机构地区:[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
出 处:《上海中医药大学学报》2023年第4期9-21,共13页Academic Journal of Shanghai University of Traditional Chinese Medicine
基 金:上海市科委科技计划项目(20Y21902700)。
摘 要:目的: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: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: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: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。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: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: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 mo
关 键 词:晚期大肠癌 维持治疗 中药 无进展生存期 总生存期
分 类 号:R273[医药卫生—中西医结合]
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