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解密“滴血测癌”:监测患癌风险 不能“包打天下”

2017-05-08 10:52:32   

肿瘤标志物是由肿瘤细胞本身合成、释放,或由机体对肿瘤细胞反应而产生的、标志肿瘤存在和生长的一类物质。它在肿瘤患者体内的含量远远超过健康人群,在肿瘤普查、诊断、判断预后和评价治疗疗效等方面,都具有较大实用价值。肿瘤标志物由于检查简便易行,对身体伤害小,仅需要血液或者体液就可以检测到早期癌症的踪迹,已成为临床实践中广泛使用的重要工具。

如今,热休克蛋白90α作为一种全新的肿瘤标志物,利用其与癌症恶性程度的相关性,发挥“侦察兵”的作用。“其在血液中浓度越高,提示患癌的风险越大。”付彦说。

其实,肿瘤标志物还有很多。2011年,美国国家癌症研究院公布了31个被明确用于癌症检测的产品。其中,以血液为检测对象的有17个,均由外国科学家发现和定义。这些标志物普遍存在灵敏度不高的缺陷,因此,寻找灵敏度高、特异性好、具有自主知识产权的新型肿瘤标志物是全球、更是中国科学家面临的巨大挑战。

罗永章及其团队经过研究,发现热休克蛋白90α在肺癌及肝癌检测的灵敏度和准确度超过了现有的常用肺癌和肝癌标志物。比如,在肝癌检测中,热休克蛋白90α灵敏度达到了93%,比常用的标志物AFP灵敏度高出近一倍。“这是目前世界上最好的数据。该项研究成果为医生的诊疗增加了有价值的信息和判断依据,是肿瘤辅助诊断的新武器,有助于提高我国癌症的诊疗水平。目前,已有很多人因检测热休克蛋白90α而获益。”付彦说。

  创新产品监测患癌风险

付彦告诉记者,尽管围绕Hsp90α的临床转化研究持续多年,国际上也有多个关于Hsp90α抑制剂治疗癌症的临床试验正在开展,但这些处于临床验证阶段的受试品在业内都只能被称作“候选药物”或“候选医疗器械”。目前,全球仅有抗肿瘤蛋白质药物国家工程实验室研发的热休克蛋白90α定量检测试剂盒是获得药监部门正式批准用于临床的产品。

“研发热休克蛋白90α定量检测试剂盒最大的难点在于,它的结构极不稳定,难以研发出性能稳定的检测产品。”付彦说。为攻克难点,罗永章团队通过大量实验,耗费十几年光阴,几十人参与研发,耗资巨大,于2009年终于捕捉到了结构稳定的热休克蛋白90α。此外,该团队还有一项与众不同的绝活——通过重组蛋白质大规模制备技术,制备出结构稳定的热休克蛋白90α。这相当于他们可以自由“制造”这种蛋白。

如何长期保存热休克蛋白90α也是难点之一。要想做出成熟的产品,一定要解决产品的稳定期问题。经过科研攻关,该团队研发出了热休克蛋白90α特定的保护体系,使产品的稳定性达到14个月以上。

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