中药维持治疗对晚期大肠癌患者生存期的影响

杜美璐; 侯风刚; 朱光辉; 石齐; 韩苏苏; 杨伊; 贾嘉柠; 殷晓聆; 赵钢

doi:10.16306/j.1008-861x.2023.04.002

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中药维持治疗对晚期大肠癌患者生存期的影响

临床研究 | 更新时间：2023-08-04

- 中药维持治疗对晚期大肠癌患者生存期的影响
- Influence of maintenance treatment with Chinese medicine on survival of patients with advanced colorectal cancer
- 上海中医药大学学报 2023年37卷第4期页码：9-21
- 作者机构：
  
  1.上海中医药大学附属市中医医院（上海　200071）
  2.上海中医药大学附属曙光医院（上海　201203）
- 作者简介：
  
  杜美璐，女，在读硕士生，主要从事中医防治胃肠道肿瘤临床研究
  赵钢，主任医师，硕士生导师；E-mail： drzhaogang@126.com
- 基金信息：
  
  上海市科委科技计划项目(20Y21902700)
- DOI：10.16306/j.1008-861x.2023.04.002
  中图分类号：
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杜美璐,侯风刚,朱光辉等.中药维持治疗对晚期大肠癌患者生存期的影响[J].上海中医药大学学报,2023,37(04):9-21.

DU Meilu,HOU Fenggang,ZHU Guanghui,et al.Influence of maintenance treatment with Chinese medicine on survival of patients with advanced colorectal cancer[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2023,37(04):9-21.
杜美璐,侯风刚,朱光辉等.中药维持治疗对晚期大肠癌患者生存期的影响[J].上海中医药大学学报,2023,37(04):9-21. DOI： 10.16306/j.1008-861x.2023.04.002.

DU Meilu,HOU Fenggang,ZHU Guanghui,et al.Influence of maintenance treatment with Chinese medicine on survival of patients with advanced colorectal cancer[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2023,37(04):9-21. DOI： 10.16306/j.1008-861x.2023.04.002.

摘要

目的,2,评估晚期大肠癌（ACC）患者一线化疗后中药参与维持治疗的临床疗效，为中药干预ACC维持治疗提供循证依据。,方法,2,采用回顾性队列研究设计，收集ACC患者的临床资料，根据维持治疗期间是否服用中药将患者分为干预组和对照组。对照组患者给予西医常规维持治疗，干预组患者在对照组治疗基础上加服中药治疗。采用倾向性评分匹配（PSM）进一步平衡组间协变量，以无进展生存期（PFS）、总生存期（OS）为结局指标，并分析中药对口服氟尿嘧啶类药物维持治疗和观察策略维持治疗方案的影响。,结果,2,共纳入850例ACC患者，PSM后纳入670例患者，包括干预组335例、对照组335例。干预组和对照组患者的中位PFS分别为10个月（95%,CI, 8.05~11.95）和7个月（95%,CI, 6.15~7.85），进展或死亡风险比（,HR,）为0.75（95%,CI, 0.64~0.88，,P,=0.000）；干预组和对照组患者的中位OS分别为32个月（95%,CI, 26.15~37.85）和21个月（95%,CI, 17.24~24.76），死亡,HR,为0.62（95%,CI, 0.53~0.73，,P,=0.000）。采用口服氟尿嘧啶类药物维持治疗的患者，干预组和对照组的中位PFS分别为13个月和10个月（,HR,=0.80， 95%,CI, 0.61~1.06，,P,=0.098），中位OS分别为31个月和22个月（,HR,=0.65， 95%,CI, 0.52~0.81，,P,=0.000）；采用观察策略维持治疗的患者，干预组和对照组的中位PFS分别为10个月和6个月（,HR,=0.78， 95%,CI, 0.63~0.96，,P,=0.013），中位OS分别为27个月和17个月（,HR,=0.65， 95%,CI, 0.52~0.81，,P,=0.000）。,结论,2,一线化疗后含中药的维持治疗方案可延长ACC患者的PFS和OS，同时，中药可延长采用氟尿嘧啶类药物维持治疗患者的OS，并对采用观察策略维持治疗患者的PFS和OS均有延长作用。

Abstract

Objective： To evaluate the clinical efficacy of maintenance therapy involved in Chinese medicine in patients with advanced colorectal cancer （ACC） after first-line chemotherapy， in order to provide an evidence-based basis for Chinese medicine intervention in ACC maintenance therapy.,Methods,2,A retrospective cohort study design was applied. The clinical data of ACC patients were collected， and the patients were divided into the intervention group and control group according to whether taking Chinese medicine during the maintenance therapy. The patients in the control group were given conventional maintenance therapy with western medicine， and the patients in the intervention group were given Chinese medicine orally based on the treatment of the control group. Propensity score matching （PSM） was used to further balance the covariates between the two groups， the progression-free survival （PFS） and overall survival （OS） were taken as outcome indicators， and the influences of Chinese medicine on oral fluorouracil maintenance therapy and the observation strategy maintenance therapy were analyzed.,Results,2,A total of 850 patients with ACC were included， and 670 patients were included after PSM and divided into the intervention group （335 cases） and the control group （335 cases）. The median PFS was 10 months （95%,CI, 8.05~11.95） in the intervention group and 7 months （95%,CI, 6.15~7.85） in the control group， with a hazard ratio（,HR,） of 0.75 （95%,CI, 0.64~0.88， ,P,=0.000） for progression or death. The median OS was 32 months （95%,CI, 26.15~37.85） in the intervention group and 21 months （95%,CI, 17.24~24.76） in the control group， with a ,HR, of 0.62 （95%,CI, 0.53~0.73， ,P,=0.000） for death. In patients treated with oral fluorouracil maintenance therapy， the median PFS was 13 months in the intervention group and 10 months in the control group （,HR,=0.80， 95%,CI, 0.61~1.06， ,P,=0.098）， and the median OS was 31 months in the intervention group and 22 months in the control group （,HR,=0.65， 95%,CI, 0.52~0.81， ,P,=0.000）. In patients treated with observation strategy maintenance therapy， the median PFS was 10 months in the intervention group and 6 months in the control group （,HR,=0.78， 95%,CI, 0.63~0.96， ,P,=0.013）， and the median OS was 27 months in the intervention group and 17 months in the control group （,HR,=0.65， 95%,CI, 0.52~0.81， ,P,=0.000）.,Conclusion,2,Maintenance therapy containing Chinese medicine after first-line chemotherapy can prolong the PFS and OS in patients with ACC， meanwhile Chinese medicine can prolong the OS in patients treated with fluorouracil maintenance therapy and prolong the PFS and OS in patients treated with observation strategy maintenance therapy.

关键词

晚期大肠癌维持治疗中药无进展生存期总生存期

Keywords

advanced colorectal cancermaintenance treatmentChinese medicineprogression-free survivaloverall survival

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