A traditional Chinese medicine composition for treating postoperative intestinal adhesion and application thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating postoperative intestinal adhesion, the application of traditional Chinese medicine composition in preparing the drug for treating postoperative intestinal adhesion The traditional Chinese medicine composition is made of the following weight parts of raw medicinal materials: peach kernel 7-11 parts, safflower 7-11 parts, prepared rehmannia 13-17 parts, angelica 7-11 parts, white peony root 7-11 parts, chuanxiong 7-11 parts, costus 7-11 parts, areca nut 4-8 parts.The present application is properly matched, can promote blood circulation to remove blood stasis, move qi and unblock stagnation, nourish blood and dredge fu organs, make blood stasis go, qi movement is smooth, new blood flows, and it is helpful for the subsidence of inflammation and the absorption of adhesion.With the continuous deepening of the study on the disease syndrome, according to the effect of blood-activating and stasis-removing, qi-moving and pain-relieving of the present application, it is often used for a variety of disease syndromes caused by qi stagnation and blood stasis, and good effect is obtained.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating postoperative intestinal adhesion and application thereof. BACKGROUND

[0002] Postoperative intestinal adhesion abdominal pain is a common complication of abdominal surgery. Intestinal adhesion refers to that due to inflammation, surgery, bleeding, foreign matter or other factors, the smoothness of the peritoneal surface is destroyed, and adhesion between peritoneal folds, between peritoneum and intestine, and between intestines is formed. Intestinal adhesion itself has no clinical manifestations, and when abdominal pain, abdominal distension, and stop of air and stool occur, it indicates that adhesive intestinal obstruction occurs.

[0003] Chinese patent document CN1278718C discloses a traditional Chinese medicine compound preparation for preventing and treating intestinal adhesion and a preparation method. The traditional Chinese medicine compound preparation for preventing and treating intestinal adhesion is composed of an oral preparation containing extracts of active components of rhubarb, bitter orange fruit, magnolia bark, mirabilite, and Raphanus sativus L. and medicinal excipients. The medicine has the functions of purgation, spleen-nourishing and dampness-drying, and qi-regulating and pain-relieving, and is mainly used for treating abdominal pain, abdominal distension, vomiting, and constipation caused by postoperative abdominal surgery and simple adhesive intestinal obstruction, and has the effect of preventing postoperative abdominal intestinal adhesion.

[0004] Chinese patent document CN105079771A discloses a traditional Chinese medicine composition for treating postoperative adhesive intestinal obstruction. The traditional Chinese medicine composition comprises the following components: bitter orange fruit, ginger, orange peel, trichosanthes, forsythia, honeysuckle, lindera, raphanus sativus, white peony root, and rhizoma coptidis. The composition is reasonable in formula and easy to prepare, has the remarkable effects of clearing heat and resolving toxins, promoting blood circulation to remove stasis, regulating qi to relieve pain, and moistening dryness to promote defecation, and is an effective medicine for treating postoperative adhesive intestinal obstruction.

[0005] There are many traditional Chinese medicine compositions for treating postoperative intestinal adhesion, but they have more or less shortcomings, such as too many medicinal ingredients, large side effects, and single efficacy, and therefore, it is particularly important to find a traditional Chinese medicine composition with moderate medicinal ingredients, small side effects, and good efficacy. SUMMARY

[0006] The present application aims at the deficiencies in the prior art, and provides a traditional Chinese medicine composition for treating postoperative intestinal adhesion and application thereof.

[0007] In a first aspect, the present application provides a traditional Chinese medicine composition for treating postoperative intestinal adhesion, which is prepared from the following raw medicinal materials by weight: peach kernel 7-11 parts, safflower 7-11 parts, prepared rehmannia 13-17 parts, angelica 7-11 parts, white peony root 7-11 parts, chuanxiong 7-11 parts, costus 7-11 parts, and areca nut 4-8 parts.

[0008] As a preferred example, the traditional Chinese medicine composition is made of the following raw medicinal materials by weight: peach kernel 8-10 parts, safflower 8-10 parts, prepared rehmannia 14-16 parts, angelica 8-10 parts, white peony root 8-10 parts, chuanxiong 8-10 parts, costus 8-10 parts, and areca nut 5-7 parts.

[0009] As a preferred example, the traditional Chinese medicine composition is made of the following raw medicinal materials by weight: peach kernel 9 parts, safflower 9 parts, prepared rehmannia 15 parts, angelica 9 parts, white peony root 9 parts, chuanxiong 9 parts, costus 9 parts, and areca nut 6 parts.

[0010] In a second aspect, the present application provides a use of the traditional Chinese medicine composition in the preparation of a drug for treating postoperative intestinal adhesion.

[0011] As a preferred example, the postoperative intestinal adhesion is postoperative intestinal adhesion abdominal pain.

[0012] As a preferred example, the postoperation refers to postoperation of abdominal surgery.

[0013] As a preferred example, the postoperation of abdominal surgery is of the syndrome of qi stagnation and blood stasis.

[0014] The invention has the advantages that: the core pathogenesis of the disease is "qi stagnation and blood stasis", and the basic treatment method is to activate blood and remove stasis, and the modified Taohong Siwu Decoction is used. The Taohong Siwu Decoction is one of the 100 classical prescriptions published in the "Ancient Classical Prescription Catalogue (First Batch)", which was first recorded in the "Gynecological Heart Method of Medical Canon of Golden Prescriptions" (Volume 44) written by Wu Qian in the fourth year of Qianlong in the Qing Dynasty. It is recorded that "if there are blood clots, purple and thick blood, there is blood stasis inside, use Siwu Decoction (Chuanxiong, Danggui, Baishao, and Shudihuang) plus Taoren and Honghua to break it, and the name is Taohong Siwu Decoction", which is used for blood stasis. "Bencao Bian Du" says: "Taoren can break blood stasis in liver collaterals". "Treatise on the Herbal" says: "Taoren is good at breaking blood". And the main effect of Honghua is to activate blood and unblock channels, remove stasis and relieve pain, so the prescription has the effects of removing stasis and breaking stasis. On the basis of Siwu Decoction for tonifying blood, Taoren and Honghua are added to break blood, activate blood, unblock channels, remove stasis and relieve pain, so the prescription can tonify blood without stasis, activate blood without breaking blood, supplement with movement, and break with collection. The six drugs are used together to achieve the effects of activating blood, unblocking channels, supporting healthy qi and removing pathogenic factors. The treatment of Taohong Siwu Decoction is caused by blood stasis and stagnation, which is a relatively mild and safe classical prescription for activating blood and removing stasis. In the long-term clinical practice, Professor Xu Yangxian uses Taohong Siwu Decoction as the basic prescription, combines with years of clinical experience and rich medicinal resources of the hospital, and adjusts the prescription to meet the individual treatment needs, and forms a unique flavored Taohong Siwu Decoction. Taoren in the prescription is strong in removing stasis and relieving pain, and Honghua is better in removing stasis and relieving pain, so the two drugs are used together as the monarch drug. Chuanxiong is a blood and qi drug that can activate blood, unblock channels, and regulate blood and qi, and is used as a ministerial drug to assist the monarch drug in activating blood. Although the injury of Jinbian is mainly caused by qi stagnation and blood stasis, if the blood and qi are not unblocked, it will definitely appear as deficiency, which means that the circulation of blood and qi is not smooth, and then pain is caused. Since the blood and qi activating drugs are often pungent, warm and dry, they need to be combined with Danggui with warm nature to achieve the effect of tonifying blood and promoting blood circulation. Baishao can nourish blood and astringe yin to increase the effect of blood. White peony root can also soothe the liver and relieve pain. The combination of Shudihuang and white peony root can nourish yin and blood, and help the generation of yin and blood, and can also consider the problem of evil toxin fumigating the intestinal collaterals and consuming blood and qi. Muxiang is slightly cold, pungent and bitter, and belongs to the liver and stomach meridians, and has the effects of unblocking channels and relieving pain, and can unblock the stagnation of the stomach and intestines. According to the record in "Jingyue Quan Shu" by Zhang Jiebin in the Ming Dynasty, "Xing is bitter and astringent, slightly bitter and slightly sweet, and the gas is slightly warm. It can digest food, remove alcohol toxicity, remove phlegm, unblock stagnation, warm the center and speed up the qi. It is used to treat abdominal distension, abdominal pain, wheezing, joint unblocking, nine orifices, and five diaphragm, and can also be used to treat biliary qi." Muxiang and Binglang can unblock channels and remove stagnation, and can also unblock qi and blood, and can also lead the drugs into the liver meridian, which can enhance the effect of unblocking channels and relieving pain. The combination of the drugs can activate blood and remove stasis, unblock channels and remove stagnation, nourish blood and unblock the bowels, remove blood stasis, unblock channels, and make new blood flow, which can also help the inflammation to subside and the adhesion to be absorbed.With the deepening of the disease research, according to the blood circulation, the role of the party, often used for qi stagnation and blood stasis caused by a variety of disease, each get good effect. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 The two groups after treatment due to abdominal adhesions and its complications caused by reoperation rate.

[0016] Figure 2 The two groups of patients before and after treatment pain score (VAS) changes.

[0017] Figure 3 The two groups of patients before and after treatment pain VAS score changes.

[0018] Figure 4 The two groups of overall symptom efficacy comparison.

[0019] Figure 5 The two groups of TCM syndrome efficacy comparison.

[0020] Figure 6 The two groups of patients before and after treatment gastrointestinal symptoms grade score changes.

[0021] Figure 7 The two groups of patients before and after treatment gastrointestinal symptoms grade score comparison.

[0022] Figure 8 The two groups of patients before and after treatment TCM syndrome score changes.

[0023] Figure 9 The two groups before and after treatment of patients with TCM syndrome score changes. DETAILED DESCRIPTION

[0024] The application will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the application and not to limit the scope of the application. In addition, it should be understood that after reading the content of the application, those skilled in the art can make various modifications or modifications to the application, and these equivalent forms also fall within the scope of the claims attached to the present application.

[0025] Example 1 postoperative intestinal adhesion of traditional Chinese medicine composition (I)

[0026] Peach kernel 9 parts, safflower 9 parts, radix rehmanniae preparata 15 parts, angelica 9 parts, white peony root 9 parts, chuanxiong 9 parts, wood 9 parts, areca nut 6 parts.

[0027] Example 2 postoperative intestinal adhesion of traditional Chinese medicine composition (II)

[0028] Peach kernel 9 parts, safflower 7 parts, radix rehmanniae preparata 17 parts, angelica 8 parts, white peony root 9 parts, chuanxiong 7 parts, wood 11 parts, areca nut 5 parts.

[0029] Example 3 Traditional Chinese medicine composition for postoperative intestinal adhesion (three)

[0030] Peach kernel 7 parts, safflower 11 parts, prepared rehmannia 14 parts, angelica 10 parts, white peony root 7 parts, chuanxiong 11 parts, costus 8 parts, areca nut 7 parts.

[0031] Example 4 Traditional Chinese medicine composition for postoperative intestinal adhesion (four)

[0032] Peach kernel 11 parts, safflower 8 parts, prepared rehmannia 16 parts, angelica 9 parts, white peony root 11 parts, chuanxiong 8 parts, costus 10 parts, areca nut 6 parts.

[0033] Example 5 Traditional Chinese medicine composition for postoperative intestinal adhesion (five)

[0034] Peach kernel 8 parts, safflower 10 parts, prepared rehmannia 15 parts, angelica 7 parts, white peony root 8 parts, chuanxiong 10 parts, costus 9 parts, areca nut 4 parts.

[0035] Example 6 Traditional Chinese medicine composition for postoperative intestinal adhesion (six)

[0036] Peach kernel 10 parts, safflower 9 parts, prepared rehmannia 13 parts, angelica 11 parts, white peony root 10 parts, chuanxiong 9 parts, costus 7 parts, areca nut 8 parts.

[0037] Example 7 Traditional Chinese medicine composition for postoperative intestinal adhesion (seven)

[0038] Peach kernel 9 parts, safflower 11 parts, prepared rehmannia 14 parts, angelica 10 parts, white peony root 7 parts, chuanxiong 11 parts, costus 8 parts, areca nut 7 parts.

[0039] Example 8 Traditional Chinese medicine composition for postoperative intestinal adhesion (eight)

[0040] Peach kernel 7 parts, safflower 8 parts, prepared rehmannia 16 parts, angelica 9 parts, white peony root 11 parts, chuanxiong 8 parts, costus 10 parts, areca nut 6 parts.

[0041] Example 9 Traditional Chinese medicine composition for postoperative intestinal adhesion (nine)

[0042] Peach kernel 11 parts, safflower 10 parts, prepared rehmannia 15 parts, angelica 7 parts, white peony root 8 parts, chuanxiong 10 parts, costus 9 parts, areca nut 4 parts.

[0043] Example 10 Traditional Chinese medicine composition for postoperative intestinal adhesion (ten)

[0044] Peach kernel 8 parts, safflower 9 parts, prepared rehmannia 13 parts, angelica 11 parts, white peony root 10 parts, chuanxiong 9 parts, costus 7 parts, areca nut 8 parts.

[0045] Example 11 Traditional Chinese medicine composition for postoperative intestinal adhesion (eleven)

[0046] Peach kernel 10 parts, safflower 7 parts, prepared rehmannia 17 parts, angelica 8 parts, white peony root 9 parts, chuanxiong 7 parts, costus 11 parts, areca nut 5 parts.

[0047] Example 12 Clinical efficacy experiment

[0048] Method and results of clinical experiment

[0049] 1 Study subjects The research cases were derived from January 1, 2023 to December 31, 2023, from the outpatient and inpatient of postoperative abdominal adhesion in Department of General Surgery II of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.

[0050] 2 Case selection

[0051] 2.1 Diagnostic criteria

[0052] Western diagnostic criteria: refer to the diagnosis of abdominal adhesion in Surgery (8th edition), Practical Surgery (4th edition), Qian Li's Abdominal Surgery (2nd edition). There is a history of abdominal surgery, and the main symptoms meet at least one of the following: (1) chronic abdominal pain, (2) repeated abdominal distension; secondary symptoms meet at least one of the following: (1) repeated acid reflux, (2) belching, (3) nausea and vomiting, (4) loss of appetite, (5) abdominal bloating, (6) increased flatus, (7) decreased flatus, (8) constipation, (9) diarrhea, (10) tenesmus, (11) urgency, (12) incomplete defecation. Other examinations such as imaging suggest the presence of adhesion bands in the abdominal cavity, which can directly support the diagnosis of abdominal adhesion.

[0053] Syndrome differentiation criteria of qi stagnation and blood stasis:

[0054] 1) Main symptoms: abdominal pain attacks, abdominal fullness and resistance.

[0055] 2) Secondary symptoms: nausea and vomiting, no flatus and defecation, belching or gas pain, and pain aggravated by anger; blood stasis, pain is more severe.

[0056] 3) Tongue coating: tongue appearance is dark red or purple.

[0057] 4) Pulse: stringy or astringent.

[0058] 5) Main symptoms with 1-2 secondary symptoms, refer to tongue and pulse for diagnosis.

[0059] 2.2 Inclusion criteria

[0060] (1) Meet the western diagnostic criteria for postoperative abdominal adhesion and the diagnostic criteria of qi stagnation and blood stasis in traditional Chinese medicine;

[0061] (2) At least 1 month from the last operation, regardless of the type of operation;

[0062] (3) Age 18-85 years old, gender unrestricted;

[0063] (4) Patients voluntarily agree to participate in the clinical trial and sign the informed consent. Sign the informed consent form.

[0064] 2.3 Exclusion criteria

[0065] (1) Patients with massive hemorrhage, severe abdominal infection, hollow organ perforation, severe obstruction requiring surgical treatment, or other acute abdomen;

[0066] (2) Patients with severe primary diseases in the whole body system such as circulation and blood;

[0067] (3) Patients with uncontrolled malignant tumors and metastasis;

[0068] (4) Patients with critical illness, shock, acidosis, and multiple organ failure;

[0069] (5) Patients who have recently received related treatment that may affect the observation index;

[0070] (6) Patients with unstable conditions that may endanger patient safety or affect their compliance with the study, such as those with fertility needs, pregnancy, breastfeeding, depression, manic depression, obsessive-compulsive disorder, or schizophrenia and other mental illnesses;

[0071] (7) Patients with allergic constitution and those allergic to the drug;

[0072] (8) Patients who have participated in other drug clinical trials or are currently participating in other drug clinical trials;

[0073] (9) Patients who are not suitable for participating in this study as determined by the investigator.

[0074] 2.4 Exclusion and dropout criteria

[0075] (1) Patients who do not complete the treatment course, are unwilling to receive follow-up treatment, and / or cannot complete the visit;

[0076] (2) During the observation period, if the patient has severe adverse reactions such as anaphylaxis, liver and kidney function damage, or the condition worsens, and the doctor determines that the clinical trial needs to be terminated;

[0077] (3) Patients who withdraw from the clinical trial due to other reasons, such as relocation, major infection, isolation, or loss of follow-up records;

[0078] (4) Key indicators such as GSRS score, TCM syndrome score, pain score (VAS), laboratory test indicators (CRP, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, TNF-α, interferon gamma, interferon alpha, PT, APTT, TT, FIB) and the like are missing.

[0079] 3 Treatment regimen

[0080] 3.1 Study design

[0081] Study design

[0082] The present study is a prospective non-randomized concurrent control clinical study.

[0083] For cases meeting the diagnosis of postoperative abdominal adhesion, patients meeting the inclusion and exclusion criteria were selected as the test group in the population treated with Modified Taohong Siwu Decoction combined with routine basic treatment, and patients meeting the inclusion and exclusion criteria were selected as the control group in the population treated with routine basic treatment.

[0084] 3.2 Treatment method

[0085] Control group:

[0086] (1) For those with abdominal pain and distension without surgical indications, give anisodamine hydrobromide injection 10 mg once im, etc.

[0087] (2) For those with severe nausea and vomiting, give metoclopramide hydrochloride injection 10 mg once im, omeprazole sodium for injection 10 mg qd ivgtt, etc.

[0088] (3) For those with bloating, belching and indigestion, give domperidone tablets 10 mg tidpo, itopride hydrochloride tablets 50 mg tidpo, etc.

[0089] (4) For those with diarrhea and unformed stools, give loperamide hydrochloride capsules 4 mg tidpo, Clostridium tyrobutyricum live bacteria tablets 20 mg tidpo, etc.

[0090] (5) For those with constipation, give lactulose 15 ml bidpo, Run Chang tablets 5# tidpo, Kaiselu 1# once anal, etc.

[0091] (6) Other routine basic treatment of traditional Chinese and Western medicine includes antispasmodic analgesic, promotion of gastrointestinal motility, acid suppression, anti-infection, nutritional support, fasting, gastrointestinal decompression, enema, etc. During the treatment process, the diet needs to be reasonably adjusted to avoid irregular diet, emotional fluctuations, cold stimulation, excessive intense exercise and other behaviors.

[0092] Experimental group:

[0093] The test group is given the modified Taohong Siwu Decoction (peach kernel 9g, safflower 9g, prepared rehmannia 15g, angelica 9g, white peony root 9g, chuanxiong 9g, costus 9g, areca nut 6g) on the basis of the control group, 150ml each time, 2 times / day, 30 minutes after breakfast and dinner. 14 days of continuous treatment is a course of treatment, continuous treatment for 2 courses (all Chinese herbal medicines are from the Chinese medicine shop of Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital, and are decocted by the Chinese medicine decoction room of Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital, 150ml / bag), and the diet needs to be reasonably adjusted during the treatment process, avoiding improper diet, emotional fluctuations, cold stimulation, violent running or violent body position rotation, etc.

[0094] 3.3 Observation index and method

[0095] 3.3.1 General information: Before the start of treatment, the general basic information of the patient is collected as baseline data:

[0096] (1) Demographic data: patient age, gender, body mass index (Body Mass Index, BMI).

[0097] (2) Clinical information: patient's disease duration, history of benign and malignant diseases, number of operations, etc.

[0098] 3.3.2 Efficacy observation index: (1) Gastrointestinal symptom rating scale (GSRS): assess the patient's gastrointestinal symptoms in the past week, the higher the score, the more severe the symptoms. Assessment is performed at treatment day 0, treatment day 28, and 3 months after treatment (see Appendix B.1).

[0099] (2) TCM syndrome score: Referring to “Guidelines for Clinical Research on New Drugs of Traditional Chinese Medicine” (People's Medical Publishing House, 1997 edition, Volume 3) and “Gastrointestinal Disease TCM Syndrome Scoring Table” developed by the Digestive System Disease Professional Committee of Chinese Medicine and Western Medicine Association in 2010, combined with the symptom characteristics of patients with qi stagnation and blood stasis, record the TCM syndrome scores of patients in both groups at treatment day 0, treatment day 28, and 3 months after treatment (scoring criteria see Appendix B.2).

[0100] (3) Laboratory examination: peripheral venous blood is collected at treatment day 0 and treatment day 28 to detect CRP, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, TNF-α, interferon gamma, interferon alpha, PT, APTT, TT, FIB.

[0101] 3.3.3 Efficacy evaluation criteria

[0102] Primary efficacy endpoint:

[0103] (1) Reoperation rate due to abdominal adhesions and its complications. Assessment was performed 3 months after treatment.

[0104] (2) Pain score: The degree of abdominal pain in patients with abdominal adhesions after surgery was assessed before and after treatment using the visual analogue scale (VAS). A score of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain. Assessment was performed once at day 0 of treatment, day 28 of treatment, and 3 months after treatment (see Appendix B.3).

[0105] Secondary efficacy endpoints:

[0106] (1) Symptom efficacy evaluation: The overall symptom efficacy assessment will be based primarily on the GSRS score. The efficacy index calculation formula for efficacy determination was developed according to the efficacy standards in the "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine" (People's Medical Publishing House, 3rd edition, 1997). Efficacy index calculation formula = (symptom score before treatment - symptom score after treatment) / symptom score before treatment x 100%.

[0107] Complete remission: GSRS score reduction rate ≥ 90% or more;

[0108] Marked effect: GSRS score reduction rate ≥ 70% or more;

[0109] Effective: GSRS score reduction rate ≥ 30% or more;

[0110] Ineffective: GSRS score reduction rate < 30%.

[0111] Total effective rate = (complete remission + marked effect + effective) case number / total case number x 100%.

[0112] (2) TCM syndrome efficacy evaluation: The efficacy index calculation formula for efficacy determination was developed according to the "Gastrointestinal Disease TCM Syndrome Score Sheet" developed by the Digestive System Diseases Professional Committee of Chinese and Western Medicine Association in 2010.

[0113] Complete remission: Clinical symptoms disappeared or basically disappeared, efficacy index ≥ 90%;

[0114] Marked effect: Clinical symptoms improved significantly compared to before, efficacy index ≥ 70%;

[0115] Effective: Clinical symptoms improved partially compared to before, efficacy index ≥ 30%;

[0116] Ineffective: Clinical symptoms did not improve significantly compared to before, or even worsened, efficacy index < 30%.

[0117] Total effective rate = (complete remission + marked effect + effective) case number / total case number x 100%.

[0118] 3.3.4 Safety indicators

[0119] Record the adverse reactions that may occur in patients, including symptoms and signs. At the same time, record the safety test indicators of patients in the test group on the 0th day of treatment and the 28th day of treatment. The specific items are blood routine, liver and kidney function (glutamic-pyruvic transaminase ALT, glutamic-oxalacetic transaminase AST, serum creatinine Cre).

[0120] 3.4 Statistical methods

[0121] SPSS 26.0 software and R4.1.0 software were used for statistical analysis of data. For measurement data, if the data were normally distributed, the mean ± standard deviation descriptive statistics would be used; if the data did not conform to normal distribution, then according to the characteristics of whether the data distribution contained many zero values, median and interquartile range (M, IQR) or median and 25th, 75th percentile [M(P 25 , P 75 )] would be used for descriptive statistics. For comparison of two groups of measurement data, independent sample t test (normal distribution) or Mann-Whitney U rank sum test (non-normal distribution) would be selected according to the distribution of data. For comparison of data within the group, paired sample t test (normal distribution) or Wilcoxon rank sum test (non-normal distribution) would be used. For count data, frequency, constituent ratio or percentage would be used for description, and chi-square test, Fisher's exact probability method or Wilcoxon rank sum test would be used for comparison of data between two groups. For comparison of mixed data within and between groups, repeated measures analysis of variance (normal distribution measurement data) or generalized estimating equation (non-normal distribution measurement data or count data) would be used. When the P value was less than or equal to 0.05, the difference was considered statistically significant.

[0122] A total of 73 patients were finally recruited in this study, including 36 patients in the test group and 37 patients in the control group. Three patients in the test group and three patients in the control group were missing key indicators, and one patient in the control group was lost to follow-up. The final data analysis included 33 patients in the test group and 33 patients in the control group, a total of 66 patients.

[0123] 4 Results

[0124] 4.1 Baseline data

[0125] In the test group, 13 males accounted for 39.39% of the whole, and 20 females accounted for 60.60% of the whole. In the control group, 20 males accounted for 60.60% of the whole, and 13 females accounted for 39.39% of the whole. The chi-square test analysis result shows that P=0.085. Therefore, it can be concluded that the difference in the percentage of genders of the patients in the two groups has no statistical significance, indicating that the gender ratio of the patients in the two groups is comparable, as shown in Table 1.

[0126] Table 1 Comparison of genders of patients in two groups

[0127]

[0128] The age data of the patients in the two groups are normally distributed, and are represented by mean ± standard deviation . The independent sample t test shows that the average age of the patients in the test group is 60.36 years old, the maximum age is 85 years old, and the minimum age is 21 years old; the average age of the patients in the control group is 61.03 years old, the maximum age is 79 years old, and the minimum age is 28 years old. The result shows that the age distribution of the patients in the two groups has no statistical difference (P=0.841), indicating that the ages of the patients in the two groups are comparable, as shown in Table 2.

[0129] Table 2 Comparison of ages of patients in two groups

[0130]

[0131] The body mass index data of the patients in the two groups are normally distributed, and are represented by mean ± standard deviation . The average body mass index of the patients in the test group is 21.66 kg / m 2 , and the average body mass index of the patients in the control group is 22.00 kg / m 2 . The independent sample t test shows that the comparison of the body mass indexes of the patients in the two groups has no statistical difference (P=0.638), indicating that the body mass indexes of the patients in the two groups are comparable, as shown in Table 3.

[0132] Table 3 Comparison of body mass indexes of patients in two groups

[0133]

[0134] Since the disease duration data of the patients in the two groups do not conform to normal distribution, the median (25th percentile, 75th percentile) [M(P 25 , P 75The median duration of peritoneal adhesion after surgery in the test group was 6 months, and the longest duration was 540 months. The median duration of peritoneal adhesion after surgery in the control group was 3 months, and the longest duration was 480 months. Mann-Whitney U rank test showed that there was no statistically significant difference in the duration of peritoneal adhesion between the two groups (Z = -0.944, P = 0.345), indicating that the duration of peritoneal adhesion in the two groups was comparable. See Table 4.

[0135] Table 4 Comparison of the duration of peritoneal adhesion between the two groups

[0136]

[0137] In the test group, 18 patients had a history of abdominal surgery for malignant tumors, accounting for 54.55% of the entire group, and 15 patients had no history of abdominal surgery for malignant tumors, accounting for 45.45% of the entire group. In the control group, 15 patients had a history of abdominal surgery for malignant tumors, accounting for 45.45% of the entire group, and 18 patients had no history of abdominal surgery for malignant tumors, accounting for 54.55% of the entire group. Chi-square test analysis showed that there was no statistically significant difference in the percentage of benign and malignant tumor history of abdominal surgery between the two groups (P = 0.460), indicating that the proportion of benign and malignant tumor history of abdominal surgery in the two groups was comparable. See Table 5.

[0138] Table 5 Comparison of the history of peritoneal adhesion between the two groups

[0139]

[0140] In the test group, 11 patients had a history of 1 abdominal surgery, accounting for 33.33% of the entire group, 13 patients had a history of 2 abdominal surgeries, accounting for 39.39% of the entire group, and 9 patients had a history of 3 abdominal surgeries, accounting for 27.27% of the entire group. In the control group, 14 patients had a history of 1 abdominal surgery, accounting for 42.42% of the entire group, 13 patients had a history of 2 abdominal surgeries, accounting for 39.39% of the entire group, and 6 patients had a history of 3 abdominal surgeries, accounting for 18.18% of the entire group. Chi-square test analysis showed that there was no statistically significant difference in the percentage of abdominal surgery times between the two groups (P = 0.619), indicating that the proportion of abdominal surgery times in the two groups was comparable. See Table 6.

[0141] Table 6 Comparison of the number of abdominal surgeries between the two groups

[0142]

[0143] Before treatment, the gastrointestinal symptom rating scale score and TCM syndrome score of the two groups were normally distributed, so the mean ± standard deviation was used indicates that there was no statistically significant difference in the comparison of the Gastrointestinal Symptom Rating Scale score and the TCM syndrome score of the two groups of patients before treatment (P>0.05), which shows that the Gastrointestinal Symptom Rating Scale score of the two groups of patients before treatment was about 16 points (total score 45 points), and the TCM syndrome score was about 19 points (total score 42 points), which were comparable. The individual score data of the Gastrointestinal Symptom Rating Scale score of the two groups of patients before treatment showed a skewed distribution, and therefore M(P 25 , P 75 ) was used to represent. The Mann-Whitney U rank sum test found that there was also no statistically significant difference in the comparison of the individual score of the Gastrointestinal Symptom Rating Scale score of the two groups of patients before treatment (P>0.05), which shows that the severity of the gastrointestinal symptoms of the two groups of patients before treatment is comparable, see Tables 7-8.

[0144] Table 7 Comparison of Gastrointestinal Symptom Rating Scale score and TCM syndrome score of two groups of patients before treatment

[0145]

[0146] Table 8 Comparison of individual scores of Gastrointestinal Symptom Rating Scale score of two groups of patients before treatment

[0147]

[0148] The pain score (VAS) data of the two groups of patients before treatment showed a skewed distribution, so M(P 25 , P 75 ) was used to represent. The Mann-Whitney U rank sum test found that there was no statistically significant difference in the comparison of the pain score (VAS) of the two groups of patients before treatment (Z=0.176, P=0.861), which shows that the median of the pain score (VAS) of the two groups of patients before treatment was 6 points, which was comparable, see Table 9.

[0149] Table 9 Comparison of pain score (VAS) of two groups of patients before treatment

[0150]

[0151] The prothrombin time and thrombin time data of the two groups of patients before treatment were normally distributed, so the mean ± standard deviation The results showed that there was no statistically significant difference between the two groups in the two variables (P>0.05) after independent sample t test analysis, indicating that the prothrombin time and thrombin time of the two groups were comparable. The CRP, interferon gamma, interferon alpha, IL-10, IL-12p70, IL-17, IL-1 beta, IL-2, IL-4, IL-5, IL-6, IL-8, TNF-alpha, activated partial thromboplastin time, fibrinogen data of the patients in the two groups did not obey normal distribution, so M(IQR) was used. After Mann-Whitney U rank sum test analysis, it was found that there was no statistically significant difference between the two groups in these variables (P>0.05), indicating that the above indexes of the two groups were comparable, see Tables 10-11.

[0152] Table 10 Comparison of laboratory tests of patients in the two groups before treatment

[0153]

[0154] Table 11 Comparison of laboratory tests of patients in the two groups before treatment

[0155]

[0156] Table 11 Comparison of laboratory tests of patients in the two groups before treatment

[0157]

[0158]

[0159] 4.2 Efficacy evaluation

[0160] 4.2.1 Comparison of reoperation rates due to abdominal adhesions and their complications in the two groups after treatment

[0161] After 3 months of treatment, no patient in the test group underwent reoperation due to abdominal adhesion and its complications. There were 3 patients in the control group who underwent reoperation, accounting for 9.09% of the whole group, and 30 patients who did not undergo reoperation, accounting for 90.91% of the whole group. After Fisher's exact test analysis, P=0.238, there was no statistically significant difference in the reoperation rate due to abdominal adhesion and its complications between the two groups after treatment, see Table 12, Figure 1 .

[0162] Table 12 Comparison of reoperation rates due to abdominal adhesions and their complications in the two groups after treatment

[0163]

[0164] 4.2.2 Comparison of pain scores (VAS) before and after treatment in the two groups

[0165] The pain scores (VAS, total score 10 points) and the difference data before and after treatment of the two groups of patients were skewed distribution, so M(IQR) was used. Using generalized estimation equation analysis, there was a statistically significant difference in the main effect of pain scores (VAS) on treatment day 0 and treatment day 28 (P<0.001), and there was a statistically significant difference in the main effect of pain scores (VAS) on treatment day 0 and 3 months after treatment (P<0.001). It is indicated that the pain degree of the two groups on treatment day 28 and 3 months after treatment is improved compared with that before treatment.

[0166] Without considering the measurement time, there was no statistically significant difference in the main effect of pain scores between the test group and the control group (P>0.05), but the interaction between groups and time was statistically significant, so the interaction result was followed.

[0167] There was an interaction between treatment on treatment day 0 to treatment day 28 (P<0.001), that is, the test group had a greater decrease in pain scores (VAS) on treatment day 0 to treatment day 28 than the control group. There was an interaction between treatment on treatment day 0 to 3 months after treatment (P<0.05), that is, the test group still had a greater decrease in pain scores (VAS) on treatment day 0 to 3 months after treatment than the control group. It is indicated that the improvement effect of the test group on the degree of pain during the whole treatment and 3 months after treatment is better than that of the control group. See Table 13, Figures 2-3 .

[0168] Table 13 Comparison of pain scores (VAS) of the two groups of patients before and after treatment

[0169]

[0170] Note a: without considering the group, the time effect compared with treatment day 0, * P<0.05, ** P<0.01, *** P<0.001; the interaction effect of groups and time, # P<0.05, ## P<0.01, ### P<0.001.

[0171] Note b: without considering the group, the time effect compared with treatment day 0, * P<0.05, ** P<0.01, *** P<0.001; the interaction effect of groups and time, # P<0.05, ## P<0.01, ### P<0.001.

[0172] 4.2.3 Comparison of overall symptom efficacy of the two groups of patients after treatment

[0173] The overall effective rate of symptom treatment in the experimental group was 69.7%, while that in the control group was 42.42%. Mann-Whitney U rank-sum test analysis showed a statistically significant difference in the overall symptom treatment effectiveness between the two groups (Z = -2.966, P = 0.003). This indicates that after treatment, the overall symptom treatment effect in the experimental group was superior to that in the control group (see Table 14). Figure 4 .

[0174] Table 14 Comparison of overall symptom relief between the two groups of patients

[0175]

[0176] 4.2.4 Comparison of therapeutic effects between the two groups of TCM syndromes

[0177] The effective rate of TCM syndrome evaluation in the experimental group was 75.76%, while that in the control group was 45.45%. Mann-Whitney U rank-sum test analysis showed a statistically significant difference in the effective rate between the two groups (Z = -2.879, P = 0.004). This indicates that the TCM syndrome efficacy in the experimental group was superior to that in the control group after treatment (see Table 15). Figure 5 .

[0178] Table 15 Comparison of therapeutic effects between the two groups of TCM syndromes

[0179]

[0180] 4.3 Efficacy observation indicators

[0181] 4.3.1 Comparison of gastrointestinal symptom severity assessment scale scores before and after treatment in the two groups of patients.

[0182] The gastrointestinal symptom scores (total 45 points) of patients in the experimental group on day 0, day 28, and 3 months after treatment did not follow a normal distribution; therefore, M(IQR) was used. Generalized estimating equation analysis, regardless of group, showed a statistically significant main effect between the GSRS scores on day 0 and day 28 (P<0.001), and between day 0 and 3 months after treatment (P<0.001). This indicates that gastrointestinal symptoms improved in both groups on day 28 and 3 months after treatment compared to before treatment.

[0183] Without considering measurement time, there was no statistically significant difference in the main effect of GSRS scores between the experimental group and the control group (P>0.05), but there was a statistically significant difference in the interaction between group and time, so the results were subject to the interaction effect.

[0184] There was an interaction between treatment and time (P<0.01) from treatment day 0 to treatment day 28, i.e. the decrease in GSRS score in the test group was greater than that in the control group from treatment day 0 to treatment day 28. There was an interaction between treatment and time (P<0.05) from treatment day 0 to 3 months after treatment, i.e. the decrease in GSRS score in the test group was still greater than that in the control group from treatment day 0 to 3 months after treatment. This shows that the improvement in gastrointestinal symptoms in the test group was better than that in the control group throughout the treatment and 3 months after treatment. See Table 16, Figures 6-7 .

[0185] Table 16 Comparison of gastrointestinal symptom rating scale scores of patients in the two groups before and after treatment

[0186]

[0187] Note c: without considering the group, the time effect compared with treatment day 0, * P<0.05, ** P<0.01, *** P<0.001; interaction effect of group and time, # P<0.05, ## P<0.01, ### P<0.001.

[0188] Note d: without considering the group, the time effect compared with treatment day 0, * P<0.05, ** P<0.01, *** P<0.001; interaction effect of group and time, # P<0.05, ## P<0.01, ### P<0.001.

[0189] The individual score data of the gastrointestinal symptom rating scale of the patients in the two groups did not conform to the normal distribution, so M(P 25 , P 75 ) was used. Using generalized estimation equation analysis, without considering the group, there were statistically significant differences in the main effects of the scores of the symptoms of "abdominal pain", "heartburn", "acid reflux", "tight and tight feeling in the upper abdomen", "abdominal rumbling", "abdominal distension", "increased defecation", "hard stool", and "incomplete defecation" (P<0.05) on treatment day 0 and 3 months after treatment. This shows that the symptoms of "abdominal pain", "heartburn", "acid reflux", "tight and tight feeling in the upper abdomen", "abdominal rumbling", "abdominal distension", "increased defecation", "hard stool", and "incomplete defecation" were improved 3 months after treatment in both groups.

[0190] Without considering measurement time, there was no statistically significant difference in the main effects of GSRS scores between the experimental and control groups (P>0.05). However, when there was a statistically significant difference in the interaction between group and time, the results of the interaction effect were accepted.

[0191] There was an interaction between the scores of "abdominal pain" and "incomplete bowel movement" symptoms from day 0 of treatment to 3 months after treatment and the treatment itself (P<0.05). Specifically, the experimental group showed a greater decrease in "abdominal pain" and "incomplete bowel movement" symptom scores from day 0 of treatment to 3 months after treatment than the control group. This indicates that the experimental group showed better improvement in "abdominal pain" and "incomplete bowel movement" symptoms, primarily at 3 months after treatment. (See Table 17.)

[0192] Table 17 Comparison of scores on the Gastrointestinal Symptom Rating Scale before and after treatment in the two groups.

[0193]

[0194] Table 17 (Continued) Comparison of scores on the Gastrointestinal Symptom Rating Scale before and after treatment in the two groups

[0195]

[0196]

[0197] 4.3.2 Comparison of TCM syndrome scores between the two groups

[0198] The TCM syndrome scores (total score of 42) of patients in the experimental group on day 0, day 28, and 3 months after treatment did not follow a normal distribution; therefore, M(IQR) was used. Generalized estimation equation analysis, regardless of group, showed statistically significant differences in the main effects of TCM syndrome scores between day 0 and day 28 (P<0.001), and between day 0 and 3 months after treatment (P<0.001). This indicates that the TCM syndromes in both groups improved on day 28 and 3 months after treatment compared to before treatment.

[0199] Without considering the measurement time, there was no statistically significant difference in the main effect of TCM syndrome scores between the experimental group and the control group (P>0.05), but there was a statistically significant difference in the interaction between group and time, so the results were subordinated to the interaction effect.

[0200] An interaction effect was observed between treatment day 0 and day 28 (P<0.01), meaning the TCM syndrome score reduction was greater in the experimental group than in the control group from day 0 to day 28. An interaction effect was also observed between treatment day 0 and 3 months post-treatment (P<0.01), meaning the TCM syndrome score reduction was still greater in the experimental group than in the control group from day 0 to 3 months post-treatment. This indicates that the experimental group showed better improvement in gastrointestinal symptoms than the control group throughout the treatment course and 3 months post-treatment. (See Table 18.) Figures 8-9.

[0201] Table 18 Comparison of TCM syndrome scores before and after treatment in two groups of patients

[0202]

[0203] Note e: Time effect compared with day 0 of treatment, regardless of group, * P<0.05, ** P<0.01, *** P<0.001; interaction effect of group and time, # P<0.05, ## P<0.01, ### P<0.001.

[0204] Note f: Time effect compared with day 0 of treatment, regardless of group, * P<0.05, ** P<0.01, *** P<0.001; interaction effect of group and time, # P<0.05, ## P<0.01, ### P<0.001

[0205] 4.3.3 Comparison of laboratory examination indicators before and after treatment in two groups

[0206] The CRP, interferon gamma, interferon alpha, IL-10, IL-12p70, IL-17, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, TNF-alpha, PT, APTT, TT, FIB data of the two groups of patients on day 0 of treatment and day 28 of treatment did not conform to the normal distribution, so M(P 25 , P 75 ) was used. Using generalized estimation equation analysis, the main effects of each laboratory index in the two groups were not statistically different. Regardless of the group, the main effects of CRP, interferon alpha, and FIB on day 0 of treatment and day 28 of treatment were statistically different (P<0.05). It is indicated that the overall CRP, interferon alpha, and FIB of the two groups on day 28 of treatment were lower than those before treatment.

[0207] Regardless of the measurement time, the main effects of each laboratory examination index in the test group and the control group were not statistically different (P>0.05), but when the interaction of group and time was statistically different, the interaction results were followed.

[0208] The FIB index from treatment day 0 to treatment day 28 has an interaction with treatment (P<0.01), that is, the FIB decrease amplitude of the test group from treatment day 0 to treatment day 28 is greater than that of the control group. It is illustrated that the improvement effect of the test group on FIB is better than that of the control group. See Table 19.

[0209] Table 19 Comparison of laboratory examination indexes before and after treatment of two groups

[0210]

[0211] Table 19 Comparison of laboratory examination indexes before and after treatment of two groups

[0212]

[0213]

[0214] Table 19 Comparison of laboratory examination indexes before and after treatment of two groups

[0215]

[0216]

[0217] 4.4 Safety evaluation

[0218] The blood routine, liver and kidney function of the patients receiving the Jia Wei Tao Hong Si Wu Tang treatment have no obvious abnormalities before and after treatment. In the test group, one patient has transient abdominal pain after taking the medicine on an empty stomach, which is self-relieved after 5 minutes. The patient is advised to stop taking the medicine for 1 day, and to continue taking the medicine after the observation of no discomfort symptoms. No discomfort symptoms occur again, which does not meet the adverse reaction judgment. It is indicated that the Jia Wei Tao Hong Si Wu Tang has good safety.

[0219] The above is only the preferred embodiment of the present application, and it should be noted that, for those skilled in the art, without departing from the method of the present application, several improvements and supplements can be made, which should also be considered as the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating postoperative intestinal adhesion, characterized in that, The traditional Chinese medicine composition is made of the following raw medicinal materials in parts by weight: peach kernel 8-10 parts, safflower 8-10 parts, prepared rehmannia 14-16 parts, angelica 8-10 parts, white peony root 8-10 parts, chuanxiong 8-10 parts, costus 8-10 parts, areca nut 5-7 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made of the following raw medicinal materials in parts by weight: peach kernel 9 parts, safflower 9 parts, prepared rehmannia 15 parts, angelica 9 parts, white peony root 9 parts, chuanxiong 9 parts, costus 9 parts, areca nut 6 parts.

3. Application of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating postoperative intestinal adhesion.

4. Use according to claim 3, characterized in that, The postoperative syndrome type is qi stagnation and blood stasis.

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