CN111375004A

CN111375004A - Traditional Chinese medicine enema for treating non-alcoholic steatohepatitis and preparation method and application method thereof

Info

Publication number: CN111375004A
Application number: CN202010308504.5A
Authority: CN
Inventors: 张晓星; 杨川; 刘延东
Original assignee: Heilongjiang Provincial Hospital
Current assignee: Heilongjiang Provincial Hospital
Priority date: 2020-04-18
Filing date: 2020-04-18
Publication date: 2020-07-07
Anticipated expiration: 2040-04-18
Also published as: CN111375004B

Abstract

The invention discloses a traditional Chinese medicine enema for treating non-alcoholic steatohepatitis and a preparation method and an application method thereof, wherein the traditional Chinese medicine enema is composed of the following raw material medicines: herba Artemisiae Scopariae, radix Paeoniae Rubra, Saviae Miltiorrhizae radix, Carthami flos, semen Persicae, bupleuri radix, radix Paeoniae alba, radix et rhizoma Rhei, Scutellariae radix, radix astragali, Poria, parched Atractylodis rhizoma, rhizoma corydalis and fructus Toosendan. Based on the theory of intestine-liver axis, the invention adopts a retention enema method to ensure that the medicine is directly absorbed through intestinal mucosa, thereby reducing the damage of gastric acid and digestive juice to the medicine and increasing the utilization rate of the medicine; but also can directly remove toxic metabolites and toxins in intestinal cavities and on intestinal mucosa, adjust intestinal flora, prevent toxic substances from entering liver through intestinal liver circulation, effectively relieve clinical symptoms and physical signs of patients, reduce liver functions and blood fat indexes, improve intestinal flora, and effectively prevent and treat nonalcoholic steatohepatitis. In addition, the traditional Chinese medicine enema can be used independently, and can be used together with other medicines and treatment methods.

Description

Traditional Chinese medicine enema for treating non-alcoholic steatohepatitis and preparation method and application method thereof

Technical Field

The invention relates to a traditional Chinese medicine enema for treating non-alcoholic steatohepatitis and a preparation method and an application method thereof, in particular to a traditional Chinese medicine enema composite for preventing and treating non-alcoholic steatohepatitis and non-alcoholic hepatic fibrosis.

Background

Non-alcoholic fatty liver disease (NAFLD) is a metabolic stress liver injury closely related to insulin resistance and genetic predisposition, including non-alcoholic liver steatosis, non-alcoholic steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma (HCC). With the improvement of living standard and the change of dietary structure, NAFLD gradually becomes the chronic liver disease with the highest morbidity in China. NASH is an intermediate stage of simple fatty liver progressing to cirrhosis and HCC and is difficult to recover by self, hepatic fibrosis of NASH patients progresses by one grade in 7-10 years on average until serious liver injury occurs, and the incidence rate of cirrhosis reaches 15% -25% within 10-15 years, so that the continuous development of NASH is blocked, the prognosis of non-alcoholic fatty liver disease can be changed, the survival quality is improved, and the survival time is prolonged.

The pathogenesis of the nonalcoholic steatohepatitis is not completely clear, and at present, the research generally considers that various factors such as dietary structure, life style, obesity, Insulin Resistance (IR), genetic susceptibility, gene polymorphism, hormone, cell factor, intestinal microecological imbalance and the like are jointly involved in the attack of NASH. Wherein, the intestinal microecological imbalance becomes the research hotspot of the current liver diseases, the intestinal dysbacteriosis is proved to play an important role in the occurrence and development of NASH, and the proposal of the 'intestinal-hepatic axis' theory also provides a new target for searching the treatment of NASH from the intestinal microecological aspect. A large number of researches show that intestinal microecological imbalance can cause overgrowth of intestinal flora and damage of mechanical barriers of intestinal mucosa, so that permeability of the intestinal mucosa is changed, bacteria and toxins in the intestinal tract enter the liver through portal veins, inherent immune cells in the liver, such as Copffer cells, Kupffer cells, hepatic stellate cells and the like, and toll-like receptors are induced to activate and proliferate, and a series of inflammatory factors are released, so that inflammatory lesions of the liver are caused. And when NASH develops to a certain extent, the NASH can also adversely affect the barrier function of the intestinal tract, aggravate the intestinal tract injury and form a vicious circle. Intestinal tract micro-ecological imbalance caused intestinal tract hepatic axis dysfunction is an important mechanism for inducing generation and development of NAFLD, and improving intestinal tract micro-ecology, protecting intestinal mucosa barrier and maintaining intestinal tract hepatic axis homeostasis can become one of innovative treatment methods and important auxiliary treatment methods for treating liver diseases.

Due to the diversity of NASH pathogenic factors and the complexity of pathogenesis, it is difficult to design effective therapeutic drugs for multiple targets in clinic, so that modern medicine is lack of therapeutic drugs and means with reliable curative effect. At present, the treatment mainly aims at adjusting the dietary structure and exercise, and the drug treatment is assisted. Western medicine treatment mostly focuses on controlling the state of an illness by adopting a single treatment means aiming at different pathological links, and the medicines for symptomatic treatment mainly comprise an insulin sensitizer, a hepatocyte protective agent, an antioxidant, a lipid-lowering medicine, a weight-reducing medicine and the like. Due to the complex mechanism of the disease onset and the single action of western medicines, the progress of NASH (NASH) cannot be effectively controlled by using the medicine aiming at a certain pathogenesis singly, while the curative effect of the western medicine combination is improved, but the problems of long medicine taking period, more adverse reactions, large economic burden of patients and the like exist. Therefore, a new medicine and a new way for treating the NASH are searched from the characteristics of multilayer, multi-link, multi-way and multi-target points of the traditional Chinese medicine, so that the treatment process can cause and result simultaneously, and the simultaneous treatment of the principal and secondary aspects is very necessary.

Although Chinese patents (patent publication Nos. CN 105833179A and CN 110339252A) disclose traditional Chinese medicines for treating nonalcoholic steatohepatitis in the prior art, most of traditional Chinese medicine compound preparations for treating nonalcoholic steatohepatitis have an oral preparation, and although the traditional Chinese medicine compound preparations have a positive curative effect, the gastrointestinal congestion, endotoxin stimulation, intestinal flora imbalance and gastrointestinal dysfunction of liver disease patients usually show more digestive tract symptoms, so that the traditional Chinese medicine compound preparations of the prior oral preparations have great stimulation to the gastrointestinal tract, and the digestive tract symptoms are aggravated after a part of patients take the traditional Chinese medicine compound preparations, and the treatment is difficult to persist. And the oral preparation is damaged by gastric acid and digestive juice, the blood concentration is reduced, and the dosage entering the liver through systemic circulation is limited, so that the utilization rate of the medicine is low. Therefore, in the process of treating the non-alcoholic steatohepatitis, the drug administration mode is switched, and the aim of multi-path and multi-target administration is particularly important.

Disclosure of Invention

The invention aims to solve the problems and provides a traditional Chinese medicine enema for treating non-alcoholic steatohepatitis and a preparation method and an application method thereof.

The technical scheme of the invention is as follows:

a traditional Chinese medicine enema for treating non-alcoholic steatohepatitis comprises the following traditional Chinese medicine raw materials in parts by weight: 10-30g of oriental wormwood, 10-20g of red paeony root, 10-20g of salvia miltiorrhiza, 5-10g of safflower, 5-10g of peach kernel, 10-30g of radix bupleuri, 10-30g of white paeony root, 5-10g of rhubarb, 10-20g of scutellaria baicalensis, 20-40g of astragalus mongholicus, 10-20g of poria cocos, 10-20g of fried bighead atractylodes rhizome, 5-15g of rhizoma corydalis and 5-15g of szechwan chinaberry fruit.

Further limited, the traditional Chinese medicine enema is composed of the following traditional Chinese medicine raw materials in proportion: 20g of oriental wormwood, 15g of red paeony root, 15g of salvia miltiorrhiza, 10g of safflower, 10g of peach kernel, 20g of radix bupleuri, 20g of white paeony root, 10g of rhubarb, 15g of scutellaria baicalensis, 30g of astragalus mongholicus, 15g of poria cocos, 15g of fried bighead atractylodes rhizome, 10g of rhizoma corydalis and 10g of szechwan chinaberry fruit.

Further limited, the traditional Chinese medicine enema is composed of the following traditional Chinese medicine raw materials in proportion: 30g of oriental wormwood, 20g of red paeony root, 20g of salvia miltiorrhiza, 10g of safflower, 10g of peach kernel, 30g of radix bupleuri, 25g of white paeony root, 10g of rhubarb, 20g of scutellaria baicalensis, 40g of astragalus mongholicus, 20g of poria cocos, 20g of fried bighead atractylodes rhizome, 10g of rhizoma corydalis and 10g of szechwan chinaberry fruit.

The traditional Chinese medicine enema is used for inhibiting or delaying the progress of non-alcoholic hepatic fibrosis and the progress of the non-alcoholic steatohepatitis into non-alcoholic cirrhosis.

Further defined, the traditional Chinese medicine enema is used in combination with one or more therapeutic agents.

Still further defined, therapeutic agents include agents for treating hypertension, agents for treating diabetes, agents for treating dyslipidemia, and agents for treating non-alcoholic fatty liver disease.

Further defined, the traditional Chinese medicine enema is combined with the traditional Chinese medicine treatment method for use.

Further, the traditional Chinese medicine treatment method is a traditional Chinese medicine treatment method for treating the non-alcoholic fatty liver disease, and comprises acupuncture therapy, abdominal massage therapy, acupoint application therapy, acupoint injection therapy, pressing, moxibustion and acupoint catgut embedding.

The preparation method of the traditional Chinese medicine enema comprises the following steps:

step one, weighing raw material medicines according to a ratio, putting all raw material medicines into a marmite, and adding clear water to soak for 15-30 min;

step two, boiling the raw materials in the casserole for 10min by using strong fire, then decocting for 15-20min by using slow fire, and filtering to obtain decoction;

step three, adding clear water into the filter residue obtained by filtering in the step two, boiling the raw material filter residue soaked in the casserole clear water for 5min by using strong fire, then decocting for 15-20min by using slow fire, and filtering to obtain decoction;

step four, mixing the decoctions obtained in the step two and the step three, uniformly stirring, and then decocting and concentrating the mixture into 200-300ml of traditional Chinese medicine enema.

The preparation method of the traditional Chinese medicine enema comprises the following specific operation processes: weighing the raw materials according to a certain proportion, adding clear water, soaking for 15-30min, decocting for 30-40min in a sealed manner, filtering to obtain decoction, and sealing into 200 ml/bag of liquid medicine under aseptic condition.

Non-alcoholic steatohepatitis belongs to the field of liver addiction in traditional Chinese medicine, is located in the liver, relates to a plurality of viscera such as spleen, stomach, kidney, large intestine and the like, and is mainly caused by liver loss and catharsis, transverse flow and spleen invasion, spleen loss and descending, transportation and transformation disorder due to improper diet, work and rest degree, emotional disorder and weak body after long-term illness, and finally causes stagnation of damp heat, phlegm turbidity and internal stagnation, blood stasis stagnation, phlegm and blood stasis mutual accumulation, heat toxin internal accumulation and liver collateral obstruction to cause diseases. The therapeutic principle focuses on clearing away heat and toxic materials and removing blood stasis. The heat, toxicity and stasis are only excreted from the feces and urine, and can not be accumulated in the body, the fu-organ is used for dredging, the intestinal tract function is normal, and the stool is kept unobstructed, which is an important principle for treating the non-alcoholic steatohepatitis. This is contrary to the view of the "gut-hepatic axis" theory of treating chronic liver disease by modulating the intestinal flora. Based on the fact, the Chinese medicine retention enema is proposed to treat NASH by combining the advices of the traditional Chinese medicine that the liver is communicated with the large intestine and the liver disease is suitable for dredging the large intestine.

The retention enema of the traditional Chinese medicine is one of the traditional external treatment methods of the traditional Chinese medicine, the medicine directly acts on the intestinal wall, is not damaged by gastric acid and digestive juice, can improve the blood concentration, enables the medicine to be quickly absorbed and fully exerts the local treatment effect of the medicine; after being absorbed by intestinal tract, the medicine enters liver through enterohepatic circulation, thereby playing a therapeutic role in liver; the medicine can directly remove toxic metabolites and toxins in intestinal lumens and on intestinal mucosa, and improve intestinal flora; but also can reduce the stimulation of the medicine to the stomach and relieve the reaction of the digestive tract; the medicine can also stimulate autonomic nerves of the rectal wall to cause reflex enterokinesia, promote fecal excretion in the intestinal cavity and relieve abdominal distension after being administrated through anus; the enterohepatic circulation of bilirubin is blocked, and the reabsorption of bilirubin is reduced; promoting ammonia excretion, reducing ammonia absorption, reducing blood ammonia, and preventing hepatic encephalopathy.

The oriental wormwood in the formula provided by the invention can reduce serum transaminase, improve liver steatosis, and simultaneously promote the removal of bilirubin by enhancing the absorption, combination and excretion capabilities of the liver on bilirubin, thereby achieving the purposes of benefiting gallbladder and removing jaundice. Radix Paeoniae Rubra has effects of reducing blood viscosity, reducing thrombosis, and regulating intestinal flora. The red peony root can cool blood and remove stasis, and the red sage root can promote blood circulation and remove stasis, and the combination of the red peony root and the red sage root can obviously improve the blood viscosity, increase the liver blood flow and remove oxygen free radicals, thereby achieving the purposes of reducing hepatocyte necrosis and inflammatory cell infiltration and preventing hepatic fibrosis. The safflower and the peach kernel can greatly strengthen the functions of activating blood and removing stasis, and further block the occurrence and development of hepatic fibrosis. The compatibility of radix bupleuri and radix paeoniae alba has the functions of softening liver and relieving spasm, soothing liver and relieving depression, and the compatibility of radix bupleuri and radix paeoniae alba has stronger functions of reducing enzyme, resisting oxygen free radical and inhibiting lipid peroxidation compared with the single-ingredient radix bupleuri and radix paeoniae alba, and can obviously improve liver injury. Radix et rhizoma Rhei has effects in purging pathogenic accumulation, clearing away heat and toxic materials, eliminating dampness, eliminating jaundice, regulating gastrointestinal function, protecting liver, promoting bile flow, reducing blood lipid, relieving inflammation, and inhibiting bacteria. The scutellaria has the function of clearing away heat and toxic materials, and the modern pharmacology shows that the scutellaria can inhibit escherichia coli, regulate intestinal flora and reduce intestinal inflammatory factors entering the liver through enterohepatic circulation, so that pathological damage of the liver is relieved. The rhubarb and the scutellaria baicalensis can obviously improve intestinal flora and have a protective effect on human colon cell tight junction protein ZO-1, so that an intestinal mucosa barrier is protected. Bighead atractylodes rhizome, rhizoma Atractylodis Macrocephalae, with the effect of strengthening the spleen and drying dampness, is in the middle energizer, Poria, with the effect of inducing diuresis and with the effect of inducing diuresis in the lower energizer, the two herbs are in the same group, and they are good at tonifying the spleen and inducing diuresis. Research also shows that the bighead atractylodes rhizome and poria cocos medicaments are compatible with astragalus, can regulate intestinal disorders and remarkably enhance the immunity of organisms. In addition, the rhubarb and scutellaria baicalensis are used for relaxing bowels, and the bighead atractylodes rhizome and poria cocos are used for promoting urination and eliminating dampness, so that water retention is relieved from the urine and the stool, and abdominal distension is relieved. The whole formula has the effects of tonification and purgation, heat clearing and detoxifying, blood stasis removing and dampness removing, and treats both principal and secondary aspect of disease.

The invention has the following beneficial effects: the invention has simple preparation process, low cost, pure natural preparation, no hormone and other chemical synthetic products and no toxic or side effect on human body. The traditional oral administration mode is changed, retention enema is adopted to administer the medicine through intestinal tract, the medicine is not damaged by gastric acid and digestive juice, and directly enters the liver through enterohepatic circulation, so that the utilization rate of the medicine is improved; the medicine directly acts on intestinal tract, solves the problem of adverse reactions such as nausea and vomiting caused by stimulating digestive tract by oral medicine, can adjust intestinal flora, and reduces toxic metabolites and toxins entering enterohepatic circulation, thereby improving liver function. The Chinese medicinal enema composition has the effects of protecting liver, promoting bile flow, improving liver circulation, and preventing hepatic fibrosis; the intestinal mucosa barrier can be protected and the immunity can be enhanced by regulating the intestinal flora; can effectively relieve clinical symptoms and physical signs of patients, reduce liver function and blood lipid indexes, and effectively prevent and treat non-alcoholic steatohepatitis.

Detailed Description

The medicinal materials used for the traditional Chinese medicine enema are all conventional Chinese medicinal materials obtained by conventional means.

Embodiment mode 1:

the traditional Chinese medicine enema composite for preventing and treating non-alcoholic steatohepatitis is prepared from the following traditional Chinese medicine raw materials in parts by mass: 20g of oriental wormwood, 15g of red paeony root, 15g of salvia miltiorrhiza, 10g of safflower, 10g of peach kernel, 20g of radix bupleuri, 20g of white paeony root, 10g of rhubarb, 15g of scutellaria baicalensis, 30g of astragalus mongholicus, 15g of poria cocos, 15g of fried bighead atractylodes rhizome, 10g of rhizoma corydalis and 10g of szechwan chinaberry fruit.

The preparation method comprises the following steps:

(1) weighing the raw materials according to the above ratio, placing into a casserole, adding clear water to submerge the powder, and soaking for 20 min;

(2) boiling the raw materials soaked in clear water of casserole with strong fire for 10min, decocting with slow fire for 25min, and filtering to obtain decoction;

(3) adding clear water into the residue filtered in the second step to submerge the surface of the raw materials, boiling the residue of the raw materials soaked in clear water of an earthenware pot with strong fire for 5min, decocting with slow fire for 15min, and filtering to obtain decoction for later use;

(4) mixing the decoctions obtained in the second step and the third step, stirring uniformly, decocting and concentrating to 250ml of traditional Chinese medicine enema solvent.

Embodiment mode 2:

the traditional Chinese medicine enema composite for preventing and treating non-alcoholic steatohepatitis is prepared from the following traditional Chinese medicine raw materials in parts by mass: 30g of oriental wormwood, 20g of red paeony root, 20g of salvia miltiorrhiza, 10g of safflower, 10g of peach kernel, 30g of radix bupleuri, 25g of white paeony root, 10g of rhubarb, 20g of scutellaria baicalensis, 40g of astragalus mongholicus, 20g of poria cocos, 20g of fried bighead atractylodes rhizome, 10g of rhizoma corydalis and 10g of szechwan chinaberry fruit.

The preparation method comprises the following steps:

(1) weighing the raw materials according to the above ratio, placing into a casserole, adding clear water to submerge the powder, and soaking for 25 min;

(2) boiling the raw materials soaked in clear water of casserole with strong fire for 10min, decocting with slow fire for 30min, and filtering to obtain decoction;

(3) adding clear water into the residue filtered in the second step to submerge the surface of the raw materials, boiling the residue of the raw materials soaked in clear water of an earthenware pot with strong fire for 5min, decocting with slow fire for 20min, and filtering to obtain decoction for later use;

(4) mixing the decoctions obtained in the second step and the third step, stirring uniformly, decocting and concentrating to obtain 200ml of traditional Chinese medicine enema solvent.

Embodiment mode 3:

the traditional Chinese medicine enema composite for preventing and treating non-alcoholic steatohepatitis is prepared from the following traditional Chinese medicine raw materials in parts by mass: 25g of oriental wormwood, 15g of red paeony root, 20g of salvia miltiorrhiza, 5g of safflower, 5g of peach kernel, 30g of radix bupleuri, 20g of white paeony root, 5g of rhubarb, 15g of scutellaria baicalensis, 25g of astragalus mongholicus, 15g of poria cocos, 15g of fried bighead atractylodes rhizome, 10g of rhizoma corydalis and 10g of szechwan chinaberry fruit.

The preparation method comprises the following steps:

(2) boiling the raw materials soaked in clear water of casserole with strong fire for 10min, decocting with slow fire for 20min, and filtering to obtain decoction;

(4) mixing the decoctions obtained in the second step and the third step, stirring uniformly, decocting and concentrating to obtain 300ml of traditional Chinese medicine enema solvent.

Embodiment 4:

the traditional Chinese medicine enema composite for preventing and treating non-alcoholic steatohepatitis is prepared from the following traditional Chinese medicine raw materials in parts by mass: 30g of oriental wormwood, 20g of red paeony root, 20g of salvia miltiorrhiza, 10g of safflower, 10g of peach kernel, 30g of radix bupleuri, 30g of white paeony root, 10g of rhubarb, 15g of scutellaria baicalensis, 40g of astragalus mongholicus, 20g of poria cocos, 20g of fried bighead atractylodes rhizome, 10g of rhizoma corydalis and 10g of szechwan chinaberry fruit.

The preparation method comprises the following steps: adding the above materials into clear water to submerge the powder, and soaking for 30 min; decocting for 40min in a sealed manner by using a decocting machine, filtering to obtain decoction, and sealing into 200ml liquid medicine bags under aseptic conditions for later use.

Embodiment 5:

the traditional Chinese medicine enema composite for preventing and treating non-alcoholic steatohepatitis is prepared from the following traditional Chinese medicine raw materials in parts by mass: 15g of oriental wormwood, 10g of red paeony root, 15g of salvia miltiorrhiza, 5g of safflower, 5g of peach seed, 15g of radix bupleuri, 10g of white paeony root, 5g of rhubarb, 10g of scutellaria baicalensis, 25g of astragalus mongholicus, 15g of poria cocos, 15g of fried bighead atractylodes rhizome, 5g of rhizoma corydalis and 5g of szechwan chinaberry fruit.

The preparation method comprises the following steps: adding clear water into the above raw materials, soaking for 15 min; decocting for 25min in a sealed manner by using a decocting machine, filtering to obtain decoction, and sealing into 300ml liquid medicine bags under aseptic conditions for later use.

The clinical experiment for treating chronic non-alcoholic steatohepatitis by applying the traditional Chinese medicine enema composition disclosed by the invention has the following specific data:

1. clinical data

1.1 diagnostic criteria

1.1.1 Western diagnostic standards

According to the diagnosis standard in the non-alcoholic fatty liver disease diagnosis and treatment guideline (revised version in 2010), ① has no history of drinking or alcohol intake in men <30 g/day and women <20 g/day, ② excludes viral hepatitis, drug hepatitis, hepatolenticular degeneration, total parenteral energy supply and the like, and can form fatty liver diseases, ③ ALT, AST and gamma-glutamyl transpeptidase (GGT) have any 1 slightly-moderately increased (less than 5 times of upper limit of normal value) for more than 3 months, ④ liver ultrasonic prompts the change of imaging of diffuse fatty liver diseases, ⑤ can have metabolic syndromes such as blood fat, fasting blood glucose, blood pressure, weight higher than normal value and (or) visceral obesity.

1.1.2 Chinese medicine dialectical diagnosis standard

The syndrome type of traditional Chinese medicine "damp-heat accumulation and phlegm-blood stasis" is determined by referring to the consensus of Chinese and western medicine combined diagnosis and treatment of non-alcoholic fatty liver disease (2017) [4 ]. The main symptoms are: (1) swelling and oppression or pain in the right hypochondrium; (2) getting tired and heavy; (3) abdominal fullness and distention or pain; (4) obesity of the body; (5) dry stool or sticky and uncomfortable. The secondary symptoms are as follows: (1) yellow body and eyes; (2) yellow urine; (3) dry mouth and bitter taste; (4) nausea or vomiting; (5) anorexia and aversion to oil; (6) red or purple-dark tongue with yellow and greasy coating; (7) wiry and rapid or slippery and rapid. Any 2 of the major symptoms and any 2 of the minor symptoms may be included.

1.2 inclusion criteria

① meets NASH Chinese medicine and Western medicine diagnosis standard, ② is 25-65 years old, ③ patients who are not prescribed any medicine for treating chronic liver disease before 1 week before treatment and during treatment, ④ patients voluntarily participate in the study of the project and can be matched with the therapist in the whole course.

1.3 exclusion criteria

① severe primary heart, brain, kidney, lung, ② serum ALT, AST or GGT 5 times higher than the upper limit of normal value or patients with liver cirrhosis, ③ allergic to the study drug, ④ pregnant or lactating women, and those orally administered with antibiotics, microecological regulators, gastrointestinal motility promoting drugs and other preparations which may affect the state of intestinal flora within ⑤ nearly 2 weeks.

1.4 general data

The subjects were 60 patients who were out-patient or hospitalized in hospitals of the heilongjiang province from 2018 to 2019, 12 months, and who met the diagnosis and inclusion criteria of non-alcoholic steatohepatitis. Patients were divided into treatment groups and control groups by random number table method, each group containing 30 cases. Before treatment, the sex, age, disease course and traditional Chinese medicine syndrome score of two groups of patients are compared, the difference has no statistical significance (P is more than 0.05), and the traditional Chinese medicine syndrome score has comparability and is shown in table 1.

TABLE 1 general data comparison of two groups of patients

2. Method of treatment

The two groups of patients were educated on health and treated with medication on the basis of a reasonable diet and appropriate exercise. The patients in the treatment group are administered with liver protecting and detoxicating decoction (Chinese medicinal enema composition comprising herba Artemisiae Scopariae 30g, radix Paeoniae Rubra 20g, Saviae Miltiorrhizae radix 20g, Carthami flos 10g, semen Persicae 10g, bupleuri radix 25g, radix Paeoniae alba 20g, radix et rhizoma Rhei 10g, Scutellariae radix 20g, radix astragali 25g, Poria 20g, parched Atractylodis rhizoma 20g, rhizoma corydalis 5g, and fructus Toosendan 5g) for retention enema (200 ml per time, 1 time per day, retention time of more than 60 min). Silybin capsules (35 mg each, acquired by Tianshili pharmaceutical group, Ltd., national Standard H20040299) were administered 3 capsules at a time 3 times a day, and orally after meals.

The control group patients were administered silibinin capsule (Shuijia) 3 times a day 3 times after meals. The treatment course is 30 days.

3. Detection index and detection method

3.1 liver function and blood lipid testing uses a full-automatic biochemical analyzer to test the liver function indexes of ALT, AST, GGT and the like and the blood lipid related indexes of TC, TG, LDL-C and the like before and after treatment of two groups of patients respectively.

3.2 detection of intestinal flora 0.5g of fresh feces of the patient is taken and placed in a sterile device for sealing and detection. And (3) carrying out bacteria detection by using a full-automatic microorganism analyzer. The number of bifidobacteria, lactobacilli, coliform bacteria and enterococci per gram of faeces (CFU/g) before and after treatment was recorded for both groups of patients and the data was expressed as 10 log.

3.3 abdomen color ultrasonography liver color ultrasonography was performed using a philips EPIQ7 color ultrasonography machine.

4. Assessment of efficacy

4.1 Chinese medicine syndrome score refer to "Combined Chinese and Western diagnosis and treatment consensus opinion of non-alcoholic fatty liver disease (2017)", all symptoms are classified into four grades according to none, mild, moderate and severe degree, the main symptoms are respectively recorded in 0, 2, 4 and 6, and the secondary symptoms are respectively recorded in 0, 1, 2 and 3. The scores before and after the treatment of each symptom are added to form the total score of the traditional Chinese medicine symptoms before and after the treatment.

4.2 evaluation of clinical efficacy

The clinical cure is as follows: disappearance of clinical symptoms or signs; the liver enzymology (ALT, AST, GGT) index returns to normal; the B-ultrasonic examination prompts the liver to recover. The effect is shown: the clinical symptoms or physical signs are obviously improved; the reduction of indexes of liver enzymology (ALT, AST and GGT) is more than or equal to 50 percent; the degree of fatty liver in B-ultrasonic examination is reduced by 2 grades or more. The method has the following advantages: the clinical symptoms or physical signs are obviously improved; the reduction of indexes of liver enzymology (ALT, AST and GGT) is more than or equal to 30 percent and less than 50 percent; the degree of fatty liver in B-ultrasonic examination is reduced by 1 grade or more. And (4) invalidation: no significant improvement, or even aggravation, of clinical symptoms or signs; the indexes of liver enzymology (ALT and AST) are reduced by less than 30 percent, and the symptoms of fatty liver are not improved by B-ultrasonic examination.

5. Statistical method

All data were analyzed by SPSS18.0 software, the measurement data were expressed in terms of x + -s, and the count data were expressed in terms of χ²And (6) checking. P < 0.05 is statistically significant.

6. Results

6.1 comparison of clinical efficacy of two groups of patients after treatment

The treatment group can cure 4 cases and has obvious effect of 15 cases, and the total effective rate is 93.3 percent; the control group is cured for 1 and the obvious effect is 7, the total effective rate is 70 percent, the total effective rate of the treatment group is obviously higher than that of the control group, and the difference has statistical significance (P is less than 0.01). See table 2.

TABLE 2 comparison of clinical efficacy [ examples (%) ]

Group of	Number of examples	Clinical recovery	Show effect	Is effective	Invalidation	Total effective
							Treatment group	30	4(13.3)	15(50.0)	9(30.0)	2(6.7)	28(93.3)*
Control group	30	1(3.3)	7(23.3)	13(43.3)	9(30.0)	21(70.0)

Note: p < 0.01 in comparison with control group

6.2 comparison of liver function before and after treatment for two groups of patients

Compared with the group before treatment, the ALT, AST and GGT indexes of the two groups of patients after treatment are all reduced, but the liver function indexes of the treatment group are more obviously reduced, and the difference has statistical significance (P is less than 0.01). See table 3.

TABLE 3 comparison of liver function before and after treatment

Group of	Number of examples	Time of day	ALT(U/L)	AST(U/L)	GGT(U/L)
						Treatment group	30	Before treatment	60.7±33.6	56.1±26.3	88.7±34.8
		After treatment	33.5±17.3^**#	31.7±14.7^**#	43.3±25.3^**#
						Control group	30	Before treatment	62.2±24.1	55.2±27.1	90.1±34.1
		After treatment	43.1±20.4^*	37.4±16.5^*	57.9±26.0^*

Note: compared with the treatment before the same group of treatment,^*P＜0.05，^**p is less than 0.01, compared with the control group after treatment,^#P＜0.01

6.3 comparison of blood lipids before and after treatment in two groups of patients

Compared with the group before treatment, the TC, TG and LDL-C levels of the two groups of patients after treatment are obviously reduced, the reduction range of the treatment group is obviously superior to that of the control group, and the difference has statistical significance (P is less than 0.01). See table 4.

Table 4 comparison of blood lipid content before and after treatment (mmol/L,

)

group of	Number of examples	Time of day	TC	TG	LDL-C
						Treatment group	30	Before treatment	5.46±0.60	2.56±0.13	3.81±0.21
		After treatment	4.17±0.72^**#	1.32±0.33^**#	2.61±0.10^**#
						Control group	30	Before treatment	5.37±0.63	2.61±0.15	3.74±0.19
		After treatment	4.51±0.63^*	1.69±0.28^*	3.14±0.13^*

6.4 comparison of the scores of the syndromes before and after treatment

Compared with the group before treatment, the total score of the traditional Chinese medicine syndromes after the treatment of the two groups and the scores of the traditional Chinese medicine syndromes such as hypochondrium swelling or pain, tiredness and heaviness of the whole body, epigastric fullness and the like are reduced (P is less than 0.05); compared with the control group, the total score of the traditional Chinese medicine syndrome scores and the scores of the main symptoms of the traditional Chinese medicine of the treatment group are obviously reduced, and the difference has statistical significance (P is less than 0.01). See table 5.

Table 5 the comparison of the scores of the syndromes of traditional Chinese medicine (score,

)

6.5 intestinal flora comparison between two groups of patients before and after treatment

Compared with the group before treatment, after treatment, the bifidobacteria and the lactobacilli in intestinal flora of the two groups of patients are increased, the escherichia coli and the enterococcus are reduced (P is less than 0.05), and the improvement degree of the treatment group is obviously better than that of the control group (P is less than 0.01). See table 6.

TABLE 6 comparison of the intestinal flora in two groups (lg)^CFU/g，

)

Group of

Number of examples

Time of day

Bifidobacterium

Lactobacillus strain

Escherichia coli

Enterococcus

Treatment group

30

Before treatment

6.83±1.1

6.16±0.9

7.71±1.2

6.33±0.9

After treatment

8.61±1.3^**#

7.60±1.0^**#

6.39±1.1^**#

5.14±1.0^**#

Control group

30

Before treatment

7.04±1.2

6.21±1.0

7.66±1.1

6.41±1.1

After treatment

7.63±1.0^*

6.93±1.1^*

6.93±1.3^*

5.73±0.9^*

7 Observation of adverse reactions

No obvious adverse reaction occurs after the treatment of the two groups of patients.

Claims

1. The traditional Chinese medicine enema for treating the non-alcoholic steatohepatitis is characterized by comprising the following traditional Chinese medicine raw materials in parts by weight: 10-30g of oriental wormwood, 10-20g of red paeony root, 10-20g of salvia miltiorrhiza, 5-10g of safflower, 5-10g of peach kernel, 10-30g of radix bupleuri, 10-30g of white paeony root, 5-10g of rhubarb, 10-20g of scutellaria baicalensis, 20-40g of astragalus mongholicus, 10-20g of poria cocos, 10-20g of fried bighead atractylodes rhizome, 5-15g of rhizoma corydalis and 5-15g of szechwan chinaberry fruit.

2. The traditional Chinese medicine enema for treating non-alcoholic steatohepatitis of claim 1, which is characterized by comprising the following traditional Chinese medicine raw materials in proportion: 20g of oriental wormwood, 15g of red paeony root, 15g of salvia miltiorrhiza, 10g of safflower, 10g of peach kernel, 20g of radix bupleuri, 20g of white paeony root, 10g of rhubarb, 15g of scutellaria baicalensis, 30g of astragalus mongholicus, 15g of poria cocos, 15g of fried bighead atractylodes rhizome, 10g of rhizoma corydalis and 10g of szechwan chinaberry fruit.

3. The traditional Chinese medicine enema for treating non-alcoholic steatohepatitis of claim 1, which is characterized by comprising the following traditional Chinese medicine raw materials in proportion: 30g of oriental wormwood, 20g of red paeony root, 20g of salvia miltiorrhiza, 10g of safflower, 10g of peach kernel, 30g of radix bupleuri, 25g of white paeony root, 10g of rhubarb, 20g of scutellaria baicalensis, 40g of astragalus mongholicus, 20g of poria cocos, 20g of fried bighead atractylodes rhizome, 10g of rhizoma corydalis and 10g of szechwan chinaberry fruit.

4. The use of a traditional Chinese medicine enema according to any one of claims 1 to 3, wherein the traditional Chinese medicine enema is used for inhibiting or delaying the progression of non-alcoholic liver fibrosis and for inhibiting or delaying the progression of non-alcoholic steatohepatitis to non-alcoholic cirrhosis.

5. The use of a Chinese medicinal enema according to claim 4, wherein the Chinese medicinal enema is used in combination with one or more therapeutic agents.

6. The use of a Chinese medicinal enema according to claim 5, wherein the therapeutic agents include agents for treating hypertension, diabetes, dyslipidemia, and non-alcoholic fatty liver disease.

7. The use of a Chinese medicinal enema according to claim 4, wherein the Chinese medicinal enema is used in combination with a Chinese medicinal treatment method.

8. The use of the enema of claim 7, wherein the TCM treatment method is a TCM treatment method for non-alcoholic fatty liver disease, and comprises acupuncture therapy, abdominal massage therapy, acupoint application therapy, acupoint injection therapy, pressing, moxibustion therapy and acupoint catgut embedding.

9. The preparation method of the traditional Chinese medicine enema for treating nonalcoholic steatohepatitis as described in any one of claims 1 to 3, which comprises the following steps:

10. The preparation method of the traditional Chinese medicine enema for treating the non-alcoholic steatohepatitis as claimed in any one of claims 1 to 3, which is characterized by comprising the following specific operation processes: weighing the raw materials according to a certain proportion, adding clear water, soaking for 15-30min, decocting for 30-40min in a sealed manner, filtering to obtain decoction, and sealing into 200 ml/bag of liquid medicine under aseptic condition.