首页|基于真实世界证据的扶正清毒法治疗胃癌疗效评价及其用药规律分析

基于真实世界证据的扶正清毒法治疗胃癌疗效评价及其用药规律分析

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目的:评价真实世界环境下扶正清毒法(Fuzheng Qingdu therapy,FZQDT)治疗胃癌的临床疗效并分析其用药规律。方法:多中心收集2012年3月1日-2022年6月30日医院信息系统数据库中符合纳入、排除标准的胃癌患者,采用真实世界研究的方法,按有、无接受FZQDT治疗分为中医组和对照组。建立Cox回归模型进行生存预后分析。采用Kaplan-Meier法及log-rank检验比较两组患者的总生存期(overall survival,OS)及无进展生存期(progression-free survival,PFS)。使用 Microsoft Excel 16。0、SPSS Modeler 18。0 及 Cytoscape 3。9。1软件对处方用药分别进行频次统计、关联规则分析及聚类分析。结果:共纳入479例胃癌患者,中医组200例,对照组279例。生存预后分析表明FZQDT是影响患者生存的独立保护因素(P<0。001)。中医组较对照组显著延长 OS(中位 OS 37。30 个月 vs。12。77 个月,HR=0。38,P<0。001)和 PFS(中位 PFS 26。80 个月 vs。10。03个月,HR=0。59,P<0。001)。亚组分析表明,不同TNM分期及手术情况的胃癌患者均能从中医治疗中获益(P<0。05)。数据挖掘共纳入200首中药处方,涉及中药180味,使用频率≥50%的核心中药16味,如炙甘草、黄芪等。核心中药关联规则分析得到支持度>35%且置信度>95%的二联药对10对,如紫苏梗-藿香等。高频中药聚类分析得到6个聚类。结论:基于"扶正清毒"指导思想治疗胃癌,"扶正"重在健脾,兼顾养肝,"清毒"以祛除"水毒"为主,消化"食毒"和清解"热毒"为辅,契合胃癌"脾虚毒聚"的病机,在真实世界中能延长胃癌患者生存期,核心用药为炙甘草、黄芪、茯苓等。
Medication regularity and effect of Fuzheng Qingdu therapy for survival of patients with gastric cancer based on real world evidence
Objective:To evaluate the clinical efficacy of Fuzheng Qingdu therapy(FZQDT)in the treatment of gastric cancer(GC)in the real world environment and analyze its medication rules.Methods:The clinical data of GC patients who met the inclusion and exclusion criteria in Hospital information system of multi-center from March 1,2012 to June 30,2022 were collected.Real world study was conducted.The patients were divided into the Traditional Chinese Medicine(TCM)group and the control group according to whether they received FZQDT or not.Cox regression model was used to analyze the survival prognosis.Kaplan-Meier survival curve and log-rank test were used to compare overall survival(OS)and progress-free survival(PFS).Microsoft Excel 16.0,SPSS Modeler 18.0 and Cytoscape 3.9.1 was used to carry out statistics of frequency,association rules and cluster analysis of prescription herbs respectively.Results:The total of 479 enrolled GC patients were divided into TCM group(n=200)and control group(n=279).The result of prognostic analysis showed that the TCM treatment of FZQDT was an independent protective factor for OS of GC patients(P<0.001).The median of OS(37.30 months vs.12.77 months,HR=0.38,P<0.001)and PFS(26.80 months vs.10.03 months,HR=0.59,P<0.001)of TCM group were significantly longer than those of control group.Subgroup analysis showed that the OS of GC patients,regardless of TNM stage and surgical history,in TCM group were longer than those in the control group(P<0.05).The total of 200 prescriptions and 180 herbs were included.There were 16 core herbs with utilization rate ≥50%,such as Glycyrrhiza uralensis Fisch,Astragalus membranaceus(Fisch)Bunge.Ten pairs of two herbs with support rate>35% and confidence rate>95%,such as Perilla frutescens(L)Britton-Agastache rugo-sa(Fisch.et Mey.)O.Kuntze,were found.The results of cluster analysis showed that the core herbs could be clustered into 6 categories.Conclusion:FZQDT is consistent with the pathogenesis of"spleen deficiency and toxic accumulation"of GC."Fuzheng"emphasizes spleen strengthening,followed by liver nourishing."Qingdu"focu-ses on removing"water poison",followed by"food poison"and"heat poison".FZQDT could prolong the survival of GC patients in the real world,the core herbs of which were Glycyrrhiza uralensis Fisch,Astragalus membrana-ceus(Fisch)Bunge,Poria cocos(Schw.),etc.

gastric cancersurvival timeFuzheng Qingdu therapymedication regularityreal world

王庆颖、张晓春、侯超

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南京中医药大学附属医院扬州市中医院肿瘤科(江苏扬州,225001)

广州中医药大学第四临床医学院深圳市中医院肿瘤与血液病科

胃癌 生存期 扶正清毒法 用药规律 真实世界

国家自然科学基金青年基金江苏省中医药领军人才培养对象项目(第二批)深圳市医疗卫生三名工程项目

82305102SX025007SZZYSM202211003

2024

中国中西医结合消化杂志
华中科技大学同济医学院,中国中西医结合学会消化系统疾病专业委员会,中华中医药学会脾胃病专业委员会

中国中西医结合消化杂志

CSTPCD
影响因子:1.363
ISSN:1671-038X
年,卷(期):2024.32(3)
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