Liver and Kidney Safety Assessment of Chinese Herbal Compound in Treatment of Gastric Cancer Based on Real-World Data
10.11735/j.issn.1004-0242.2025.05.A011
- VernacularTitle:基于真实世界数据评估中药复方治疗胃癌的肝肾安全性
- Author:
Yumiao SHEN
1
;
Xiaohong ZHU
;
Yi WANG
;
Ya'nan ZHANG
;
Ruohan ZHAO
;
Fangqi MA
;
Yan XU
;
Lin ZENG
;
Mingjie CHEN
;
Aiguang ZHAO
Author Information
1. 上海中医药大学附属龙华医院,上海 200032
- Publication Type:Journal Article
- Keywords:
real-world study;
clinical information system;
gastric cancer;
Chinese herbal com-pound;
safety assessment
- From:
China Cancer
2025;34(5):408-415
- CountryChina
- Language:Chinese
-
Abstract:
[Purpose]To evaluate the liver and kidney safety of traditional Chinese medicine(TCM)compounds in the treatment of gastric cancer.[Methods]The clinical data of gastric cancer patients who attended in Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2012 to February 2022 were collected.The results of liver and renal func-tion tests were rated according to National Cancer Institute-Common Terminology Criteria for Ad-verse Events(NCI-CTCAE)V5.0.The patients were divided into 4 groups:TCM group,TCM+chemotherapy/targeted/antivascular therapy group,TCM+TCM preparation group and TCM+chemotherapy/targeted/antivascular therapy+TCM preparation group,and the effects of TCM on liver and renal functions were analyzed.[Results]A total of 7 943 patients were included in the analysis,of which 2 941 cases receiving TCM ≥12 months,1 468 months ≥36 months,and 687 months≥60 months.The highest incidence rate of liver function abnormality was 13.71％,the highest in-cidence rate of grade 3/4 abnormality was 2.58％;the highest incidence of creatinine abnormality was 2.32％,the highest incidence rate of grade 3/4 abnormality was 0.37％in patients with differ-ent duration of taking TCM.Most of liver and renal function abnormalities occurred in the early stage of drug taking.The incidence of liver and renal function abnormalities in the TCM group was lower than that of the other three groups.The incidence of grade 3/4 abnormality for direct biliru-bin(DBIL)in the TCM group was 0.14％,for aspartate transaminase(AST)was 0.11％,for alka-line phosphatase(ALP)was 0.16％,for alanine aminotransferase(ALT)was 0.06％and for total bilirubin(TBIL)was 0.07％,and there was no grade 3/4 creatinine abnormality observed.The ab-normal liver and renal function indexes were not increased with the increase of the length of herbal medicine taking.[Conclusion]The study shows that long term taking TCM drugs and stan-dardized prescriptions for gastric cancer patients are safe.
