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| 基于真实世界数据评估中药复方在治疗胃癌中的肝肾安全性 |
| Safety assessment on liver and kidney of Chinese herbal compound in the treatment of gastric cancer based on real-world data |
| 投稿时间：2024-11-21 修订日期：2025-01-21 |
| DOI： |
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| 中文关键词: 真实世界研究 临床信息系统 胃癌 中药复方 安全性评估 |
| 英文关键词:real-world study, Clinical Information System, gastric cancer, Chinese herbal medicine combination, safety assessment |
| 基金项目:国家中医药管理局中医药创新团队及人才支持计划项目，ZYYCXTD-C-202208；上海市中医肿瘤临床医学研究中心，上海市科学技术委员会，21MC930500 |
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| 摘要点击次数: 39 |
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| 中文摘要: |
| [目的] 评估中药复方在胃癌临床应用中的安全性。[方法] 通过医院临床信息系统收集10年来就诊于上海中医药大学附属龙华医院肿瘤一科的胃癌临床数据，经标准化处理，依据NCI-CTCAE V5.0对其肝肾功能检验数据进行评级，通过可视化的方式评估临床实际中中药复方对肝肾功能的影响。[结果] 共有7943例患者纳入分析，肝肾功能指标异常1-4级发生率从高至低依次为DBIL、AST、ALP、TBIL、ALT、Cr。肝肾功能指标异常发生率并未发现随着服用中药时长的增长而增加。在异常检查数据发生时间与开始服用中药时间的时间差分析中发现肝肾功能指标异常均集中在服药前期，后期较少出现。进一步以治疗方式进行分组，中药队列的肝肾功能指标异常发生率低于其它三个队列。[结论] 胃癌患者服用中药复方是安全的，可长期应用。中药复方联合化疗/靶向/抗血管治疗并不会增加肝肾功能异常的发生。 |
| 英文摘要: |
| [Objective] To evaluate the safety of TCM compounds in the clinical application of gastric cancer. [Methods] The clinical data of gastric cancer patients attending the Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, were collected through the clinical information system of the hospital in the past 10 years, and after standardized processing, the liver and kidney function test data were graded according to NCI-CTCAE V5.0, so as to evaluate the effects of Chinese herbal medicine prescriptions on the liver and kidney functions in clinical practice in a visualized way. [Results] A total of 7943 patients were included in the analysis, and the incidence rates of abnormal liver and kidney function indexes grades 1-4 were, in descending order, DBIL, AST, ALP, TBIL, ALT, and Cr. The incidence rates of abnormal liver and kidney function indexes were not found to increase with the increase in the length of time of taking traditional Chinese medicine. In the analysis of the time difference between the time of occurrence of abnormal examination data and the time of starting to take traditional Chinese medicine, it was found that the abnormalities of liver and kidney function indexes were concentrated in the early stage of taking traditional Chinese medicine, and were less frequent in the later stage. When further grouped by treatment modality, the incidence of abnormal liver and kidney function indexes was lower in the traditional Chinese medicine cohort than in the other three cohorts. [Conclusion] It is safe for gastric cancer patients to take TCM compound prescription and can be used for a long time. The combination of traditional Chinese medicine and chemotherapy/targeted/antivascular therapy did not increase the occurrence of abnormal liver and kidney function. |
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