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慢性髓细胞白血病的规范化疗效监测

2017-10-30 袁昊 闵俊 中华医学信息导报

近年来,血液学、细胞遗传学和分子学监测已成为慢性髓细胞白血病(CML)治疗的重要组成部分。2014年,中华医学会血液学分会、中国CML联盟共同组织专家根据国外指南与推荐,结合我国研究经验,起草制定了中国CML诊疗监测规范,为国内血液科医师提供有关CML诊疗的重要参考。中国CML诊疗监测规范制定至今已有三年,目前国内CML疗效监测发展如何?还存在哪些问题?未来又应该向哪个方向前进?带着这些问题,记者

近年来,血液学、细胞遗传学和分子学监测已成为慢性髓细胞白血病(CML)治疗的重要组成部分。2014年,中华医学会血液学分会、中国CML联盟共同组织专家根据国外指南与推荐,结合我国研究经验,起草制定了中国CML诊疗监测规范,为国内血液科医师提供有关CML诊疗的重要参考。中国CML诊疗监测规范制定至今已有三年,目前国内CML疗效监测发展如何?还存在哪些问题?未来又应该向哪个方向前进?带着这些问题,记者采访了苏州大学附属第一医院陈苏宁教授。

记者:慢性髓细胞白血病(CML)疗效监测的临床意义是什么?目前我国血液科在CML疗效监测中存在哪些问题?

陈苏宁教授:CML是一个非常特殊的病种,具有特征性的染色体异常t(9;22)(q34;q11),形成BCR-ABL融合基因。目前CML的治疗中使用的一些非常有效的治疗药物,实际上也是针对CML特殊的遗传学或者分子生物学靶点。此外,CML与其他多数的肿瘤相比有一个特别之处,它有极其有效的监测方法来监测染色体异常或融合基因,可以让临床医师相对准确地判断药物的疗效,并以此评估患者体内残留的恶性细胞数量。

CML患者在进行治疗时,临床医师需要注意两点:第一是选择合适的靶向药物,并要规范化地应用于患者。第二是要进行规范的疗效监测,其临床意义在于能够帮助临床医师评估药物的疗效,同时也能预测患者将来能否尝试停药,达到无治疗生存。

目前我们对CML患者的治疗主要有三类疗效监测手段:第一类是最基本的血液学监测;第二类是遗传学监测;第三类是现在发展最快的分子生物学监测。这三类监测手段各有特点,需要交叉进行才能达到理想的监测目的。

近几年CML疗效监测技术发展很快,临床医师与患者对其观念的理解也有很大程度的改善,但还存在一些问题。其中尤其应该注意的是,要严格按照CML疗效监测指南中建议的时间点进行监测。目前我国血液科的临床医师对规范化CML疗效监测的理解比较深入,但部分患者还不够重视。一些患者在长期治疗中会遗漏某些监测,尤其是带有痛苦性的监测手段,这时候就需要医师及时与患者沟通,让患者理解每一项监测都有各自的意义,这是CML疗效监测临床应用中的关键。近年来,部分企业积极履行社会责任,也在某种程度上起到了重要的推动作用,而且承担了部分患者接受疗效监测的费用,减轻了患者的经济负担,受到医患双方的一致欢迎。

记者:请您谈一谈标准实验室建设的必要性,中国RQ-PCR国际标准化项目取得了哪些进展和成绩?

陈苏宁教授:对于CML疗效监测,特别是分子生物学监测,标准化的实验室建设非常重要。因为分子监测的影响因素很多,标本的采集运输、后期的数据分析、实验室场地的设置、仪器的选择以及实验人员的操作等等因素都可能对监测结果产生影响。所以,标准化分子诊断实验室的建设重点有两个,第一是实验室内部的质量控制建设,即每一个实验室都要在人员、场地、设备、流程等影响因素上达到足够高的标准,这是一个基本要素。

第二是在实验室内部质控的基础上,达到与外部实验室之间的数据转换,即室间质控。比如说在苏州进行CML治疗的患者转院到北京去治疗,两地的分子诊断实验室受到人员与场地等因素的影响,结果数据会有所不同,如何达成统一?通过室间质控方法,建立一个包括样品和数据的交换标准,获得两个实验室之间的数据转换系数,数据之间可以互相参考,得出准确的监测结果。室间质控还可以通过与其他单位样品交换来衡量实验室内部质控情况,帮助判断人员调换、设备更新、季节更替等影响因素变化后实验数据是否稳定。同时,室间质控的数据对CML治疗的多中心临床研究很有帮助,能够帮助研究者使用统一的标准来衡量药物对患者的疗效。

室间质控在欧美国家已经有很好的先例。我国在这方面起步较晚,但发展很快,尤其是近几年,在北京大学人民医院黄晓军教授牵头下,国内近40家PCR检测实验室在内部质控标准良好的基础上,通过样品交换等方式获得了标准数据转换系数,为我国CML疗效监测技术的发展作出了重要贡献。

记者:关于CML治疗反应的监测技术,请您谈一谈,近年来,定量PCR和突变监测技术取得了哪些进展?

陈苏宁教授:定量PCR是目前CML疗效监测中最重要的技术之一,近年来的主要进展有两点。第一是标准化,国内外在定量PCR对CML治疗效果的标准监测体系、内部参数选择以及内部质控体系等方面都有所进展。第二个主要进展集中在数字PCR技术上,数字PCR与传统的荧光定量PCR相比,在微量残留检测的可靠性方面极具优势。

目前不论国内还是国外,主要的突变监测手段都是以PCR扩增及桑格法测序为基础。桑格法测序也是我国目前CML分子监测的标准技术,但它有一个缺陷,就是对基因突变的检测敏感度很低。目前突变监测技术的进展主要体现在一些新的分子监测技术,特别是第二代基因测序技术。很多患者都是在前期治疗效果不佳后才发现有突变的情况,如果积极应用第二代基因测序技术,临床医师甚至可以在用药之前就发现患者的突变情况,从而转换治疗方法。目前,第二代基因测序技术体现出越来越重要的价值,它能够大幅度提高突变监测的敏感性,这是其与传统分子监测技术相比之下的主要优势。

记者:我们了解到,您担任了中华医学会血液学分会青年委员会副主任委员、实验诊断学组副组长。请您谈一谈,我国在CML的规范化、标准化监测中做出的努力,未来实验诊断学组在这些方面有哪些工作计划?

陈苏宁教授:近几年来,我国在CML疗效分子监测的规范化或者标准化建设方面进展很快,国内规范化的实验室数量越来越多,其中不仅有大型的血液病诊疗中心,还包括一些颇具规模的第三方检验机构。另一个进展是在提高检测敏感性和稳定性方面,国内的实验室不仅在进行内部的质控建设和外部的室间质控,同时也在一些国际先进的大型实验室帮助下,评估实验室检测能力、敏感性以及稳定性。

实验诊断学组在吴德沛教授的带领下,接下来主要有几个方面的工作,第一是继续推进标准化PCR实验室的建设,包括内部的质量控制建设与外部的室间质控。第二个是加强CML细胞遗传学监测技术的标准化与规范化。细胞遗传学监测技术是一种比较依靠个人经验的技术,所以学组一直在尝试通过国内多个单位的协作来推进遗传学监测技术的标准化和规范化。

陈苏宁,1973年生于江苏省南通市,苏州大学附属第一医院血液科副主任、血液研究室主任,教授,主任医师,博士生导师,江苏省特聘教授,江苏省杰出青年基金获得者,江苏省医学重点人才,姑苏卫生重点人才;中华医学会血液学分会青年委员会副主任委员、实验诊断学组副组长、白血病淋巴瘤学组委员,中国病理生理学会实验血液学分会委员,江苏省医学会血液学分会副主任委员。2003年7月获苏州大学内科学(血液病)博士学位,学位论文荣获2005年全国优秀博士学位论文提名。2003年8月起于苏州大学附属第一医院血液科从事血液病临床诊疗工作。2007年4月获得德国洪堡基金会资助,作为洪堡学者于德国DSMZ从事白血病合作研究。2010年,作为项目负责人获美国白血病淋巴瘤协会(LLS)和国际华氏巨球蛋白血症基金会(IWMF)科研资助。先后主持国家自然科学基金面上项目、“863”计划子项目、“973”计划子项目和江苏省社会发展重点项目等10项。荣获国家科技进步奖二等奖1项、省部级科技进步奖一等奖3项,作为通讯作者或第一作者发表SCI论文40余篇,主编专着1部。

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    2017-11-01 chengjn
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    2017-10-31 三生有幸9135

    学习一下谢谢分享

    0

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    2017-10-30 wqkm

    ^_^^_^^_^^_^

    0

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    2017-10-30 changjiu

    学习一下.谢谢

    0

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