美国FDA意将真实世界研究取代传统临床试验

2017-01-12 MedSci MedSci原创

有专家称,真实世界研究(Real-World Study,以下简称RWS)将是未来研究的趋势,相对随机对照试验(Randomized Controlled Trial,以下简称RCT)而言,RWS的研究范围更广,更具有代表性,能够真实地反映研究的情况。2016年12月25日,美国国会在官方网站上公布了《21世纪治愈法案(21st Century Cures Act)》(以下简称法案)最终版本, 该

有专家称,真实世界研究(Real-World Study,以下简称RWS)将是未来研究的趋势,相对随机对照试验(Randomized Controlled Trial,以下简称RCT)而言,RWS的研究范围更广,更具有代表性,能够真实地反映研究的情况。

2016年12月25日,美国国会在官方网站上公布了《21世纪治愈法案(21st Century Cures Act)》(以下简称法案)最终版本, 该法案从提出到一次次修改,再到这次最终版推出,历经两年多时间,终于让这一推动美国未来10年或更长时间内生物医学创新研发、疾病治疗及大健康领域发展的法案落地生根。

而法案中关于利用“真实世界证据”取代传统临床试验进行扩大适应症的批准,更是牵动了业界的神经,对此,业内人士认为会加快药品获批速度,但也担忧这降低了审评的科学性,预示着不良趋势的开端,甚至认为是好不容易建立起来的科学审评的倒退,21世纪法案简直是重回20世纪以前。

为此,FDA在《新英格兰医学》上发表了一篇文章《真实世界证据——它是什么以及它能告诉我们什么?》(Real-World Evidence — What Is It and What Can It Tell Us?),呼应法案的同时向外界展示FDA自己的考量。


而此次FDA在《新英格兰医学》发文也意在澄清两个问题:一是真实世界证据(Real-World Evidence,以下简称RWE)并不等于不采用干预性试验和随机化的试验设计;二是RWE用于审批仍要遵循严格的科学基础。

这篇文章在纠正目前对于RWE这一概念的误读,认为它与传统临床试验等其他科学证据的区别不在于类似随机对照试验(RCT)的设计,而在于获取数据的环境界定。

RWE vs. RCT

  


而RWE最终用于支持审评审批,仍要通过科学的研究方法,对获得的数据进行合理的组织和解读,形成有效的结论,而这些研究方法既可以包括干预性甚至随机对照的设计,也可以是观察性的。据此FDA认为,RWE要从两个维度进行考量,即数据获得和研究方法。

RWS代表未来研究趋势?

RWS是起源于实用性的临床试验,属于药物流行病学的范畴。是基于临床真实的情况采取的一种非随机、开放性、不使用安慰剂的研究,因此其得出的结果具有很高的外部有效性。目前RWS已得到很多医学领域的重视,有些学科已经建立了较为完整的观察性队列、登记和管理型数据库。

RWS是以患者为中心的结局研究,具有以下特点:研究的实施地点以及干预条件为真实的临床实践环境;受试者的选择一般不加特别的限制条件;干预措施也如临床实际,并可由患者和医师进行交流而改变干预方法。真实世界研究环境无盲法,无随机对照,无安慰剂治疗,研究的结论可直接推之于临床实践。

实际上,中国临床科研里程碑式的跨越也都源于对真实世界的数据研究,从2004年发起的中国慢性病前瞻性研究(KSCDC),到2015年中国癌症统计数据登上世界殿堂级学术期刊CA(IF:144.8)这都是开展真实世界研究的典型范例,而伴随这些研究也产生大量高水平的研究成果。

真实世界研究不仅可以减少传统研究的限制,而且还可以反映真实世界中治疗药物的临床疗效,为临床选择使用新药及新型设备提供客观的对比依据。通过真实世界数据证据,充分了解指南与实践的差距,为指南的制定与规范提供参考,而且还能平衡临床疗效和成本效益。

RWS也有“窘境”

虽然真实世界研究有那么多好处,但是也存在一些难题:真实世界研究一般不是以药品为中心,而是以患者为中心,药企是否愿意投入是其中一个问题;真实世界研究需要大量的研究样本,甚至多中心事件,收集数据难度高,工作量庞大;数据异质性强,对统计方法的要求比传统研究更高;多属于回顾性分析或事后分析,研究证据等级受到挑战。面对如此多的问题,RWS似乎显得举步维艰,这些急需解决的问题需要后来者解决,以推动RWS的发展。

就在上个月,美国国会在官方网站上公布了《21世纪治愈法案(21st Century Cures Act)》(以下简称法案)最终版本, 该法案从提出到一次次修改,再到这次最终版推出,历经两年多时间,终于让这一推动美国未来10年或更长时间内生物医学创新研发、疾病治疗及大健康领域发展的法案落地生根。

而法案中关于利用“真实世界证据”取代传统临床试验进行扩大适应症的批准,更是牵动了业界的神经,对此,业内人士认为会加快药品获批速度,但也担忧这降低了审评的科学性,预示着不良趋势的开端,甚至认为是好不容易建立起来的科学审评的倒退,21世纪法案简直是重回20世纪以前。

为此,FDA在《新英格兰医学》上发表了一篇文章《真实世界证据——它是什么以及它能告诉我们什么?》(Real-World Evidence — What Is It and What Can It Tell Us?),呼应法案的同时向外界展示FDA自己的考量。

而此次FDA在《新英格兰医学》发文也意在澄清两个问题:一是真实世界证据(Real-World Evidence,以下简称RWE)并不等于不采用干预性试验和随机化的试验设计;二是RWE用于审批仍要遵循严格的科学基础。

这篇文章在纠正目前对于RWE这一概念的误读,认为它与传统临床试验等其他科学证据的区别不在于类似随机对照试验(RCT)的设计,而在于获取数据的环境界定。

而RWE最终用于支持审评审批,仍要通过科学的研究方法,对获得的数据进行合理的组织和解读,形成有效的结论,而这些研究方法既可以包括干预性甚至随机对照的设计,也可以是观察性的。据此FDA认为,RWE要从两个维度进行考量,即数据获得和研究方法。

RWS vs RCT :数据的获得方式及研究方法

RCT以其对无关变量的控制、极其标准化的结果生成形式和专业化人员的持续监察,在产生科学证据方面拥有巨大优势。相对而言,人们往往认为RWE是对于现有临床实践证据的总结、分析和解读,而这些证据由于缺乏预先设计,难以排除诸多干扰因素,也就难以得出更为真实的结论。

但在FDA看来,RCT也有其本质上的缺陷。从科学的角度来说,RCT通过一系列入选排除标准选取一定样本的特定人群,无法确定在真实临床实践中的可推广性,另外出于控制变量的设计,RCT很少获得关于伴随疾病和伴随治疗的信息,并且为了依从研究方案往往采取较多的干预措施,这在临床实践中也不太现实。

从成本角度来说,大型传统临床试验的费用水涨船高,但由此获得的临床证据却没有得到相应程度的积累,也就是说,每次审批决策都要重新开展规模相似的临床试验,这意味着成本经济性较差。

相反,RWE植根于真实的临床实践,来源相当广泛,可以包括电子病历、医保数据库、电子设备和app、患者登记项目,甚至社交媒体。FDA认为,这些资源的合理使用可以产生一些新的价值。

当然,FDA承认这里存在的问题很多,比如非研究目的产生的数据如何标准化,并且保证其准确性和可靠性,此外不经过严格的知情同意也会带来数据隐私暴露的风险。

但FDA认为这些问题是可以尝试解决的,包括建立大规模研究网络,并构建计算化的模型,直接从复杂的数据来源中提取所需的临床特征数据。最终目的是让研究人员能够利用这些特征数据,按照自己的目的识别和构建研究队列。

研究方法:老法酿出新酒

孤立的数据没有任何意义,RWE数据也只有在合理的研究设计中才能体现出价值,并最终引向审批决策。FDA认为,对RWE数据的分析并没有突破临床试验的设计方法,但除了通常认为的观察性试验以外,也可以采用类似于RCT设计的干预性试验。

FDA认为,真实世界的干预性试验可以不像传统RCT那样需要劳动密集的临床研究支持,对试验人员的临床研究水平可能也不用要求太高。随后FDA耐人寻味地列举了两个在真实世界中采取干预性试验的著名案例,分别是1954年进行的麻痹性脊髓灰质炎疫苗大型试验,以及2015年启动的阿司匹林心血管获益研究(ADAPTABLE)。

前者是有史以来进行的规模最大、结果最为公开的试验之一,疫苗和安慰剂对照组共计~60万儿童,另有开放试验组~100万儿童。当时已有小规模临床试验表明疗效,但决策方对该疫苗的安全性以及作用机制的有效性提出质疑。

研发人员认为,“计算出的风险(calculated risk)”支持该疫苗的临床应用,而如果继续进行大样本研究,可能会让更多的儿童患上这种脊髓灰质炎,错失疾病预防的最佳时机。因此,设计了这项真实世界的随机对照研究,但对照组的使用增加了“计算出的风险”,因此又增设了一个开放性试验组。

阿司匹林的大型试验离我们时间很近,起因是我们感觉到它在心血管疾病中的获益,但从现有的回顾分析中无法得出确证性的结论,也无法确定最佳的给药方案,而一旦这个百年老药确实有效,人们每天仅需要花不到一美分的钱。因此在2万名患者中设计了1:1两种给药方案的随机对照研究。

这两个案例,一为新药开发,一为适应症扩展,共同特点是在进行临床实用性研究之前有足够的理论和试验支持表明获益大于风险,并且规模巨大

采取这种研究,或者是有较为明确的获益迫切的临床需求,如疫苗、某些孤儿药,或者是已有大量临床应用但证据不够明确,如案例中的阿司匹林。

此外,这种研究介于上市前研究和上市后研究之间,研究成本由谁负担可能是一个问题。这两个案例均由公共机构资助。FDA称也在与业界合作,探索传统试验设计与临床实践结合的其他途径。

观察性研究可能是人们对RWE的主要期待。FDA也认为,观察性研究具有重要价值,但多是从辅助功能来阐述的,比如为前瞻性试验提供理论假设,评估干预性试验的结果外推性,用于安全性和用药实践的监测等等。

但如果要直接利用观察性研究得出药物是否有效的结论,FDA认为需要有充分依据来消除观察性研究中的众多不确定因素。随后FDA列举了一反一正两个例子。

对于精准医疗药物和罕见病药物,由于大多实行加速批准,其最终临床效果的不确定性本就很大,如果再采用观察性试验结果来判别疗效,就更容易导致不真实的结论。

对于医疗器械来说,产品迭代是典型的研发路径,可以根据以往前代产品的临床经验了解观察性试验中存在的不确定因素,这样利用观察性试验就有可能得出更真实的结论,支持审批决策。

FDA还特别友情提醒,不要过于指望通过观察性研究做到“quick win”,具体如何操作还要等待FDA出台指南。

21世纪治愈法案:审批改革的未来?

如果说到药品器械审批的进化,那必然存在于三个方面,即更科学的标准,更快的速度,更低的成本。

从RWE这件事来看,FDA并非完全放弃传统的临床试验,也并非一股脑地将RWE作为审批的单一标准,并且提出未来更加合理利用RWE的一些方向,这至少比单纯考量传统的临床试验在方法论上更加科学,并且即使只有部分产品满足利用RWE的要求,至少整体的审批速度不会更慢。

成本方面,唯一有可能扩大成本的地方在于大规模的真实世界干预性试验,但一方面考虑到省去了传统临床试验的大量人力成本,一方面有可能会受到公共机构的部分资助(如阿司匹林研究PCORnet),似乎也不会显著增加审批决策的成本。

21世纪治愈法案的棋局已定,就看FDA如何落子。RWE的考量,无论是不是审评审批的进化,至少是在审批体系中纳入了一个新的决策维度,即RWE在审评决策中的权重。

政策作为调节工具,每个决策维度上的严格程度应该有相应的价值与之匹配,更严格的决策标准理应带来更明显的价值。比如,新药比仿制药审评要求更严格,相应有独占权和先发定价优势,否则会出现政策套利,改变现有的产业发展格局。

RWE相比于传统的临床试验,更大可能是降低了成本,缩短了时间。在这一政策维度上,FDA已经提到,对于孤儿药和精准医疗药物等一些产品的适应症扩展,可能不适合采用RWE观察性研究作为审批标准,但比起未来可能利用观察性试验就可实现适应症扩展的药物,相对成本就有所升高。

那么是否还应有别的鼓励或者限制措施?这对于未来药企的研发布局、CRO的业务整合方式和资本的配置都会有深远的影响。FDA的风向也可能会变,但市场需要知道游戏规则是什么。

大数据将助力RWS

或许未来我们可以看到,通过大数据是可以助力真实世界研究的,因为大数据能帮RWS充分掌握研究背景 ,提出有创新性的研究设想和完善的研究设计。大数据可以提供可利用的多源数据和强大的统计分析,保证了数据的多元性、重要性和时效性。对于数据的分析可以采用一体化的数据管理模式,避免原始数据的错误,提高数据处理效率和准确性。定制临床研究云平台,加强研究者项目管理水平,通过各方合作提高科研效率,实现数据的实时化、标准化和格式化。

相关阅读:真实世界证据 PK 传统研究

简单而言,真实世界证据(RWE)是从传统临床科研以外的多个数据集中挖掘出的信息,涉及的数据集有电子病历,医保理赔,疾病登记库,可穿戴设备和移动健康app。

RWE可以补充从传统临床研究方法得到的知识。用传统方法得到的知识往往很难适用于更广泛的患者人群,而且跟实际的临床环境也很不相同;也可以用于药品研发、治疗有效性研究、患者管理、医疗系统研究和治疗安全性分析等。更重要的,RWE可以研究不同的治疗场景,医院和医疗系统对治疗效果和结局的影响。

以往,传统临床试验是基于特定的患者群和特定的研究环境(不同于真实的临床或居家环境)。比如,临床试验会定义很长的入组条件来选择病人,使用严格的CRF (Case-Report Forms)表来记录信息,并配备专门的人员来监督患者的依从性等。这些严格的条件限制了临床试验结果在真实世界的适用性。

而RWE的数据跟临床试验就很不同,表现在:

  1)数据特别杂,包括电子病历,医保,可穿戴设备,软件app,登记库和社交媒体等;

  2)不是为了某个特定研究收集和优化的;

  3)数据的可靠性不如临床试验。

RWE可以用于广泛的临床研究,比如观察性研究或者针对特定干预的研究。在观察性研究中,RWE可以用来生成前瞻性实验(Prospective Trials)的假设,评估干预性实验(Interventional Trials)结果的通用性(generalizability)等。

目前RWE最被看好的应用领域是得出不同治疗方案有效性对比,进行因果推理。因为RWE所依赖数据自身的不确定性,混杂因子的去除是必须的,甚至需要医学统计方法的创新来处理这些不确定性。

小编来一句广告:如果您要开展真实世界研究,可以直接找梅斯医学哦,从研究的设计,到数据库建立,以及随访安排,都可以做到专业化的服务,相关服务请进

(内容源于医药魔方等进行整理)

原始出处:

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM. Real-World Evidence - What Is It and What Can It Tell Us? N Engl J Med. 2016 Dec 8;375(23):2293-2297.

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  1. [GetPortalCommentsPageByObjectIdResponse(id=198366, encodeId=e9fb19836695, content=技术与理念的进步必将带来医学的发展。, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=00501987275, createdName=130****4638, createdTime=Mon May 15 12:41:57 CST 2017, time=2017-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=195127, encodeId=280b19512ed7, content=很好的资料, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xjZ9qh3bhXrJtUlmycKGfQKPuADVZQsdNAQj5IrHHlzbGsDwScictBgogYRk8KhicpgEKwTEfOHgqw/0, createdBy=bc931611963, createdName=jin321, createdTime=Mon May 08 00:08:32 CST 2017, time=2017-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173658, encodeId=f7331e36581d, content=总结的很好,学习了,多谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Wed Feb 01 20:30:57 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173625, encodeId=d2691e362524, content=这个对统计要求好高啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170201/IMG589191708D5BD6502.jpg, createdBy=e9e22008791, createdName=Lidu20002000, createdTime=Wed Feb 01 15:21:46 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=172914, encodeId=82371e291471, content=得得得好好好!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=2cc41668195, createdName=ffaadd, createdTime=Fri Jan 27 21:10:52 CST 2017, time=2017-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170523, encodeId=1bdb1e0523fc, content=学习了,收藏了, beContent=null, objectType=article, channel=null, level=null, likeNumber=12, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sun Jan 15 12:23:06 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551388, encodeId=de991551388e9, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295164, encodeId=1f85129516477, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170172, encodeId=14c51e017248, content=好熟悉事项, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2e4105146, createdName=wolixiang2012, createdTime=Sat Jan 14 00:06:18 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170153, encodeId=c3951e0153f0, content=中医学早就这么干了, beContent=null, objectType=article, channel=null, level=null, likeNumber=14, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=547e1998644, createdName=拍手笑沙鸥, createdTime=Fri Jan 13 20:39:27 CST 2017, time=2017-01-13, status=1, ipAttribution=)]
    2017-05-15 130****4638

    技术与理念的进步必将带来医学的发展。

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=198366, encodeId=e9fb19836695, content=技术与理念的进步必将带来医学的发展。, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=00501987275, createdName=130****4638, createdTime=Mon May 15 12:41:57 CST 2017, time=2017-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=195127, encodeId=280b19512ed7, content=很好的资料, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xjZ9qh3bhXrJtUlmycKGfQKPuADVZQsdNAQj5IrHHlzbGsDwScictBgogYRk8KhicpgEKwTEfOHgqw/0, createdBy=bc931611963, createdName=jin321, createdTime=Mon May 08 00:08:32 CST 2017, time=2017-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173658, encodeId=f7331e36581d, content=总结的很好,学习了,多谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Wed Feb 01 20:30:57 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173625, encodeId=d2691e362524, content=这个对统计要求好高啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170201/IMG589191708D5BD6502.jpg, createdBy=e9e22008791, createdName=Lidu20002000, createdTime=Wed Feb 01 15:21:46 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=172914, encodeId=82371e291471, content=得得得好好好!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=2cc41668195, createdName=ffaadd, createdTime=Fri Jan 27 21:10:52 CST 2017, time=2017-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170523, encodeId=1bdb1e0523fc, content=学习了,收藏了, beContent=null, objectType=article, channel=null, level=null, likeNumber=12, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sun Jan 15 12:23:06 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551388, encodeId=de991551388e9, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295164, encodeId=1f85129516477, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170172, encodeId=14c51e017248, content=好熟悉事项, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2e4105146, createdName=wolixiang2012, createdTime=Sat Jan 14 00:06:18 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170153, encodeId=c3951e0153f0, content=中医学早就这么干了, beContent=null, objectType=article, channel=null, level=null, likeNumber=14, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=547e1998644, createdName=拍手笑沙鸥, createdTime=Fri Jan 13 20:39:27 CST 2017, time=2017-01-13, status=1, ipAttribution=)]
    2017-05-08 jin321

    很好的资料

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=198366, encodeId=e9fb19836695, content=技术与理念的进步必将带来医学的发展。, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=00501987275, createdName=130****4638, createdTime=Mon May 15 12:41:57 CST 2017, time=2017-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=195127, encodeId=280b19512ed7, content=很好的资料, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xjZ9qh3bhXrJtUlmycKGfQKPuADVZQsdNAQj5IrHHlzbGsDwScictBgogYRk8KhicpgEKwTEfOHgqw/0, createdBy=bc931611963, createdName=jin321, createdTime=Mon May 08 00:08:32 CST 2017, time=2017-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173658, encodeId=f7331e36581d, content=总结的很好,学习了,多谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Wed Feb 01 20:30:57 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173625, encodeId=d2691e362524, content=这个对统计要求好高啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170201/IMG589191708D5BD6502.jpg, createdBy=e9e22008791, createdName=Lidu20002000, createdTime=Wed Feb 01 15:21:46 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=172914, encodeId=82371e291471, content=得得得好好好!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=2cc41668195, createdName=ffaadd, createdTime=Fri Jan 27 21:10:52 CST 2017, time=2017-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170523, encodeId=1bdb1e0523fc, content=学习了,收藏了, beContent=null, objectType=article, channel=null, level=null, likeNumber=12, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sun Jan 15 12:23:06 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551388, encodeId=de991551388e9, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295164, encodeId=1f85129516477, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170172, encodeId=14c51e017248, content=好熟悉事项, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2e4105146, createdName=wolixiang2012, createdTime=Sat Jan 14 00:06:18 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170153, encodeId=c3951e0153f0, content=中医学早就这么干了, beContent=null, objectType=article, channel=null, level=null, likeNumber=14, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=547e1998644, createdName=拍手笑沙鸥, createdTime=Fri Jan 13 20:39:27 CST 2017, time=2017-01-13, status=1, ipAttribution=)]
    2017-02-01 虈亣靌

    总结的很好,学习了,多谢分享

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=198366, encodeId=e9fb19836695, content=技术与理念的进步必将带来医学的发展。, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=00501987275, createdName=130****4638, createdTime=Mon May 15 12:41:57 CST 2017, time=2017-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=195127, encodeId=280b19512ed7, content=很好的资料, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xjZ9qh3bhXrJtUlmycKGfQKPuADVZQsdNAQj5IrHHlzbGsDwScictBgogYRk8KhicpgEKwTEfOHgqw/0, createdBy=bc931611963, createdName=jin321, createdTime=Mon May 08 00:08:32 CST 2017, time=2017-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173658, encodeId=f7331e36581d, content=总结的很好,学习了,多谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Wed Feb 01 20:30:57 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173625, encodeId=d2691e362524, content=这个对统计要求好高啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170201/IMG589191708D5BD6502.jpg, createdBy=e9e22008791, createdName=Lidu20002000, createdTime=Wed Feb 01 15:21:46 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=172914, encodeId=82371e291471, content=得得得好好好!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=2cc41668195, createdName=ffaadd, createdTime=Fri Jan 27 21:10:52 CST 2017, time=2017-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170523, encodeId=1bdb1e0523fc, content=学习了,收藏了, beContent=null, objectType=article, channel=null, level=null, likeNumber=12, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sun Jan 15 12:23:06 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551388, encodeId=de991551388e9, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295164, encodeId=1f85129516477, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170172, encodeId=14c51e017248, content=好熟悉事项, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2e4105146, createdName=wolixiang2012, createdTime=Sat Jan 14 00:06:18 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170153, encodeId=c3951e0153f0, content=中医学早就这么干了, beContent=null, objectType=article, channel=null, level=null, likeNumber=14, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=547e1998644, createdName=拍手笑沙鸥, createdTime=Fri Jan 13 20:39:27 CST 2017, time=2017-01-13, status=1, ipAttribution=)]
    2017-02-01 Lidu20002000

    这个对统计要求好高啊

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=198366, encodeId=e9fb19836695, content=技术与理念的进步必将带来医学的发展。, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=00501987275, createdName=130****4638, createdTime=Mon May 15 12:41:57 CST 2017, time=2017-05-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=195127, encodeId=280b19512ed7, content=很好的资料, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xjZ9qh3bhXrJtUlmycKGfQKPuADVZQsdNAQj5IrHHlzbGsDwScictBgogYRk8KhicpgEKwTEfOHgqw/0, createdBy=bc931611963, createdName=jin321, createdTime=Mon May 08 00:08:32 CST 2017, time=2017-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173658, encodeId=f7331e36581d, content=总结的很好,学习了,多谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Wed Feb 01 20:30:57 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=173625, encodeId=d2691e362524, content=这个对统计要求好高啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170201/IMG589191708D5BD6502.jpg, createdBy=e9e22008791, createdName=Lidu20002000, createdTime=Wed Feb 01 15:21:46 CST 2017, time=2017-02-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=172914, encodeId=82371e291471, content=得得得好好好!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=2cc41668195, createdName=ffaadd, createdTime=Fri Jan 27 21:10:52 CST 2017, time=2017-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170523, encodeId=1bdb1e0523fc, content=学习了,收藏了, beContent=null, objectType=article, channel=null, level=null, likeNumber=12, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sun Jan 15 12:23:06 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551388, encodeId=de991551388e9, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295164, encodeId=1f85129516477, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Sat Jan 14 10:26:00 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170172, encodeId=14c51e017248, content=好熟悉事项, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d2e4105146, createdName=wolixiang2012, createdTime=Sat Jan 14 00:06:18 CST 2017, time=2017-01-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170153, encodeId=c3951e0153f0, content=中医学早就这么干了, beContent=null, objectType=article, channel=null, level=null, likeNumber=14, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=547e1998644, createdName=拍手笑沙鸥, createdTime=Fri Jan 13 20:39:27 CST 2017, time=2017-01-13, status=1, ipAttribution=)]
    2017-01-27 ffaadd

    得得得好好好!!

    0

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    2017-01-15 虈亣靌

    学习了,收藏了

    0

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    2017-01-14 wolixiang2012

    好熟悉事项

    0

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    2017-01-13 拍手笑沙鸥

    中医学早就这么干了

    0

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