CN114191528B - Traditional Chinese medicine composition for treating cholelithiasis and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating cholelithiasis and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating cholelithiasis as well as a preparation method and application thereof, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 18 to 22 portions of angelica, 18 to 22 portions of white peony root, 9 to 11 portions of radix bupleuri, 18 to 22 portions of red peony root, 14 to 16 portions of endothelium corneum gigeriae galli, 9 to 11 portions of radix curcumae, 14 to 16 portions of desmodium, 27 to 33 portions of spora lygodii, 5 to 7 portions of rhubarb, 27 to 33 portions of salvia miltiorrhiza, 9 to 11 portions of spina gleditsiae, 9 to 11 portions of szechwan chinaberry fruit, 9 to 11 portions of costustoot, 9 to 11 portions of green tangerine peel, 9 to 11 portions of dried orange peel and 5 to 7 portions of honey-fried licorice root. The traditional Chinese medicine composition provided by the invention has the advantages that the raw materials are compatible with each other, the curative effect of treating cholelithiasis by combining the auricular point therapy is definite, the symptoms can be effectively improved, the pain of patients can be effectively relieved, the medicine is effective and cheap, the operation is simple, the applicability is wide, and the popularization is worth.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating cholelithiasis as well as a preparation method and application thereof.
Background
Gallstone is one of common and frequent diseases in clinical digestive internal medicine, and after stones are formed in a gallbladder, mucous membranes of the gallbladder can be stimulated, so that not only can chronic inflammation of the gallbladder be caused, but also secondary infection can be caused after the stones are embedded in the neck or a cystic duct of the gallbladder, and acute inflammation of the gallbladder can be caused. The chronic stimulation of calculus to the gallbladder mucosa may also lead to the occurrence of gallbladder cancer, and it has been reported that the incidence rate of such gallbladder cancer can reach 1% -2%, and more than 96% of gallbladder cancer patients are accompanied by choledocholithiasis. Bile drainage is not smooth due to calculus obstruction, bile stasis, hepatomegaly and liver function damage occur, and infection aggravates liver function damage. Meanwhile, calculus blocks and stimulates the sphincter Oddi at the lower end of the common bile duct to cause poor pancreatic juice drainage and reflux, pancreatitis is induced, acute hemorrhagic necrotizing pancreatitis of severe patients is life-threatening, and more than 60% of patients with pancreatitis are counted to have gallstone. In addition, cholelithiasis causes many complications, arrhythmia, septic shock, liver abscess, biliary tract hemorrhage, liver failure, hepatorenal syndrome, etc., and may also induce diabetes.
Western medicine mainly takes western medicines and operations in the aspect of treating cholelithiasis, and the oral medicine is mainly Western medicines of ursodesoxycholic acid capsules and tauroursodeoxycholic acid capsules. The tauroursodeoxycholic acid capsule is the medicine which dissolves stones most quickly and has the most definite curative effect in the world at present, the effective rate is about 60 percent, the treatment course is more than half a year, the cost is high, and the relapse is easy after the medicine is stopped, but the burden of patients is increased. The curative effect of the operation treatment on silt-shaped and small-particle multiple calculi is not satisfactory, and the incidence rate, the stone recurrence rate and the reoperation rate of postoperative complications (such as biliary leakage, residual calculi in biliary tract, colon cancer, acute pancreatitis, pyogenic infection of abdominal cavity and the like) are still the main problems which are puzzling the western medicine treatment of the cholelithiasis.
Although the traditional Chinese medicine treatment of cholelithiasis has many advantages, the following points are also lacked: 1. the Chinese patent medicine for treating cholelithiasis and the research on the compound prescription thereof are not many, the clinical random contrast test design of clinical reports is not scientific, the reports are incomplete and the like, and the authenticity and the accuracy of test results are influenced, so the curative effect of the common Chinese patent medicine for removing and dissolving the gallstones is not exact; 2. in recent years, the traditional Chinese medicine treatment of cholelithiasis is reported to be single or independent application of methods such as auricular points, electric needles and the like, and the calculus removing rate is low. Therefore, finding a safe, highly effective, less side-effects, and inexpensive drug is a major goal in the medical field of cholelithiasis.
Disclosure of Invention
Aiming at the problems and the defects in the prior art, the invention aims to provide a traditional Chinese medicine composition for treating cholelithiasis and a preparation method and application thereof.
Based on the above purpose, the technical scheme adopted by the invention is as follows:
the invention provides a traditional Chinese medicine composition for treating cholelithiasis, which is prepared from the following raw materials in parts by weight: 18-22 parts of angelica, 18-22 parts of white peony root, 9-11 parts of radix bupleuri, 18-22 parts of red peony root, 14-16 parts of endothelium corneum gigeriae galli, 9-11 parts of radix curcumae, 14-16 parts of desmodium, 27-33 parts of spora lygodii, 5-7 parts of rheum officinale, 27-33 parts of salvia miltiorrhiza, 9-11 parts of spina gleditsiae, 9-11 parts of szechwan chinaberry fruit, 9-11 parts of elecampane, 9-11 parts of green tangerine peel, 9-11 parts of dried orange peel and 5-7 parts of honey-fried licorice root, wherein the source of the raw material medicines is a traditional Chinese medicine or a traditional Chinese medicine extract equivalent to the crude medicine amount of the traditional Chinese medicine.
Preferably, the traditional Chinese medicine composition is prepared from the following raw medicines in parts by weight: 20 parts of angelica sinensis, 20 parts of white peony root, 10 parts of radix bupleuri, 20 parts of red peony root, 15 parts of endothelium corneum gigeriae galli, 10 parts of radix curcumae, 15 parts of desmodium, 30 parts of spora lygodii, 6 parts of rheum officinale, 30 parts of salvia miltiorrhiza, 10 parts of spina gleditsiae, 10 parts of szechwan chinaberry fruit, 10 parts of elecampane, 10 parts of pericarpium citri reticulatae viride, 10 parts of dried tangerine peel and 6 parts of honey-fried licorice root, wherein the source of the raw materials is a traditional Chinese medicine or a traditional Chinese medicine extract equivalent to the crude drug amount of the traditional Chinese medicine.
Preferably, the traditional Chinese medicine composition is a water extract of raw material medicines.
In a second aspect, the present invention provides a method for preparing a traditional Chinese medicine composition for treating cholelithiasis, including the following steps: the preparation method comprises the steps of taking the raw materials, adding water with the mass 2-5 times of the total mass of the raw materials, soaking for 0.5-2 hours, decocting for 2 times, after boiling each time, boiling with strong fire, turning to mild fire for 0.5-1 hour, stopping the fire, pouring out, filtering, and combining filtrates to obtain the traditional Chinese medicine composition.
In a third aspect of the present invention, there is provided an application of the above-mentioned traditional Chinese medicine composition for treating cholelithiasis in preparing a medicine for treating cholelithiasis.
The fourth aspect of the invention provides a pharmaceutical preparation for treating cholelithiasis, which is prepared from the traditional Chinese medicine composition of the first aspect and pharmaceutically acceptable auxiliary materials.
Preferably, the pharmaceutical formulation is an oral dosage form.
Preferably, the pharmaceutical preparation is a decoction, a honeyed pill, a water-honeyed pill, a granule, a capsule, a tablet, an oral liquid or a syrup.
The fifth aspect of the invention provides a medicament for treating cholelithiasis, which consists of an oral medicament and an auricular point patch pressing medicament, wherein the oral medicament is the medicinal preparation of the fourth aspect, and the auricular point patch pressing medicament is a cowherb seed auricular point patch.
More preferably, the oral medicament is prepared by decocting the raw materials in water, 1 dose in 1 day, and is taken warm in the morning and evening on an empty stomach; when the auricular point pressing plaster is used, the medicinal pressing bean cowherb seed is accurately pasted at the auricular point by the auricular point pressing plaster, 5 to 6 times of pressing are carried out every day, and each acupuncture point is massaged for about 30s every time.
The auricular points in the invention comprise: liver, pancreas, gallbladder, spleen, duodenum, endocrine, sympathetic, subcortical, and auricular labyrinth root.
Liver: in the lower rear portion of the cymba concha, i.e. in the region of concha 12; soothing liver and gallbladder, promoting qi circulation and relieving pain; it can be used for treating hypochondriac pain, bitter taste in mouth, regurgitation, and alternating cold and heat caused by cholelithiasis.
Pancreas and gallbladder: in the rear upper portion of the cymba concha, i.e. in the region of concha 11; clearing heat, promoting bile flow and removing calculus; can be used for treating cholecystitis, cholelithiasis, ascariasis of biliary tract, and acute pancreatitis.
Spleen: below the BD line, the lower rear portion of the concha cavity, the concha 13 region; invigorating spleen, replenishing qi, regulating stomach function, and eliminating dampness; has remarkable effects on symptoms such as hypochondriac pain, abdominal distention, diarrhea, constipation, inappetence, nausea, emesis, vertigo and the like caused by damp-heat accumulation in gallstone.
Duodenum: at the posterior 1/3 between the crus of the helix and the line AB, the concha 5 region; invigorating spleen, regulating stomach function, clearing away heat, and promoting function of gallbladder; can be used for treating cholelithiasis, cholecystitis, pylorospasm, and duodenal ulcer.
Endocrine: within the intertragic notch, the anterior lower portion of the concha cavity, the concha 18 region; regulating qi-flowing for relieving pain, and clearing away heat and toxic materials; it can be used for treating various pains, such as hypochondriac pain caused by cholelithiasis, radiation pain of right shoulder and back, abnormal diet, and mental stress.
Interaction: the intersection of the tail end of the lower corner of the antihelix and the inner edge of the antihelix, namely the front end of the antihelix 6 area; regulating qi-flowing for relieving spasm, dredging collaterals and relieving pain; can be used for treating biliary colic, gastrointestinal spasm, calculus, shoulder and back pain, lumbosacral pain, etc.
Subcortical: in the inner side of the antitragus, namely the area of the antitragus 4; regulating qi to alleviate pain, clearing heat and promoting bile flow, subcutaneous points of the digestive system: can be used for treating dyspepsia caused by cholelithiasis, cholecystitis, pancreatitis, gastritis, gastric and duodenal ulcer, nausea, emesis, abdominal distention, diarrhea, constipation, and various diseases of liver, gallbladder, and pancreas.
And (3) auricular root: at the root of the posterior sulcus of the helix; regulating qi-flowing, relieving spasm, promoting bile flow, and removing calculus, and can be used for treating cholelithiasis, cholecystitis, ascariasis of biliary tract, radiopain, abdominal pain, and diarrhea.
Compared with the prior art, the invention has the following beneficial effects:
(1) The Chinese medicinal composition takes the angelica and the white paeony root as monarch medicaments, and the angelica and the white paeony root have the effects of promoting blood circulation to remove blood stasis, benefiting gallbladder and nourishing liver, and dredging collaterals and relieving pain. Chinese angelica, radix Angelicae sinensis, sweet and heavy in flavor, is specialized in tonifying blood, and light and pungent in flavor, is also capable of moving blood, tonifying middle-jiao and moving, and tonifying middle-jiao is the essential herb in blood; it can tonify blood, promote blood circulation, dredge meridians, and activate collaterals. For cholelithiasis, it is refined for a long time by blood stasis and obstruction of collaterals, and phlegm coagulation and stasis, so it is used twice as the monarch herb in blood to promote blood circulation and remove blood stasis, resolve food stagnation and alleviate pain. Modern pharmacological research shows that the main component of the angelica is volatile oil, has the effects of promoting hematopoiesis, inhibiting platelet aggregation, resisting thrombus, dilating blood vessels and the like, and has obvious effect on pain of cholelithiasis (stabbing pain of blood stasis) found in clinical application. White peony root, radix Paeoniae alba and white peony root, radix Paeoniae alba have sour flavor, mainly enter liver and gallbladder meridians, can be used for acid astringing liver yin, nourishing blood and softening liver to relieve pain, can be used for treating costalgia caused by cholelithiasis, and can be used for treating abdominal pain and diarrhea caused by spleen deficiency and liver hyperactivity, and cholelithiasis caused by yin and blood deficiency and channel failure to nourish right back radioactive pain.
(2) The invention takes radix bupleuri, red paeony root, endothelium corneum gigeriae galli, radix curcumae and longhairy antenoron herb as ministerial drugs. The radix bupleuri and the red paeony root are matched and scattered and collected, so that the radix bupleuri and the red paeony root can achieve the effect of liver qi, nourish the liver, soften the liver, tonify qi, promote the circulation of qi, regulate the flow of qi, harmonize blood, regulate qi and blood smoothly and clear yang to achieve stretch effect, and are used as ministerial drugs together. Zhang Zhongjing was created in Shang Han miscellaneous diseases Lun for the first time and combined with Shaoyao, in treating liver depression syndrome, it is believed that Bupleurum enters liver meridian ascending and dispersing, which is a good drug for soothing liver and relieving depression, shaoyang is sweet, slow and sour, nourishing blood and regulating nutrient, and nourishing liver and relieving urgency, and the two drugs are combined delicately, and have effects of smoothing and harmonizing, dispersing and dissolving moderately, astringing middle energizer without stagnation, and regulating viscera, and replenishing qi and blood. In Yun from Ben Cao fen Jing, the chai Hu can disperse and smooth qi and blood, resolve stagnation and regulate menstruation, and can release exterior and harmonize interior at best. Radix Paeoniae Rubra is used for astringing yin, nourishing blood and softening liver, and is combined with bupleuri radix for tonifying liver and promoting liver function. Endothelium corneum Gigeriae Galli, radix Curcumae, and herba Lysimachiae Christinae "Sanjin" are combined to strengthen the actions of normalizing gallbladder function and removing urinary calculus.
(3) The invention takes Japanese climbing fern spore, rhubarb, salvia miltiorrhiza and spina gleditsiae as adjuvant drugs, assists monarch drugs in promoting blood circulation to remove blood stasis, nourishing the liver to relieve pain, can also assist ministerial drugs in soothing the liver and benefiting the gallbladder, strengthening the spleen and harmonizing the stomach, and is used as adjuvant drugs together to strengthen the efficacy of the monarch drugs and the ministerial drugs. Spora lygodii has effects of clearing away heat and toxic materials and removing calculus; rhubarb clears heat and purges fire, lowers the bowels and purges intestines; the red sage root promotes blood circulation to remove blood stasis; spina Gleditsiae can be used for inducing menstruation, promoting blood circulation and removing blood stasis. Cholelithiasis is caused by the loss of the spleen and the liver in the flow of qi, which leads to damp-heat retention and qi stagnation, manifested as abdominal distention and pain, hypochondriac pain, and jaundice, while spora Lygodii and radix et rhizoma Rhei purge heat and remove toxicity, which can be indicated for damp-heat jaundice. Long-term damp retention can lead to qi stagnation and blood stasis, manifested as abdominal distention, discomfort and hypochondriac pain, so it is combined with Dan Shen and Zao jiao to regulate qi, promote blood circulation, remove blood stasis, unblock collaterals and alleviate pain.
(4) The invention takes toosendan fruit, costustoot, green tangerine orange peel, tangerine peel and honey-fried licorice root as guiding drugs, and all guiding drugs can be used for widening and all zang fu organs and spreading dampness of the whole body. The combination of toosendan fruit, costus root and green tangerine peel is beneficial to the syndrome of liver depression and spleen-earth restriction, and spleen and stomach mainly transport and resolve water-dampness, so the qi circulation of spleen and stomach can remove dampness, invigorate spleen and resolve phlegm. In addition, chenpi can nourish spleen, activate spleen due to pungent flavor, and invigorate spleen due to bitter flavor. Because Chen Pi governs qi movement of spleen and stomach, spleen and stomach are in the middle energizer and qi of middle energizer passes through, qi of triple energizer also surges. The triple energizer is an organ responsible for drainage and circulates water and dampness; it also refers to the zang fu exterior, the upper and heart, lung, lower and liver, kidney. Prepared licorice root, radix Glycyrrhizae Praeparata has the effects of relieving spasm and pain, clearing away heat and toxic material, and harmonizing the effects of the other drugs in the recipe.
(5) The invention is mainly set for diseases such as cholelithiasis, has reasonable prescription, supplements each other by virtue of monarch, minister, assistant and guide, and has remarkable curative effects in the aspects of benefiting gallbladder, removing calculus, resisting bacteria and inflammation, improving microcirculation, regulating immunity and the like. The invention assists the prepared Guishao paishi xishi decoction with the ear acupuncture therapy, and can effectively control the development of cholelithiasis and reduce the risks of acute abdominal diseases, tumors and the like caused by the cholelithiasis by multi-target and multi-path integral regulation. Because the auricular points are connected with the meridian network of the whole body, the auricular points form a meridian whole body together. In traditional Chinese medicine, the seed of cowherb seed enters stomach and liver meridians, is mild and bitter in property, and has the functions of promoting blood circulation to remove meridian obstruction and promoting blood circulation. The seed of cowherb seed is pressed on the ear acupoint, so that the therapeutic effect reaches the affected viscera, the gallbladder contraction is strengthened, the movement of the oddi sphincter is increased, the calculus removal is promoted, and the ear acupoint can be stimulated at any time during the treatment. The traditional Chinese medicine combination therapy provides a new method for treating cholelithiasis, which is simple in operation, convenient (treatment is carried out at any time without special contraindication), effective (high effective rate) and cheap (low charge), and is worthy of clinical popularization and application.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail by the following examples. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present application will be described in detail with reference to examples.
Example 1
The embodiment of the invention provides a traditional Chinese medicine composition for treating cholelithiasis, which is prepared from the following raw material medicines in parts by weight: 20g of angelica sinensis, 20g of white peony root, 10g of radix bupleuri, 20g of red peony root, 15g of endothelium corneum gigeriae galli, 10g of radix curcumae, 15g of desmodium, 30g of spora lygodii, 6g of rheum officinale, 30g of salvia miltiorrhiza, 10g of spina gleditsiae, 10g of szechwan Chinaberry fruit, 10g of costustoot, 10g of green tangerine peel, 10g of dried orange peel and 6g of honey-fried licorice root.
The preparation method of the traditional Chinese medicine composition comprises the following specific steps: soaking the raw materials in water 2 times the total mass of the raw materials for 0.5-2 h, boiling with strong fire, decocting with slow fire for 0.5h, filtering the filtrate, adding water 2 times the total mass of the raw materials into the filter residue, decocting for 1 time by the same method, and mixing the filtrates.
Example 2
The embodiment of the invention provides a traditional Chinese medicine composition for treating cholelithiasis, which comprises the following raw material medicines in parts by weight: 18 parts of angelica sinensis, 18 parts of radix paeoniae alba, 9 parts of radix bupleuri, 18 parts of radix paeoniae rubra, 14 parts of endothelium corneum gigeriae galli, 9 parts of radix curcumae, 14 parts of desmodium, 27 parts of spora lygodii, 5 parts of rheum officinale, 27 parts of radix salviae miltiorrhizae, 9 parts of spina gleditsiae, 9 parts of szechwan chinaberry fruit, 9 parts of elecampane, 9 parts of pericarpium citri reticulatae viride, 9 parts of pericarpium citri reticulatae and 5 parts of radix glycyrrhizae preparata.
The preparation method of the traditional Chinese medicine composition comprises the following specific steps: soaking the raw materials in water 2 times the total mass of the raw materials for 0.5-2 h, boiling with strong fire, decocting with slow fire for 0.5h, filtering to obtain filtrate, adding water 2 times the total mass of the raw materials into the filter residue, decocting for 1 time by the same method, and mixing the filtrates.
Example 3
The embodiment of the invention provides a traditional Chinese medicine composition for treating cholelithiasis, which is prepared from the following raw material medicines in parts by weight: 22 parts of angelica, 22 parts of white peony root, 11 parts of radix bupleuri, 22 parts of red peony root, 16 parts of endothelium corneum gigeriae galli, 11 parts of radix curcumae, 16 parts of longhairy antenoron herb, 33 parts of spora lygodii, 7 parts of rhubarb, 33 parts of salvia miltiorrhiza, 11 parts of spina gleditsiae, 11 parts of szechwan chinaberry fruit, 11 parts of costustoot, 11 parts of green tangerine orange peel, 11 parts of dried tangerine peel and 7 parts of honey-fried licorice root.
The preparation method of the traditional Chinese medicine composition comprises the following specific steps: soaking the raw materials in water 2 times the total mass of the raw materials for 0.5-2 h, boiling with strong fire, decocting with slow fire for 1h, filtering the filtrate, adding water 4 times the total mass of the raw materials into the filter residue, decocting for 1 time by the same method, and mixing the filtrates.
Example 4
The embodiment of the invention provides a traditional Chinese medicine composition for treating cholelithiasis, which is prepared from the following raw material medicines in parts by weight: 19 parts of angelica, 19 parts of white peony root, 9 parts of radix bupleuri, 19 parts of red peony root, 14 parts of endothelium corneum gigeriae galli, 9 parts of radix curcumae, 14 parts of desmodium, 29 parts of spora lygodii, 5 parts of rheum officinale, 29 parts of salvia miltiorrhiza, 9 parts of spina gleditsiae, 9 parts of szechwan chinaberry fruit, 9 parts of elecampane, 9 parts of green tangerine peel, 9 parts of dried tangerine peel and 5 parts of honey-fried licorice root.
The preparation method of the traditional Chinese medicine composition comprises the following specific steps: soaking the raw materials in water 2 times the total mass of the raw materials for 0.5-2 h, boiling with strong fire, decocting with slow fire for 1h, filtering the filtrate, adding water 3 times the total mass of the raw materials into the filter residue, decocting for 1 time by the same method, and mixing the filtrates.
Example 5
The embodiment of the invention provides a traditional Chinese medicine composition for treating cholelithiasis, which is prepared from the following raw material medicines in parts by weight: 21 parts of angelica, 21 parts of white peony root, 11 parts of radix bupleuri, 21 parts of red peony root, 16 parts of endothelium corneum gigeriae galli, 11 parts of radix curcumae, 16 parts of longhairy antenoron herb, 31 parts of spora lygodii, 7 parts of rhubarb, 31 parts of salvia miltiorrhiza, 11 parts of spina gleditsiae, 11 parts of szechwan chinaberry fruit, 11 parts of costustoot, 11 parts of green tangerine orange peel, 11 parts of dried tangerine peel and 7 parts of honey-fried licorice root.
The preparation method of the traditional Chinese medicine composition comprises the following specific steps: soaking the raw materials in water 2 times the total mass of the raw materials for 0.5-2 h, boiling with strong fire, decocting with slow fire for 0.5h, filtering to obtain filtrate, adding water 2 times the total mass of the raw materials into the filter residue, decocting for 1 time by the same method, and mixing the filtrates.
Example 6
The embodiment of the invention provides a medicine for treating cholelithiasis, which comprises a traditional Chinese medicine composition and cowherb seed, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20g of angelica sinensis, 20g of white peony root, 10g of radix bupleuri, 20g of red peony root, 15g of endothelium corneum gigeriae galli, 10g of radix curcumae, 15g of desmodium, 30g of spora lygodii, 6g of rheum officinale, 30g of salvia miltiorrhiza, 10g of spina gleditsiae, 10g of szechwan Chinaberry fruit, 10g of costustoot, 10g of green tangerine peel, 10g of dried orange peel and 6g of honey-fried licorice root.
The use method of the medicine comprises the following specific steps: the traditional Chinese medicine composition is prepared into a water decoction according to the preparation method provided by the embodiment 1, 1 dose is taken 1 day in the morning and evening with empty stomach; the semen Vaccariae can be applied by sticking the pressed bean onto ear acupoints (liver, pancreas, gallbladder, spleen, duodenum, endocrine, sympathetic, subcortical, and auricular labyrinth root) with adhesive plaster, and massaging about 30s per acupoint for 5-6 times per day.
And (3) effect test:
test example 1
The clinical study of the medicine (Guishao Paishi decoction in combination with auricular point therapy) prepared in example 6 of the present invention on cholelithiasis due to damp-heat in liver and gallbladder is mainly tested.
The experimental process comprises the following steps:
1. acquiring experimental subject information: 100 patients with cholelithiasis due to damp-heat in liver and gallbladder in outpatient service of the hospital are selected and randomly divided into two groups, namely a control group and a treatment group, 50 patients respectively by adopting a random digital table method. Wherein, 1 patient in the control group withdraws midway due to economic reasons, and the other patients in the control group have good compliance and do not have adverse drug reactions or serious complications, and the treatment is completed according to the requirements. In the comparison of indexes such as gender, age, disease course and the like, the difference of the two groups of patients has no statistical significance and has balanced comparability.
2. Dosing and method:
the ursodeoxycholic acid tablet is administered orally for the control group 2 tablets/time, 1 time before sleep; 1 month is 1 course of treatment, and 3 courses of treatment are total.
The composition is administered with GUISHAO PAISHI decoction 1 day in the morning and evening with empty stomach; performing ear acupoint pressing intervention measure 6h after operation, and collecting 8 acupoints of liver, pancreas, gallbladder, spleen, duodenum, endocrine, sympathetic, subcortical, and auricle root; 1 month is 1 course of treatment, and 3 courses of treatment are total. The ear acupoint pressing intervention measure specifically comprises the following steps: probing the sensitive points of the patient's acupuncture points with an ear acupuncture point probe, sticking and pressing the probed acupuncture points with an ear acupuncture point patch after alcohol disinfection, informing the patient of a kneading method after sticking and pressing, and guiding the patient or family members to press regularly within 1h after sticking and pressing, and scoring for 1 time every 10 min. The number of times of pressing is 5-6 times per day after operation, the massage maintaining time of each acupuncture point is about 30s, and the patient can pause pressing when having a rest at night. The time of the kneading and pressing stop is that the gastrointestinal function of the patient is recovered to normal. The pressing force should be noticed in the sticking and pressing process, the finger abdomen is pressed lightly, the patient can find out local swelling pain, if the patient has allergy such as pruritus and blister, the ear acupoint pressing operation should be stopped immediately, and the treatment is aimed in time.
3. The treatment effect judgment standard and the observation index are as follows:
(1) Calculus ablation curative effect: under the examination of imaging, the change of the size and the number of the calculus is evaluated according to B-ultrasonography according to the clinical research guiding principle of treating the cholelithiasis by using the new traditional Chinese medicine, and the CT or MRCP result is referred to for the patient with poor color ultrasonography. Wherein, the cure (the imaging examination proves that the calculus shadow disappears), the obvious effect (the calculus size is reduced by more than 50 percent, or the calculus number is reduced by more than or equal to 1/3), the effectiveness (the ablation change exists, the size is reduced by less than 50 percent, the quantity is reduced by less than 1/3), the ineffectiveness (the calculus size is not changed, even the quantity is increased, the calculus ablation total effective rate = the cure rate + the obvious effective rate + the effective rate).
(2) The curative effect of the traditional Chinese medicine symptoms is as follows: the standard of the curative effect is evaluated according to the clinical research guiding principle of treating cholelithiasis by using new traditional Chinese medicines, the clinical research guiding principle of treating hypochondriac pain by using new traditional Chinese medicines and the report data of clinical research of the disease: clinical recovery, clinical symptoms and physical signs disappear, the symptom integral is reduced by more than or equal to 90 percent, and the imaging examination is normal; the effect is shown, the integral of symptoms and signs is reduced by more than or equal to 60 percent and less than 90 percent, and the imaging examination accords with the effect showing standard; the method is effective, the integral of symptoms and signs is reduced by more than or equal to 30% and less than 60%, and the imaging examination meets the effective standard; and (4) invalidation: the integral of symptoms and signs is reduced by n less than 30 percent, and the imaging examination is not improved.
(3) Scoring of traditional Chinese medicine syndromes: according to the guidance principle of clinical research on new Chinese medicines (2002 edition) of Ministry of health, a specific scoring method for the syndrome integrals of traditional Chinese medicine is formulated: adopting a semi-quantitative grade data scoring evaluation method, and according to 4 grades of no, light, medium and heavy, the main symptoms (hypochondriac pain, constipation, fever and dark urine) are counted for 0 minute, 2 minutes, 4 minutes and 6 minutes, and the secondary symptoms (physical weakness, dry and bitter mouth, nausea and vomiting and inappetence) are counted for 0 minute, 1 minute, 2 minutes and 3 minutes; the tongue and pulse are counted as 1 point or 0 point according to the presence or absence of pale red or red tongue, yellow and greasy tongue coating, wiry and rapid pulse or wiry and slippery pulse.
(4) Biochemical indexes of serum: changes of liver function (ALT, AST, TBIL, TBA and GGT) indexes before and after treatment of two groups of patients are observed. Liver function is used as both a therapeutic index and a safety index.
4. Statistics of resultsThe method comprises the following steps: and processing by SPSS 25 statistical analysis software. The measurement data is expressed by mean (x) +/-standard deviation(s), if the measurement data accords with normal distribution, t test is adopted; if the distribution is not in accordance with normal distribution, adopting rank sum test; the data of the counting is as follows 2 Checking; and rank sum inspection is adopted for the grade data. Verify level α =0.05.
5. Results and discussion:
(1) The ablation efficacy of the stones after the two groups of treatments is compared: compared with the imaging, the total effective rate of the treatment group is 82.00%, the gallstone can be obviously promoted to be discharged or reduced, the total effective rate of the control group is 57.14%, and the difference has statistical significance (P is less than 0.05). Specific results are shown in table 1.
TABLE 1 comparison of ablation effects of two groups of drugs
| Group of | Number of examples | Recovery method | Show effect | Is effective | Invalidation | Total effective rate |
| Treatment group | 50 | 7 | 20 | 14 | 9 | 82.00％ * |
| Control group | 49 | 3 | 18 | 7 | 21 | 57.14％ |
Note: * Representing two comparisons p < 0.05.
(2) The curative effect of two groups of patients is compared: compared with the curative effect of the traditional Chinese medicine symptoms, the clinical symptoms of patients in a treatment group are relieved, the total effective rate is 100 percent, the clinical symptoms of a control group are not completely improved, and the total effective rate is 87.76 percent, so that the treatment group has more obvious clinical symptom improvement (P is less than 0.05). The specific results are shown in Table 2.
TABLE 2 comparison of the therapeutic effects of two groups of patients
| Group of | Number of examples | Clinical recovery | Show effect | Is effective | Nullification | Total effective rate |
| Treatment group | 50 | 4 | 21 | 25 | 0 | 100.00％ * |
| Control group | 49 | 2 | 9 | 32 | 6 | 87.76％ |
Note: * Representing two comparisons p < 0.05.
(3) The traditional Chinese medicine syndrome integral comparison of two groups of patients: because the symptom integral is a discontinuous variable, the rank sum test is selected for statistical treatment, and the improvement conditions of the traditional Chinese medicine clinical symptoms of two groups of patients are quantitatively compared. The difference of the total integrals of the traditional Chinese medicine symptoms of the two groups of patients before treatment has no statistical significance (P is more than 0.05), the clinical symptoms of the two groups of patients after treatment are obviously improved, and the total integrals of the traditional Chinese medicine symptoms are reduced (P is less than 0.05); the treatment group is preferred (P < 0.05). Specific results are shown in Table 3.
Wherein, the score difference of the main symptoms of the two groups before treatment has no statistical significance (P is more than 0.05) through the rank sum test. After treatment, the clinical symptoms of the two groups are improved, the symptom score is reduced (P is less than 0.05), the symptoms of hypochondriac pain and constipation of the treatment group are improved more obviously, and the score is lower than that of a control group (P is less than 0.05). In the aspect of minor symptoms, results of two groups are compared by adopting a rank-sum test, the integral difference of each symptom of the two groups before treatment has no statistical significance (P is more than 0.05), and each minor symptom of the two groups is obviously improved after treatment (P is less than 0.05). In the aspect of tongue coating pulse condition, the results of two groups are compared by adopting rank sum test, the difference between the two groups before treatment has no statistical significance (P is more than 0.05), and the difference between the treated groups is higher than that of the control group after treatment, and the difference has statistical significance (P is less than 0.05).
TABLE 3 integral comparison of TCM syndromes of two groups of patients
Note: * After treatment, P < 0.05 for both groups; after treatment, P < 0.05 was compared between the two groups before treatment.
(4) Liver function comparison of two groups of patients: through t test, ALT, AST, TBIL, TBA and GGT of two groups of patients are reduced compared with those before treatment. Wherein, the TBA and the GGT of the treatment group are reduced more obviously (P is less than 0.05) compared with the control group, and the index difference of other groups has no statistical significance (P is more than 0.05). The specific results are shown in Table 4.
TABLE 4 hepatic function Change before and after two groups of treatments
Post-treatment, P < 0.05 for both groups; after treatment, P < 0.05 was compared between the two groups before treatment.
The results of multiple clinical observations show that the traditional Chinese medicine comprehensive therapy formed by the traditional Chinese medicine plus ear acupoint combination therapy has obvious curative effects on gallbladder shrinkage, gallbladder wall thinning, calculus discharge, primary and secondary symptom improvement and other aspects, can obviously improve the symptoms of patients without side effects such as liver and kidney damage and the like, and has better symptom improvement effect than a control group. The improvement of the symptoms of the patients can correspondingly increase the compliance of the patients and promote the treatment effect of the patients.
Test example 2
The medicine prepared in example 6 of the present invention (Guishao Paishi decoction in combination with auricular point therapy) was mainly tested for its effect of promoting postoperative recovery of patients with cholelithiasis.
The experimental process comprises the following steps:
1. acquiring experimental subject information: 103 patients with cholecystolithiasis collected in hepatobiliary, spleen and stomach department of the hospital are selected, all the objects to be brought in are treated by the laparoscopic cholecystolithiasis which is confirmed by imaging, and the objects are randomly divided into a control group and a treatment group by adopting a random digital table method. The celioscope gallbladder-protecting lithotomy operation is performed on both groups of patients.
2. Dosing and method:
after anus exhaust after operation, the ursodeoxycholic acid tablet is orally taken 2 tablets/time and 1 time before sleep; 1 month of treatment is 1 course of treatment, and 3 courses of treatment are total.
After anus exhaust after treatment group, 1 dose of Guishao calculus removing decoction is given for 1 day, and warm taken in the morning and evening on an empty stomach; performing ear acupoint pressing intervention measure 6h after operation, and collecting 8 acupoints of liver, pancreas, gallbladder, spleen, duodenum, endocrine, sympathetic, subcortical, and auricle root; 1 month of treatment is 1 course of treatment, and 3 courses of treatment are total. The ear acupoint pressing intervention measures are specifically as follows: probing the sensitive points of the patient's acupuncture points with an ear acupuncture point probe, sticking and pressing the probed acupuncture points with an ear acupuncture point patch after alcohol disinfection, informing the patient of a kneading method after sticking and pressing, and guiding the patient or family members to press regularly within 1h after sticking and pressing, and scoring for 1 time every 10 min. The number of times of pressing is 5-6 times per day after operation, the massage maintaining time of each acupuncture point is about 30s, and the patient can pause pressing when having a rest at night. The time of the kneading and pressing is the time when the gastrointestinal function of the patient is recovered to normal. The pressing force should be noticed in the pressing process, the finger abdomen is pressed lightly, the patient can find local distending pain, if the patient has allergy such as pruritus and blister, the ear acupoint pressing operation should be stopped immediately, and the treatment is performed in time.
3. The curative effect judgment standard and the observation index are as follows:
(1) Gastrointestinal function recovery observation: the gastrointestinal function recovery conditions of the two groups of patients are observed after operation, the time of first feeding, first anus exhaust and first defecation of the two groups of patients after operation is recorded, and the difference of the two groups of patients is compared.
(2) Pain perception scoring: the pain feeling of the patients before and after the operation is evaluated by a Visual Analogue Scale (VAS), the full score is 10, and the higher the self-rating score of the patients is, the higher the pain degree is.
(3) Two groups of adverse reactions occur: and observing and recording the adverse reaction occurrence conditions of the two groups of patients, and taking effective intervention measures to count the adverse reaction occurrence rates of the two groups of patients.
(4) Anxiety self-rating scale (SAS) and depression self-rating scale (SDS) scores and compliance: the postoperative psychological condition of the patients was evaluated by SAS and SDS, and 20 self-rating scales with 4 grades were used. The SAS standard score is more than or equal to 50 for anxiety, the SDS standard score is more than or equal to 53 for depression, the two scores are respectively divided into mild anxiety or depression 50-59, moderate anxiety or depression 60-69 and severe anxiety or depression more than 69. Patient compliance assessment patient compliance (number of prescribed treatments/number of actual treatments received x 100%) was calculated using a self-compliance questionnaire from the third affiliated hospital of the university of traditional Chinese medicine, henan, and statistical analysis of the compliance of both groups of patients was performed.
4. And (3) a result statistical method comprises the following steps: SPSS 21.0 statistical analysis software was used for processing. Measuring data by averaging
Expressed as ± standard deviation(s), using t test; the counting data adopts x 2 Checking; ridit analysis was used for the grade data. Inspection level α =0.05.
5. Results and discussion:
(1) Comparison of gastrointestinal function recovery after treatment in both groups: compared with the control group after treatment, the food intake time, the first air exhaust time and the first defecation time of the treatment group after treatment are all obviously reduced, and specific results are shown in a table 5.
TABLE 5 comparison of gastrointestinal function recovery after two groups of treatments
| Group of | Number of examples | Eating time (h) | Exhaust for the first time (h) | Defecation for the first time (h) |
| Treatment group | 52 | 27.8±6.1** | 22.1±3.4** | 32.5±1.9** |
| Control group | 51 | 49.3±7.4 | 43.7±4.5 | 58.3±9.2 |
Note: p < 0.01 compared to control group post treatment.
(2) Comparison of pain perception before and after two groups of operations: the difference between the pain sensation score levels before operation of the two groups is not statistically significant; compared with the control group after treatment, the pain feelings of the treatment group after 24h, 48h and 72h after the operation are obviously weakened, and the specific results are shown in the table 6.
TABLE 6 comparison of pain perception before and after operation in two groups
| Group of | Number of examples | Preoperative in | 24h after operation | 48h after operation | 72h after operation |
| Treatment group | 52 | 6.0±0.5 | 3.8±0.5** | 3.5±0.2** | 1.6±0.3** |
| Control group | 51 | 6.1±0.6 | 5.1±0.3** | 4.3±0.6** | 3.2±0.4** |
Note: p < 0.01 compared to control group post treatment.
(3) Two groups of adverse reactions were compared: the treatment group had abdominal distension 2 cases, vomiting 1 case, and other 2 cases, the incidence rate was 9.6%; the control group showed 7 cases of abdominal distension, 5 cases of vomiting, and 3 other cases with an incidence of 29.4%.Two groups are compared and tested by chi-square test 2 =6.45, P < 0.05, the difference being statistically significant.
(4) Comparison of psychological mood and compliance after treatment in both groups: compared with the control group after treatment, the SAS and SDS scores of the treatment group after treatment are reduced, the compliance is better, and the specific results are shown in a table 7.
TABLE 7 comparison of psychological mood and compliance after two groups of treatments
| Group of | Number of examples | SAS | SDS | Compliance |
| Treatment group | 52 | 34.2±7.3** | 31.8±6.3** | 86.1±10.5** |
| Control group | 51 | 51.7±11.4 | 55.9±8.7 | 76.4±12.6 |
Note: p < 0.01 compared to control after treatment.
The research shows that the traditional Chinese medicine comprehensive therapy formed by the traditional Chinese medicine plus ear acupoint combination therapy can obtain obvious curative effects on gallbladder shrinkage, gallbladder wall thinning, calculus discharge and the like, provides effective improvement effects on gastrointestinal function recovery, pain recovery, psychological anxiety recovery and the like in postoperative recovery of patients, and has less adverse reactions, and the compliance of the patients can be correspondingly improved by improving the symptoms of the patients. The medicine treatment method is proved to be integrally regulated through multiple targets and multiple ways, has the characteristics of quick response, short treatment course and good effect, can effectively control the development of cholelithiasis, and reduces the risks of acute abdominal diseases, tumors and the like caused by the cholelithiasis.
In conclusion, the present invention effectively overcomes the disadvantages of the prior art and has high industrial utilization value. The above-described embodiments are intended to illustrate the substance of the present invention, but are not intended to limit the scope of the present invention. It should be understood by those skilled in the art that various modifications and equivalents may be made to the present invention without departing from the spirit and scope of the invention.
Claims (8)
1. The traditional Chinese medicine composition for treating cholelithiasis is characterized by being prepared from the following raw material medicines in parts by weight: 20 parts of angelica sinensis, 20 parts of white peony root, 10 parts of radix bupleuri, 20 parts of red peony root, 15 parts of endothelium corneum gigeriae galli, 10 parts of radix curcumae, 15 parts of desmodium, 30 parts of spora lygodii, 6 parts of rheum officinale, 30 parts of salvia miltiorrhiza, 10 parts of spina gleditsiae, 10 parts of szechwan chinaberry fruit, 10 parts of elecampane, 10 parts of pericarpium citri reticulatae viride, 10 parts of dried tangerine peel and 6 parts of honey-fried licorice root, wherein the source of the raw materials is a traditional Chinese medicine or a traditional Chinese medicine extract equivalent to the crude drug amount of the traditional Chinese medicine.
2. The traditional Chinese medicine composition for treating cholelithiasis according to claim 1, wherein the traditional Chinese medicine composition is a water extract of bulk drugs.
3. The method for preparing a Chinese medicinal composition for treating cholelithiasis according to any one of claims 1 to 2, comprising the steps of: taking the raw materials, adding water with the mass 2-5 times of the total mass of the raw materials, soaking for 0.5-2 hours, decocting for 2 times, after boiling each time, boiling with strong fire, turning to mild fire for 0.5-1 hour, stopping fire, pouring out, filtering, and combining filtrates to obtain the traditional Chinese medicine composition.
4. The use of the Chinese medicinal composition for treating cholelithiasis as claimed in any one of claims 1 to 2 in the preparation of a medicament for treating cholelithiasis.
5. A pharmaceutical preparation for treating cholelithiasis, which is characterized in that the pharmaceutical preparation is prepared from the traditional Chinese medicine composition of any one of claims 1 to 2 and pharmaceutically acceptable auxiliary materials.
6. The pharmaceutical formulation for treating cholelithiasis according to claim 5, wherein the pharmaceutical formulation is in an oral dosage form.
7. The pharmaceutical preparation for treating cholelithiasis according to claim 6, wherein the pharmaceutical preparation is a water decoction, a honeyed pill, a water-honeyed pill, a granule, a capsule, a tablet, an oral liquid or a syrup.
8. A medicine for treating cholelithiasis is characterized by comprising an oral medicine and an auricular point patch, wherein the oral medicine is the pharmaceutical preparation of any one of claims 5 to 7, and the auricular point patch is a cowherb seed auricular point patch.
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| CN102824610A (en) * | 2012-09-17 | 2012-12-19 | 长治市郊区黄碾镇中心卫生院 | Medicine for treating chronic cholecystitis |
| CN104689236A (en) * | 2015-03-12 | 2015-06-10 | 赵伟 | Liver-gall stone-dissolving capsules |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102824610A (en) * | 2012-09-17 | 2012-12-19 | 长治市郊区黄碾镇中心卫生院 | Medicine for treating chronic cholecystitis |
| CN104689236A (en) * | 2015-03-12 | 2015-06-10 | 赵伟 | Liver-gall stone-dissolving capsules |
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| Title |
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| 归芍白芥汤加减配合微创手术治疗胆石症及并发症86例;彭惠娟等;《陕西中医》;20111231;第32卷(第1期);31-32 * |
| 柴芍疏肝利胆排石汤对胆结石合并慢性胆囊炎患者炎症、应激反应及胃肠功能的影响;娄静等;《中国实验方剂学杂志》;20191231;第25卷(第23期);86-92 * |
| 自拟金柴枳芩汤治疗胆石症60例;徐建坤等;《光明中医》;20080731;第23卷(第07期);961 * |
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