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作 者:边江昱 何文婷 王学谦[3] 刘传波 蔡琳琳[1] 许云[1] 张彤[1] BIAN Jiangyu;HE Wenting;WANG Xueqian;LIU Chuanbo;CAI Linlin;XU Yun;ZHANG Tong(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine,Urumqi 830000,China;Guang′anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China)
机构地区:[1]中国中医科学院西苑医院,北京100091 [2]新疆维吾尔自治区中医医院 [3]中国中医科学院广安门医院 [4]北京中医药大学东方医院
出 处:《北京中医药大学学报》2024年第12期1759-1768,共10页Journal of Beijing University of Traditional Chinese Medicine
基 金:国家自然科学基金项目(No.82174461);中国中医科学院西苑医院能力提升项目(No.XYZX0201-22);中国中医科学院科技创新工程项目(No.CI2021A01811)。
摘 要:目的观察祛邪胶囊联合呋喹替尼三线阶段治疗转移性结直肠癌(mCRC)的临床疗效。方法采用前瞻性、非随机、对照的研究方法,在中国中医科学院西苑医院、中国中医科学院广安门医院、北京中医药大学东方医院、新疆维吾尔自治区中医医院收集二线治疗进展后拟行三线阶段治疗的mCRC患者,治疗组给予祛邪胶囊联合呋喹替尼治疗,对照组给予呋喹替尼治疗。主要结局指标为三线阶段总生存期(OS),次要结局指标为三线阶段无进展生存期(PFS)。结果共纳入142例mCRC患者,其中治疗组79例,对照组63例。治疗组中位总生存期(mOS)为19.0个月,对照组mOS为8.1个月,差异有统计学意义[HR=0.285,95%CI(0.183,0.436),P<0.001]。治疗组中位无进展生存期(mPFS)为7个月,对照组mPFS为2个月,差异有统计学意义[HR=0.248,95%CI(0.165,0.362),P<0.001]。亚组分析:在年龄、性别、原发肿瘤部位、腹膜转移、基因类型等亚组中,治疗组mOS与对照组相比均延长(P<0.001)。多因素COX比例风险回归模型分析显示,腹膜转移是独立预后因素,死亡风险提高2.14倍;联合祛邪胶囊是保护性因素,可降低76.8%的死亡风险。结论祛邪胶囊联合呋喹替尼可以延长mCRC三线阶段治疗的mOS和mPFS。Objective To observe the clinical efficacy of Quxie Capsule combined with fruquintinib in the treatment of metastatic colorectal cancer(mCRC).Methods A prospective,non-randomized,controlled study was used to collect patients with mCRC who planned to receive third-line treatment after second-line treatment at Xiyuan Hospital of China Academy of Chinese Medical Sciences,Guang′anmen Hospital of China Academy of Chinese Medical Sciences,Dongfang Hospital Beijing University of Chinese Medicine,and Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine.The treatment group received Quxie Capsule combined with fruquintinib.The control group was treated with fruquintinib.The primary outcome measure was third-line overall survival(OS),and the secondary outcome measure was third-line progression-free survival(PFS).Results A total of 142 patients with mCRC were included in this study(79 in the treatment group and 63 in the control group).The median OS(mOS)was 19.0 months in the treatment group and 8.1 months in the control group,and the difference was statistically significant[HR=0.285,95%CI(0.183,0.436),P<0.001].The median PFS(mPFS)in the treatment group was 7 months,mPFS in the control group was 2 months,and the difference was statistically significant[HR=0.248,95%CI(0.165,0.362),P<0.001].In subgroups,such as age,gender,primary site,peritoneal metastasis,and genotype,mOS in the treatment group was longer than in the control group(P<0.001).Multivariate COX proportional hazard model analysis showed that peritoneal metastasis was an independent prognostic factor and the risk of death increased 2.14 times.The combination with Quxie Capsule was a protective factor,reducing the risk of death by 76.8%.Conclusion The Quxie Capsule combined with fruquintinib can prolong mOS survival and mPFS of mCRC treated in the third-line stage.
关 键 词:祛邪胶囊 呋喹替尼 转移性结直肠癌 三线阶段治疗 阴阳攻积丸 温阳通下
分 类 号:R273[医药卫生—中西医结合]
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