A Chinese medicine enema for treating abdominal distension caused by Crohn's disease

Abstract

The invention relates to a traditional Chinese medicine enema for treating abdominal distension caused by Crohn's disease, which can effectively solve the problem of preparing medicine for treating abdominal distension caused by Crohn's disease. The enema is prepared from the following raw materials by weight: 10-20g of costusroot, 15-20g of cyperus rotundus, 10-20g of patchouli, 9-15g of kudzu root, 12-15g of scutellaria, 12-15g of coptis root, 20-30g of purslane, 20-30g of houttuynia, 6-9g of lithospermum and 15-20g of astragalus. 400-600ml of water is added to the raw materials, and the raw materials are soaked at 18-25℃ for 15-25min, boiled over high heat, decocted over low heat for 20-30min, filtered to obtain a first filtrate; 400-600ml of water is added to the residue, boiled over high heat, decocted over low heat for 20-30min, filtered to obtain a second filtrate, and the two filtrates are combined and mixed to obtain the enema. The components of the invention support each other, have the effects of regulating qi and clearing bowels, strengthening the spleen and clearing away heat and removing dampness, are effectively used for treating abdominal distension caused by Crohn's disease, are easy to use, safe and have good effects, are innovations in drugs for treating abdominal distension caused by Crohn's disease, have practical clinical application value, and have huge economic and social benefits.

Description

Technical Field

[0001] The invention relates to medicine, in particular to a traditional Chinese medicine enema for treating abdominal distension caused by Crohn's disease. Background Art

[0002] Crohn's disease (CD) is a type of inflammatory bowel disease, with the main clinical manifestations of abdominal distension, abdominal pain, diarrhea, often accompanied by fever and extraintestinal damage such as joint, skin, eye, and oral mucosal ulcers. Western medicine mainly uses glucocorticoids, immunosuppressants, and biological agents (anti-TNF-α monoclonal antibodies) to induce and maintain remission. Surgical treatment has a certain effect, but it only treats the symptoms and not the root cause.

[0003] During the onset of Crohn's disease, the spleen and stomach are often damaged due to improper diet, exposure to external pathogens, emotional stimulation, etc., resulting in spleen dysfunction, endogenous phlegm and dampness, accumulation of damp heat, stagnation of qi and blood, and damage to the intestines, leading to recurrence of CD. Repeated attacks of CD can aggravate spleen deficiency, so spleen deficiency is the root cause of CD and runs through the entire disease. Deficiency must lead to stagnation, and qi deficiency is unable to push, resulting in qi stagnation. "Medical Seeking Truth" says: "The power of ascending and descending lies in the middle qi. When the middle qi is strong, the spleen rises and the stomach descends, and the zang-fu organs can rotate. When the middle qi is weak, the spleen is depressed and the stomach is reversed." Repeated attacks of CD damage the spleen and stomach, resulting in middle qi deficiency, qi stagnation, abnormal ascending and descending, obstruction of body fluid circulation, and accumulation and dampness. In addition to affecting the qi of the middle jiao, spleen and stomach weakness also affect the qi of the intestines. The small intestine separates the clear from the turbid, and the large intestine conducts the waste. Both are smooth when they are descended, and both rely on the descending of the stomach qi. Spleen deficiency leads to stagnation of the qi in the middle jiao, and the stomach qi does not descend. The qi deficiency is unable to push and the intestinal viscera are abnormal, and the visceral qi is blocked. The function of conducting and excreting waste is reduced, and symptoms such as abdominal distension and incomplete defecation appear. Even "pain, vomiting, distension, and constipation" may occur, which is "intestinal knot". Among them, the symptom of abdominal distension lasts the longest in Crohn's disease, and it bothers patients the most, leading to a decrease in the quality of life of patients. It is advisable to adopt the treatment method of "tongyin tongyong". Tong means to dredge, which implies "tongyin tongyong". In a narrow sense, "tongyin tongyong" refers to the use of tongli drugs to treat some evidences with tongli symptoms. Gao Shizong of the Qing Dynasty wrote in "The True Transmission of Medicine: Heart and Abdominal Pain": "The methods of unblocking are different. Regulating qi to harmonize blood, regulating blood to harmonize qi, unblocking... Helping the weak to unblock, warming the cold to unblock, nothing but unblocking methods." This further expanded the ideological connotation of the unblocking method. Use products that can unblock qi, clear away heat and dampness, and the evil will be gone, so that the spleen and stomach can rise and fall in an orderly manner, and the internal organs can be unblocked. Injecting the unblocking medicine directly into the large intestine, the organ of conduction, without oral administration, can accelerate the unblocking of the internal organs and eliminate the evil. However, traditional enema has a greater irritation to the intestines, and the medication is not fixed and standardized. Its use and efficacy are not satisfactory, so it is imperative to develop new drugs. Summary of the invention

[0004] In view of the above situation, in order to overcome the defects of the prior art, the purpose of the present invention is to provide a Chinese medicine enema for treating abdominal distension caused by Crohn's disease, which can effectively solve the problem of preparing medicine for treating abdominal distension caused by Crohn's disease.

[0005] The technical solution provided by the present invention is a traditional Chinese medicine enema for treating abdominal distension caused by Crohn's disease. The enema is prepared from the following raw materials by weight: 10-20g of costusroot, 15-20g of cyperus, 10-20g of patchouli, 9-15g of kudzu root, 12-15g of scutellaria, 12-15g of coptis root, 20-30g of purslane, 20-30g of houttuynia, 6-9g of lithospermum and 15-20g of astragalus. 400-600ml of water is added to the raw materials, and the raw materials are soaked at 18-25°C for 15-25 minutes, boiled over high heat, decocted over low heat for 20-30min, filtered to obtain a first filtrate; 400-600ml of water is added to the residue, boiled over high heat, decocted over low heat for 20-30min, filtered to obtain a second filtrate, and the two filtrates are combined and mixed to obtain the enema.

[0006] The components of the invention support each other, have the effects of regulating qi and clearing bowels, strengthening the spleen and clearing away heat and removing dampness, are effectively used for treating abdominal distension caused by Crohn's disease, are easy to use, safe and have good effects, are innovations in drugs for treating abdominal distension caused by Crohn's disease, have practical clinical application value, and have huge economic and social benefits. DETAILED DESCRIPTION

[0007] The specific implementation modes of the present invention are described in detail below in combination with embodiments and specific situations.

[0008] The present invention is specifically implemented by the following examples.

[0009] Example 1

[0010] The invention discloses a Chinese medicine enema for treating abdominal distension caused by Crohn's disease. The enema is prepared from the following raw materials by weight: 15g of costusroot, 18g of cyperus rotundus, 15g of patchouli, 12g of kudzu root, 13g of scutellaria, 14g of coptis root, 25g of purslane, 25g of houttuynia, 7g of lithospermum and 18g of astragalus. 500ml of water is added to the raw materials, and the raw materials are soaked at 18-25℃ for 15-25 minutes, boiled over high heat, decocted over low heat for 25 minutes, filtered to obtain a first filtrate; 500ml of water is added to the residue, boiled over high heat, decocted over low heat for 25 minutes, filtered to obtain a second filtrate, and the two filtrates are combined and mixed to obtain the enema.

[0011] Example 2

[0012] The invention discloses a Chinese medicine enema for treating abdominal distension caused by Crohn's disease. The enema is prepared from the following raw materials by weight: 12g of costusroot, 19g of cyperus rotundus, 12g of patchouli, 14g of kudzu root, 14g of scutellaria baicalensis, 13g of coptis root, 22g of purslane, 28g of houttuynia cordata, 8g of lithospermum officinale and 16g of astragalus. 550ml of water is added to the raw materials, and the raw materials are soaked at 18-25 DEG C for 15-25 minutes, boiled over high heat, decocted over low heat for 20 minutes, filtered to obtain a first filtrate; 450ml of water is added to the residues, boiled over high heat, decocted over low heat for 30 minutes, filtered to obtain a second filtrate, and the two filtrates are combined and mixed to obtain the enema.

[0013] Example 3

[0014] The invention discloses a Chinese medicine enema for treating abdominal distension caused by Crohn's disease. The enema is prepared from the following raw materials by weight: 18g of costusroot, 16g of cyperus rotundus, 18g of patchouli, 10g of kudzu root, 13g of scutellaria, 14g of coptis root, 28g of purslane, 22g of houttuynia cordata, 9g of lithospermum officinale and 19g of astragalus. 600ml of water is added to the raw materials, and the raw materials are soaked at 18-25 DEG C for 15-25 minutes, boiled over high heat, decocted over low heat for 30 minutes, filtered to obtain a first filtrate; 400ml of water is added to the residues, boiled over high heat, decocted over low heat for 20 minutes, filtered to obtain a second filtrate, and the two filtrates are combined and mixed to obtain the enema.

[0015] Among the above drugs,

[0016] Costus root: pungent, bitter, warm, enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians, promotes qi and relieves pain, strengthens the spleen and aids food.

[0017] Cyperus rotundus: pungent, slightly bitter, slightly sweet, neutral, enters the liver, spleen, and triple burner meridians, promotes qi and relieves depression, regulates menstruation and relieves pain.

[0018] Patchouli: spicy in taste, warm in nature, enters the spleen, stomach, and lung meridians, eliminates dampness and invigorates the spleen, eliminates filth and harmonizes the stomach, relieves heat, and releases exterior.

[0019] Pueraria root: sweet and spicy in taste, cool in nature, enters the lung and stomach meridians, relieves muscles and reduces fever, promotes the production of body fluids and quenches thirst, raises yang and stops diarrhea.

[0020] Scutellaria baicalensis: bitter in taste, cold in nature, enters the lung, gallbladder, spleen, large intestine and small intestine meridians, clears away heat and dampness, purges fire and detoxifies, stops bleeding, and calms the fetus.

[0021] Coptis chinensis: bitter in taste, cold in nature, enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. Clears away heat and dampness, purges fire and detoxifies.

[0022] Portulaca oleracea: sour, cold, enters the liver and large intestine meridians, clears away heat and detoxifies, cools blood and stops bleeding, and stops dysentery.

[0023] Houttuynia cordata: It is pungent in nature, slightly cold, and enters the lung and bladder meridians. It can clear away heat and detoxify, eliminate carbuncles and discharge pus, and promote diuresis and relieve stranguria. It also combines the functions of clearing away heat, discharging pus, promoting diuresis, and penetrating the surface.

[0024] Lithospermum officinale: sweet, salty, cold in nature. Enters the heart and liver meridians. Has the functions of cooling blood, activating blood circulation, detoxifying and clearing rashes.

[0025] Astragalus: sweet in taste, slightly warm in nature; enters the spleen and lung meridians. Strengthens the spleen and replenishes the middle, raises yang and lifts the sunken, strengthens the body's defense system, promotes urination, removes toxins and promotes tissue regeneration.

[0026] The above-mentioned drug components support and cooperate with each other. Costus root and Cyperus rotundus can relieve qi stagnation in the intestines and viscera. "Compendium of Materia Medica" says: "Cyperus rotundus with costus root can relieve stagnation and harmonize the middle"; Patchouli can transform dampness and turbidity, promote qi and regulate the middle. The three medicines are the main medicines, and they are used together to help unblock the qi of the spleen, stomach, intestines and viscera; Pueraria root, Scutellaria baicalensis, and Coptis chinensis are the ministerial medicines, which can clear away heat and dampness and treat the symptoms; Portulaca oleracea, Houttuynia cordata, and Lithospermum officinale are the adjuvants, which can help clear away heat and detoxify, and eliminate dampness, heat, turbidity and toxicity; Astragalus is the messenger medicine, which can help replenish qi and strengthen the spleen. When the spleen and stomach are healthy, the qi can flow freely, and dampness cannot be generated. The whole prescription has the effects of promoting qi and removing stagnation, clearing the bowels and purging heat. It is effectively used to treat abdominal distension caused by Crohn's disease, and has achieved very good beneficial effects through experiments. The relevant information is as follows:

[0027] 1. General information: From December 2016 to December 2021, 65 patients with Crohn's disease and abdominal distension were diagnosed in the outpatient clinic and ward. They were randomly divided into a Chinese medicine group and a mesalazine group. The Chinese medicine group (i.e., the present invention group, the same below) had 33 cases, including 18 males and 15 females; the oldest was 59 years old and the youngest was 20 years old. The mesalazine group had 32 cases, including 19 males and 13 females; the oldest was 58 years old and the youngest was 21 years old.

[0028] 2. Criteria for selecting cases:

[0029] Patients with Crohn's disease often experience abdominal bloating, which is related to the following factors:

[0030] Intestinal obstruction: Crohn's disease patients have intestinal transmural inflammation and intestinal stenosis. Such patients often experience intestinal bloating after eating.

[0031] Intestinal inflammation: It can affect intestinal motility. When intestinal motility is slow, the patient will experience bloating.

[0032] Changes in intestinal microecology: Crohn's disease patients have more severe intestinal inflammation, disordered intestinal microecology, a decrease in beneficial intestinal bacteria and an increase in harmful bacteria. These harmful bacteria often include some gas-producing bacteria, which can cause abdominal distension in patients after producing gas. Therefore, abdominal distension is a very common symptom in patients with Crohn's disease.

[0033] Anyone with the above symptoms can be used as a criterion for case selection.

[0034] 3. Diagnostic criteria (formulated with reference to the diagnostic criteria for Crohn's disease recommended by the World Health Organization in 2014): ①, patients with typical clinical symptoms. ②, X-ray manifestations include gastrointestinal fissure-like ulcers, cobblestone signs, pseudopolyps, multiple strictures, fistula formation, etc. The lesions are distributed in segments. CT can show intestinal loops with thickened intestinal walls, and abscesses in the pelvic or abdominal cavities. ③, longitudinal or serpiginous ulcers with a jumping distribution can be seen under endoscopy, and the surrounding mucosa is normal, or the hyperplasia is pebble-like. ④, Lesion biopsy shows non-caseous necrotic granulomas, or a large number of lymphocytes are gathered.

[0035] 4. Inclusion criteria

[0036] (1) Patients who meet the diagnostic criteria for Crohn's disease and whose clinical severity is mild or moderate. (According to the internationally accepted CDAI score, a score of 150-275 is mild, 275-450 is moderate, and a score greater than 450 is severe. This study included mild and moderate patients, and severe patients were excluded). The CDAI scoring system includes 8 dimensions: the number of loose stools per day in the past week, daily abdominal pain (none = 0, 2, severe = 3), daily overall health status (healthy = 0, need to take phenoxylate / opioid drugs (none = 0), product, (standard body weight - actual body weight) / standard body weight. The above 8 dimensions are observed and scored for 1 week, multiplied by the corresponding weight, and the sum of the 8 scores is the total score of CDAI. For the specific scoring table, see CDAI, a publicly known technology.

[0037] (2) Applicants must be between 18 and 65 years old, regardless of gender.

[0038] 5. Exclusion criteria

[0039] (1) Patients with severe disease.

[0040] (2) Patients with infectious colitis such as bacillary dysentery, amoebic dysentery, chronic schistosomiasis, intestinal tuberculosis, ulcerative colitis, ischemic enteritis, and radiation enteritis.

[0041] (3) Patients with severe complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic colon dilatation, colon cancer, rectal cancer and anal diseases

[0042] (4) Pregnant and lactating women.

[0043] (5) Those with serious primary heart, liver, lung, kidney, blood or other serious diseases that affect their survival.

[0044] (6) Persons with disabilities as defined by law (blind, deaf, dumb, intellectually disabled, mentally disabled, physically disabled).

[0045] (7) Suspected or confirmed history of alcohol or drug abuse.

[0046] (8) Other diseases that, according to the investigator’s judgment, reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in work environment that may result in loss to follow-up.

[0047] (9) Patients with allergies, such as those with a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of this drug.

[0048] 6. Treatment options:

[0049] The Chinese medicine group was treated with 400 mL of the Chinese medicine enema of the present invention (using Example 1 as an example), and retention enema was performed once every night, with 14 days as a course of treatment. Two courses of treatment were observed to determine the efficacy.

[0050] The mesalazine group took 4 mesalazine tablets orally 3 times a day. The treatment course was the same as that of the Chinese medicine group.

[0051] 6.1 Grading criteria for abdominal distension:

[0052] Grade I (mild): The abdomen is distended, slightly above the chest, and soft. Percussion produces a low-pitched tympanic sound. Bowel sounds may be weakened, slightly hyperactive, or normal. There may be a mild feeling of abdominal distension.

[0053] Grade II (moderate): The abdomen is bulging, significantly higher than the chest, and has a certain tension. Percussion produces a medium-pitched tympanic sound, with increased range and intensity. Bowel sounds are mostly weakened, and the patient feels obvious abdominal distension, which affects eating or other metabolism.

[0054] Grade III (severe): The whole abdomen is obviously bulging and spherical, hard and uncomfortable to press, and there is no rebound pain. Percussion produces a high-pitched tympanic sound, which may produce a metallic knocking sound and does not change with body position. Bowel sounds are significantly weakened or disappeared, and occasionally a sound of water flowing can be heard, with obvious gastrointestinal reactions.

[0055] The following formula was used to judge the efficacy:

[0056] Efficacy judgment value = pre-treatment score - post-treatment score / pre-treatment score × 100%

[0057] The efficacy standards are as follows: markedly effective: judgment value > 2 / 3, effective: 1 / 3 < judgment value < 2 / 3, ineffective: judgment value < 1 / 3.

[0058] Table 1 Comparison of total effective rate between the Chinese medicine prescription group and the mesalazine group

[0059] Group Number of cases Significant effect efficient invalid Effectiveness% Chinese Medicine Group 33 10 21 2 93.9 Mesalazine group 32 7 15 10 68.7*

[0060] Note: *P<0.05

[0061] The total effective rate of the Chinese medicine group was 93.9%, which was significantly better than that of the mesalazine group (68.7%). After statistical processing, there was a significant difference (P<0.05).

[0062] While testing Example 1, other examples were also tested, and the same or similar results were obtained, which will not be listed here one by one.

[0063] Experiments show that the Chinese medicine enema prepared by the present invention has a stable and reliable efficacy in treating Crohn's disease abdominal distension, has no obvious toxic and side effects, is safe to use, has a stable and reliable efficacy, and the efficacy reaches 93.9%. It has obvious advantages over existing drugs in treatment and has a strong clinical use value. It is an innovation in drugs for treating Crohn's disease abdominal distension and has huge economic and social benefits.

Claims

1. A Chinese medicine enema for treating abdominal distension caused by Crohn's disease, characterized in that: The enema is prepared from the following raw materials by weight: 10-20g of costusroot, 15-20g of cyperus, 10-20g of patchouli, 9-15g of kudzu root, 12-15g of scutellaria, 12-15g of coptis root, 20-30g of purslane, 20-30g of houttuynia, 6-9g of lithospermum and 15-20g of astragalus. 400-600ml of water is added to the raw materials, and the mixture is soaked at 18-25℃ for 15-25min, boiled over high heat, decocted over low heat for 20-30min, and filtered to obtain a first filtrate. 400-600ml of water is added to the residue, boiled over high heat, decocted over low heat for 20-30min, and filtered to obtain a second filtrate. The two filtrates are combined and mixed to obtain the enema.

2. The Chinese medicine enema for treating Crohn's disease abdominal distension according to claim 1, characterized in that: The enema is prepared from the following raw materials by weight: 15g of costusroot, 18g of cyperus rotundus, 15g of patchouli, 12g of kudzu root, 13g of scutellaria, 14g of coptis root, 25g of purslane, 25g of houttuynia, 7g of lithospermum and 18g of astragalus. 500ml of water is added to the raw materials, and the mixture is soaked at 18-25℃ for 15-25min, boiled over high heat, decocted over low heat for 25min, and filtered to obtain a first filtrate; 500ml of water is added to the residue, boiled over high heat, decocted over low heat for 25min, and filtered to obtain a second filtrate. The two filtrates are combined and mixed to obtain the enema.

3. The Chinese medicine enema for treating Crohn's disease abdominal distension according to claim 1, characterized in that: The enema is prepared from the following raw materials by weight: 12g of costusroot, 19g of cyperus rotundus, 12g of patchouli, 14g of kudzu root, 14g of scutellaria baicalensis, 13g of coptis root, 22g of purslane, 28g of houttuynia cordata, 8g of lithospermum officinale and 16g of astragalus. 550ml of water is added to the raw materials, and the mixture is soaked at 18-25℃ for 15-25min, boiled over high heat, decocted over low heat for 20min, and filtered to obtain a first filtrate; 450ml of water is added to the residue, boiled over high heat, decocted over low heat for 30min, and filtered to obtain a second filtrate. The two filtrates are combined and mixed to obtain the enema.

4. The Chinese medicine enema for treating Crohn's disease abdominal distension according to claim 1, characterized in that: The enema is prepared from the following raw materials by weight: 18g of costusroot, 16g of cyperus rotundus, 18g of patchouli, 10g of kudzu root, 13g of scutellaria, 14g of coptis root, 28g of purslane, 22g of houttuynia cordata, 9g of lithospermum officinale and 19g of astragalus. 600ml of water is added to the raw materials, and the mixture is soaked at 18-25℃ for 15-25min, boiled over high heat, decocted over low heat for 30min, and filtered to obtain a first filtrate; 400ml of water is added to the residue, boiled over high heat, decocted over low heat for 20min, and filtered to obtain a second filtrate. The two filtrates are combined and mixed to obtain the enema.