A traditional Chinese medicine acupoint sticking for perioperative period of colon cancer

Abstract

The application belongs to the technical field of colon cancer drugs, and particularly relates to a traditional Chinese medicine acupoint sticking plaster for colon cancer perioperative period. Traditional Chinese medicine components include atractylodes, costus, raw areca nut, baizhi, soapberry and mirabilite, and the proportion is atractylodes:costus:raw areca nut:baizhi:soapberry:mirabilite=2:1:1:2:1:2. The preparation method of the sticking plaster is as follows: step 1: weighing atractylodes:costus:raw areca nut:baizhi:soapberry:mirabilite=2:1:1:2:1:2 according to the proportion; step 2: adding honey to the medicine weighed in step 1 to make pills, each pill weighs 3g, and the pills are pressed into round cakes with a diameter of 2.5cm and a thickness of 0.2cm, and then the cakes are placed in blank sticking films for standby. The application provides a traditional Chinese medicine acupoint sticking plaster for colon cancer perioperative period, which can accelerate the recovery of postoperative exhaust function of patients, shorten the hospitalization time to a certain extent, has few adverse reactions, and can promote the rehabilitation of colon cancer postoperative patients.

Description

Technical Field

[0001] This invention belongs to the field of colorectal cancer drug technology, specifically relating to a traditional Chinese medicine acupoint patch for perioperative use in colorectal cancer. Background Technology

[0002] According to estimates by the World Health Organization (WHO), there were approximately 1.88 million new cases of colorectal cancer globally in 2020, and nearly 935,000 people died from it, making colorectal cancer the third most common cancer worldwide. Data collected by the National Cancer Center from 682 registries across China shows that in 2016, the number of new colorectal cancer cases in my country ranked second only to lung cancer among all cancers, at approximately 408,000; and colorectal cancer is one of the leading causes of death among cancer patients. Currently, the treatment plan for colorectal cancer is a comprehensive approach centered on surgery. How to strengthen perioperative management and accelerate patient recovery has gradually become a hot topic of clinical concern. Summary of the Invention

[0003] To comprehensively address the above-mentioned problems, this invention proposes a traditional Chinese medicine acupoint patch for perioperative use in colon cancer patients. This patch can accelerate the recovery of postoperative gas expulsion function, shorten hospital stay to a certain extent, has few adverse reactions, and promotes the recovery of colon cancer patients after surgery.

[0004] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0005] A traditional Chinese medicine acupoint patch for perioperative use in colon cancer, the formula of which includes Atractylodes lancea, Aucklandia lappa, Areca catechu, Angelica dahurica, Gleditsia sinensis and Glauber's salt, in the following ratio: Atractylodes lancea: Aucklandia lappa: Areca catechu: Angelica dahurica: Gleditsia sinensis: Glauber's salt = 2:1:1:2:1:2.

[0006] A method for preparing a traditional Chinese medicine acupoint patch for perioperative use in colon cancer, step 1: weighing Atractylodes lancea: Aucklandia lappa: Areca catechu: Angelica dahurica: Gleditsia sinensis: Glauber's salt = 2:1:1:2:1:2;

[0007] Step 2: Add honey to the weighed medicine in Step 1 and mix to form pills, each weighing 3 grams. Press the pills into round cakes with a diameter of 2.5 cm and a thickness of 0.2 cm, and place them in blank adhesive film for later use.

[0008] Compared with the prior art, the beneficial effects of the present invention are:

[0009] This invention combines enhanced recovery after surgery (ERAS) for colorectal cancer with traditional Chinese medicine acupoint application. The experimental group showed lower rates of complications and catheter re-insertion compared to the control group, and accelerated postoperative gas expulsion. The median length of hospital stay was also lower in the experimental group, suggesting that the integrated traditional Chinese and Western medicine ERAS approach for colorectal cancer has a trend towards shortening postoperative hospital stay. Therefore, traditional Chinese medicine acupoint application can accelerate the recovery of postoperative gas expulsion and shorten hospital stay to some extent, with fewer adverse reactions, thus promoting the recovery of patients after colorectal cancer surgery. Attached Figure Description

[0010] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof.

[0011] In the attached diagram:

[0012] Figure 1 This is a flowchart of the preparation method of the patch of the present invention; Detailed Implementation

[0013] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0014] A traditional Chinese medicine acupoint patch for perioperative use in colon cancer, the formula of which includes Atractylodes lancea, Aucklandia lappa, Areca catechu, Angelica dahurica, Gleditsia sinensis and Glauber's salt, in the following ratio: Atractylodes lancea: Aucklandia lappa: Areca catechu: Angelica dahurica: Gleditsia sinensis: Glauber's salt = 2:1:1:2:1:2.

[0015] A method for preparing a traditional Chinese medicine acupoint patch for perioperative use in colon cancer, step 1: weighing Atractylodes lancea: Aucklandia lappa: Areca catechu: Angelica dahurica: Gleditsia sinensis: Glauber's salt = 2:1:1:2:1:2;

[0016] Step 2: Add honey to the weighed medicine in Step 1 and mix to form pills, each weighing 3 grams. Press the pills into round cakes with a diameter of 2.5 cm and a thickness of 0.2 cm, and place them in blank adhesive film for later use.

[0017] Experimental procedure:

[0018] I. Clinical Data

[0019] 1.1 General Information

[0020] 142 patients with colorectal malignancies hospitalized at the Gastrointestinal Center of Peking University Cancer Hospital from September 2020 to February 2021 were selected and randomly divided into an experimental group and a control group, with 71 patients in each group. Seven patients dropped out of the experimental group, and three dropped out of the control group. In the experimental group, there were 35 males and 29 females, with an average age of (61.70±8.08) years and a BMI of (24.80±2.99) kg / m². 46 patients underwent laparoscopic surgery and 22 underwent open surgery. In the control group, there were 48 males and 20 females, with an average age of (59.54±10.20) years and a BMI of (24.79±3.93) kg / m². 45 patients underwent laparoscopic surgery and 19 underwent open surgery. There were no statistically significant differences in general characteristics between the two groups (P>0.05). This study was approved by the Ethics Committee of Peking University Cancer Hospital (Ethics Approval No. 2020KT89).

[0021] 1.2 Diagnostic criteria

[0022] 1.2.1 Western medicine diagnosis: The diagnostic criteria for colorectal cancer in the "Guidelines for the Diagnosis and Treatment of Common Malignant Tumors in China" issued by the Medical Administration Department of the Ministry of Health of the People's Republic of China were used; the TNM staging was based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging criteria.

[0023] 1.2.2 TCM syndrome differentiation criteria: Refer to "Traditional Chinese Medicine Diagnostics", "Guiding Principles for Clinical Research of New Chinese Medicine Drugs", and "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine.

[0024] 1.3 Inclusion Criteria

[0025] Participants must be between 18 and 75 years old; have a pathological diagnosis of malignant colorectal tumor; undergo radical surgical treatment; voluntarily participate in this study and sign an informed consent form.

[0026] 1.4 Exclusion Criteria

[0027] Patients who cannot be radically removed during surgery; patients with skin allergies, skin ulcers, or poorly controlled diabetes; patients with severe organ dysfunction such as heart, liver, or kidney dysfunction; pregnant or breastfeeding women; patients with mental illness or language communication difficulties who cannot complete this study; and patients who cannot cooperate with this study for other reasons.

[0028] 1.5 Rejection Criteria

[0029] If a participant who has already been enrolled develops a condition during the trial that makes it unsuitable for them to continue, the researchers decide that they should withdraw from the trial.

[0030] 1.6 Shedding Criteria

[0031] For any reason, if a participant is unwilling or unable to continue the clinical study, they may request to withdraw from the study; or if a participant does not explicitly request to withdraw from the study but is lost to follow-up due to no longer receiving treatment and testing.

[0032] II. Treatment and Observation Methods

[0033] 2.1 Sample Size Estimation

[0034] This study integrates clinical research and experience summaries on postoperative complications of colorectal cancer, estimating the incidence of postoperative complications at 30%. Combined treatment with traditional Chinese medicine acupoint application reduces the incidence of postoperative complications to 10% (α = 0.05, β = 0.20). The sample size ratio of the experimental group to the control group is set at 1:1. Using PASS2020 software, a sample size of 59 cases is required per group. Considering that conducting clinical research on traditional Chinese medicine treatment in Western medicine hospitals is more difficult to accept than in traditional Chinese medicine hospitals, the dropout rate is estimated at 20%, requiring 71 subjects per group, thus a total of 142 cases are expected to be included.

[0035] 2.2 Grouping Method

[0036] The corresponding random access sequence list was generated by GCP researchers at Xiyuan Hospital of the China Academy of Chinese Medical Sciences using SAS 9.4 software. The generated random access sequences were then given to a third party to prepare opaque, sealed envelopes, with the patient's enrollment information number printed on the surface. Simultaneously, the random access sequences were given to the hospital's pharmacy, where pharmacists coded the corresponding medications.

[0037] 2.3 Treatment methods

[0038] The experimental group adopted the optimized perioperative accelerated recovery program for rectal cancer, which was jointly formulated by Peking University Cancer Hospital and Xiyuan Hospital of China Academy of Chinese Medical Sciences. This program combined enhanced recovery after surgery (ERAS) with the application of herbal patches prepared by the Department of Anorectal Surgery of Xiyuan Hospital of China Academy of Chinese Medical Sciences.

[0039] Traditional Chinese medicine patch application method: The traditional Chinese medicine consists of Atractylodes lancea, Aucklandia lappa, Areca catechu, Angelica dahurica, and Gleditsia sinensis. The patch is applied to the Zusanli acupoint from day 1 to day 7 post-surgery. Each application lasts 6 hours, once daily. The control group received the ERAS protocol plus a placebo-like traditional Chinese medicine patch application (black bean powder, honey, and 5% of the observation group's medication).

[0040] 2.4 Observation Indicators and Methods

[0041] 2.4.1 Main efficacy indicators: incidence of postoperative complications (anastomotic leakage, urinary retention, infection, intestinal obstruction).

[0042] 2.4.2 Secondary observation indicators: record the time of first flatus, time of defecation, time of catheter removal, the rate of catheter reinsertion, and length of hospital stay.

[0043] 2.4.3 Safety: Perioperative monitoring of patients' blood routine, biochemistry, and electrocardiogram, and recording of adverse events. Adverse reaction grading was based on the "Skin Reactions" section of the National Cancer Institute (NCI) Adverse Reaction Grading Standard CTCAE-4.0.

[0044] 2.5 Statistical Methods

[0045] Data analysis was performed using SPSS 22.0 statistical software. Normally distributed continuous data were expressed as mean ± standard deviation. Data were expressed as follows: t-tests were used for comparisons between groups; non-normally distributed continuous data were expressed as median (interquartile range), and the rank-sum test was used for comparisons. Count data were expressed as number of cases and percentage (%), and the χ² test was used for comparisons. P < 0.05 was considered statistically significant.

[0046] III. Results

[0047] 3.1 Primary therapeutic indicators

[0048] The complication rate in the experimental group was 15.63%, while that in the control group was 23.53%, with no statistically significant difference (P>0.05). See Table 1.

[0049] Table 1 Comparison of postoperative complication events (cases)

[0050]

[0051] 3.2 Secondary efficacy indicators

[0052] 3.2.1 Postoperative time to first flatus, time to defecation, and time to catheter removal: There was a statistically significant difference in the time to first flatus between the two groups (P<0.05); there was no statistically significant difference in the time to first defecation and time to catheter removal between the two groups (P>0.05). See Table 2. The time to first flatus in the experimental group of laparoscopic surgery patients was shorter than that in the control group of laparoscopic surgery patients (P<0.05), while there was no statistically significant difference in the time to first flatus between the two groups of open surgery patients (P>0.05). See Table 3.

[0053] Table 2. Comparison of first flatus time, defecation time, and catheter removal time between the two groups (h). )

[0054] Group Number of examples First gas expulsion after surgery First bowel movement after surgery Removal of urinary catheter experimental group 64 34.20±21.37 67.36±27.74 3.05±0.82 control group 68 44.88±27.70 71.87±32.82 3.37±1.13 t-value -2.488 -0.85 -1.869 p-value 0.014 0.397 0.066

[0055] Table 3. Comparison of first postoperative flatus time (h) between two groups of patients with different surgical procedures

[0056] Group Laparoscopic surgery open surgery experimental group 34.40±21.44 33.74±21.75 control group 44.43±25.68 45.81±32.16 t-value -2.021 -1.385 p-value 0.046 0.174

[0057] 3.2.2 Percentage of patients requiring urinary catheterization: 2 patients (3.16%) in the experimental group required urinary catheterization again; 4 patients (5.88%) in the control group required urinary catheterization again. There was no statistically significant difference (P>0.05).

[0058] 3.2.3 Length of hospital stay: The length of hospital stay in the experimental group was 7 (4) days and the length of hospital stay in the control group was 7 (5) days. There was no statistically significant difference (P>0.05).

[0059] 3.3 Safety Evaluation

[0060] There were no statistically significant differences in the quantitative safety indicators between the two groups (P>0.05). See Table 4. Two cases of Grade I adverse reactions (skin redness) occurred in the experimental group, and two cases of Grade I adverse reactions (skin itching) occurred in the control group. The symptoms improved after discontinuation of the patch treatment, and no obvious abnormalities were observed at the 30-day follow-up after the procedure.

[0061] Table 3 Comparison of 42 groups of safety quantitative indicators

[0062]

[0063] 4. Conclusion:

[0064] The results showed that, in addition to enhanced recovery after surgery (ERAS) for colorectal cancer patients, the intervention of traditional Chinese medicine acupoint application resulted in lower complication rates and catheter re-insertion rates in the experimental group compared to the control group, although the differences were not statistically significant. However, it accelerated the recovery of postoperative flatus function. Although the experimental group required less time to resume defecation postoperatively, the difference was not statistically significant compared to the control group. There was no statistically significant difference in hospital stay between the two groups, but the median hospital stay in the experimental group was lower than that in the control group, suggesting that the application of the integrated traditional Chinese and Western medicine ERAS regimen in the perioperative period of colorectal cancer has a trend towards shortening postoperative hospital stay. In conclusion, traditional Chinese medicine acupoint application can accelerate the recovery of postoperative flatus function in patients, and also shorten hospital stay to a certain extent, with fewer adverse reactions, thus promoting the recovery of patients after colorectal cancer surgery.

[0065] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine acupoint patch for perioperative use in colon cancer, characterized in that: The traditional Chinese medicine acupoint patch is made from the following ratio of Chinese medicinal materials: Atractylodes lancea: Aucklandia lappa: Areca catechu: Angelica dahurica: Gleditsia sinensis: Glauber's salt = 2:1:1:2:1:2.

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