeding caused by liver cirrhosis, wherein the pharmaceutical composition is composed of a traditional Chinese medicine composition.

[0015] In a fourth aspect, the present invention provides the use of a pharmaceutical composition in the preparation of drugs for preventing and treating liver cirrhosis, portal hypertension due to liver cirrhosis, and EGVB due to liver cirrhosis.

[0016] The advantages of the present invention are:

[0017] The Chinese medicine composition of the present invention is a large number of clinically effective cases summarized and sorted out by the inventor. On the basis of the theory of "deficiency and accumulation", it is further summarized that "deficiency of vital energy and blood stasis" is the basic pathogenesis theory of esophageal and gastric variceal bleeding in cirrhosis, and the treatment is based on "tonifying qi and nourishing yin, clearing away heat and detoxifying, removing blood stasis and unblocking the meridians, and softening and dispersing hard masses" as the basic treatment method, and summarizes the basic prescription - Wuhuang Tongluo Fang, which is composed of nine medicines such as astragalus, raw rehmannia, cooked rhubarb, scutellaria, and coptis, and is modified from classical famous prescriptions such as Huangqi Decoction in "Hejijufang", Xiayuxue Decoction and Xiexin Decoction in "Jinkui Yaolue", and Biejia Dihuang Decoction in "Yilue Liushu", and has good clinical efficacy. The Chinese medicine composition of the present invention, combined with Western medicine sequential treatment (endoscopy + carvedilol), can significantly reduce the incidence of rebleeding in patients with cirrhosis EGVB compared with Western medicine sequential treatment alone. The present invention can be used to develop new target drugs for treating liver cirrhosis, portal hypertension and EGVB, and is used to treat liver cirrhosis, portal hypertension and EGVB caused by various causes. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 .Comparison of the incidence of rebleeding between the treatment group and the control group.

[0019] Figure 2 .Comparison of mortality rates between the treatment group and the control group. DETAILED DESCRIPTION

[0020] Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiments are only used to illustrate the present invention and are not used in limiting the scope of the present invention.In addition, should be understood that after reading the content of the present invention record, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall equally within the scope limited by the application's appended claims.

[0021] Example 1 Chinese medicine composition of the present invention (1)

[0022] 30 parts of Astragalus, 15 parts of Rehmannia root, 9 parts of Rhubarb, 15 parts of Scutellaria root, 9 parts of Coptis root, 9 parts of stir-fried peach kernel, 6 parts of Eupolyphaga sinensis, 15 parts of Carapace of Trionycis, and 15 parts of Fritillaria thunbergii.

[0023] Example 2 Chinese medicine composition of the present invention (II)

[0024] 30 parts of Astragalus, 13 parts of Rehmannia root, 11 parts of Rhubarb, 14 parts of Scutellaria root, 10 parts of Coptis root, 9 parts of stir-fried peach kernel, 4 parts of Eupolyphaga sinensis, 17 parts of Carapace of Trionycis, and 14 parts of Fritillaria thunbergii.

[0025] Example 3 Chinese medicine composition of the present invention (III)

[0026] 28 parts of Astragalus, 17 parts of Rehmannia root, 8 parts of Rhubarb, 16 parts of Scutellaria, 9 parts of Coptis chinensis, 7 parts of stir-fried peach kernel, 8 parts of Eupolyphaga sinensis, 14 parts of Carapace of Trionycis, and 16 parts of Fritillaria thunbergii.

[0027] Example 4 Chinese medicine composition of the present invention (four)

[0028] 32 parts of Astragalus, 14 parts of Rehmannia root, 10 parts of Rhubarb, 15 parts of Scutellaria root, 7 parts of Coptis root, 11 parts of stir-fried peach kernel, 5 parts of Eupolyphaga sinensis, 16 parts of Carapace of Trionycis, and 15 parts of Fritillaria thunbergii.

[0029] Example 5 Chinese medicine composition of the present invention (V)

[0030] 29 parts of Astragalus, 16 parts of Rehmannia root, 9 parts of Rhubarb, 13 parts of Scutellaria, 11 parts of Coptis chinensis, 8 parts of stir-fried peach kernel, 7 parts of Eupolyphaga sinensis, 15 parts of Carapace of Trionycis, and 13 parts of Fritillaria thunbergii.

[0031] Example 6 Chinese medicine composition of the present invention (six)

[0032] 31 parts of Astragalus, 15 parts of Rehmannia root, 7 parts of Rhubarb, 17 parts of Scutellaria, 8 parts of Coptis chinensis, 10 parts of stir-fried peach kernel, 6 parts of Eupolyphaga sinensis, 13 parts of Carapace of Trionycis, and 17 parts of Fritillaria thunbergii.

[0033] Example 7 Chinese medicine composition of the present invention (VII)

[0034] 30 parts of Astragalus, 17 parts of Rehmannia root, 8 parts of Rhubarb, 16 parts of Scutellaria root, 9 parts of Coptis root, 7 parts of stir-fried peach kernel, 8 parts of Eupolyphaga sinensis, 14 parts of Carapace of Trionycis, and 16 parts of Fritillaria thunbergii.

[0035] Example 8 Chinese medicine composition of the present invention (VIII)

[0036] 28 parts of Astragalus, 14 parts of Rehmannia root, 10 parts of Rhubarb, 15 parts of Scutellaria root, 7 parts of Coptis root, 11 parts of stir-fried peach kernel, 5 parts of Eupolyphaga sinensis, 16 parts of Carapace of Trionycis, and 15 parts of Fritillaria thunbergii.

[0037] Example 9 Chinese medicine composition of the present invention (IX)

[0038] 32 parts of Astragalus, 16 parts of Rehmannia root, 9 parts of Rhubarb, 13 parts of Scutellaria, 11 parts of Coptis chinensis, 8 parts of stir-fried peach kernel, 7 parts of Eupolyphaga sinensis, 15 parts of Carapace of Trionycis, and 13 parts of Fritillaria thunbergii.

[0039] Example 10 Chinese medicine composition of the present invention (10)

[0040] 29 parts of Astragalus, 15 parts of Rehmannia root, 7 parts of Rhubarb, 17 parts of Scutellaria root, 8 parts of Coptis root, 10 parts of stir-fried peach kernel, 6 parts of Eupolyphaga sinensis, 13 parts of Carapace of Trionycis, and 17 parts of Fritillaria thunbergii.

[0041] Example 11 Chinese medicine composition of the present invention (XI)

[0042] 31 parts of Astragalus, 13 parts of Rehmannia root, 11 parts of Rhubarb, 14 parts of Scutellaria root, 10 parts of Coptis root, 9 parts of stir-fried peach kernel, 4 parts of Eupolyphaga sinensis, 17 parts of Carapace of Trionycis, and 14 parts of Fritillaria thunbergii.

[0043] Example 12 Clinical efficacy experiment

[0044] (1) Source of cases

[0045] The study enrolled patients from the Department of Hepatology at Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, between January 2023 and December 2024 and who met the inclusion criteria. The study was reviewed and approved by the Ethics Committee of Shuguang Hospital, Shanghai University of Traditional Chinese Medicine. The study was conducted in strict accordance with the Declaration of Helsinki, and all enrolled patients provided signed informed consent.

[0046] (2) Sample size calculation

[0047] According to the literature on the efficacy of combined traditional Chinese and Western medicine for secondary prevention of EGVB in cirrhosis, the rebleeding rate within 1 year was the main efficacy evaluation indicator. The rebleeding rate within 1 year of the conventional Western medicine secondary prevention control group (endoscopic treatment + carvedilol, referred to as the control group) was 36.86%, and the rebleeding rate of the combined traditional Chinese and Western medicine experimental group (endoscopic treatment + carvedilol + Chinese herbal medicine combination, referred to as the experimental group) was 16.04%. If the type I error α of the hypothesis test is 0.05, the type II error β is 0.2, and the sample size ratio of the Western medicine group to the traditional Chinese and Western medicine group is 1:1, then the sample size estimation formula for the cohort study is:

[0048]

[0049] n1=n2, the sample size of the control group is 67 and the sample size of the experimental group is 67. Taking into account the missing samples, the sample size is increased by 10%, that is, the sample size of the control group and the experimental group is 74.

[0050] (3) Inclusion criteria

[0051] 1. Liver cirrhosis confirmed by laboratory and imaging examinations, and EGVB confirmed by endoscopy;

[0052] 2. The patient is in accordance with the TCM syndrome of “deficiency of vital energy and stasis of heat”;

[0053] 3. Ages 18-75, genders are not limited;

[0054] 4. Patients with EGVB who have undergone endoscopic combined with carvedilol treatment;

[0055] 5. Patients with liver function class A and Child B;

[0056] 6. Patients with good compliance, who can understand the study and sign the informed consent.

[0057] (IV) Exclusion criteria

[0058] 1. Patients with gastrointestinal bleeding caused by other reasons;

[0059] 2. Patients with Child C liver function class;

[0060] 3. Those who have undergone liver transplantation, splenectomy, transjugular intrahepatic portosystemic shunt, or surgical disconnection or shunting;

[0061] 4. Combined with malignant tumor;

[0062] 5. Patients with severe diseases of important organs and dysfunction;

[0063] 6. Pregnant or breastfeeding women;

[0064] 7. Patients with missing follow-up and incomplete baseline information.

[0065] (V) Research Methods

[0066] This study was a single-center, prospective, nonrandomized, parallel-controlled clinical trial. A total of 148 patients with cirrhotic EGVB were enrolled and divided into a control group and an experimental group according to treatment. The patients were observed for one year. Patients were recorded or followed up from the onset of EGVB until rebleeding or after one year of follow-up. The effects of different treatment regimens on rebleeding outcomes were compared to evaluate the efficacy of traditional Chinese medicine and analyze risk factors for rebleeding in patients with cirrhotic EGVB.

[0067] (1) Control group: secondary prevention (endoscopy + carvedilol);

[0068] (2) Experimental group: secondary prevention (endoscopy + carvedilol) + Chinese medicine combination.

[0069] The secondary prevention treatment plan for patients refers to the "Guidelines for the Prevention and Treatment of Esophageal and Gastric Variceal Bleeding in Cirrhosis with Portal Hypertension", which uses endoscopic treatment combined with oral carvedilol tablets.

[0070] Carvedilol tablets, oral, 10 mg each time, twice a day.

[0071] The traditional Chinese medicine composition was purchased from Shanghai Wanshicheng Pharmaceutical Products Co., Ltd. by Shuguang Hospital, affiliated with Shanghai University of Traditional Chinese Medicine, and prepared in the hospital's decoction room. The composition includes: Astragalus 30g, Rehmannia glutinosa 15g, Rhubarb 9g, Scutellaria baicalensis 15g, Coptis chinensis 9g, stir-fried peach kernel 9g, Eupolyphaga sinensis 6g, Carapace of Trionycis 15g, and Fritillaria thunbergii 15g. Take orally, once daily.

[0072] (VI) Efficacy evaluation

[0073] 1. Main efficacy indicator: incidence of rebleeding.

[0074] 2. Secondary efficacy indicators:

[0075] (1) case fatality rate;

[0076] (2) median time to rebleeding;

[0077] (3) Child-Pugh score;

[0078] (4) Varicose vein elimination rate;

[0079] (5) Evaluation of TCM syndrome efficacy: A TCM syndrome scoring scale was developed with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines" and "Internal Medicine of Traditional Chinese Medicine". Scores were given before and after treatment based on the patient's subjective symptoms and objective physical signs obtained by professional physicians. Each item was divided into 4 levels and scored as 0, 3, 6, and 9 points, respectively.

[0080] (VII) Drug safety evaluation standards

[0081] (1) No adverse reactions: safe and without any adverse reactions.

[0082] (2) Mild adverse reactions: relatively safe, with slight impact on the subjects.

[0083] (3) Moderate adverse reactions: There are safety issues that the subjects cannot tolerate, and the trial needs to be terminated or certain treatments need to be taken.

[0084] (4) Severe adverse reactions: pose a threat to the safety of the subjects and are highly likely to cause death or disability. The trial must be terminated immediately and emergency treatment must be given.

[0085] (8) Statistical methods

[0086] This part of the study was statistically analyzed using R language version 4.3.2 (https: / / www.R-project.org). According to the normality of data distribution, the normal distribution data in the measurement data were calculated by adding or subtracting the standard deviation. Statistical descriptions were performed in the form of . Non-normally distributed data were described in the form of median and interquartile range [M(Q1,Q3)]. Enumeration data were reported in the format of frequency percentage [N(%)]. Normality was tested using the Shapiro-Wilk test. Inter-group or intra-group comparisons of continuous variables were performed using the Student's t-test (normally distributed data) or the Mann-Whitney U test (non-normally distributed data). Inter-group or intra-group comparisons of categorical variables were performed using the Pearson χ 2 The independent risk factors for prognostic events were evaluated using the Cox multivariate regression analysis (minimum group count > 5) or the Fisher's exact test (minimum group count < 5). Modified Kaplan-Meier survival curves were plotted to assess the temporal trends of rebleeding among the different groups, and the modified Log-rank test was used to compare differences between the groups. A two-sided P < 0.05 indicated statistical significance. The stratified test was corrected for multiple comparisons using the Bonferroni method, with the test level adjusted to α = 0.05 / 3 ≈ 0.017. The adjusted P < 0.017 was used as the threshold for statistical significance.

[0087] (IX) Results

[0088] 1. Comparison of the main efficacy indicators between the two groups: as shown in Table 1, Figure 1 As shown in the data, the incidence of rebleeding in the Chinese and Western medicine group at 6 weeks, 12 weeks of treatment and 40 weeks of follow-up (2.25%, 3.37%, 13.48%, respectively) was significantly lower than that in the Western medicine group (15.07%, 20.55%, 31.51%) (P<0.05).

[0089] Table 1 Statistics of rebleeding and death in the two groups [N (%)]

[0090]

[0091]

[0092] 2. Comparison of secondary efficacy indicators between the two groups:

[0093] (1) Mortality rate: as shown in Table 1, Figure 2As shown in the data, in terms of death events, the mortality rates of the experimental group at 6 weeks, 12 weeks after treatment and 40 weeks of follow-up (0, 0, 1.12%, respectively) were significantly lower than those of the control group (6.85%, 8.22%, 9.59%) (P<0.05).

[0094] (2) Median time to rebleeding: All 35 patients with EGVB rebleeding due to cirrhosis were analyzed. The median time to rebleeding in the control group was lower than that in the experimental group, but the difference was not statistically significant (62 days vs 113.5 days, P>0.05).

[0095] (3) Child-Pugh score: As shown in Table 2, the intra-group comparison results showed that compared with the baseline level, the CTP score of the experimental group was significantly reduced at 12 weeks of treatment and 40 weeks of follow-up (P < 0.05); the CTP score of the control group was significantly reduced at 12 weeks of treatment (P < 0.05), but the change in CTP score at 40 weeks of follow-up was not statistically significant (P > 0.05). The inter-group comparison results showed that the CTP score of the experimental group was significantly lower than that of the control group at 12 weeks of treatment and 40 weeks of follow-up (P < 0.05).

[0096] Table 2 Comparison of CTP scores between the two groups [M(Q1,Q3)]

[0097]

[0098]

[0099] #Compared with the baseline of the same group, P<0.05; *Compared with the control group of the same period, P<0.05.

[0100] (4) Varicose vein elimination rate: After treatment, 37 cases (50.68%) of EGV were eliminated in the control group and 60 cases (67.42%) were eliminated in the experimental group. The difference in varicose vein elimination rate between the two groups was statistically significant (P=0.045).

[0101] (5) TCM syndrome score: As shown in Table 3, the intra-group comparison results showed that compared with the baseline level, the TCM syndrome scale scores of the two groups were significantly lower after 12 weeks of treatment than before treatment (P<0.05). The inter-group comparison results showed that there was no statistically significant difference in the TCM syndrome scale scores between the two groups before treatment (P>0.05), while the scores of the patients in the experimental group were significantly lower than those in the control group after 12 weeks of treatment (P<0.05). Table 3 shows the TCM syndrome efficacy of the two groups of patients after 12 weeks of treatment. The results showed that the total TCM syndrome efficacy of the experimental group was significantly higher than that of the control group (P<0.05).

[0102] Table 3 Comparison of TCM syndrome scale scores between the two groups before and after treatment [M(Q1,Q3)]

[0103]

[0104] Note: # compared with the baseline of the same group, P < 0.05; * compared with the control group of the same period, P < 0.05.

[0105] 3. Safety analysis and adverse event reporting

[0106] As shown in Table 4, intra-group comparisons showed no significant statistical differences in safety indicators such as blood routine tests, liver and kidney function, and coagulation function before and after treatment (P>0.05). Inter-group comparisons showed no significant statistical differences in safety indicators between the two groups (P>0.05).

[0107] Table 4 Comparison of safety indicators before and after treatment between the two groups M(Q1,Q3)]

[0108]

[0109] Note: 7 patients dropped out of the two groups during the trial, and 6 patients died in the control group during the treatment. Finally, 67 patients in the control group and 89 patients in the experimental group completed the follow-up of laboratory indicators.

[0110] As shown in Table 5, by week 12 of treatment, a total of 8 mild adverse events occurred among all subjects, all manifesting as gastrointestinal discomfort, including mild diarrhea or nausea. Seven events occurred in the experimental group and one in the control group. All symptoms resolved spontaneously within 48 hours of onset, and no patient discontinued or increased medication during this period. There was no statistically significant difference in the incidence of adverse reactions in the experimental group compared with the control group (P>0.05), indicating that both treatment regimens had good safety.

[0111] Table 5 Comparison of the incidence of adverse reactions between the two groups [N (%)]

[0112]

[0113] Note: NA indicates data not available.

[0114] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for preventing and treating liver cirrhosis, portal hypertension caused by liver cirrhosis and esophagogastric variceal bleeding (EGVB) caused by liver cirrhosis, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 28-32 parts of astragalus, 13-17 parts of raw rehmannia, 7-11 parts of cooked rhubarb, 13-17 parts of scutellaria, 7-11 parts of coptis, 7-11 parts of stir-fried peach kernel, 4-8 parts of earthworm, 13-17 parts of turtle shell, and 13-17 parts of thunbergia thunbergii.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 29-31 parts of astragalus, 14-16 parts of raw rehmannia, 8-10 parts of cooked rhubarb, 14-16 parts of scutellaria, 8-10 parts of coptis, 8-10 parts of stir-fried peach kernel, 5-7 parts of earthworm, 14-16 parts of turtle shell, and 14-16 parts of thunbergia thunbergii.

3. The Chinese medicine composition according to claim 2, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of astragalus, 15 parts of raw rehmannia, 9 parts of cooked rhubarb, 15 parts of scutellaria, 9 parts of coptis, 9 parts of stir-fried peach kernel, 6 parts of earthworm, 15 parts of turtle shell, and 15 parts of thunbergia thunbergii.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that The pharmaceutical composition is prepared as an oral preparation based on the raw material drug according to a conventional method, or is prepared as a common oral preparation by adding pharmaceutically acceptable excipients.

5. The Chinese medicine composition according to claim 4, characterized in that: The oral preparation is in the form of pills, powders, tablets, granules, capsules, oral liquids, injections, or the above-mentioned dosage forms of the original formula extract.

6. Use of the Chinese medicine composition according to any one of claims 1 to 3 in preparing medicaments for preventing and treating liver cirrhosis, liver cirrhosis portal hypertension, and liver cirrhosis EGVB.

7. The use according to claim 6, characterized in that: The TCM pathogenesis of liver cirrhosis, portal hypertension and EGVB is "vital deficiency and blood stasis", and the liver function grade is Child A-C.

8. A pharmaceutical composition for preventing and treating liver cirrhosis, portal hypertension due to liver cirrhosis, and EGVB due to liver cirrhosis, characterized in that: The pharmaceutical composition is composed of the traditional Chinese medicine composition according to any one of claims 1 to 3.

9. Use of the pharmaceutical composition according to claim 8 in the preparation of drugs for preventing and treating liver cirrhosis, portal hypertension due to liver cirrhosis, and EGVB due to liver cirrhosis.

10. The use according to claim 9, characterized in that: The TCM pathogenesis of cirrhosis, portal hypertension, and EGVB is "vital energy deficiency and blood stasis and heat", and the liver function grade is Child A-C.

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