A traditional Chinese medicine composition for treating liver-gallbladder damp-heat syndrome after ERCP stone extraction, a preparation method, a preparation and a use

Abstract

The present application relates to the technical field of traditional Chinese medicine composition and its medical use, and particularly relates to a traditional Chinese medicine composition for treating liver and gallbladder damp-heat syndrome after ERCP stone extraction and a preparation method. The composition is composed of Bupleurum chinense, Radix Pseudostellariae, Radix Scrophulariae, Radix Glycyrrhizae, Rhizoma Zingiberis Recens, Radix et Rhizoma Rhei, Fructus Aurantii Immaturus, Poria cocos, Radix Paeoniae Alba, Lysimachia christinoides, Curcuma zedoary, Galla Rhois and Herba Rubi parvifolii. Each raw material is soaked and then decocted twice, and the decoction is filtered and combined to prepare an oral preparation. Clinical tests show that the composition can reduce the TCM syndrome score of patients with liver and gallbladder damp-heat syndrome after ERCP stone extraction, improve the clinical effective rate, and improve the SF-36 score and GIQLI score, and has good safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions and their medicinal uses, and in particular to a traditional Chinese medicine composition, preparation method, formulation and use for treating damp-heat syndrome of the liver and gallbladder after ERCP stone removal. Background Technology

[0002] Common bile duct stones are a common biliary tract disease in clinical practice. These stones can cause complications such as biliary obstruction, cholangitis, jaundice, and pancreatitis. Endoscopic retrograde cholangiopancreatography (ERCP) is characterized by minimal invasiveness, high stone removal efficiency, and rapid postoperative recovery, and has been used for the diagnosis and treatment of common bile duct stones. However, patients undergoing ERCP may still experience symptoms such as rib or upper abdominal distension and pain, bitter taste in the mouth, nausea, poor appetite, yellow urine, red tongue, and yellow greasy tongue coating. Some patients may also experience problems such as impaired bile excretion, slow recovery of digestive function, and reduced quality of life.

[0003] Traditional Chinese medicine typically categorizes the above symptoms under the categories of "hypochondriac pain," "jaundice," or "gallbladder distension." Their pathogenesis is related to damp-heat accumulation in the liver and gallbladder, impaired gallbladder function, and stagnation of Qi. Clinically, it can manifest as damp-heat syndrome of the liver and gallbladder. For these patients, after ERCP stone removal to relieve mechanical obstruction of the bile duct, how to further clear damp-heat in the liver and gallbladder, regulate liver and gallbladder Qi, improve gastrointestinal function, and promote postoperative recovery remains a problem that needs to be addressed in the adjuvant treatment of traditional Chinese medicine.

[0004] Several traditional Chinese medicine compositions for treating gallstones have been disclosed in the prior art. For example, patent document CN111166848A discloses a drug formula for treating gallstones, the raw materials of which include Bupleurum chinense, Pinellia ternata, Scutellaria baicalensis, Coptis chinensis, Curcuma longa, Gallus gallus domesticus gizzard lining, Lysimachia christinae, Lygodium japonicum, Angelica sinensis, Paeonia lactiflora, Citrus aurantium, Codonopsis pilosula, Rhus chinensis, and Glycyrrhiza uralensis. The main purpose of this composition is to clear heat and promote bile secretion, improve the symptoms of gallstone patients, and reduce the recurrence rate. However, its applicable target is general gallstone patients, and it is not specifically designed for the pathophysiological characteristics and postoperative recovery needs of patients with hepatobiliary damp-heat syndrome after ERCP stone removal.

[0005] For example, patent document CN102370951A discloses a traditional Chinese medicine composition for treating gallstones. Its ingredients include Lysimachia christinae, Akebia trifoliata, Lonicera japonica, Lygodium japonicum, Gallus gallus domesticus gizzard lining, Liquidambar formosana, Taraxacum mongolicum, Elephantopus scabra, Bupleurum chinense, Gardenia jasminoides, Corydalis yanhusuo, Curcuma longa, Citrus aurantium, Areca catechu, Glauber's salt, Rheum palmatum, Pinellia ternata, Citrus reticulata peel, Paeonia lactiflora, Melia toosendan, Artemisia capillaris, and Ziziphus jujuba. This composition contains various heat-clearing, dampness-removing, bile-promoting, stone-expelling, qi-regulating, and pain-relieving drugs, mainly for the treatment of gallstones themselves. However, it contains many herbs, and the formulation structure and proportions of each ingredient differ from the symptom management needs of patients after ERCP stone removal. Furthermore, it does not explicitly address the clinical application of liver and gallbladder damp-heat syndrome after ERCP stone removal.

[0006] While the aforementioned existing technologies provide traditional Chinese medicine (TCM) treatments for gallstones, they primarily focus on eliminating or expelling the stones themselves or improving general gallstone symptoms. They lack a TCM composition specifically designed for patients with hepatobiliary damp-heat syndrome after ERCP stone removal, aiming to clear damp-heat, soothe the liver and gallbladder, harmonize the spleen and stomach, and promote postoperative recovery, with clearly defined medicinal components and proportions. Therefore, it is necessary to provide a TCM composition suitable for hepatobiliary damp-heat syndrome after ERCP stone removal to improve patients' postoperative symptoms and quality of life. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine composition for improving liver and gallbladder damp-heat syndrome after ERCP stone removal. By rationally combining raw materials that clear damp-heat, soothe the liver and gallbladder, regulate qi and bowel, harmonize the stomach and relieve nausea, and invigorate qi and regulate the middle jiao, this composition can improve postoperative symptoms such as rib or upper abdominal distension and pain, bitter taste in the mouth, nausea, poor appetite, and yellow urine, promote the recovery of postoperative digestive function, and improve the patient's quality of life.

[0008] Firstly, in order to achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0009] A traditional Chinese medicine composition for treating damp-heat syndrome of the liver and gallbladder after ERCP stone removal, wherein the active ingredients of the traditional Chinese medicine composition are composed of the following raw materials in parts by weight: Bupleurum chinense 8-10 parts, Codonopsis pilosula 13-17 parts, Scutellaria baicalensis 8-10 parts, processed Pinellia ternata 8-10 parts, processed Glycyrrhiza uralensis 8-10 parts, dried ginger 5-7 parts, rhubarb 2-4 parts, stir-fried Citrus aurantium 8-10 parts, stir-fried Paeonia lactiflora 13-17 parts, Lysimachia christinae 13-17 parts, Curcuma longa 8-10 parts, chicken gizzard lining 8-10 parts, Lygodium japonicum 13-17 parts, and Liquidambar formosana 8-10 parts.

[0010] Preferably, the active ingredients of the traditional Chinese medicine composition are composed of the following raw materials in parts by weight: Bupleurum chinense 9 parts, Codonopsis pilosula 15 parts, Scutellaria baicalensis 9 parts, processed Pinellia ternata 9 parts, processed Glycyrrhiza uralensis 9 parts, dried ginger 6 parts, rhubarb 3 parts, stir-fried Citrus aurantium 9 parts, stir-fried Paeonia lactiflora 15 parts, Lysimachia christinae 15 parts, Curcuma longa 9 parts, chicken gizzard lining 9 parts, Lygodium japonicum 15 parts, and Liquidambar formosana 9 parts.

[0011] Preferably, the traditional Chinese medicine composition is a mixture of the raw materials of traditional Chinese medicine decoction pieces, or an aqueous extract obtained by water extraction of the raw materials.

[0012] Secondly, the present invention also provides a traditional Chinese medicine preparation for treating hepatobiliary damp-heat syndrome after ERCP stone removal, wherein the traditional Chinese medicine preparation is an oral preparation and includes the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0013] Preferably, the oral preparation is selected from decoctions, granules, capsules, tablets, pills, oral liquids, or mixtures.

[0014] Thirdly, the present invention also provides a method for preparing an aqueous decoction of the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0015] S1. Weigh out the following ingredients according to their respective weight proportions: Bupleurum chinense, Codonopsis pilosula, Scutellaria baicalensis, processed Pinellia ternata, prepared Glycyrrhiza uralensis, dried ginger, rhubarb, stir-fried Citrus aurantium, stir-fried Paeonia lactiflora, Lysimachia christinae, Curcuma longa, chicken gizzard lining, Lygodium japonicum and Liquidambar formosana, and mix them to obtain a mixture of raw materials.

[0016] S2, add water to the mixture of raw materials for soaking;

[0017] S3, the soaked raw materials and soaking liquid are decocted for the first time, filtered, and the first decoction and the first dregs are obtained respectively.

[0018] S4, add water to the first dregs for a second decoction, filter, and obtain the second decoction;

[0019] S5, combine the first decoction and the second decoction to obtain the aqueous decoction.

[0020] As a further improvement, in step S2, the mixture of active pharmaceutical ingredients is soaked until each active pharmaceutical ingredient is fully saturated.

[0021] As a further improvement, in steps S3 and S4, the simmering process includes first heating over high heat to a boil, and then continuing to simmer over low heat.

[0022] As a further improvement, step S5 also includes adjusting the combined first and second decoctions to 200 mL to obtain a daily dose of the decoction.

[0023] As a further improvement, after merging the first decoction and the second decoction, the combined decoction is further concentrated to obtain a Chinese medicine concentrate or Chinese medicine extract, and the Chinese medicine concentrate or Chinese medicine extract is mixed with pharmaceutically acceptable excipients to prepare granules, capsules, tablets, pills, oral liquids or mixtures.

[0024] Fourthly, the present invention also provides the use of the aforementioned traditional Chinese medicine composition or the aforementioned traditional Chinese medicine preparation in the preparation of a medicine for treating hepatobiliary damp-heat syndrome after ERCP stone removal.

[0025] Preferably, the drug is used to treat patients with common bile duct stones who develop damp-heat syndrome of the liver and gallbladder after ERCP stone removal.

[0026] Preferably, the ERCP stone removal procedure includes endoscopic retrograde cholangiopancreatography, duodenal papillary incision for stone removal, and nasobiliary drainage.

[0027] Preferably, the liver and gallbladder damp-heat syndrome has one or more of the following symptoms: hypochondriac distending pain, bitter taste in the mouth, nausea, vomiting, poor appetite, yellow urine, red tongue, and yellow and greasy tongue coating.

[0028] Preferably, the drug is used to reduce the TCM syndrome score of patients with damp-heat syndrome of the liver and gallbladder after ERCP stone removal, and / or to treat patients' gastrointestinal symptoms and quality of life.

[0029] Preferably, the drug is formulated as a unit dose suitable for use starting from the second day after ERCP stone removal, one dose daily, taken orally twice a day for 12 consecutive weeks.

[0030] This invention utilizes Bupleurum and Scutellaria to soothe the liver and clear heat; Lysimachia, Lygodium japonicum, Gallus gallus domesticus gizzard lining, Curcuma longa, and Liquidambar formosana to clear the liver and gallbladder, promote qi circulation, and eliminate stagnation; Rheum palmatum and stir-fried Citrus aurantium to purge heat from the bowels, promote qi circulation, and relieve fullness; processed Pinellia ternata and dried ginger to harmonize the stomach and relieve nausea; stir-fried Paeonia lactiflora to soften the liver and relieve spasms; and Codonopsis pilosula and prepared Glycyrrhiza uralensis to tonify qi, regulate the middle jiao, and harmonize the other herbs. The synergistic effect of these ingredients ensures that the treatment clears damp-heat without excessively damaging the spleen and stomach, and soothes the liver and bowels while also supporting postoperative recovery of vital energy. This approach is suitable for patients with damp-heat syndrome of the liver and gallbladder after ERCP stone removal. Clinical application can improve symptoms such as rib or upper abdominal distension and pain, bitter taste in the mouth, nausea, vomiting, poor appetite, yellow urine, red tongue, and yellow greasy tongue coating, reduce TCM syndrome scores, promote appetite and gastrointestinal function recovery, and improve patients' health and quality of life. Meanwhile, this invention clearly defines the composition and dosage relationship of each active pharmaceutical ingredient, ensuring stable prescription composition and simple preparation method. It can be made into decoctions and other oral preparations, which helps to ensure the consistency of composition of different batches of preparations and the reproducibility of clinical applications. Detailed Implementation

[0031] The present invention will be further illustrated below with reference to embodiments and comparative examples. It should be understood that the following embodiments are for illustrative purposes only and are not intended to limit the scope of protection of the present invention. Without departing from the concept of the present invention, those skilled in the art can make conventional adjustments to the specific batches of the active pharmaceutical ingredient, the decoction equipment, the amount of water added, and the pharmaceutical excipients.

[0032] I. Terminology Explanation

[0033] The "ERCP stone removal procedure" referred to in this invention refers to endoscopic retrograde cholangiopancreatography (ERCP) followed by one or more procedures, including duodenal papilla incision, balloon dilation, basket stone removal, or balloon stone removal, based on the cholangiography results. Preferably, after ERCP stone removal, a nasobiliary drainage tube is inserted endoscopically for drainage, i.e., endoscopic nasobiliary drainage is performed simultaneously.

[0034] The "post-ERCP stone removal liver and gallbladder damp-heat syndrome" referred to in this invention refers to the condition in patients with common bile duct stones who, after ERCP stone removal, still exhibit liver and gallbladder damp-heat syndrome according to Traditional Chinese Medicine (TCM) diagnosis. Its primary symptoms include one or more of the following: right hypochondriac or upper abdominal pain, abdominal distension, jaundice, chills and fever, loose stools or constipation, and dark yellow urine; secondary symptoms include one or more of the following: bitter taste in the mouth, sticky mouth, dry mouth, poor appetite, nausea and vomiting, fatigue, and heaviness in the limbs; the tongue and pulse may show a red tongue, a yellow and greasy tongue coating, and a wiry, slippery, and rapid pulse. In actual diagnosis, at least two primary symptoms and one or two secondary symptoms are required, combined with tongue appearance, pulse examination, and the Western medical diagnosis of common bile duct stones.

[0035] In this invention, the names of the raw materials are determined according to the common names of traditional Chinese medicine decoction pieces. Specifically, processed Pinellia ternata refers to Pinellia ternata decoction pieces that have been processed according to law and meet medicinal requirements; stir-fried Citrus aurantium refers to Citrus aurantium decoction pieces stir-fried with wheat bran; stir-fried Paeonia lactiflora refers to Paeonia lactiflora decoction pieces that have been stir-fried; roasted Glycyrrhiza uralensis refers to Glycyrrhiza uralensis decoction pieces that have been honey-roasted; chicken gizzard lining refers to cleaned or stir-fried chicken gizzard lining; and Lygodium japonicum can be placed in a gauze bag and decocted. All raw materials should comply with the current pharmacopoeia or relevant quality standards for traditional Chinese medicine decoction pieces.

[0036] II. Formulation Principles

[0037] This invention relates to a traditional Chinese medicine composition derived from Da Chai Hu Tang (Major Bupleurum Decoction) combined with four types of metal-based drugs. Bupleurum (Chai Hu) soothes the liver, relieves stagnation, and regulates the Qi of the liver and gallbladder; Scutellaria (Huang Qin) clears heat and dries dampness. Together, they harmonize the Shao Yang (Lesser Yang) and clear damp-heat from the liver and gallbladder. Prepared Pinellia (Zhi Ban Xia) harmonizes the stomach, descends rebellious Qi, dries dampness, and resolves phlegm; Rhubarb (Da Huang) purges heat, unblocks the bowels, and promotes the elimination of stagnation and turbidity; and stir-fried Citrus aurantium (Zhi Ci) regulates Qi and eliminates stagnation. The combination of these three ingredients is beneficial for the recovery of postoperative gallbladder function and gastrointestinal motility

[0038] The combination of Lysimachia christinae, Lygodium japonicum, chicken gizzard lining, and Curcuma longa works synergistically to clear heat and dampness, soothe the liver and gallbladder, eliminate stagnation and promote urination and expel stones; Luffa cylindrica is used to unblock the meridians, promote urination, and regulate Qi. Fried Paeonia lactiflora softens the liver and relieves spasms, working with Bupleurum chinense to soothe the liver without harming liver Yin, and also helps improve pain in the hypochondriac region. Codonopsis pilosula, prepared licorice root, and dried ginger are used to invigorate Qi and strengthen the spleen, warm the middle Jiao and harmonize the stomach, and harmonize the other herbs, ensuring that the entire formula, while clearing heat and dampness, regulating Qi and relieving constipation, also considers the recovery of spleen and stomach function and vital energy after ERCP, reducing the irritation of bitter and cold purgative drugs on the gastrointestinal tract.

[0039] This invention does not simply combine the raw materials, but rather, based on the characteristics of "mechanical obstruction has been relieved after ERCP stone removal, but damp heat has not been completely eliminated, the gallbladder and intestines have not recovered, and the spleen and stomach are relatively weak," it combines the effects of clearing damp heat, soothing the liver and gallbladder, regulating qi and intestines, harmonizing the stomach and relieving nausea, and tonifying qi and regulating the middle jiao, in order to improve the postoperative liver and gallbladder damp heat syndrome and the patient's quality of life.

[0040] III. General Preparation Method

[0041] The herbal composition of this invention can be prepared into a decoction according to the following method:

[0042] Weigh out the following ingredients according to the prescription: Bupleurum, Codonopsis, Scutellaria, Prepared Pinellia, Prepared Licorice, Dried Ginger, Rhubarb, Fried Immature Bitter Orange, Fried White Peony Root, Lysimachia, Curcuma, Chicken Gizzard Membrane, Lygodium japonicum, and Liquidambar formosana. Remove any visible foreign matter and mix them to obtain a mixture of raw materials. Place the Lygodium japonicum in a medicinal gauze bag and put it in a decoction container along with the other raw materials.

[0043] Add drinking water or purified water to the decoction container to fully saturate the raw materials. As an optional method, the initial water volume is 6 to 10 times the total mass of the raw materials, and the soaking time is 20 to 40 minutes; preferably, the initial water volume is 8 times the total mass of the raw materials, and the soaking time is 30 minutes.

[0044] After soaking, heat over high heat to a boil, then reduce to a simmer for the first decoction. The first decoction should last 25–35 minutes after boiling, preferably 30 minutes. After decoction, filter through a strainer or filter cloth to collect the first decoction and the dregs separately.

[0045] Add 4 to 8 times the total mass of the raw materials to the dregs, preferably 6 times the total mass of the raw materials. Heat over high heat until boiling, then reduce to low heat for a second decoction. The second decoction can be 15 to 25 minutes after boiling, preferably 20 minutes. Filter to obtain the second decoction.

[0046] Combine the first and second decoctions, and concentrate or add water at a temperature not exceeding normal boiling point. Adjust the combined decoction for each daily dose to 200 mL, and divide into two portions of 100 mL each. Take one dose daily, twice a day, in the morning and evening, while warm.

[0047] When preparing granules, capsules, tablets, pills, oral liquids, or mixtures, the combined decoction can be concentrated under reduced pressure to obtain a concentrated Chinese medicine solution or extract. The concentrated solution or extract is then dried and pulverized to obtain a dry powder, which is then mixed with dextrin, microcrystalline cellulose, lactose, starch, sodium carboxymethyl starch, magnesium stearate, or other pharmaceutically acceptable excipients, and formulated into the corresponding oral preparations according to conventional pharmaceutical processes. Each oral preparation is packaged according to the equivalent amount of raw drug, ensuring that the daily dose contains the same amount of Chinese medicine extract as the daily dose of the corresponding prescription's raw material.

[0048] IV. Prescription and Preparation Examples

[0049] Example 1: Preferred prescription decoction

[0050] Weigh out 9g of Bupleurum chinense, 15g of Codonopsis pilosula, 9g of Scutellaria baicalensis, 9g of processed Pinellia ternata, 9g of roasted Glycyrrhiza uralensis, 6g of dried ginger, 3g of rhubarb, 9g of stir-fried Citrus aurantium, 15g of stir-fried Paeonia lactiflora, 15g of Lysimachia christinae, 9g of Curcuma longa, 9g of chicken gizzard lining, 15g of Lygodium japonicum, and 9g of Liquidambar formosana.

[0051] After decocting the Lygodium japonicum, mix it with the remaining raw materials and add an appropriate amount of water to soak the raw materials until they are fully moistened. First, bring it to a boil over high heat, then simmer over low heat for the first decoction, and filter to obtain the first decoction. Add water to the dregs for a second decoction, and filter to obtain the second decoction. Combine the two decoctions and adjust the volume to 200mL, then divide them into two 100mL packets to obtain a daily dose of traditional Chinese medicine decoction.

[0052] When the resulting decoction is used for patients with common bile duct stones due to damp-heat syndrome after ERCP stone removal and nasobiliary drainage, it should be taken starting from the second day after surgery, one dose daily, 100mL each time in the morning and evening, for 12 consecutive weeks. This example is the preferred prescription used in the following randomized controlled clinical trial.

[0053] Example 2: Decoction with lower limit of prescription range

[0054] Weigh out 8g of Bupleurum chinense, 13g of Codonopsis pilosula, 8g of Scutellaria baicalensis, 8g of processed Pinellia ternata, 8g of roasted Glycyrrhiza uralensis, 5g of dried ginger, 2g of rhubarb, 8g of stir-fried Citrus aurantium, 13g of stir-fried Paeonia lactiflora, 13g of Lysimachia christinae, 8g of Curcuma longa, 8g of chicken gizzard lining, 13g of Lygodium japonicum, and 8g of Liquidambar formosana.

[0055] The preparation method of Example 1 was followed, including soaking, first decoction, second decoction, and filtration. The two decoctions were combined and adjusted to 200 mL, then packaged into two bags. This example demonstrates that the lower limit ratio of each active ingredient as defined in the claims can be used to prepare a decoction using the same decoction steps as the preferred prescription, without the problem of being unable to soak, decoct, filter, or package due to a reduction in the total amount of medicinal materials.

[0056] Example 3: Decoction with upper limit of prescription range

[0057] Weigh out 10g of Bupleurum chinense, 17g of Codonopsis pilosula, 10g of Scutellaria baicalensis, 10g of processed Pinellia ternata, 10g of prepared Glycyrrhiza uralensis, 7g of dried ginger, 4g of rhubarb, 10g of stir-fried Citrus aurantium, 17g of stir-fried Paeonia lactiflora, 17g of Lysimachia christinae, 10g of Curcuma longa, 10g of chicken gizzard lining, 17g of Lygodium japonicum, and 10g of Liquidambar formosana.

[0058] The preparation was carried out according to the preparation method of Example 1. During the soaking process, the initial water volume was appropriately increased based on the total volume of the raw materials, ensuring that all raw materials were fully soaked. After two decoctions, the decoctions were combined and adjusted to 200 mL, then packaged into two bags. This example demonstrates that the upper limit ratio of each raw material as defined in the claims can be used to prepare a decoction using the same process.

[0059] Example 4: Traditional Chinese Medicine Granules

[0060] Weigh out each raw material according to 10 times the amount of the prescription in Example 1, and decoct and filter twice according to general preparation methods. Combine the decoctions and concentrate under reduced pressure at a temperature not exceeding 70°C to obtain a concentrated Chinese medicine solution; continue concentration to obtain a Chinese medicine extract, or vacuum dry the Chinese medicine extract to obtain a dry extract. Crush the obtained dry extract and sieve it, add pharmaceutically acceptable dextrin or other granulation excipients, mix evenly, and then perform wet granulation or dry granulation. Dry and granulate, and package according to a standard of 150g of raw material per day to obtain Chinese medicine granules. Take with warm water, one dose per day, divided into two doses, morning and evening.

[0061] Example 5: Capsules or tablets

[0062] The dry extract powder was prepared according to the method of Example 4. For capsule preparation, the dry extract powder was mixed with microcrystalline cellulose, starch, or other fillers, granulated, or directly mixed and then filled into capsules. For tablet preparation, the dry extract powder was mixed with fillers, disintegrants, and lubricants, granulated, dried, and compressed to obtain tablets. The daily dosage for both capsules and tablets was determined according to the equivalent amount of the raw drug, such that the herbal extract contained in one daily dose was equivalent to the extract obtained by water extraction of 150g of the raw drug described in Example 1.

[0063] V. Clinical Trial Examples

[0064] 1 Research Data

[0065] 1.1 Source of Cases

[0066] This study selected patients with hepatobiliary damp-heat syndrome and common bile duct stones who underwent ERCP treatment at the inpatient department of Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine from February 2024 to February 2025 as the subjects of observation.

[0067] 1.2 Diagnostic Criteria

[0068] 1.2.1 Western Medicine Diagnostic Criteria

[0069] According to the diagnostic criteria for common bile duct stones in the ERCP Diagnosis and Treatment Guidelines (2018 Edition):

[0070] (1) The diagnosis of common bile duct stones is confirmed or highly suspected by transabdominal ultrasound, abdominal X-ray, computed tomography (CT) or magnetic resonance cholangiopancreatography (MRCP).

[0071] (2) Clinical symptoms include upper abdominal discomfort, such as bloating or stabbing pain; if there is bile duct obstruction before surgery, there will be yellowing of the skin and sclera, yellow urine, and even skin pain and itching, high fever and chills.

[0072] (3) Laboratory tests: abnormal liver function; abnormal serum amylase; in cases of biliary tract infection, there may be an increase in infection markers such as white blood cells, neutrophils, and procalcitonin.

[0073] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0074] This condition conforms to the syndrome of damp-heat in the liver and gallbladder. The diagnostic criteria for this syndrome are based on the "Consensus Opinions on the Diagnosis and Treatment of Cholelithiasis with Integrated Traditional Chinese and Western Medicine (2017)".

[0075] (1) Main symptoms: ① Pain in the right hypochondrium or upper abdomen, which may be tender to the touch and may radiate to the right shoulder ② Yellowing of the skin and eyes ③ Chills and fever ④ Loose stools or constipation ⑤ Yellow urine.

[0076] (2) Secondary symptoms: ① Bitter or sticky taste in the mouth or dry mouth ② Abdominal distension with poor appetite ③ Nausea and vomiting ④ General weakness and heaviness in the limbs. Tongue and pulse: Red tongue with yellow and greasy coating, wiry, slippery and rapid pulse.

[0077] Two primary symptoms plus one or two secondary symptoms can be used to diagnose damp-heat syndrome of the liver and gallbladder. For those with mild or no symptoms, refer to tongue and pulse examinations and physical and chemical tests.

[0078] 1.3 Inclusion Criteria

[0079] (1) Those who meet the Western medical diagnosis criteria for choledocholithiasis and the TCM diagnosis criteria for cholelithiasis with damp-heat syndrome of liver and gallbladder and are scheduled to undergo ERCP surgery.

[0080] (2) Patients aged 18 to 85 years, regardless of gender;

[0081] (3) Obtain informed consent and related notifications;

[0082] (4) Good compliance.

[0083] 1.4 Exclusion Criteria

[0084] (1) Patients with acute suppurative cholangitis or severe pancreatitis before surgery;

[0085] (2) Patients diagnosed with acute cholecystitis, acute pancreatitis, pancreatic cancer, decompensated cirrhosis, liver failure, gallbladder cancer, or those with severe cardiopulmonary diseases, hematopoietic system diseases, or mental illness;

[0086] (3) Pregnant or lactating women;

[0087] (4) Individuals who have participated in other clinical trials within 6 months prior to the start of this trial;

[0088] (5) Those who do not accept traditional Chinese medicine or cannot cooperate with research, etc.

[0089] (6) Other researchers who believe that they should not be included.

[0090] 1.5 Exclusion Criteria

[0091] (1) Patients diagnosed with common bile duct stones before surgery, but diagnosed with non-common bile duct stones after surgery;

[0092] (2) Those who cannot tolerate traditional Chinese medicine or have poor medication adherence;

[0093] (3) Patients who develop serious postoperative complications such as gastrointestinal bleeding, acute severe pancreatitis, or toxemia;

[0094] (4) Those with incomplete clinical data.

[0095] 1.6 Standards and Treatment for Shedding

[0096] 1.6.1 Criteria for detachment

[0097] All patients enrolled in the study have the right to withdraw from the clinical trial at any time, regardless of when or why they withdraw. Failure to complete the full clinical trial observation period constitutes a dropout case, including:

[0098] (1) The subjects did not cooperate with the trial;

[0099] (2) Subjects withdraw from the study voluntarily due to serious adverse reactions or other special illnesses;

[0100] (3) The subject took other drugs that could affect the trial during the study;

[0101] (4) The subject research data is incomplete.

[0102] 1.6.2 Management of Dropout Cases

[0103] (1) When a subject falls off, the researcher must write down the reason for the fall off, contact the patient as much as possible, complete the assessment items that can be completed, fill in the retention treatment record form, and record the last observation time as much as possible;

[0104] (2) For research cases that drop out due to adverse reactions, researchers should take appropriate treatment measures according to the actual situation;

[0105] (3) All relevant research data must be properly preserved.

[0106] 2 Research Methods

[0107] 2.1 Sample Size Estimation

[0108] The STATBOX clinical trial statistical network superiority test was used to estimate the sample size of the study. Based on the observation indicators and statistical test requirements, the primary efficacy endpoint was estimated as the treatment effectiveness rate. According to previous research data, the overall effective rate of traditional Chinese medicine treatment was 93.3%, and the overall effective rate of Western medicine treatment was 80.0%, i.e., P1=0.933, P2=0.80. Let α=0.025, 1-β=0.90, and Δ (critical value)=-0.15, then n1=n2=30. Considering a 10% dropout rate, n1=n2=34 participants were rounded up, resulting in a total of 68 participants to be included.

[0109] 2.2 Grouping Method

[0110] Complete randomization was used for grouping. Using Excel software, a random allocation table was generated according to the number of included cases, listing the treatment allocations corresponding to serial numbers 001-068 (i.e., the overall random code table). The corresponding numbers were assigned according to the order of the patients' visits, and the order of the numbers could not be changed arbitrarily. The patients were divided into a treatment group (common bile duct stone prescription group) of 34 cases and a control group (ursodeoxycholic acid group).

[0111] 2.3 Intervention Measures

[0112] 2.3.1 ERCP Operation Procedure

[0113] Preoperatively, patients routinely fast for at least 8 hours and receive routine fluid resuscitation. Thirty minutes before surgery, 10 ml of dimethyl silicone oil is administered orally. Fifteen minutes before surgery, general anesthesia is administered based on the anesthesiologist's assessment. During the procedure, the patient is assisted to maintain a left lateral decubitus position, and the electronic duodenoscope is used to access the descending duodenum. After straightening the duodenoscope and carefully locating and observing the papilla, selective cannulation is employed. Once the cannula successfully enters the pancreaticobiliary duct, cholangiopancreatography (CPP) is performed. If common bile duct stones are suspected after successful CP, duodenal papilla incision and balloon dilation are performed depending on the intraoperative findings. Stone retrieval methods may include using a stone retrieval basket and a balloon dilation device.

[0114] After successful ERCP stone removal, the imaging results showed no residual stones. Under endoscopic guidance, the nasobiliary tube was inserted into the bile duct through the duodenal papilla. The specific depth was determined based on the imaging results. The nasobiliary tube was led out of the body through the patient's duodenum and esophagus and one nostril, and the end was connected to a negative pressure drainage bag for drainage.

[0115] After the patient returns to the ward, their vital signs should be closely monitored, and any postoperative clinical manifestations such as abdominal pain, vomiting, or fever should be observed. Depending on the actual situation, anti-infection, pancreatic enzyme secretion inhibition, and fluid replacement therapy to maintain internal homeostasis should be administered.

[0116] 2.3.2 Treatment Plan

[0117] Both groups received routine Western medicine treatment, including: preoperative fasting, ERCP combined with endoscopic lithotripsy and endoscopic nasobiliary drainage (ENBD), routine postoperative care, anti-infection treatment with cephalosporins and ornidazole, and fluid replacement to replenish electrolytes and energy. Postoperatively, patients were routinely fasted for 24 hours (without medication restrictions), and were given liquid or semi-liquid diets or resumed normal diets as needed. If the pain was severe, symptomatic analgesia was given.

[0118] (1) Treatment regimen for the control group:

[0119] In addition to standard basic treatment, Ursodeoxycholic acid capsules (imported drug registration standard: JX20140243) were administered orally at a dose of 250 mg twice daily for 12 weeks. Ursodeoxycholic acid treatment began on the second day after surgery.

[0120] (2) Treatment regimen for the treatment group:

[0121] A formula for treating bile duct stones: Bupleurum chinense 9g, Codonopsis pilosula 15g, Scutellaria baicalensis 9g, processed Pinellia ternata 9g, prepared Glycyrrhiza uralensis 9g, dried ginger 6g, rhubarb 3g, stir-fried Citrus aurantium 9g, stir-fried Paeonia lactiflora 15g, Lysimachia christinae 15g, Curcuma longa 9g, chicken gizzard lining 9g, Lygodium japonicum 15g, Liquidambar formosana 9g.

[0122] Drug source: Purchased and prepared by Shuguang Hospital.

[0123] Dosage: One dose daily, taken with 200ml of warm water, divided into two doses, morning and evening, for a course of 12 weeks. Traditional Chinese medicine treatment begins on the second day after surgery.

[0124] 2.4 Observation and Evaluation Indicators

[0125] 2.4.1 Traditional Chinese Medicine Symptom Scoring Table

[0126] Based on the "Consensus Opinion on the Diagnosis and Treatment of Cholelithiasis with Integrated Traditional Chinese and Western Medicine (2017)," a scoring scale for major and minor symptoms in Traditional Chinese Medicine (TCM) was developed. Major symptoms included appetite, abdominal distension, hypochondriac distension and pain, jaundice of the face and skin, and tongue coating. Accompanying symptoms included bitter or sticky mouth, dry mouth, nausea and vomiting, fatigue, heaviness in the limbs, dark yellow urine, loose stools, and constipation. According to the severity of symptoms, appetite and abdominal distension were divided into four levels, scored 0, 2, 4, and 6 points respectively; hypochondriac distension and pain were divided into five levels, scored 0, 2, 4, 6, and 8 points respectively; and jaundice of the face and skin and tongue coating were divided into three levels, scored 0, 2, and 4 points respectively. Accompanying symptoms were divided into five levels according to severity: none, mild, moderate, relatively severe, and very severe, scored 0, 1, 2, 3, and 4 points respectively. The total score for the TCM syndrome was calculated by summing the scores of major and minor symptoms; a lower score indicated milder symptoms. For detailed scoring, please refer to the appendix.

[0127] 2.4.2 Health Survey Short Form (SF-36) Scoring Sheet

[0128] The Short Form Health Survey (SF-36) was used to assess patients' physical and mental health across eight dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Physical health was assessed based on the first four dimensions, and mental health on the latter four. The total score determined overall health status. Higher scores indicated better health. See the appendix for details.

[0129] 2.4.3 Gastrointestinal Quality of Life Index (GIQ-LI) Scoring Scale

[0130] The Gastrointestinal Quality of Life Index (GIQLI) is a standardized tool for assessing the quality of life of patients with gastrointestinal diseases. The scoring scale consists of 36 questions, covering four dimensions: digestive symptoms, psychological state, physical functioning, and social functioning. Each question is graded on a 5-point scale (from "Never" to "All the time") based on symptom frequency or severity, corresponding to a score of 0-4. The total score ranges from 0-144, with higher scores indicating better quality of life. See the appendix for details.

[0131] 2.4.4 General Baseline Data

[0132] General information collected upon enrollment included: gender, age, body mass index, and routine preoperative examinations, including complete blood count, C-reactive protein (CRP), liver and kidney function tests, and amylase (AMS).

[0133] 2.5 Efficacy Assessment

[0134] The clinical efficacy evaluation criteria are as follows: Efficacy Index = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%; Effective rate = (Number of clinically cured cases + Number of cases with significant improvement + Number of effective cases) / Total number of cases × 100%

[0135] 2.6 Safety Observation

[0136] (1) Observe the general condition, vital signs, blood and urine routine tests, and changes in liver and kidney function of the two groups of patients before and after treatment.

[0137] (2) Observe whether the patient experiences adverse drug reactions during the trial. Adverse drug reactions include dizziness, palpitations, chest tightness, rash, etc.

[0138] (3) Observe whether the patient experiences ERCP-related adverse reactions during the trial, mainly referring to ERCP complications such as pancreatitis, bleeding, perforation, and infection after ERCP. The postoperative complication assessment scale is used for scoring, and the four dimensions of pancreatitis (2-12 hours after the operation), infection (8 hours after the operation), pain (VAS), and occult blood test are divided into four levels: none, mild, moderate, and severe, with scores of 0, 1, 2, and 3 respectively. A total score of less than or equal to 3 indicates no postoperative ERCP complications, 4 to 8 indicates postoperative ERCP complications, and 9 to 12 indicates severe postoperative complications.

[0139] If the above situation occurs, carefully analyze the cause and record the treatment process and the patient's outcome, while also conducting a safety assessment:

[0140] Grade 0: Safe; no adverse reactions occurred during treatment.

[0141] Grade 1: Relatively safe; mild adverse reactions occurred during treatment, requiring no treatment, and the trial can continue. Grade 2: Moderate adverse reactions occurred during treatment, but the trial can still be completed after intervention.

[0142] Grade 3: The adverse reaction is too severe to continue the trial.

[0143] 2.7 Statistical Analysis

[0144] Data analysis was performed using SPSS 25.0 and GraphPad Prism 8.0. Quantitative data were expressed as mean ± standard deviation if they followed a normal distribution; otherwise, they were expressed as median and interquartile range. Categorical data were expressed as frequency and percentage. For quantitative data that followed a normal distribution, an independent samples t-test was used; if the difference before and after treatment was normally distributed, a paired samples t-test was used for within-group comparisons. For quantitative data that did not follow a normal distribution, the Mann-Whitney U test was used for between-group comparisons, and the Wilcoxon signed-rank test was used for within-group comparisons. Chi-square test or Fisher's exact test was used to analyze between-group differences in categorical variables. A p-value < 0.05 was considered statistically significant.

[0145] 3. Research Results

[0146] 3.1 Case Completion Status

[0147] This clinical study included 68 patients with hepatobiliary damp-heat syndrome and common bile duct stones who met the inclusion criteria. There were 34 patients in the control group and 34 patients in the treatment group, for a total of 68 patients who completed the trial.

[0148] 3.2 Baseline Data Comparison

[0149] 3.2.1 Gender Composition

[0150] The control group consisted of 17 male patients (50%) and 17 female patients (50%), while the treatment group consisted of 13 male patients (38.24%) and 21 female patients (61.76%). The chi-square value was determined using a chi-square test. The p-value was 0.954, P=0.329, P>0.05, therefore there was no statistically significant difference in gender distribution between the control group and the treatment group. The two groups were evenly distributed in terms of gender, making them comparable for future studies. See Table 1.

[0151] Table 1. Gender distribution of the two groups of patients (cases)

[0152] 3.1.2 Age and BMI

[0153] The age and body mass index (BMI) of the two groups of patients at admission were statistically calculated to conform to a normal distribution and homogeneity of variance. Therefore, a t-test was used for analysis. The calculated p-values ​​for age were 0.960 and for BMI were 0.944, both greater than 0.05. There were no significant differences in the distribution of age and BMI between the two groups at admission, making them comparable for subsequent studies. The distribution of overweight (BMI ≥ 25) and age groups in both groups was not statistically significant, as indicated by chi-square tests (p-values ​​> 0.05). Therefore, they are comparable for subsequent studies. See Tables 2 and 3.

[0154] Table 2. Age and body mass index (±S) of the two groups of patients.

[0155]

[0156] Table 3. Overweight status and age distribution of the two groups of patients.

[0157] 3.2.3 Preoperative blood routine, CRP, liver and kidney function, amylase

[0158] Preoperative RBC, WBC, Hb, and N% in both groups of patients followed a normal distribution. A t-test showed no statistically significant differences (P > 0.05), indicating baseline comparability. CRP, TB, IB, DB, AST, γ-GT, ALP, BUN, and AMS did not follow a normal distribution. A Mann-Whitney U test showed no statistically significant differences (P > 0.05), indicating baseline comparability. Overall baseline comparability does not affect the comparability of subsequent studies. See Tables 4 and 5.

[0159] Table 4. Serum RBC, WBC, Hb, and N% expression levels in the two groups of patients before treatment (mean ± standard deviation)

[0160]

[0161] Table 5. Serum liver and kidney function, CRP, and AMS expression levels in the two groups of patients before treatment [M(P25,P75)]

[0162]

[0163] 3.3 Clinical observation of treatment efficacy

[0164] 3.3.1 Results of Traditional Chinese Medicine Syndrome Scores

[0165] 3.3.1.1 Comparison of TCM symptom scores before and after treatment

[0166] Before treatment, the scores of the main symptoms in the two groups showed no statistically significant difference (P>0.05), indicating comparability. After treatment, the tongue coating in the control group improved compared to before treatment (P=0.002), indicating that the tongue coating symptoms in the control group improved. In the treatment group, the tongue coating symptoms improved significantly (P<0.001). Both groups showed significant improvement in appetite, abdominal distension, hypochondriac pain, and jaundice of the face and skin before and after treatment (P<0.001). After treatment, the treatment group showed better improvement in appetite, abdominal distension, hypochondriac pain, and jaundice of the face and skin than the control group (P<0.05), with significant improvement in abdominal distension (P<0.001), as shown in Table 6.

[0167] Table 6. Comparison of main symptom scores before and after treatment in the two groups [M(P25,P75)]

[0168]

[0169] Note: *P < 0.001 compared to pre-treatment levels in the same group. #P = 0.002

[0170] 3.3.1.2 Comparison of secondary symptom scores before and after treatment

[0171] Before treatment, the scores of minor symptoms in the two groups of patients showed no statistically significant difference (P>0.05), indicating that they were comparable.

[0172] Within-group comparisons after treatment, the control group showed improvement in constipation symptoms (P < 0.05), but no improvement in loose stool symptoms. Significant improvements were observed in all other dimensions (P < 0.001). The treatment group showed improvement in both constipation (P < 0.05) and loose stool symptoms (P < 0.05), and significant improvements were observed in all other dimensions (P < 0.001).

[0173] After treatment, the treatment group showed no statistically significant difference in improving constipation symptoms compared to the control group (P>0.05), but had a significant advantage in improving nausea, fatigue, heaviness in the limbs, and dark yellow urine (P<0.001), and a certain advantage in improving bitter taste, sticky mouth, dry mouth, and loose stools (P<0.05). See Table 7.

[0174] Table 7 Comparison of secondary symptom scores before and after treatment in the two groups [M(P25,P75)]

[0175]

[0176] Note: *P<0.001 compared with the same group before treatment, #P<0.05.

[0177] 3.3.1.3 Comparison of total TCM syndrome scores before and after treatment

[0178] Before treatment, there was no statistically significant difference in the total TCM syndrome scores between the two groups (P > 0.05), indicating comparability. After treatment, both groups showed a significant reduction in total TCM syndrome scores (P < 0.001), with the treatment group showing a significantly greater reduction than the control group (P < 0.001). See Table 8.

[0179] Table 8 Comparison of clinical efficacy between the two groups (cases)

[0180]

[0181] 3.3.2 Clinical efficacy results

[0182] In the control group, 0 cases achieved clinical cure, 3 cases showed significant improvement, 20 cases showed improvement, and 1 case showed no improvement. In the treatment group, 1 case achieved clinical cure, 17 cases showed significant improvement, 13 cases showed improvement, and 3 cases showed no improvement. The overall effective rate in the control group was 67.65%, and the cure rate was 0%. The overall effective rate in the treatment group was 91.18%, and the cure rate was 3%. The difference in clinical effective rates between the two groups was statistically significant (P < 0.05) according to Fisher's exact test, indicating that the overall clinical efficacy of the treatment group was superior to that of the control group. Furthermore, the cure rate of 3% in the treatment group compared to 0% in the control group suggests that the treatment regimen in the treatment group was more effective. See Table 9.

[0183] Table 9 Comparison of clinical efficacy between the two groups (cases)

[0184] 3.3.3 Health Survey Short Form (SF-36) Scoring Results

[0185] The pre-treatment scores of the Short Form Health Survey (SF-36) in both groups showed no statistically significant difference (P > 0.05), indicating comparability. After treatment, the MCS dimension of the SF-36 score in the control group did not change significantly compared to before treatment (t = 0.886, P = 0.381 > 0.05), indicating that the MCS dimension in the control group did not show significant improvement after treatment. All other scores in both groups increased significantly compared to before treatment (P < 0.001), and the increase in each dimension and total score in the treatment group was greater than that in the control group (P < 0.001), as shown in Tables 10 and 11.

[0186] Table 10. Within-group comparisons of scores on the Short Form Health Survey (SF-36) (mean ± standard deviation)

[0187]

[0188] Table 11 Comparison of scores from the Short Form Health Survey (SF-36) between groups (mean ± standard deviation)

[0189]

[0190] 3.3.4 Gastrointestinal Quality of Life Index (GIQ-LI) Score Results

[0191] There was no statistically significant difference in the pre-treatment Gastrointestinal Quality of Life Index (GIQ-LI) scores between the two groups (P > 0.05), indicating comparability. After treatment, the total GIQ-LI scores of both groups significantly increased compared to pre-treatment levels (P < 0.001), with a greater increase in the total score in the treatment group compared to the control group (P < 0.001), as shown in Tables 12 and 13.

[0192] Table 12 Intragroup comparisons of Gastrointestinal Quality of Life Index (GIQ-LI) scores (mean ± standard deviation)

[0193]

[0194] Table 13 Comparison of Gastrointestinal Quality of Life Index (GIQ-LI) scores between groups (mean ± standard deviation)

[0195]

[0196] 3.4 Safety Comparison

[0197] In this study, a total of 6 patients (3 in the control group and 3 in the experimental group) developed postoperative pancreatitis after ERCP. All 6 patients achieved effective control of their pancreatitis after treatment including fasting, fluid resuscitation, and inhibition of pancreatic enzyme secretion. No adverse reactions such as drug or food allergies were reported by any patients throughout the clinical trial.

[0198] 4. Analysis of Research Results

[0199] 4.1 Traditional Chinese Medicine Syndrome Scoring

[0200] Traditional Chinese Medicine (TCM) syndrome scoring, which quantifies and assesses patients' symptoms and signs, is an important method for evaluating the clinical efficacy of TCM. This study included common symptoms in patients with common bile duct stones of the liver and gallbladder damp-heat syndrome, such as dietary status, abdominal distension, hypochondriac pain and discomfort, constipation, loose stools, jaundice, and tongue coating, as observation indicators. After treatment, the total TCM syndrome scores of both groups showed significant improvement (P < 0.001). Some symptoms in both groups improved compared to before treatment. The two groups showed comparable efficacy in improving constipation (P > 0.05), while the treatment group was superior to the control group in improving abdominal pain and fatigue (P < 0.05). Furthermore, the treatment group effectively improved symptoms such as abdominal distension, hypochondriac pain and discomfort, constipation, loose stools, jaundice, and tongue coating (P < 0.05). In terms of overall clinical efficacy, the treatment group's 91.18% effective rate was also superior to the control group's 67.65% effective rate. This indicates that the traditional Chinese medicine formula for treating choledocholithiasis in patients with hepatobiliary damp-heat syndrome after ERCP can more effectively improve the TCM syndrome manifestations. This therapeutic result is attributed to the accurate grasp of the core pathogenesis of hepatobiliary damp-heat syndrome, namely "damp-heat in the liver and gallbladder, stagnation of qi, and blood stasis leading to nodules," and the precise formulation under the guidance of the treatment principle of "damp-heat in the liver and gallbladder as the root cause, and qi stagnation and blood stasis as the manifestation," achieving a synergistic relationship between "disease-syndrome-medicine-formula," and using a single formula for syndrome differentiation and treatment, ultimately achieving good clinical therapeutic effects.

[0201] 4.2 Health Survey Short Form (SF-36) Scoring

[0202] The Short Form Health Survey (SF-36) originated in 1988 from an optimization of the Medical Outcomes Study Scale (MOS-SF) developed by the Boston Health Institute in the United States. It aims to comprehensively assess an individual's physical and mental health through a concise questionnaire. After being introduced to Chinese by Zhejiang University School of Medicine in 1991, it has gradually become an important tool in clinical research and public health in my country.137 The scale contains 36 questions covering eight dimensions: physical functioning (PF), physical role (RP), bodily pain (BP), general health (GH), energy (VT), social functioning (SF), emotional role (RE), and mental health (MH). It also includes a health change (HT) indicator to reflect the dynamics of health status over a year. Scores for each dimension are converted to a standardized scale from 0 to 100, with higher scores indicating better health.

[0203] The core value of SF-36 lies in its multi-dimensional quantitative assessment capabilities. Through comprehensive scoring across dimensions such as physiological function, pain intensity, and social function, researchers can objectively measure patients' quality of life and provide a basis for evaluating the effectiveness of medical interventions. For example, in chronic disease management, SF-36 can effectively track patients' functional improvements before and after treatment, assisting in the development of individualized rehabilitation plans. Furthermore, its data can be used for health policy formulation and epidemiological research, serving as a bridge connecting individual health perceptions with macro-level health strategies.

[0204] Patients with hepatobiliary damp-heat syndrome and common bile duct stones often experience a significant decline in quality of life due to biliary obstruction, recurrent infections, and pain. The SF-36, with its multiple dimensions, can accurately capture changes in the health status of these patients: Physical Function (PF) and Bodily Pain (BP): Severe abdominal pain and limited mobility caused by cholangitis or stone impaction can be quantified through PF scores (e.g., the ability to walk 1500 meters) and BP scores (pain frequency and intensity). Social Function (SF) and Emotional Role (RE): Long-term illness can lead to social withdrawal or depression; the impact of social interaction and emotional state issues in the SF-36 can reflect their psychosocial adaptability. General Health Status (GH) and Health Changes (HT): Patients with hepatobiliary damp-heat syndrome often experience systemic symptoms (e.g., jaundice, fatigue); the GH score can assess their perception of overall health, while the HT score can compare the degree of health improvement before and after surgery. In clinical practice, comparing SF-36 scores before and after minimally invasive surgery (e.g., laparoscopic choledochotomy) can quantify patient recovery outcomes.

[0205] SF-36 provides a comprehensive analytical framework for the health status of patients with common bile duct stones due to damp-heat syndrome in the liver and gallbladder through a systematic and standardized assessment system. Its multidimensional scoring can guide clinical decision-making and promote the development of patient-centered treatment models. Especially with the widespread use of minimally invasive techniques, the data support from SF-36 will further enhance the correlation between precision medicine and improved quality of life.

[0206] 4.3 Gastrointestinal Quality of Life Index (GIQLI) score

[0207] The Gastrointestinal Quality of Life Index (GIQLI), developed by German scholars Eypasch et al. in 1995, aims to address the shortcomings of general-purpose scales (such as the SF-36) in assessing the specificity of digestive system diseases. Its design is based on clinical observations that patients with gastrointestinal diseases often experience a significant decline in quality of life due to symptoms (such as abdominal pain, bloating, and abnormal bowel movements) and treatment side effects (such as postoperative digestive dysfunction), details that general-purpose scales struggle to accurately quantify. The GIQLI comprises 36 items covering four dimensions: gastrointestinal symptoms (such as nausea and diarrhea), physical function (diet and digestion), psychological state (anxiety and depression), and the degree of limitation in social activities. The total score ranges from 0 to 144, with higher scores indicating better quality of life. Compared to the broad applicability of the SF-36, the GIQLI focuses more on the specific issues of digestive system diseases, and is particularly adept at capturing subtle postoperative functional changes.

[0208] The core value of GIQLI lies in its disease targeting and sensitivity. By refining the assessment of postoperative digestive function (such as food tolerance), local symptoms (such as bile reflux), and psychosocial adaptation, GIQLI can more directly reflect the recovery process of patients after hepatobiliary and pancreaticobiliary surgery. For example, after ERCP (endoscopic retrograde cholangiopancreatography) in patients with common bile duct stones, their biliary obstruction is relieved, but they may also have the risk of Oddi sphincter dysfunction or pancreatitis. The impact of such complications on daily diet, bowel movements, and mood can be precisely quantified through the "symptom frequency" and "social function" dimensions of GIQLI. In addition, GIQLI data can provide evidence-based support for postoperative nutritional support and TCM syndrome intervention (such as regulating damp-heat syndrome in the liver and gallbladder), compensating for the limitations of SF-36 in assessing local function.

[0209] Patients with common bile duct stones exhibiting liver and gallbladder damp-heat syndrome typically present with hypochondriac pain, jaundice, bitter taste in the mouth, and dark urine. Although ERCP relieves biliary obstruction, digestive dysfunction (such as loss of appetite and abdominal distension) and mood fluctuations (irritability and insomnia) caused by damp-heat accumulation may persist. Targeted assessment using GIQLI can establish the following correlations: Symptom dimension: quantifying the frequency of abdominal distension and diarrhea caused by postoperative bile drainage obstruction, or the impact of TCM syndromes such as yellow and greasy tongue coating due to unresolved damp-heat on diet; Physiological function dimension: assessing the patient's tolerance to lipid foods postoperatively, reflecting the recovery of biliary function; Psychosocial dimension: capturing anxiety caused by repeated medical visits or economic stress. Compared to the "emotional function" of SF-36, GIQLI places greater emphasis on the psychological burden directly caused by the disease.

[0210] 4.4 Differential Application of Short Form Health Survey (SF-36) Scores and Gastrointestinal Quality of Life Index (GIQLI) Scores

[0211] SF-36 emphasizes a multidimensional assessment of overall health (such as physical pain and general vitality), while GIQLI focuses on digestive system-specific issues; the two can be used complementaryly. Assessment depth: SF-36 reflects overall postoperative quality of life improvement (such as physical recovery), while GIQLI reflects the specific impact of ERCP on quality of life, such as changes in bile metabolism and gut microbiota. GIQLI can guide the evaluation of the efficacy of Traditional Chinese Medicine treatments for spleen and stomach function, while SF-36 is more suitable for assessing overall condition (with an emphasis on emotional changes).

[0212] 4.5 Security Analysis

[0213] Studies have shown that some patients may experience postoperative pancreatitis, bleeding, or perforation after ERCP treatment. Among these, postoperative pancreatitis is the most common complication. In this study, postoperative pancreatitis occurred in both the control and treatment groups, but this incidence rate is consistent with previous literature reports. Furthermore, no adverse drug events were reported throughout the clinical study. Therefore, overall, the prescribed formula for treating bile duct stones demonstrates a high level of safety.

Claims

1. A traditional Chinese medicine composition for treating damp-heat syndrome of the liver and gallbladder after ERCP stone removal, characterized in that, The active ingredients of the traditional Chinese medicine composition are composed of the following raw materials in parts by weight: Bupleurum chinense 8-10 parts, Codonopsis pilosula 13-17 parts, Scutellaria baicalensis 8-10 parts, processed Pinellia ternata 8-10 parts, processed Glycyrrhiza uralensis 8-10 parts, dried ginger 5-7 parts, rhubarb 2-4 parts, stir-fried Citrus aurantium 8-10 parts, stir-fried Paeonia lactiflora 13-17 parts, Lysimachia christinae 13-17 parts, Curcuma longa 8-10 parts, chicken gizzard lining 8-10 parts, Lygodium japonicum 13-17 parts, and Liquidambar formosana 8-10 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The active ingredients of the traditional Chinese medicine composition are composed of the following raw materials in parts by weight: Bupleurum chinense 9 parts, Codonopsis pilosula 15 parts, Scutellaria baicalensis 9 parts, processed Pinellia ternata 9 parts, processed Glycyrrhiza uralensis 9 parts, dried ginger 6 parts, rhubarb 3 parts, stir-fried Citrus aurantium 9 parts, stir-fried Paeonia lactiflora 15 parts, Lysimachia christinae 15 parts, Curcuma longa 9 parts, chicken gizzard lining 9 parts, Lygodium japonicum 15 parts, and Liquidambar formosana 9 parts.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition is a mixture of the raw materials of traditional Chinese medicine decoction pieces, or an aqueous extract obtained by water extraction of the raw materials.

4. A traditional Chinese medicine preparation for treating damp-heat syndrome of the liver and gallbladder after ERCP stone removal, characterized in that, The traditional Chinese medicine preparation is an oral preparation; it includes the traditional Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

5. The traditional Chinese medicine preparation according to claim 4, characterized in that, The oral preparations are selected from decoctions, granules, capsules, tablets, pills, oral liquids, or mixtures.

6. A method for preparing an aqueous decoction of the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, Includes the following steps: S1. Weigh out the following ingredients according to their respective weight proportions: Bupleurum chinense, Codonopsis pilosula, Scutellaria baicalensis, processed Pinellia ternata, prepared Glycyrrhiza uralensis, dried ginger, rhubarb, stir-fried Citrus aurantium, stir-fried Paeonia lactiflora, Lysimachia christinae, Curcuma longa, chicken gizzard lining, Lygodium japonicum and Liquidambar formosana, and mix them to obtain a mixture of raw materials. S2, add water to the mixture of raw materials for soaking; S3, the soaked raw materials and soaking liquid are decocted for the first time, filtered, and the first decoction and the first dregs are obtained respectively. S4, add water to the first dregs for a second decoction, filter, and obtain the second decoction; S5, combine the first decoction and the second decoction to obtain the aqueous decoction.

7. The preparation method according to claim 6, characterized in that, In step S2, the mixture of raw materials is soaked until each raw material is fully saturated; And / or, in steps S3 and S4, the simmering process includes first heating over high heat to a boil, and then continuing to simmer over low heat. And / or, step S5 further includes adjusting the combined first and second decoctions to 200 mL to obtain a daily dose of the decoction; And / or, after combining the first decoction and the second decoction, the method further includes concentrating the combined decoction to obtain a concentrated Chinese medicine liquid or a Chinese medicine extract, and mixing the concentrated Chinese medicine liquid or the Chinese medicine extract with pharmaceutically acceptable excipients to prepare granules, capsules, tablets, pills, oral liquids or mixtures.

8. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine preparation according to any one of claims 4 to 5 in the preparation of a medicine for treating damp-heat syndrome of the liver and gallbladder after ERCP stone removal.

9. The use according to claim 8, characterized in that, The drug is used to treat patients with common bile duct stones who develop damp-heat syndrome of the liver and gallbladder after ERCP stone removal. And / or, the ERCP stone removal procedure includes endoscopic retrograde cholangiopancreatography, duodenal papilla incision for stone removal, and nasobiliary drainage; And / or, the liver and gallbladder damp-heat syndrome has one or more of the following symptoms: hypochondriac distending pain, bitter taste in the mouth, nausea, vomiting, poor appetite, yellow urine, red tongue, and yellow and greasy tongue coating.

10. The use according to claim 8, characterized in that, The drug is used to reduce the TCM syndrome score of patients with damp-heat syndrome of liver and gallbladder after ERCP stone removal, and / or to treat patients' gastrointestinal symptoms and quality of life. And / or, the drug is formulated as a unit-dose formulation suitable for use starting on day 2 after ERCP stone removal, one dose daily, taken orally twice daily for 12 weeks.

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