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深度解析中美瑞德西韦实验结果为何大相径庭?曹彬: 中国研究设计更严格

摘要: 哪些原因会导致截然相反的结论出现?钛媒体App在研究了中美科研团队目前公布的研究资料发现,有三大主要不同。

钛媒体5月1日消息,彩票平台美国生物制药公司吉利德科学(Gilead Sciences Inc., GILD)于29日美股盘前发布新冠肺炎候选治疗药物瑞德西韦(Remdesivir)针对397名新冠肺炎患者的一项开放标签III期SIMPLE临床试验结果。

公告中,吉利德表示,瑞德西韦美国试验已达到主要评估指标。

彩票平台jieguoxianshi,xinguanhuanzhejieshouruidexiwei10tianzhiliaoyu5tianzhiliaodelinchuanggaishanqingkuangxiangsi,jieshou5tianruidexiweizhiliaodehuanzhezhong,zhishaoyou50%dehuanzhexinguanzhengzhuangyousuogaishan。ciwai,64%dehuanzhezai14tianneichuxianlinchuanggaishan,61%dehuanzhezuizhongchuyuan。liangzuzhiliaojunweifaxianxindebuliangshijian。

彩票平台zai30rilingchen,meiguoguoliweishengyanjiuyuan(nih)zaigongbulingyigepingguruidexiweizhiliaoxinguanfeiyanlinchuangshiyan(actt)jieguo,gaiyanjiusheji1063minghuanzhedesuijiduizhaoshiyan,shujuxianshi,jieshouruidexiweidexinguanyiqinghuanzhedehuifushijianbijieshouanweijidehuanzhekuai31%(p <0.001),xinguanhouxuanyaowuruidexiweiyouhuifuzuoyong。

shoucixiaoxiyingxiang,jilidegujiazaimeigupanqianxunsuzhangchao10%。zhenggeshichangyeyincidedaotizhen。jiezhijinzaomeigushoupan,jilidegujiashangzhang5.68%,baoshou83.14meiyuan。shizhichaoguoqianyimeiyuan。

然而,更早些时候,中国团队发布的另一项关于瑞德西韦应用于中国新冠重症患者的研究则显示出相反结果。

tongyangzai4yue30rilingchen,zhongriyouhaoyiyuandecaobinjiaoshouhebeijingxieheyixueyuanwangchenjiaoshoulvlingdeyanjiutuandui,zaiquanweiyixueqikan《liuyedao》(the lancet)shangruidexiweizhiliaozhongguozhongzhenghuanzhedesuijishuangmangshiyanjieguo。ciqian,jilidekexueyixuanbu,youyuruzurenshubuzu,zheixianglinchuangshiyanyitiqianzhongzhi。erzheicifabudekeyanlunwen,shijiyuduishiyanzhongzhishiyijingruzude237minghuanzhedefenxijieguo。

彩票平台jieguoxianshi,ruidexiweimeiyouxianshichujuyoutongjixueyiyidelinchuanghuoyi。yejiushishuo,ruidexiweiduiyuzhongzhenghuanzhewuxianzhuliaoxiao。

caobintuanduiyanjiutongshizhichu,suiranmeiyoudadaotongjixianzhubiaozhun,danruidexiweijiakuailezheixiehuanzhelinchuanggaishandeshijian。

瑞德西韦从出场开始,就被冠以“人民的希望”,大众对其期望值很高。一夜之间,3项瑞德西韦治疗全球新冠患者的临床试验数据都已经公布,为何会出现这样大相径庭的结果?

WHO泄露瑞德西韦临床疗效“负面”,吉利德否认

ruidexiweishiyizhonghegansuanleisiwuqianyao,nenggouyizhiyilairnadernahechengmei(rdrp),youjilidekexuegongsi(gilead)yanfa,gengduobeiyingyongyuduikangaibolabingdudangzhong。ruidexiweizhijinrengshiyizhongzaiyanyaowu,shangmeiyoudedaorenhejianguanjigoudepizhun。

ruidexiweizhisuoyibeishouguanzhu,yeshiyinweiqitaxinguanhouxuanyaowuliaoxiaobuxianzhu。

彩票平台conggongkaiziliaolaikan,lvkui(chloroquine)、qianglvkui、luopineiweideshiyanjieguoyedoubujinrurenyi。meiguomashengzongyiyuanfeiyuzhongzhengyixuekedeyixuejia,yixueboshiraghu chivukulazhichu,zheixieyaowukenenggenbenwuxiao,erqie,ruguohuanzheshiyongle,yekenengyoufuzuoyong,shenzhichaoguoxinguanbingduganrandeweili。

shijiandaohuizhilianggeyueqian。

1yue31ri,dingjiyixueqikan《xinyinggelanyixuezazhi》(nejm)kanfameiguoshoulixinguanfeiyanzhenliaozhengminglunwen,benzhe“tongqingyongyao”(compassionate use)yuanze,shiyongruidexiweihou,gaixinguanhuanzhedelinchuangzhengzhuangdedaolegaishan,bingqingchuxianlexunsuhuanjiejixiang。zheibeigengduorenrenweishi,ruidexiweiduixinguanfeiyanshiyouxiaode。

彩票平台ciwai,zairibenzhiliao 14 mingmeiguoxinguanfeiyanhuanzheshiyongruidexiweihou,duoshuhuanzhekangfu。

彩票平台2yue2ri,jilidekexuexuanbu,gaigongsihemeiguoshipinyuyaopinjianduguanliju(fda)、zhongguojibingyufangkongzhizhongxin、zhongguoguojiayaopinjianduguanliju(nmpa)、shijieweishengzuzhi(who)dengquanqiuweishengjigoumiqiehezuo,zhankailinchuangshiyan,yuji4yuemojieshu。

jingguolianggeyuezailinchuangshangbuduanshiyanhou,4yue14ri,《xinyinggelanyixuezazhi》fabu53mingshiyongruidexiweizhiliaozhongzhengxinguanfeiyandeshiyanjieguo。shujubiaoming,53minghuanzhezhongyou36ming(68%)guanchadaolinchuanggaishan,yibanyishangdehuanzhebaituo“huxiji”。qizhongyou7minghuanzhesiwang,siwanglv13%。yanjiurenyuanrenwei,zheigejieguoyaoyouyuciqianluopineiweizaixinguanzhongdexiaoguo。houzhezai28tiansiwanglvwei22%。

彩票平台dangshijiuyouxuezhecheng,ruidexiweikeyidangzuoxinguantexiaoyaowushiyongzaimeiguoxinguanyiliaofanganzhong。

彩票平台raner,zhengyidianjiuzaishitianhoudaolai。

4月24日凌晨,瑞德西韦在中国进行临床试验的部分数据被提前公布在了世界卫生组织(WHO)的官网上。

shujuxianshi,zaijieshouruidexiweide158mingxinguanfeiyanhuanzhezhong,jinguanduoshuhuanzhefarehehuxidaozhengzhuangkexunsuhuifu,zhiliaoyizhouhouchuyuan,danqizhongyouduorensiwang,shiyanzubingsilvda13.9%,jieshouzhengchangzhiliaodebingsilvjinwei12.8%,liangzhewumingxianchayi。ciwai,gaiyaohaixianshichumingxiandefuzuoyong,daozhile18minghuanzhetuichushiyan。

这一消息直接让吉利德科学的股价大跌,盘中跌4%,报77.78美元。

两个小时后,吉利德科学发布公告,证实该消息的真实性,并表示,试验结果还未完全发布,提前泄漏的试验可能是“不完美的”,由于提前终止了入组过程,这可能会影响到最终的试验结果。

彩票平台jilidekexuezaidangshibiaoshi,gaigongsiyijingweimeiguo、ouzhouheribendeshubaiminghuanzhetigongleruidexiwei。danzheixieanlibingbunengshuomingruidexiweiduixinguanfeiyanyouxiao,yangedejielunrengxudengdaisuijishuangmangduizhaolinchuangshiyanjieguo。

rujin,shiyanshujuquanshuchulu,ruwenzhangkaipiansuoyan,chengxianchuleyuwhogongbuxiangfandejieguo。

彩票平台caipiaopingtaixuyaolvqingdeshi,tongyizhongyaowu,zaijinxinglejixiangjiweiyangedelinchuangshiyanhou,jiujingshinaxieyinsudaozhilejieranxiangfandejielunchuxian?

哪些原因会导致截然相反的结论出现?

钛媒体App在阅读了科研团队目前公布出来的研究资料后,发现有这几项不同

首先是论文数据中病入入组标准不同。根据曹彬等人在《柳叶刀》发文指,原计划该试验有453名入组的患者,但由于国内疫情迅速好转,最终只有237名实际入组,尽管仍是随机分组,但远远小于NIH发布的1063例患者随机、对照、双盲试验入组数量。

genju(linchuangshiyanshujuku。tashinihxiashujigou)tigongdeshujuxianshi,zaihesuanjiancequezhendeqiantixia,zhongguolinchuangshiyanruzujunweizhongzhenghuanzhe,jiyaoqiuchuxianyingxiangxuetezheng,qiexueyangnongdudiyu94%,nihruzuhuanzhebingweiqufenqing、zhong、zhongzheng,jinxumanzuyouyingxiangxuezhengju、xueyangdiyu94%、xuyaojiyang、xuyaohuxijisigetiaojianzhiyi,jikeruzu。ciwai,zhongguoshiyanyaoqiuruzuhuanzhechuxianzhengzhuangzai12tiannei,qie30tianneiweijieshouqitashiyanxingyaowuzhiliao,nihduiciwuyaoqiu。

aidingbaodaxueyixuetongjixuejiaoshou、linchuangyanjiuzhongxinzhurenyuehan·nuoli(john norrie)(tameiyoucanyushiyan)zai《liuyedao》shangfabudepinglunwenzhangcheng,zhongguodelinchuangshiyanshejishihenhaode,shiyanzhixingqingkuangbucuo,danshujukenengbujuyoutongjixueyiyi,suoyiwufadechuqueqiejielun。“jibunengzhengshiruidexiweizhishaonengchanshengyidingdelinchuangxiaoguo,yewufapaichuruidexiweideyouxiaoxing。

曹彬则认为,237例患者不算少了,如果瑞德西韦真的是神药,自然有疗效显现。他表示,每个医生都有自己的判断,数据只是统计学结果,最终瑞德西韦是否可以成为新冠特效药,要放在临床背景下重新判断,而非0和1一样,断然下定论。

caobintongshizhi,jiyumeiguoshiyandedingyiheguocheng,jinguanruidexiweibushixinguantexiaoyaowu,dankerenweiqiyouyidingliaoxiao。

其次是临床研究终点设计的不同。曹彬在4月30日接受多家媒体采访时表示,研究终点不同导致了结果的差异,中国的研究设计更严格。

彩票平台linchuangzhongdianzhideshi,yongyupingguyaowuliaoxiaoheanquanxingdengyaowuzuoyongyouguandexiaoyingbianliang,qizhongbaokuozhuyaolinchuangzhibiaoheciyaolinchuangzhibiao,zheiliangzheshiwanquanbutongde,yigeyuyanjiuguagou,lingyigezeshishizhichixingzhibiao。

曹彬领衔的瑞德西韦重症试验的主要终点指标为临床改善的时间(TTCI),定义为从研究治疗药物(瑞德西韦或安慰剂)随机分配到出院,或者是临床状态级别降低两级所需的时间(以天为单位)。

患者临床状态以6分复合指标显示,分别为:

彩票平台6.siwang;5.zhongzhengjianhubingfang,xuyaoecmohe/huoimv;4.zhongzhengjianhubingfang/zhuyuanzhiliao,xuyaoniv / hfnczhiliao;3.zhuyuan,xuyaobuchongyangqi(danbuxuyaoniv / hfnc);2.zhuyuanzhiliao,buxuyaobuchongyangqi;1.chuyuanhuodadaochuyuanbiaozhun(chuyuanbiaozhundingyiyixinguanzhenliaofanganweizhun)。(zhu: suoxie: imv,youchuangjixietongqi;niv,wuchuangjixietongqi;hfnc,gaoliuliangbidaoguan)

而美国NIH临床试验主要终点指标定义为: 29天内“临床恢复时间”。

jiandanlaishuo,meiguoxinguanhuanzhehuifuzhisanzhongqingkuang: yi,zhuyuan,buxuyaoyangqizhichi;er,buzhuyuan,xingdongshouxianhuoxuyaoyangqizhichi;san,buzhuyuan,xingdongbushouxian(buxuyaoyangqizhichi)。er8fenliangbiaozezuoweizhongyaodeciyaozhongdianzhibiaochuxian。

彩票平台congzhuyaozhongdianlaikan,meiguoshejidezhibiaoweilinchuanghuifushijian,zhongguozeshishejilejiyu6fenliangbiaodelinchuanggaishanshijian。“nihdehuifudingyibijiaokuanfan,baokuozhuyuan,danbuxuyaoyangliao、chuyuan(dankenengrengyouhuodongshouxian、xuyaoxiyang),xiangdangyucaipiaopingtaide1-2ji+huijiaxiyang。”caobinbiaoshi。

也就是说,两个研究终点指标的不同,直接导致两个团队研究数据产生差异性。

曹彬认为,这相当于是两个试验过程,无法完全去进行比较。

caipiaopingtaidezhuyaozhongdian,jiuleisidaxuekaoshidezonghechengji,zheigeshibijiaogongrende,yeshibijiaoyangede,meiguonihjiubijiaojiandan,jiuxiangshizhikanshulihuachengji,tayongzheijigejiandande(biaozhun)zuoweizhuyaozhongdian。zheiliangxiangyanjiudeyangechengdushibuyiyangde。

第三点仅为猜测: 中美两国试验时使用了其他药物。

彩票平台genju《liuyedao》lunwentigongdeshuofa,zhongguoshiyanyunxuhuanzhetongshishiyongluopineiweilituoneiwei、ganraosuhetangpizhijisu,danbingweitouluhuanzheyingyongqitayaowuyijizhongyaoshifouhuizaochengruzupaichu。

caobinzhi,huanzheciqiankeshiyongzhiliaozhinantuijiandeyaowu,qieshiyanzuheduizhaozuhuanzheyongyaoxiangpipei,chushifoushiyongruidexiweiwai,meiyouqitaganraoyinsu。

duiyuzheiyishuofashifouhuiyingxiangshiyanxiaoguo,zanshihaiweiyouwanquandinglun,rengxuguancha。

彩票平台muqian,genjujilidekexuegongsiguanwangtigongdexinxi,ruidexiweizai6xianglinchuangshiyanzhongjieshoujianyan。chulezaizhongguoyijingtingzhideliangxianglinchuangshiyanyiwai,jilidekexuegongsiqidongleliangxiangsuiji、kaifangbiaoqianquanqiuxing3qilinchuangshiyan。

彩票平台yuji5yuedi,ruidexiweijianggongbulaizidierxiangsimpleyanjiudeshuju,congerpingguruidexiweizaizhongduxinguanfeiyanhuanzhezhongde5tianhe10tianjiyaochixushijian。,zheiyishujumeiyouduizhaozu。

彩票平台caobindengrenzai《liuyedao》lunwenzhongjianyi,xuyaojinyibuguancharuidexiweiyongyuzaoqifabinghuanzhehegaojiliangyanjiu,yijiyuqitakangbingduyaowuhuokangtiyaowulianheyongyaodeyanjiu。

但即便是在美国的学术界,也并不是全都认可吉利德科学所公布的实验结果。

,美国心血管疾病学会 (ACC) 主席、克利夫兰临床中心史蒂文·尼森(Steven Nissen)提出了质疑。他表示,吉利德科学的研究尚未公开数据,在没有同行评议的前提下,直接公开发表试验结论是“违法”的,科学家需要看到数据而非如此草率地结论。

斯坦福大学传染病学专家米歇尔·巴里(Michele Barry)直接表示,“这是有缺陷的研究,瑞德西韦不是一个神奇的药物”。

buguo,meiguozongtongtelangpuyijingzai29ridebaigongjianbaohuishangbiaoshi,taxiwangmeiguoshipinyaopinguanliju(fda)jinkuaixingdong,pizhunruidexiweiyongyuzhiliaoxinguanfeiyan。

彩票平台meiguojilidekexuegongsideceodannier·aodai(daniel o'day)zaijieshoubiaoshi,muqiangaigongsiyizhunbeihaole5wanduogeliaochengderuidexiwei,jiangzaimeiguojianguanjigoupizhunqijinjishiyonghoulijifahuo。yujidaojinnianniandi,jilidekeyishengchanzugouderuidexiweilaizhiliaoyibaiwanxinguanhuanzhe。

彩票平台genjuhuaerjieribaodeyifenneibubaipishuxianshi,meiguozhengfuzhengyunxugengduodegongsilaishengchanruidexiwei,bingcaiqucuoshibangzhuqiyezhongxinliyonghuaxueyiyaoshengchanxian,shengchandaliangxinguanyaowu,congerhuanjiemeiguoyiqingwenti。

“今天的结果,为接下来探索瑞德西韦的应用和潜力带来很多机会。彩票平台的团队将研究其他的剂型和用药方法,探寻将此药物带给更广泛患者人群的方式。”吉利德方面表示。

(本文首发钛媒体App,作者/林志佳,编辑/赵宇航)

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