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免疫哨兵-肺癌早期诊断

 

MIANYISHAOBING-FEIAIZAOQIZHENDUAN

 

1  前言:
在我国以及全世界范围内,肺癌发病率和死亡率均居恶性肿瘤之首,尽管全球投入巨大资金,但离攻克肺癌还有非常远的路要走。在过去10年中,全球新靶点、新作用机制的抗肿瘤药物不断涌现,为临床提供了更多用药选择,然而一个客观现实是,现有的抗肿瘤药物对肺癌患者仍只能起到缓解病情的作用。肺癌依旧是一个世界性难题。

       GUOJIAAIZHENGZHONGXIN2015NIANFABUDESHUJUXIANSHI,2006NIAN-2011NIANWOGUOFEIAI5NIANHUANBINGLVSHI130.2(1/10WAN),QIZHONGNANXING84.6(1/10WAN),JUEXINGZHONGLIUDI2WEI,NVXING45.6(1/10WAN),JUEXINGZHONGLIUDI4WEI。FEIAIYIJIUSHISHIJIEXINGNANTI,ZAIWANQIEXINGZHONGLIUZHILIAOJINZHANHUANMANDEQINGKUANGXIA,HENDUOZHUANJIAHUYUJIANGGENGDUODEYILIAOZIYUANTOURUAIZHENGDEZAOQIZHENDUANZHONG,TIGAOFEIAIZHENGTISHENGCUNLV。MUQIANLINCHUANGSHANGGUANGFANYUNYONGDEDADUOSHUZHONGLIUBIAOZHIWUJINZAIJIBINGJINZHANDAOWANQISHI,CAINENGJIANCEDAOXUEYEZHONGQINONGDUSHENGGAO,QUEFAZAOQIZHENDUANDEJIAZHI。

       AIZHENGZAOQIFAXIANSHIYIGEFEICHANGFUZADELINCHUANGNANTI,LINCHUANGJIXUYIGEDUIFEIAIYOUGAOTEYIXINGXUEQINGLEIBIAOZHIWU。ZAIGUOJIAWEIJIWEIFEIAIZHUANJIAZUCHENGYUAN、SHANGHAISHIFEIKEYIYUANZHONGLIUKEZHURENZHOUCAICUNJIAOSHOUZUZHIDELINCHUANGYANJIUTUANDUIDEDAILINGXIA,JINGGUOZHONGGUOLIUJIALINCHUANGDUOZHONGXINJINXINGLEDAYANGBENLINCHUANGYANJIU,HANGZHOUKAIBAOLUOSHENGWUKEJIYOUXIANGONGSIZIZHUYANFADEQIZHONGZISHENKANGTIJIANCESHIJIHE,BEIGUOJIASHIPINYAOPINJIANDUGUANLIJUSHOUGEPIZHUNYONGYUZAOQIFEIAIJIANCE。

        SHANGHAISHIFEIKEYIYUANZHONGLIUNEIKEZHURENZHOUCAICUNJIAOSHOUJIESHAO,ZAILIXIANGDEZHUANGTAIXIA,LINCHUANGSHAICHAZHENDUANFEIAIDEFANGFAYAOQIUJIANDAN、KUAIJIE、GAOTEYIXING。CONGXUEYEZHONGJIANCESHIQUANQIUFEIAIZAOQIZHENDUANNULIDEFANGXIANG,ZAIZHONGDUOFENZISHENGWUBIAOZHIWUXINJISHUZHONG,FEIAIZISHENKANGTIPUXUEYEJIANCEJISHUYIJINGCONGSHIYANSHIZOUXIANGLINCHUANG,ZAIBEIMEICONG2009NIANKAISHIZAILINCHUANGSHANGGUANGFANYUNYONG,2012NIANYINGGUONHSKAIZHANLEJIYUFEIAIQIZHONGZISHENKANGTIXUEQINGBIAOJIWUDEDAGUIMOFEIAISHAICHAXIANGMU,ZHEISHIMUQIANSHIJIESHANGZUIDADEJIYUXUEQINGBIAOZHIWUFEIAISHAICHAYANJIUXIANGMU,GAIXIANGMUZAI2015NIANSHIJIEFEIAIDAHUISHANGGONGBULEDIYIJIEDUANDEYANJIUCHENGGUO,TEYIXINGGAODA91%;2015NIANZHONGGUOCFDAYEPIZHUNLEFEIAIQIZHONGZISHENKANGTIXUEQINGJIANCEJISHUZAILINCHUANGSHANGDEYUNYONG。

         GAIFEIAIKANGTIPUJIANCEJISHUSHOUDAOQUANQIUFEIAIQUANWEIJIGOUYUZHONGLIUQUANWEIJIGOUDEGAODURENKE。2015NIANSHIJIEFEIAIDAHUI(WCLC)、MEIGUOZHONGLIUXUEHUINIANHUI(ASCO)XIANGJIYAOQINGGAILINCHUANGTUANDUIJINXINGDAHUIFAYANYUJIAOLIU。SHIJIEFEIAIDAHUISHIQUANQIUFEIAILINGYUGUIMOZUIDA、GUIGEZUIGAODEXUESHUHUIYI,ZAI2015NIAN9YUEMEIGUODANFOJUXINGDEDI16JIESHIJIEFEIAIDAHUISHANG,SHANGHAISHIFEIKEYIYUANSHOUYAOXIANGQUANQIUDINGJIANFEIAIZHUANJIABAOGAOQIZHONGFEIAIZISHENKANGTIFEIAIZAOQIZHENDUANYANJIUCHENGGUO,SHOUDAOSHIJIEZHUANJIAGAODUPINGJIA。TONGSHI,GAICHANPINLINCHUANGYANJIUZAI2015NIANBEIMEIGUOLINCHUANGZHONGLIUXUEHUINIANHUI(ASCO)SHOULUCHENGWEICANHUITAOLUNXIANGMU。

2、七种肺癌自身抗体谱检测产品简介

       TASHIYISHENGKAICHUDEXUEYEJIANCHA,TONGGUOJIANCERENXUEQINGZHONGQIGEFEIAIZISHENKANGTIDENONGDULAIJIANCERENTINEIZHONGLIUXIBAODECUNZAI,LINCHUANGDUIFEIXIAOJIEJIEFEIAIWEIXIANFENCENG,DUIFEIAIGAOWEIRENQUNZHONGDEFEIAIZAOQIJIANCE。

       RENTIDUIKANGZHONGLIUDEMIANYIFANYINGSHIZHONGLIUFASHENGZAOQISHIJIANZHIYI。ZISHENKANGTIDEJIANCEKEYIZAIZHONGLIUZAOQISHIDUIZHONGLIUJINXINGYOUXIAOZHENDUAN,BIANYUZAOQIZHILIAO,TIGAOZHIYULV。

GUOWAIYANJIUXIANSHIZAIFEIAIQUEZHEN5NIANQIANJIUKEYIJIANCEDAOXUEQINGZHONGYOUZHENDUIZHONGLIUKANGYUANDEKANGTI[1,2]。

3、   产品机理

          CHANPIN“QIZHONGZISHENKANGTIJIANCESHIJIHE(MEILIANMIANYIFA)”DEJISHUHEXINSHIZHONGLIUMIANYIYINGDAJILI,ZAIZHONGLIUFABINGZAOQI,JITIDEMIANYIXITONGKESHIBIEZHONGLIUXIBAONEIBIAODAYICHANGDEDANBAI,MIANYIYINGDAZAIAIZHENGZAOQIYOUHENQIANGDESHENGWUXINHAOFANGDAZUOYONG,ZAIZHONGLIUBIAOXINGXIANXIANZHIQIANJIUKEYIJIANCEDAOXUEQINGDEKANGTISHUIPING。YUCHUANTONGDEKANGYUANLEIBIAOZHIWUXIANGBI,ZISHENKANGTIZHONGLIUBIAOZHIWUYOUTIANRANDEGAOTEYIXINGYUMIANYISHENGWUFANGDAXINHAOXITONGDENGDUTEYOUSHI,YIJINGCHENGWEIGUOJISHANGZHONGLIUZAOQIZHENDUANLINCHUANGYINGYONGDEJISHUFAZHANQUSHI。QIGEFEIAIZISHENKANGTIBENSHIJIHEJIANCEYIXIAKANGYUANDANBAICHANSHENGDEZISHENKANGTI:KANGYUAN FENZILIANG

GAGE7   13 kDa

SHUYUZHONGLIU-GAOWANKANGYUAN,ZAIFEIAIZHONGGUOBIAODA,LINZHUANGXIBAOAIBIANZENGSHENGJIANCHUDEBIAODAWEI86%[3,4],GUOWAIYOUDUIYUFEIXIAOXIBAOFEIAIDEZHILIAOBADIANYANJIU

CAGE   69 kDa

SHUYUZHONGLIU-GAOWANKANGYUAN,ZAIFEIAIZHONGBIAODAZENGGAO,ZAIFEIXIAOXIBAOBIAODAYUE13%-23%[5]

MAGE A1  34 kDa

ZAIFEIXIAOXIBAOFEIAIZHONG32%BIAODA,ZAIXIANAIZHONGDEBIAODALIANGYUZHONGLIUHUAISICHENGZHENGXIANGGUAN[6-8]。

SOX2   34 kDa

TONGGUODIAOKONGRAS→MAPK→SURVIVINXINHAOTONGLULAISHIXIANFEIAIXIBAOZHONGAIJIYINDEBIAODA,JINERDIAOKONGFEIAIDEFASHENG。ZAIFEIAIFASHENGYUDIAOWANGXINHAOTONGLUZHONGQIDAOZHONGYAOZUOYONG,CANYUDIAOKONGFEIAIGANXIBAOSHENGZHANGJIDIAOJIEDEFENZIJIZHI。ZAIXIAOXIBAOFEIAIZHONGYOU50%-60%BIAODA[9-12]。

GBU4-5   45 kDa

SHUYUZHONGLIU-GAOWANKANGYUAN,ATPYILAIDEJIEXUANMEI,KONGZHIXIBAOFENHUAGUOCHENGZHONGZHUANZUOZIDEJIAJIHUAHEJIYINBIAODAYIZHIZUOYONG。ZAIFEIXIAOXIBAOFEIAIZHONGBIAODAZENGGAO,4%-9%BIAODA[3,13-15]。

PGP9.5   25 kDa

FANSUSHUIJIEMEI,DIAOJIEXIBAOZHOUQIJIYINDEBIAODA。QIBIAODAZENGGAOYUFEIAIDEJINZHANXIANGGUAN。ZAILINAIHEFEILINAIZHONGDOUYOUJIAOGAODEBIAODA。ZAIYUANFAXINGFEIXIAOXIBAOFEIAIZHONG,54%DEBINGLIPGP9.5RANSEYANGXING[16,17]。

p53    53 kDa

YIAIJIYIN,YUZHONGLIUFASHENG、DIAOKONGYIJIZHONGLIUXIBAODIAOWANGDENGGUANXISHIFENMIQIE;JIYINTUBIANSHIRENLEIZHONGLIUZUICHANGJIANDEJIYINGAIBIAN,YUE50%~60%DEFEIXIAOXIBAOFEIAIHE80%XIAOXIBAOFEIAIYOUp53TUBIAN[18-21]。

4、为什么选择这一组肺癌抗体谱检测?

ZHEIYIZUZISHENKANGTISHIHANGZHOUKAIBAOLUOSHENGWUKEJIYOUXIANGONGSIZHENDUIZHONGGUORENZHONGFANFUYANFAERDING。

ZHEIZUZISHENKANGTIBIAOZHIWUXUANZEYIJU:DUIBUTONGLEIXINGFEIAIJUNYOUHENGAOTEYIXINGHEMINGANXING;DUIYINGKANGTIDEKANGYUANWEIZHONGLIUTEYIXINGKANGYUAN(tumor specific antigens,TSA),TSASHIZHONGLIUXIBAOSUOTEYOUDE,BUCUNZAIYUZHENGCHANGXIBAOSHANGDEKANGYUAN。TSAJUYOUQIANGMIANYIYUANXINGNENGCHANSHENGZHONGLIUZISHENKANGTI。

CHUANTONGDECEADENGZHONGLIUBIAOZHIWUWEIZHONGLIUXIANGGUANKANGYUAN(tumor-associated antigens,TAA),ZHONGLIUXIANGGUANKANGYUANSHIZHIFEIZHONGLIUXIBAOSUOCHIYOU,YEKECUNZAIYUZHENGCHANGZUZHIXIBAOTEBIESHIPEITAIZUZHISHANGDEKANGYUAN。YINERZAIZHONGLIUXIBAOHEZHENGCHANGZUZHIZHIJIAN,TAAZHIXIANSHILIANGDEBIANHUA。TAAMIANYIYUANXINGBIJIAORUO,WUFACHANSHENGZHONGLIUZISHENKANGTI。

  1. 临床应用:有代表性临床研究本产品在全国多中心进行广泛深入的临床研究,比较有代表性的研究是由中国抗癌协会肺癌专业委员会常委、上海肺科医院肿瘤科主任周彩存教授牵头的6家多中心2008例临床样本研究[22]。本次临床试验为了能够在多中心临床试验上具有地域分布、经济发展状况分布和学科分布的代表性,根据我国肺癌高发的区域,选择了以下六家临床中心:上海市肺科医院、北京胸科医院、浙江省肿瘤医院、河南省肿瘤医院、湖北省人民医院和南京鼓楼医院。

‚QUANGUOMUQIANLINCHUANGYINGYONGQINGKUANGGAICHANPINMUQIANYITONGGUOYIYUANNEIZHAOBIAOJINRUDISIJUNYIDAXUETANGDOUYIYUANSHIYONG,CHANPINDINGJIA840YUAN/RENFEN,SHIQUANGUODIYIGECAIGOU、SHIYONGGAICHANPINDEYILIAOJIGOU。ƒQUANGUOWUJIAXINXI

MUQIANQUANGUOGESHENGDEYILIAOJIGOUDOUZHENGZAIJIJISHENBAOSHOUFEIXIANGMU,GENJUDIYUCHABIEDINGJIAFANWEIZAI840YUAN/RENFENDAO1200YUAN/RENFENZHIJIAN。

ƒGUOWAITONGLEICHANPINZAIBEIMEIHEOUZHOUYUNYONGRUHE?GUOWAIZISHENKANGTIPUJIANCECONG2009NIANKAISHIYIBEIMEIGUOHEJIANADALINCHUANGGUANGFAYUNYONG,YONGYUFEIAIGAOWEIRENQUNDEFEIAIZAOQIJIANCEYUFEINEIXIAOJIEJIELIANGEXINGGAOWEIFENCENGGUANLI。

MUQIANBEIMEIYIJINGYOUCHAOGUO2000MINGYISHENGZAILINCHUANGZHONGYUNYONGGAICHANPIN,ZAICHAOGUO12WANMINGHUANZHEZHONGJINXINGLEJIANCE。

YINGGUONHS(GUOJIAYILIAOFUWUTIXI)ZAI2012NIANKAISHIYONGFEIAIZISHENKANGTIPUJINXINGGUOLIFEIAISHAICHAYANJIU。

ZHEISHIQUANQIUZUIDADEYONGXUEYEBIAOZHIWUJINXINGFEIAISHAICHADEYANJIU,BIAOZHIZHEFEIAIZISHENKANGTIPUZUOWEIFEIAISHAICHAHOUXUANJISHUSHOUDUANDEDAOLEGUOWAIGUOJIAWEISHENGJIGOUCENGMIANDERENKE。

6. 社会意义

FEIAIDEFASHENG、FAZHAN、QINXIHEZHUANYISHIYIGEFUZADEDUOJIEDUAN、DUOBUZHOUJIANBIANDEGUOCHENG,FEIAIJIHUANZHE、HUANZHEJIATINGHESHEHUIDAILAILENANYIMIBUDECHUANGSHANG。FEIAIBINGRENJINGSHOUSHUZHILIAODE5NIANSHENGCUNLVWEI30%~42%,FEISHOUSHUZHILIAODE5NIANSHENGCUNLVWEI4%~12%。ZAOQIHEZHONGWANQIZHILIAOXIAOGUOJIERANBUTONG,CHAYIHENDA。0~ⅠQI5NIANSHENGCUNLV>80%,ERⅢ-ⅣQIZHONGWEISHENGCUNQIJINWEI6~10YUE。YINCIWEIYIDECUOSHISHIJIANGFEIAIZHENDUANGUANKOUQIANYI,JINXINGZAOFAXIAN、ZAOZHENDUAN、ZAOZHILIAO,YIQIJIANGDIGUODUZHENLIAODAILAIDESUNHAOHEYILIAOZIYUANLANGFEI,ZUIDACHENGDUDIYANZHANGHUANZHEDESHENGCHANSHIJIAN、TIGAOSHENGCUNLV、GAISHANHUANZHESHENGHUOZHILIANG。

7、适应症

TONGSHIJIANCEFEIXIAOXIBAOFEIAIYUXIAOXIBAOFEIAI

‚NENGJIANCEBUTONGZUZHIYAXINGFEIAI(LINAI、XIANAI、DAXIBAOFEIAIDENG)

ƒNENGJIANCEBUTONGFENQIFEIAIZHENG(BAOKUOZAOQIFEIAI)

8、参考文献

1[1]Autoantibodies in Lung cancer: possibilities for early detection and subsequentcure.Thorax 2008; 63: 228-233.

2[2]P53 autoantibodies predict subsequent development of cancer. Int. J. Cancer 2005;114: 157-160.

  1. [3]Chapman CJ, et al. (2008) Autoantibodies in lung cancer:possibilities for earlydetection and subsequent cure. Thorax63(3):228-233.
  2. [4]AmericanJournal of Respiratory and Critical Care Medicine. 2005;172:1308-1314.
  3. [5]Park S, et al. (2003) Identification and characterization of a novelcancer/testis antigen gene CAGE-1. BiochimBiophys Acta 1625(2):173-182.
  4. [6]Yanagawa N, Tamura G, Oizumi H, Endoh M, & Motoyama T (2011) MAGEexpressions mediated by demethylation of MAGE promoters induce progression ofnon-small cell lung cancer. AnticancerRes 31(1):171-175.
  5. [7]Matkovic B, et al. (2011) Expression of MAGE-A and NY-ESO-1 cancer/testisantigens in medullary breast cancer: retrospective immunohistochemical study. Croat Med J 52(2):171-177.
  6. [8] Jungbluth AA, et al. (2000) Monoclonalantibody MA454 reveals a heterogeneous expression pattern of MAGE-1 antigen informalin-fixed paraffin embedded lung tumours. Br J Cancer 83(4):493-497.
  7. [9]Hirohashi Y, et al. (2009) The functioning antigens: beyond just as theimmunological targets. Cancer Sci100(5):798-806.
  8. [10]Rudin CM,et al. (2012) Comprehensive genomic analysis identifies SOX2 as afrequently amplified gene in small-cell lung cancer. Nat Genet 44(10):1111-1116.
  9. [11]Maddison P, Thorpe A, Silcocks P, Robertson JF, & Chapam CJ(2010)Autoimmunity to SOX2, clinical phenotype and survival in patients withsmall-cell lung cancer. Lung Cancer70(3):335-339.
  10. [12]Gure AO, et al. (2000) Serological identification of embryonic neural proteinsas highly immunogenic tumor antigens in small cell lung cancer. Proc Natl Acad Sci U S A97(8):4198-4203.
  11. [13]Murray A, et al. (2010) Technical validation of an autoantibody test for lungcancer. Ann oncol 21(8):1687-1693.
  12. [14]Lam S, et al. (2011) EarlyCDT-Lung: an immunobiomarker test as an aid to earlydetection of lung cancer. Cancer Prev Res(Phila) 4(7):1126-1134.
  13. [15]Boyle P, et al. (2011) Clinical validation of an autoantibody test for lungcancer. Ann Oncol 22(2):383-389.
  14. [16]Hibi K, et al. (1999) PGP9.5 as a candidate tumor marker for non-small-celllung cancer. Am J Path l 155(3):711-715.
  15. [17]Sasaki H, et al. (2001) Expression of the protein gene product 9.5, PGP9.5, iscorrelated with T-status in non-small cell lung cancer. Jpn J Clin Oncol 31(11):532-535.
  16. [18] Wu M, Mao C, Chen Q, Cu XW, & ZhangWS (2010) Serum p53 protein and anti-p53 antibodies are associated withincreased cancer risk: a case-control study of 569 patients and 879 healthycontrols. Mol Biol Rep 37(1):339-343.
  17. [19] Mack U, Ukena D, Montenarh M, &Sybrecht GW (2000) Serum anti-p53 antibodies in patients with lung cancer. Oncol Rep 7(3):669-674.
  18. [20] Shimada H, Ochiai T, & Nomura F(2003) Titration of serum p53 antibodies in 1,085 patients with various typesof malignant tumors: a multiinstitutional analysis by the Japan p53 AntibodyResearch Group. Cancer 97(3):682-689.
  19. [21] Park Y, Kim Y, Lee JH, Lee EY, & KimHS (2011) Usefulness of serum anti-p53 antibody assay for lung cancerdiagnosis. Arch Pathol Lab Med 135(12):1570-1575.
  20. [22]September 7, 2015 InternationalAssociation for the Study of Lung Cancer (IASLC);
  21. [23]Progress with an RCT of the Detectionof Autoantibodies to Tumour Antigens in Lung Cancer Using theEarlyCDT-Lung Test in Scotland (ECLS)
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