| 沈雨苗,朱晓虹,王 怡,等.基于真实世界数据评估中药复方治疗胃癌的肝肾安全性[J].中国肿瘤,2025,34(5):408-415. |
| 基于真实世界数据评估中药复方治疗胃癌的肝肾安全性 |
| Liver and Kidney Safety Assessment of Chinese Herbal Compound in Treatment of Gastric Cancer Based on Real-World Data |
| 投稿时间：2024-11-21 |
| DOI：10.11735/j.issn.1004-0242.2025.05.A011 |
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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 compound 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（21MC930500） |
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| 摘要点击次数: 27 |
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| 中文摘要: |
| 摘 要：［目的］ 评估中药复方在胃癌临床应用中的肝肾安全性。［方法］ 通过医院临床信息系统收集2012年1月1日至2022年2月28日期间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，依据美国国立癌症研究所（National Cancer Institute，NCI）常见不良反应评价标准（Common Terminology Criteria for Adverse Events，CTCAE）5.0版（NCI-CTCAE V5.0）对其肝肾功能检验数据进行评级，先进行全组的观察分析，再根据不同的治疗方式分为中药队列、中药联合化疗/靶向/抗血管治疗队列、中药联合中药制剂队列、中药联合化疗/靶向/抗血管及中药制剂队列4个队列分别观察，通过可视化的图表展现中药复方对肝肾功能的影响。［结果］ 共有7 943例患者纳入分析，其中2 941例服用中药12个月及以上，1 468例服用中药36个月及以上，687例服用中药60个月及以上。在不同服用中药时长下，肝功能指标异常发生率最高为13.71%，其中3/4级异常的发生率最高为2.58%；肌酐（creatinine，Cr）异常发生率最高为2.32%，3/4级异常的发生率最高为0.37%。且肝肾功能指标异常均集中在服药前期，后期较少出现。中药队列的肝肾功能指标异常发生率低于其他3个队列，中药队列直接胆红素（direct bilirubin，DBIL）的3/4级异常发生率为0.14%；天冬氨酸氨基转移酶（aspartate transaminase，AST）的3/4级异常发生率为0.11%；碱性磷酸酶（alkaline phosphatase，ALP） 的3/4级异常发生率为0.16%；丙氨酸氨基转移酶（alanine aminotransferase，ALT）的3/4级异常发生率为0.06%；总胆红素（total bilirubin，TBIL）的3/4级异常发生率为0.07%；Cr未出现3/4级异常。肝肾功能指标异常发生率未发现随服用中药时长的增长而增加。［结论］ 基于医院临床信息系统数据分析显示胃癌患者接受中医临床诊疗方案和规范处方是安全的，并可长期应用。 |
| 英文摘要: |
| 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 function tests were rated according to National Cancer Institute-Common Terminology Criteria for Adverse 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 incidence 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 different 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 bilirubin(DBIL) in the TCM group was 0.14%， for aspartate transaminase (AST) was 0.11%， for alkaline 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 abnormal 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 standardized prescriptions for gastric cancer patients are safe. |
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