Effect of Modified Xiangsha Liujunzi Decoction （香砂六君子汤） on Clinical Symptoms and Immune Function in Advanced HR+/HER2- Breast Cancer Patients with Abemaciclib-Related Diarrhea of Spleen-Stomach Deficiency Type
10.13288/j.11-2166/r.2026.21.010
- VernacularTitle:香砂六君子汤加减对晚期HR+/HER2-乳腺癌阿贝西利相关性腹泻脾胃虚弱型患者临床症状及免疫功能的影响
- Author:
Zhanfei GUO
1
;
Luxia QI
2
;
Xiao WEI
1
;
Xuemei ZHANG
1
;
Xuekai WANG
1
;
Jingyu CUI
1
Author Information
1. Xinxiang Central Hospital，Henan Province，453000
2. East Campus，Xinxiang Central Hospital
- Publication Type:Journal Article
- Keywords:
breast cancer;
abemaciclib;
diarrhea;
immune function;
spleen-stomach deficiency;
Xiangsha Liujunzi Decoction （香砂六君子汤）
- From:
Journal of Traditional Chinese Medicine
2026;67(21):2311-2318
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the clinical efficacy of modified Xiangsha Liujunzi Decoction （香砂六君子汤， XLD） in the treatment of abemaciclib-related diarrhea of spleen-stomach deficiency type， and its regulatory effect on immune function in patients with advanced hormone receptor-positive/human epidermal growth factor receptor 2-negative （HR+/HER2-） breast cancer. MethodsA prospective， randomized， open-label， blinded-endpoint （PROBE） study was conducted. A total of 70 patients with advanced HR+/HER2- breast cancer and abemaciclib-related diarrhea were randomly divided into two groups， with 35 cases in each group. In addition to abemaciclib， the control group was treated with oral loperamide， while the trial group was treated with oral modified XLD. Both groups received treatment for 7 days as one course. The efficacy for diarrhea after treatment was compared between groups. Traditional Chinese medicine （TCM） syndrome score， Karnofsky performance status （KPS） score， inflammatory markers including interleukin-6 （IL-6） and C-reactive protein （CRP）， and immune function indicators including CD4+， CD8+， and CD4+/CD8+ ratio were compared between groups before and after treatment. Adverse events during the study were recorded， and safety was assessed. ResultsDuring the study， 1 case in the trial group and 2 cases in the control group， were lost to follow-up leaving 34 cases in the trial group and 33 cases in the control group for final analysis. The total effective rate of diarrhea in the trial group was 94.12% （32/34）， higher than 72.73% （24/33） in the control group （P＜0.05）. After treatment， both groups showed decreased TCM syndrome scores， increased KPS scores， increased CD4⁺， CD8⁺， and CD4⁺/CD8⁺ ratio， and decreased IL-6 and CRP levels （all P＜0.05）. Compared to the control group， the trial group had higher KPS scores， CD4⁺ levels， and CD4⁺/CD8⁺ ratios， and lower TCM syndrome scores and IL-6， CRP， and CD8⁺ levels （P＜0.05）. The incidence of adverse events in the trial group was 20.59% （7/34）， with an incidence of adverse drug reactions of 14.71% （5/34） after causality assessment； in the control group， the corresponding rates were 45.45% （15/33） and 39.39% （13/33）， respectively. The incidence of adverse events in the trial group was significantly lower than that in the control group （P＜0.05）. ConclusionModified XLD can effectively alleviate abemaciclib-related diarrhea in patients with advanced HR+/HER2- breast cancer of the spleen-stomach deficiency type， reduce levels of inflammatory cytokines， and regulate immune function， with a favorable safety profile.
