ObjectiveTo develop a patient-reported traditional Chinese medicine kidney deficiency pattern (TCM-KDP) scale for colorectal cancer (CRC) patients and evaluate its reliability and validity.MethodsWe administered the TCM-KDP questionnaire to postoperative patients with stage II and III CRC as part of a multicenter randomized controlled trial (RCT) conducted in China from December 2018 to September 2021. The TCM-KDP scale consists of eight items on patient-reported symptoms and is scored on a five-point Likert scale. The scale’s reliability was assessed using Cronbach’s α and test-retest reliability, while content validity was evaluated with the content validity index. We compared the differences in serum cytokine levels and other clinical factors between patients with higher and lower KDP scores.ResultsOf the 378 patients analyzed in the original RCT, 352 (93.2%) completed the TCM-KDP questionnaire. The Cronbach’s α of the eight-item TCM-KDP scale was 0.734, and the test-retest reliability was 0.745. Our exploratory factor analysis yielded eight factors that explained the variance of 50.34%. The mean TCM-KDP score was 2.80 ± 0.92. Compared with patients with stage II CRC, those with stage III CRC had significantly higher TCM-KDP scores (2.25 vs. 2.50, P = .026). We categorized all patients into high- or low-KDP score groups (the cut-off score was 2.8). Patients with lower TCM-KDP scores had significantly higher serum interleukin-1β expression levels (P = .04).ConclusionThe patient-reported TCM-KDP scale demonstrated relatively good feasibility, internal consistency, and test-retest reliability among patients with CRC. Future studies could apply this scale to other cancer types and diseases.

Objective:To explore the potential target and signaling pathway of Sijunzi Decoction in treating Colorectal Cancer (CRC) with network pharmacology.Methods:The Traditional Chinese Medicine System Platform (TCMSP) and Swiss Target Prediction database were adopted to establish the database of Sijunzi Decoction effective ingredients and targets. Therapeutic Target Database (TTD), Online Mendelian Inheritance in Man, Drugbank and GeneCards were used to build the CRC target database. The common gene names of target proteins were checked in Uniprot database. The STRING database was applied to analyze the interactions between the targets and the DAVID was used for the enrichment analysis on gene ontology (GO) biological process and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway. The network topology results were analyzed by Cytoscape 3.7.1 software.Results:134 active compounds of Sijunzi Decoction were gained, and PPI includes 125 targets protein (TP53,AKT1,IL-6,et al.). The 516 cellular biological processes, 53 cellular component and 98 molecular function were obtained through GO biological process enrichment analysis. The result of KEGG pathway enrichment showed that PI3K-Akt signaling pathway, TNF signaling pathway and FoxO signaling pathway were the main pathways.Conclusion:Sijunzi Decoction is mainly used to treat CRC by regulating key proteins such as TP53,AKT1, IL-6 and interfering with signal pathways such as PI3K-Akt, TNF and FoxO, reflecting the characteristics of Sijunzi Decoction in the treatment of CRC with multi-component,multi-target and multi-pathway characters.