Jianpi Lishi Jiedu Granules for Prevention of Postoperative Recurrence in Colorectal Advanced Adenomas

The Karnofsky Performance Status (KPS) Scale is a standardized tool used to assess the functional status and quality of life of patients. The scale ranges from 0 to 100, with higher scores indicating better quality of life. A score of 100 represents normal function with no complaints or evidence of disease, while a score of 0 indicates death. The interpretation of score changes is categorized as follows: significant improvement (KPS score increase of >20 points), improvement (score increase of 10-20 points), stability (score change of <10 points increase or decrease), and decline (score decrease of >10 points). The score is rated by the investigator based on the patient's clinical status at each time point.

The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item instrument used to assess gastrointestinal symptoms over the past week. The scale covers five symptom clusters: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is rated on a scale from 0 to 3, where 0 indicates no symptoms and 3 indicates severe symptoms. The total score ranges from 0 to 45, with higher scores indicating worse gastrointestinal symptoms (poorer outcome). The total score is calculated by summing the scores of all 15 items. The scale is administered by the investigator through patient interview at each specified time point.

The TCM Syndrome Severity Scale is used to evaluate the severity of Spleen Deficiency and Dampness Toxin syndrome. The scale assesses five primary symptoms (abdominal distension and pain, constipation, diarrhea, poor appetite, dry mouth with sticky sensation) and four secondary symptoms (fatigue and laziness to speak, heavy sensation and drowsiness, nausea and vomiting tendency, borborygmus). Each symptom is rated on a 4-point scale: 0 (none), 1 (mild), 3 (moderate), and 5 (severe). The total score ranges from 0 to 45, with higher scores indicating more severe TCM syndrome symptoms (worse outcome). The total score is calculated by summing the scores of all nine items. The scale is administered by the investigator through patient interview and clinical assessment at each specified time point.

Renal impairment is defined as an increase in serum creatinine level of ≥50% from baseline. Serum creatinine is measured through routine biochemical testing, with units reported in μmol/L or mg/dL. Fasting venous blood samples are collected at baseline (before treatment), 3 months, 6 months, and 1 year after treatment. A participant is considered to have experienced renal impairment if the criterion is met at any of the scheduled visit time points. The final data will be reported as the number and percentage of participants who develop renal impairment.

The concentrations of the following inflammatory cytokines in participants' serum are measured using Enzyme-Linked Immunosorbent Assay (ELISA): tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-17A (IL-17A), interleukin-1β (IL-1β), interleukin-4 (IL-4), and interferon-gamma (IFN-γ). All cytokines are reported in the same unit (pg/mL). Fasting venous blood samples (5ml) are collected in the morning at baseline (before treatment), 3 months, 6 months, and 1 year after treatment. Samples are centrifuged to separate serum, stored at -80°C, and tested uniformly. For each inflammatory cytokine, the mean, standard deviation, and change from baseline are reported at each time point. If data are normally distributed, they are described as mean ± standard deviation; if not normally distributed, they are described as median and interquartile range.

Drug-induced liver injury (DILI) is assessed using the Hy's Law criteria, which requires meeting all three of the following conditions: (1) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation ≥ 3 times the upper limit of normal (ULN); (2) total bilirubin (TBil) elevation ≥ 2 times the ULN; (3) alkaline phosphatase (ALP) within normal range (< 2 times ULN), indicating no biliary obstruction. Other causes of liver injury, such as viral hepatitis, alcoholic liver disease, and autoimmune liver disease, must be excluded. ALT, AST, TBil, and ALP are measured through routine liver function biochemical tests. Fasting venous blood samples are collected at baseline (before treatment), 3 months, 6 months, and 1 year after treatment. A participant is considered to have experienced DILI if all three criteria are met at any of the scheduled visit time points. The final data will be reported as the number and percentage of participants who develop DILI.

Fresh fecal samples (approximately 5g) are collected from participants. Bacterial genomic DNA is extracted, and gut microbiota analysis is performed using 16S rRNA gene sequencing (targeting the V3-V4 hypervariable region). The alpha diversity indices include: Chao1 index (reflecting species richness), Shannon index (reflecting species richness and evenness), and Simpson index (reflecting species dominance). These indices are dimensionless; higher values indicate better microbial diversity. Data are presented as mean ± standard deviation or median (interquartile range).

Fresh fecal samples (approximately 5g) are collected from participants. Bacterial genomic DNA is extracted, and gut microbiota analysis is performed using 16S rRNA gene sequencing (targeting the V3-V4 hypervariable region). Beta diversity is assessed using principal coordinate analysis (PCoA) based on Bray-Curtis distance to evaluate differences in microbial composition between samples. Results are visualized graphically to show clustering of samples across groups, and permutational multivariate analysis of variance (PERMANOVA) is used to compare the significance of differences between groups.

Fresh fecal samples (approximately 5g) are collected from participants. Bacterial genomic DNA is extracted, and gut microbiota analysis is performed using 16S rRNA gene sequencing (targeting the V3-V4 hypervariable region). Relative abundance of gut microbiota is assessed at various taxonomic levels (phylum, class, order, family, genus). Relative abundance is expressed as percentages (%), and differentially abundant taxa between groups are compared using statistical methods. Data are presented as mean ± standard deviation or median (interquartile range) for the average relative abundance of each taxon.