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JCO:“价廉”是否“物美”—— 曲妥珠单抗(赫赛汀)vs. 生物仿制药

2018-02-04 慧语 肿瘤资讯

曲妥珠单抗(TRZ,商品名赫赛汀)是癌症治疗领域第一个分子靶向性药物,它是一种重组DNA衍生的人源化单克隆抗体,能够靶向作用于HER2(人表皮生长因子受体-2)的细胞外部位。赫赛汀于1998年获FDA批准上市, 2012年销售额突破60亿美元。然而任何新药都难逃专利到期的命运,2014年赫赛汀在欧洲和日本的专利到期,2015年在美国到期,专利到期,会促使大量的低价仿制药抢夺市场份额。继印度Bioc

2018年1月26日,《JCO》杂志在线发表了曲妥珠单抗生物仿制药SB3的一项生物等效性的III期临床试验(NCT02149524),仿制药与原研药相比,疗效和安全性究竟如何呢?

背 景

曲妥珠单抗(TRZ,商品名赫赛汀)是癌症治疗领域第一个分子靶向性药物,它是一种重组DNA衍生的人源化单克隆抗体,能够靶向作用于HER2(人表皮生长因子受体-2)的细胞外部位。赫赛汀于1998年获FDA批准上市, 2012年销售额突破60亿美元。然而任何新药都难逃专利到期的命运,2014年赫赛汀在欧洲和日本的专利到期,2015年在美国到期,专利到期,会促使大量的低价仿制药抢夺市场份额。继印度Biocon、韩国Celltrion公司之后,韩国三星生物制药也加入了曲妥珠单抗生物仿制药(药品代号:SB3)的大军。这项III期研究比较了曲妥珠单抗(TRZ)的生物仿制药SB3与TRZ在HER2阳性早期乳腺癌患者中的疗效、安全性和免疫原性。

患者和方法

2014年4月~2015年8月,共有14个国家97个研究中心的875例II~III期HER2阳性的单侧乳腺原发浸润癌患者,按照乳腺癌的类型及雌激素受体的状态分层随机化,分配到术前新辅助SB3(437例)或TRZ(438例)组进行8个疗程治疗,同时给予化疗(4个周期的多西紫杉醇+4个周期的氟尿嘧啶、表柔比星和环磷酰胺),然后进行手术,术后10个周期辅助SB3或TRZ治疗(图1)。两药之间采取等效性检验。


图1 研究设计

主要研究终点是符合方案集(PP)中的乳腺病理完全缓解率(bpCR),如果两组率比值的95%可信区间在0.785?1.546之间,或差值的95%可信区间在±13%之内,则宣告等效。次要终点包括总病理完全缓解率(tpCR)、总缓解率、无事件存活率、总生存率、安全性、药代动力学以及免疫原性。

结 果

1、 疗效

本研究共计入组875人,其中SB3组437人,TRZ组438人。共计有800名患者完成整个研究进入PP集(SB3,n = 402; TRZ,n = 398)。 SB3和TRZ组的bpCR率分别为51.7%和42.0%。 bpCR的调整比值为1.259(95% CI,1.085至1.460),在预定的等效范围内。调整后的bpCR差值为10.70%(95% CI,4.13%?17.26%),下限在等效区间之内,上限在等效区间之外。 SB3和TRZ病理完全缓解率分别为45.8%和35.8%,总有效率分别为96.3%和91.2%。

2、安全性

整个治疗过程中全程监测紧急不良事件(TEAEs),预先指定尤其关注的TEAE包括输注相关反应,充血性心力衰竭(CHF)和无症状左心室收缩功能障碍。新辅助治疗过程中,在SB3和TRZ组间分别有96.6%(422/437)和95.2%(417/438)的患者发生TEAE,10.5%和10.7%有严重不良事件。最常见的TEAE包括中性粒细胞减少,脱发,恶心,白细胞减少等。4名患者死亡,但均与药物无关(1名SB3组患者自杀;3名TRZ组患者分别死于心肌梗死、猝死和肺栓塞)。

3、免疫原性

进行免疫原性测试的目的是来搜索SB3和TRZ的抗药物抗体(ADA)和中和抗体。直到第9个周期才在SB3组发现3例(0.7%)ADA阳性患者,TRZ组仍未有ADA阳性患者出现。

结论

根据bpCR比值认为SB3与TRZ之间等性,安全性和免疫原性相当。

点评

随着原研药的专利到期,大量生物等效药逐步登上历史舞台,等效性研究在仿制药的研发和评价中起着非常重要的作用。而等效性研究的又分生物等效性和临床等效性,前者是将试验药和参比药均有关的药代动力学参数进行等效性分析,而后者是选用能反映药物疗效的临床指标作等效性分析。本研究即是临床等效性分析。

对于等效性研究,首要问题是确定等效界值,即试验药与参比药相比,最低不能低于多少或最高不能超过多少才可认为是等效。一般等效界值的确定要根据疾病的自然进程、参比药疗效和主要评价指标等因素综合考虑,由统计学家和临床医生一起谨慎选择。这里注意,由于安慰剂效应的存在,所以等效界值必须将参比药与安慰剂的疗效范围区分开。

等效性研究的分析集与优效性研究不同,一般首选PP集,而不是ITT集。这是由于PP分析是将违背方案的受试者排除,可能会扩大组间的疗效差,而ITT集是对接受随机患者进行分析,更倾向于稀释两组的差异。基于临床试验保守的原则,在优效性研究中一般推荐ITT分析。而在非劣或等效研究中,由于原假设与优效研究不同,试验药与参比药之差越小越容易拒绝原假设,所以ITT分析反而容易得出药物疗效相近的结论,而PP分析则会更保守。基于此,ICH E9中指出,对于非劣效或等效研究,应选用结果更为保守的PP分析。

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    2018-05-26 lidong40
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    2018-02-10 大爰

    学习了谢谢分享!!

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1891483, encodeId=806c1891483d1, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat May 26 12:26:00 CST 2018, time=2018-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648116, encodeId=5abb164811617, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sat Nov 17 06:26:00 CST 2018, time=2018-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=286778, encodeId=077d286e78f1, content=学习了谢谢分享!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Sat Feb 10 10:43:36 CST 2018, time=2018-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261385, encodeId=e85a1261385c9, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410635, encodeId=1934141063586, content=<a href='/topic/show?id=08ad9264106' target=_blank style='color:#2F92EE;'>#赫赛汀#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92641, encryptionId=08ad9264106, topicName=赫赛汀)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=05462758965, createdName=wrj0122, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412908, encodeId=838a1412908d5, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285341, encodeId=bb2e285341a0, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/10/0ae663c226d225666642f99237187203.jpg, createdBy=ec481939803, createdName=一米阳光的温暖, createdTime=Mon Feb 05 11:32:09 CST 2018, time=2018-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285131, encodeId=fa362851315e, content=一般首选PP集.而不是ITT集.这是由于PP分析是将违背方案的受试者排除.可能会扩大组间的疗效差.而ITT集是对接受随机患者进行分析.更倾向于稀释两组的差异.仿制药的研究结果还要慎重., beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Sun Feb 04 20:54:12 CST 2018, time=2018-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285118, encodeId=25a42851187a, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sun Feb 04 20:33:07 CST 2018, time=2018-02-04, status=1, ipAttribution=)]
    2018-02-06 drwjr
  5. [GetPortalCommentsPageByObjectIdResponse(id=1891483, encodeId=806c1891483d1, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat May 26 12:26:00 CST 2018, time=2018-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648116, encodeId=5abb164811617, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sat Nov 17 06:26:00 CST 2018, time=2018-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=286778, encodeId=077d286e78f1, content=学习了谢谢分享!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Sat Feb 10 10:43:36 CST 2018, time=2018-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261385, encodeId=e85a1261385c9, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410635, encodeId=1934141063586, content=<a href='/topic/show?id=08ad9264106' target=_blank style='color:#2F92EE;'>#赫赛汀#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92641, encryptionId=08ad9264106, topicName=赫赛汀)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=05462758965, createdName=wrj0122, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412908, encodeId=838a1412908d5, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285341, encodeId=bb2e285341a0, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/10/0ae663c226d225666642f99237187203.jpg, createdBy=ec481939803, createdName=一米阳光的温暖, createdTime=Mon Feb 05 11:32:09 CST 2018, time=2018-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285131, encodeId=fa362851315e, content=一般首选PP集.而不是ITT集.这是由于PP分析是将违背方案的受试者排除.可能会扩大组间的疗效差.而ITT集是对接受随机患者进行分析.更倾向于稀释两组的差异.仿制药的研究结果还要慎重., beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Sun Feb 04 20:54:12 CST 2018, time=2018-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285118, encodeId=25a42851187a, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sun Feb 04 20:33:07 CST 2018, time=2018-02-04, status=1, ipAttribution=)]
    2018-02-06 wrj0122
  6. [GetPortalCommentsPageByObjectIdResponse(id=1891483, encodeId=806c1891483d1, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat May 26 12:26:00 CST 2018, time=2018-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648116, encodeId=5abb164811617, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sat Nov 17 06:26:00 CST 2018, time=2018-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=286778, encodeId=077d286e78f1, content=学习了谢谢分享!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Sat Feb 10 10:43:36 CST 2018, time=2018-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261385, encodeId=e85a1261385c9, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410635, encodeId=1934141063586, content=<a href='/topic/show?id=08ad9264106' target=_blank style='color:#2F92EE;'>#赫赛汀#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92641, encryptionId=08ad9264106, topicName=赫赛汀)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=05462758965, createdName=wrj0122, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412908, encodeId=838a1412908d5, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285341, encodeId=bb2e285341a0, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/10/0ae663c226d225666642f99237187203.jpg, createdBy=ec481939803, createdName=一米阳光的温暖, createdTime=Mon Feb 05 11:32:09 CST 2018, time=2018-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285131, encodeId=fa362851315e, content=一般首选PP集.而不是ITT集.这是由于PP分析是将违背方案的受试者排除.可能会扩大组间的疗效差.而ITT集是对接受随机患者进行分析.更倾向于稀释两组的差异.仿制药的研究结果还要慎重., beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Sun Feb 04 20:54:12 CST 2018, time=2018-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285118, encodeId=25a42851187a, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sun Feb 04 20:33:07 CST 2018, time=2018-02-04, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1891483, encodeId=806c1891483d1, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat May 26 12:26:00 CST 2018, time=2018-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648116, encodeId=5abb164811617, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sat Nov 17 06:26:00 CST 2018, time=2018-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=286778, encodeId=077d286e78f1, content=学习了谢谢分享!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Sat Feb 10 10:43:36 CST 2018, time=2018-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261385, encodeId=e85a1261385c9, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410635, encodeId=1934141063586, content=<a href='/topic/show?id=08ad9264106' target=_blank style='color:#2F92EE;'>#赫赛汀#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92641, encryptionId=08ad9264106, topicName=赫赛汀)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=05462758965, createdName=wrj0122, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412908, encodeId=838a1412908d5, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285341, encodeId=bb2e285341a0, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/10/0ae663c226d225666642f99237187203.jpg, createdBy=ec481939803, createdName=一米阳光的温暖, createdTime=Mon Feb 05 11:32:09 CST 2018, time=2018-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285131, encodeId=fa362851315e, content=一般首选PP集.而不是ITT集.这是由于PP分析是将违背方案的受试者排除.可能会扩大组间的疗效差.而ITT集是对接受随机患者进行分析.更倾向于稀释两组的差异.仿制药的研究结果还要慎重., beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Sun Feb 04 20:54:12 CST 2018, time=2018-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285118, encodeId=25a42851187a, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sun Feb 04 20:33:07 CST 2018, time=2018-02-04, status=1, ipAttribution=)]
    2018-02-05 一米阳光的温暖

    学习

    0

  8. [GetPortalCommentsPageByObjectIdResponse(id=1891483, encodeId=806c1891483d1, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6da1120, createdName=lidong40, createdTime=Sat May 26 12:26:00 CST 2018, time=2018-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1648116, encodeId=5abb164811617, content=<a href='/topic/show?id=d5c560226fc' target=_blank style='color:#2F92EE;'>#曲妥珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=60226, encryptionId=d5c560226fc, topicName=曲妥珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a67b23554000, createdName=linlin2320, createdTime=Sat Nov 17 06:26:00 CST 2018, time=2018-11-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=286778, encodeId=077d286e78f1, content=学习了谢谢分享!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Sat Feb 10 10:43:36 CST 2018, time=2018-02-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261385, encodeId=e85a1261385c9, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410635, encodeId=1934141063586, content=<a href='/topic/show?id=08ad9264106' target=_blank style='color:#2F92EE;'>#赫赛汀#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92641, encryptionId=08ad9264106, topicName=赫赛汀)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=05462758965, createdName=wrj0122, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1412908, encodeId=838a1412908d5, content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Tue Feb 06 10:26:00 CST 2018, time=2018-02-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285341, encodeId=bb2e285341a0, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/10/10/0ae663c226d225666642f99237187203.jpg, createdBy=ec481939803, createdName=一米阳光的温暖, createdTime=Mon Feb 05 11:32:09 CST 2018, time=2018-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285131, encodeId=fa362851315e, content=一般首选PP集.而不是ITT集.这是由于PP分析是将违背方案的受试者排除.可能会扩大组间的疗效差.而ITT集是对接受随机患者进行分析.更倾向于稀释两组的差异.仿制药的研究结果还要慎重., beContent=null, objectType=article, channel=null, level=null, likeNumber=106, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Sun Feb 04 20:54:12 CST 2018, time=2018-02-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=285118, encodeId=25a42851187a, content=学习了受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLDicHg2ldsSNmib46PmdzpO7CQEmPjuULp1v45zPWwMYhrnXgvl3OtmUCZSQfgITWn96X9moL94nUGA/0, createdBy=28072041016, createdName=131****1460, createdTime=Sun Feb 04 20:33:07 CST 2018, time=2018-02-04, status=1, ipAttribution=)]
    2018-02-04 lovetcm

    一般首选PP集.而不是ITT集.这是由于PP分析是将违背方案的受试者排除.可能会扩大组间的疗效差.而ITT集是对接受随机患者进行分析.更倾向于稀释两组的差异.仿制药的研究结果还要慎重.

    0

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    2018-02-04 131****1460

    学习了受益匪浅

    0

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