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运用倾向性评分匹配分析益气养精方对Ⅰ~ⅢA期肺腺癌术后患者生存预后的影响
中医药治疗优势病种与重大疾病研究:肿瘤疾病专题 | 更新时间:2023-06-16
    • 运用倾向性评分匹配分析益气养精方对Ⅰ~ⅢA期肺腺癌术后患者生存预后的影响

    • Propensity score matching analysis of the effect of the Yiqi Yangjing Prescription on the survival prognosis of patients with stage Ⅰ⁃ⅢA lung adenocarcinoma after surgery

    • 汪宇涵

      ,  

      董昀

      ,  

      杨轶

      ,  

      崔清

      ,  

      蔡霄月

      ,  

      周亚宁

      ,  

      张时

      ,  

      张铭

      ,  
    • 上海中医药杂志   2023年57卷第6期 页码:50-55
    • DOI:10.16305/j.1007-1334.2023.2301003    

      中图分类号:

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  • 汪宇涵,董昀,杨轶,等.运用倾向性评分匹配分析益气养精方对Ⅰ~ⅢA期肺腺癌术后患者生存预后的影响[J].上海中医药杂志,2023,57(6):50-55. DOI: 10.16305/j.1007-1334.2023.2301003.

    WANG Yuhan,DONG Yun,YANG Yi,et al.Propensity score matching analysis of the effect of the Yiqi Yangjing Prescription on the survival prognosis of patients with stage Ⅰ⁃ⅢA lung adenocarcinoma after surgery[J].Shanghai Journal of Traditional Chinese Medicine,2023,57(6):50-55. DOI: 10.16305/j.1007-1334.2023.2301003.

  •  
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    摘要

    目的

    探析益气养精方对Ⅰ~ⅢA期肺腺癌根治术后患者生存预后的影响。

    方法

    以2012年1月1日至2015年12月31日上海交通大学医学院附属胸科医院中西医结合科收治的Ⅰ~ⅢA期肺腺癌根治术后患者为研究对象,根据是否接受过益气养精方为主的中药治疗,分为中药组和对照组;采用倾向性评分匹配(PSM)平衡组间混杂因素,Kaplan-Meier法分析比较两组总生存期(OS)和无病生存期(DFS),Cox回归模型分析预后风险因素。

    结果

    ①共纳入357例Ⅰ~ⅢA期肺腺癌根治术后患者,按1∶1进行PSM后,成功匹配204例,中药组和对照组均为102例。②PSM前,中药组5年OS率高于对照组(79.7% vs 64.2%,P=0.001),且5年DFS率较对照组更高(60.6% vs 47.2%,P=0.005);PSM后,中药组5年OS率高于对照组(68.6% vs 52.5%,P=0.038),5年DFS率较对照组高但差异无统计学意义(49.0% vs 43.1%,P=0.176)。③PSM后的Cox单因素分析显示,组织学亚型是否含有高危病理因素(P=0.009)和是否服用中药(P=0.046)与OS显著相关;组织学亚型是否含有高危病理因素(P=0.031)和TNM分期(P=0.002)与DFS显著相关。④Cox多因素分析显示,是否含有高危病理因素(P=0.002)和是否服用中药(P=0.030)是影响Ⅰ~ⅢA期肺腺癌根治术后患者OS的独立预后因素;而是否含有高危病理因素(P=0.027)和临床TNM分期(P=0.001)是影响Ⅰ~ⅢA期肺腺癌根治术后患者DFS的独立预后因素。

    结论

    Ⅰ~ⅢA期肺腺癌根治术后尤其是组织学亚型有高危病理因素的患者,在西医治疗基础上服用益气养精方为主的中药,可达到延长生存期的治疗效果。

    Abstract

    Objective

    To retrospectively analyze the effect of the Yiqi Yangjing (benefiting qi and nourishing essence) Prescription on the survival prognosis of patients with stage Ⅰ-ⅢA lung adenocarcinoma after radical surgery.

    Methods

    We included patients with stage Ⅰ-ⅢA non-small cell lung adenocarcinoma after radical surgery who were admitted to the Department of Integrative Medicine, Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from January 1, 2012 to December 31, 2015, and these study subjects were divided into traditional Chinese medicine (TCM) and control groups depending on whether they had received Yiqi Yangjing Prescription-based TCM treatment. The propensity score matching (PSM) was used to exclude the confounding factors and bias, the Kaplan-Meier method was used to compare the overall survival (OS) and disease-free survival (DFS) between the two groups, and the Cox Proportional-Hazards Model was used to analyze the prognostic risk factors.

    Results

    ①A total of 357 patients with stage Ⅰ-ⅢA lung adenocarcinoma after radical surgery were included. After conducting a 1∶1 propensity score matching procedure, we got 204 successfully matched cases, with 102 cases in each group. ②Before PSM analysis, the 5-year OS rate was higher in the TCM group than that in the control group (79.7% vs. 64.2%, P=0.001), and the 5-year DFS rate was higher than that in the control group (60.6% vs. 47.2%, P=0.005); after PSM analysis, the 5-year OS rate was higher in the TCM group than that in the control group (68.6% vs. 52.5%, P=0.038), and the 5-year DFS rate was higher than that in the control group, but the difference was not statistically significant (49.0% vs 43.1%, P=0.176). ③The Cox univariate analysis after PSM showed that the presence of high-risk pathological factors in histological subtypes (P=0.009) and the administration of TCM (P=0.046) were significantly associated with OS; and the presence of high-risk pathological factors in histological subtypes (P=0.031) and TNM stage (P=0.002) were significantly associated with DFS. ④The Cox multifactorial analysis showed that the presence of high-risk pathological factors (P=0.002) and the administration of TCM (P=0.030) were independent prognostic factors affecting OS in patients with stage Ⅰ-ⅢA lung adenocarcinoma after radical surgery; while the presence of high-risk pathological factors (P=0.027) and clinical TNM stage (P=0.001) were independent prognostic factors affecting DFS in patients with stage Ⅰ-ⅢA lung adenocarcinoma after radical surgery.

    Conclusion

    The treatment effect of prolonging survival can be achieved by using Yiqi Yangjing Prescription-based TCM treatment in addition to Western medicine conventional treatment in patients with stage Ⅰ-ⅢA lung adenocarcinoma after radical surgery, especially those with high-risk pathological factors in histological subtypes.

    肺癌是近年来最常见的恶性肿瘤,在人群中的发病率和病死率均居于高位,而非小细胞肺癌(non-small cell lung cancer,NSCLC)在肺癌中占比超过80%

    1-2。肺腺癌在过去几十年中发病率不断上升,成为我国最常见的NSCLC组织学亚型3。由于肺癌有着高复发性和转移性的特点,导致肺癌患者的5年生存率较低,Ⅰ~ⅢA期肺腺癌的主要治疗方式为手术切除,但术后复发率高达30%~40%4-5。近年来相关研究6表明,肺腺癌患者的不同组织学亚型对患者总生存期(OS)和无病生存期(DFS)有着很大的影响。微乳头/实体成分为主的肺腺癌预后较其他组织学分型预后更差7-12。临床上对于肺腺癌术后病理有高危因素的患者建议进行辅助治疗,包括放射治疗(简称“放疗”)和化学疗法(简称“化疗”)。然而辅助治疗引起的不良反应较大,一定程度上会影响患者预后13-14。因此,我们认为有必要让肺腺癌术后患者尽早接受中医药治疗。益气养精方(肺岩宁方)是徐振晔教授总结并研制出的治疗肺癌的经验方剂,对肺癌细胞增殖、侵袭和转移具有抑制作用15,能稳定晚期肺癌患者瘤体、延长患者生存期和提高患者的生活质量16。本研究运用倾向性评分匹配(PSM)回顾性分析益气养精方对Ⅰ~ⅢA期肺腺癌根治术后患者生存预后的影响。

    1 资料与方法

    1.1 病例选择

    1.1.1 纳入标准

    ①已完成肺癌根治性手术;②术后病理为肺腺癌

    17,分期为I~ⅢA期18;③具有完整的临床病历资料。

    1.1.2 排除标准

    ①对本研究药物过敏者;②同时患有其他恶性肿瘤者;③临床资料缺失或不完整者;④存在精神障碍或其他严重的伴随疾病者。

    1.2 一般情况

    本研究纳入的病例均为2012年1月1日至2015年12月31日上海交通大学医学院附属胸科医院中西医结合科收治的Ⅰ~ⅢA期肺腺癌根治术后患者。根据是否接受过1个月及以上益气养精方为主的中药治疗,分为中药组和对照组。

    1.3 观察项目与方法

    1.3.1 基线资料

    收集纳入研究病例的临床资料,包括性别、年龄、吸烟史、脏层胸膜侵犯、伴随癌栓、高危病理因素、分化程度、TNM分期以及是否辅助化疗。

    1.3.2 生存分析

    主要观察终点为5年OS和DFS。OS定义为非小细胞肺腺癌确诊至任何原因导致死亡的时间,DFS定义为从根治性手术切除肿瘤到肿瘤局部/全身复发的时间。

    1.3.3 预后相关因素分析

    采集可能影响预后的因素,以OS和DFS为主要评价指标,进行Cox单因素和多因素分析。

    1.4 统计学方法

    研究数据采用SPSS26.0软件进行统计学分析。建立Logistic回归模型,对两组患者按1∶1进行PSM。计数资料采用 χ2检验,应用Kaplan-Meier法、Log-rank检验进行生存分析,建立Cox比例风险模型对预后进行单因素和多因素分析。以P<0.05为差异有统计学意义。

    2 结果

    2.1 基线资料

    PSM前,纳入357例患者,其中中药组251例,对照组106例。两组性别(P=0.004)、脏层胸膜侵犯(P<0.001)、伴有癌栓(P=0.044)、高危病理因素(P=0.001)、分化程度(P<0.001)、TNM分期(P<0.001)以及辅助化疗(P=0.041)情况比较,差异具有统计学意义(P<0.05)。PSM后,中药组和对照组均为102例,两组基线资料差异均无统计学意义(P>0.05)。见表1

    表1  PSM前后两组基线资料比较(例)
    项目PSM前PSM后
    中药组(n=251)对照组(n=106)P中药组(n=102)对照组(n=102)P
    性别
    112 65 0.004 69 61 0.244
    139 41 33 41
    年龄
    ≤60岁 124 56 0.554 46 53 0.327
    >60岁 127 50 56 49
    吸烟史
    198 75 0.098 69 73 0.543
    53 31 33 29
    脏层胸膜侵犯
    184 55 <0.001 57 54 0.673
    67 51 45 48
    伴随癌栓
    214 81 0.044 76 80 0.509
    37 25 26 22
    高危病理因素
    142 40 0.001 39 38 0.885
    109 66 63 64
    分化程度
    G1-G2 133 34 <0.001 65 68 0.659
    G3-G4 118 72 37 34
    TNM分期
    155 34 <0.001 35 34 0.888
    35 28 24 27
    ⅢA 61 44 43 41
    辅助化疗
    117 37 0.041 32 35 0.655
    134 69 70 67

    注:  PSM为倾向性评分匹配,TNM为肿瘤分期。高危病理因素为手术后病理标本中组织学亚型含微乳头或实体成分超过10%,否则为不具有高危病理因素。G1为高分化⁃低级别,G2为中分化⁃中级别,G3为低分化⁃高级别,G4为未分化⁃高级别。

    icon 下载:  导出CSV

    2.2 生存分析

    PSM前,中药组5年OS率高于对照组(79.7% vs 64.2%,P=0.001),且5年DFS率较对照组更高(60.6% vs 47.2%,P=0.005)。PSM后,中药组5年OS率高于对照组(68.6% vs 52.5%,P=0.038),中药组5年DFS率较对照组高但差异无统计学意义(49.0% vs 43.1%,P=0.176)。见图1

    fig

    图1  PSM前后两组OS和DFS比较

    注:  OS为总生存期,DFS为无病生存期。A为PSM前两组OS比较(P=0.001),B为PSM前两组DFS比较(P=0.005),C为PSM后两组OS比较(P=0.038),D为PSM后两组DFS比较(P=0.176)。

    icon 下载:  原图 | 高精图 | 低精图

    2.3 预后相关因素分析

    2.3.1 Cox单因素分析

    PSM后的Cox单因素分析结果显示,组织学亚型是否含有高危病理因素(P=0.009)和是否服用中药(P=0.046)与Ⅰ~ⅢA期肺腺癌根治术后患者OS显著相关;组织学亚型是否含有高危病理因素(P=0.031)和TNM分期(P=0.002)与Ⅰ~ⅢA期肺腺癌根治术后患者DFS显著相关。见表2

    表2  影响预后的Cox单因素分析结果
    项目OSDFS
    平均数/月HR(95% CIP平均数/月HR(95% CIP
    性别
    47.208 1 0.786 37.977 1 0.622
    52.189 0.919(0.501~1.686) 37.681 1.131(0.693~1.847)
    年龄
    ≤60岁 48.040 1 0.900 36.963 1 0.886
    >60岁 49.933 0.971(0.609~1.546) 38.724 0.972(0.662~1.427)
    吸烟史
    51.021 1 0.064 39.601 1 0.299
    44.419 1.689(0.970~2.941) 33.903 1.286(0.800~2.065)
    脏层胸膜侵犯
    49.486 1 0.518 38.562 1 0.427
    48.452 1.170(0.726~1.887) 37.043 1.171(0.793~1.728)
    伴随癌栓
    49.231 1 0.950 38.650 1 0.570
    48.313 0.983(0.573~1.686) 35.333 1.135(0.733~1.756)
    高危病理因素
    55.195 1 0.009 45.623 1 0.031
    45.268 2.126(1.206~3.748) 33.169 1.595(1.043~2.438)
    分化程度
    G1-G2 51.732 1 0.719 43.563 1 0.610
    G3-G4 47.564 1.100(0.655~1.846) 34.830 0.895(0.585~1.370)
    TNM分期
    50.971 1 0.149 43.101 1 0.002
    50.176 0.898(0.457~1.768) 44.294 0.850(0.475~1.520)
    ⅢA 46.702 1.512(0.817~2.797) 29.671 2.105(1.271~3.485)
    辅助化疗
    49.403 1 0.332 38.961 1 0.385
    48.825 0.782(0.476~1.285) 37.336 0.828(0.541~1.267)
    服用中药
    46.088 1 0.046 34.837 1 0.193
    51.941 0.623(0.391~0.992) 40.902 0.972(0.662~1.982)

    注:  OS为总生存期,DFS为无病生存期。高危病理因素为手术后病理标本中组织学亚型含微乳头或实体成分超过10%,否则为不具有高危病理因素。G1为高分化⁃低级别,G2为中分化⁃中级别,G3为低分化⁃高级别,G4为未分化⁃高级别。

    icon 下载:  导出CSV

    2.3.2 Cox多因素分析

    将上述单因素分析结果中差异有统计学意义的预后影响因素纳入Cox多因素分析中,结果显示,组织学亚型是否含有高危病理因素(P=0.002)和是否服用中药(P=0.030)是影响Ⅰ~ⅢA期肺腺癌根治术后患者OS的独立因素;组织学亚型是否含有高危病理因素(P=0.027)和临床TNM分期(P=0.001)是影响Ⅰ~ⅢA期肺腺癌根治术后患者DFS的独立因素。组织学亚型有高危病理因素患者5年OS的相对危险度是无高危病理因素患者的2.317倍[95%CI(1.359~3.950),P=0.002],服用中药患者5年OS的相对危险度低于未服用中药者[95% CI(0.382~0.952), P=0.030];组织学亚型有高危病理因素患者术后复发转移的相对危险度是无高危病理因素患者的1.579倍[95%CI(1.052~2.370),P=0.027],在高危病理因素不变的情况下,TNM分期越晚术后复发转移相对危险度增加1.552倍[95% CI(1.225~1.966),P=0.001]。见表3表4

    表3  影响OS的Cox多因素分析结果
    预后因素βSEWalddfPHR(95%CI)
    高危病理因素(否/是) 0.840 0.272 9.524 1 0.002 2.317(1.359~3.950)
    服用中药(否/是) 0.506 0.233 4.713 1 0.030 0.603(0.382~0.952)

    注:  OS为总生存期。高危病理因素为手术后病理标本中组织学亚型含微乳头或实体成分超过10%,否则为不具有高危病理因素。

    icon 下载:  导出CSV
    表4  影响DFS的Cox多因素分析结果
    预后因素βSEWalddfPHR(95%CI)
    高危病理因素(否/是) 0.457 0.207 4.865 1 0.027 1.579(1.052~2.370)
    TNM分期(Ⅰ/Ⅱ/ⅢA) 0.440 0.121 13.276 1 0.001 1.552(1.225~1.966)

    注:  DFS为无病生存期,TNM为肿瘤分期。高危病理因素为手术后病理标本中组织学亚型含微乳头或实体成分超过10%,否则为不具有高危病理因素。

    icon 下载:  导出CSV

    3 讨论

    NSCLC中鳞状细胞癌预后较好,而微乳头状/实体成分腺癌复发的可能性明显高于其他组织学类型

    319。对于Ⅰ期NSCLC术后组织学亚型为微乳头状/实体成分为主的患者是否需要进行辅助治疗临床尚有争议。一项研究20显示,微乳头状/实体成分I B期肺腺癌患者可能从辅助化疗中获益更多,DFS可有效延长。结合此研究,我们临床发现Ⅰ~ⅢA期肺腺癌患者可以通过辅助化疗或靶向治疗结合中医药治疗延长生存期、减少复发。

    徐振晔教授认为肺癌的病因病机主要是精气亏虚、邪毒聚积所致的阴阳失调,采用益气养精、解毒散结法治之,总结并研制出益气养精方(主要由生黄芪、白术、七叶一枝花、干蟾皮、女贞子、黄精、淫羊藿等组成)。前期研究

    21-22显示,益气养精方能够下调肺腺癌A549细胞中肿瘤相关转录因子缺氧诱导因子-1α(HIF-1α)以及血管内皮生长因子(VEGF)受体表达,并能调节A549细胞的糖酵解作用,从而抑制其增殖。临床试验23-24发现,益气养精方治疗晚期肺癌的优势在于改善患者的生活质量、延长生存期。

    临床疗效是中医发展的基础与前提,除了开展临床试验,回顾性研究同样能提供科学有效的临床依据。本研究通过收集临床病例数据,运用PSM法使中药组和对照组间基线资料具有可比性。生存分析发现,PSM前,中药组5年OS率高于对照组(79.7% vs 64.2%,P=0.001),且5年DFS率较对照组更高(60.6% vs 47.2%,P=0.005);PSM后,中药组5年OS率高于对照组(68.6% vs 52.5%,P=0.038),5年DFS率较对照组高但差异无统计学意义(49.0% vs 43.1%,P=0.176)。预后相关因素分析证实,是否含有高危病理因素(P=0.002)和是否服用中药(P=0.030)是影响Ⅰ~ⅢA期肺腺癌根治术后患者OS的独立预后因素;而是否含有高危病理因素(P=0.027)和临床TNM分期(P=0.001)是影响Ⅰ~ⅢA期肺腺癌术后患者DFS的独立预后因素。上述结果提示,Ⅰ~ⅢA期肺腺癌根治术后尤其是组织学亚型有高危病理因素的患者,在西医治疗的基础上服用益气养精方为主的中药,可达到延长生存期的治疗效果。

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