美国批准首个结直肠癌筛查血液检测，仍不能替代结肠镜检查—新闻

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font: 12px 宋体; float: right"> 选择字号：<span onclick="showsize(12)" style="background-color: #587c19; color: #fff; font-size: 12px; cursor: pointer">小</span> <span onclick="showsize(14)" style="background-color: #587c19; color: #fff; font-size: 12px; cursor: pointer">中</span> <span onclick="showsize(16)" style="background-color: #587c19; color: #fff; font-size: 12px; cursor: pointer"> 大</span> </div> </td> </tr> <tr> <td align="center"> <div id="content1" style=" padding:15px; text-align: left; line-height: 24px; word-wrap: break-word;word-break:break-all" class="f14"> <table width="100%" border="0" cellspacing="0" cellpadding="0"> <tr> <td height="20"> </td> </tr> <tr> <td align="center" valign="middle" class="style1" style="font-size: 13px; color: #333333; font-family: 宋体; line-height: 20px"> <b></b></td> </tr> <tr> <td align="center" class="style1" style="font-size: 22px; color: #587c19; font-family: 黑体; line-height: 30px"> 美国批准首个结直肠癌筛查血液检测，仍不能替代结肠镜检查</td> </tr> <tr> <td align="center" valign="middle" class="style1" style="font-size: 13px; color: #333333; font-family: 宋体; line-height: 20px"> <b></b></td> </tr> </table> <p > </p><html> <head></head> <body> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;"><em>·需要注意的是，Shield血液测试不能替代结肠镜检查。研究表明，虽然该测试能够发现83%的癌症，但很少发现结肠镜检查发现的癌前病变。</em></p> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">当地时间2024年7月29日，美国食品药品监督管理局（FDA）批准美国生物技术公司Guardant Health的结直肠癌（CRC）筛查项目——Shield?血液检测上市。这是FDA批准的首个作为结直肠癌主要筛查选择的血液检测，也是第一个符合医疗保险覆盖要求的结直肠癌筛查血液检测。</p> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">FDA的此次批准基于2024年3月14日在《新英格兰医学杂志》（The New England Journal of Medicine）上发布的一项研究结果，其显示，Shield检测结直肠癌的灵敏度为83%，检测晚期肿瘤的特异性为90%。</p> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">据国际癌症研究机构（International Agency for Research on Cancer，IARC）最新的GLOBCAN数据，结直肠癌已成为第三大常见癌症和第二大癌症相关死亡原因，其患病风险因素包括久坐、大量饮酒、吸烟和食用红肉或加工肉类等。美国癌症协会估计，2024年将有超过15万人被诊断出结直肠癌，5.3万人因该病死亡。</p> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">预防是减轻全球结直肠癌负担的关键策略。Guardant Health公告称，在早期阶段被发现的结直肠癌患者，其5年相对存活率高达91%，如果癌症已经扩散到身体远端部位，其5年相对存活率则会显著下降至13%。然而，超过3/4的结直肠癌患者因没有及时进行筛查而死亡。</p> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">据《新英格兰医学杂志》子刊 NEJM Evidence 2022年的一篇综述，迄今为止，只有基于愈创木脂的粪便潜血试验（gFOBT）和乙状结肠镜检查在随机试验中被证明可以降低结直肠癌的发病率和相关死亡率。然而目前最常用的筛查手段是粪便免疫化学检测（FIT）和结肠镜检查。结肠镜检查是结肠癌筛查的“黄金标准”，可以通过去除息肉（癌前病变）来预防结直肠癌。</p> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">Guardant Health公告称，截至2021年，美国的结直肠癌筛查率仅为59%左右，远低于美国国家结直肠癌圆桌会议（National Colorectal Cancer Roundtable）设置的80%的目标。超过1/3的符合条件的美国人（超过5000万人）没有完成结直肠癌筛查。</p> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">“这通常是因为人们认为其他可用的选择，如结肠镜检查或粪便检查，是侵入性的、不愉快的或不方便的。”公告写道。相对于已有的筛查方式，Shield血液测试提供了更为简单、方便和愉快的筛查选择，具有提高结直肠癌筛查率的潜力。</p> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">Guardant Health公告介绍，自2022年5月LDT（实验室开发测试）商业化以来，Shield测试的总体依从率已超过90%，这意味着在现实世界的临床环境中，超过90%的患者完成了测试。相比之下，研究表明只有28%-71%的患者接受了结肠镜检查或粪便检查等其他筛查方法。初级保健医生可以让患者在常规就诊期间通过简单的抽血完成Shield测试，不需要特殊的准备、饮食改变、时间安排，也没有与结肠镜检查相关的不适或处理粪便的不愉快。</p> <p style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">该公告称，Shield由医生或其他医疗专业人员以处方的形式对符合条件的个人开放。据美联社2024年7月29日报道，医生为病人订购Shield测试的费用为895美元。</p> <p class="lastPadding" style=";; margin: 0px 0px 26px; text-align: justify; word-break: break-all;">需要注意的是，Shield血液测试不能替代结肠镜检查。上述《新英格兰医学杂志》2024年3月14日发表的研究表明，虽然该测试能够发现83%的癌症，但很少发现结肠镜检查发现的癌前病变。该测试漏诊了17%的癌症，与基于粪便的检测结果相当。</p> </body> </html><div> </div><div style="text-indent:2em;color: #587c19;font-size:13px; ">特别声明：本文转载仅仅是出于传播信息的需要，并不意味着代表本网站观点或证实其内容的真实性；如其他媒体、网站或个人从本网站转载使用，须保留本网站注明的“来源”，并自负版权等法律责任；作者如果不希望被转载或者联系转载稿费等事宜，请与我们接洽。</div> <div style="border-bottom: solid 1px #bfc89d; vertical-align: bottom; width: 100%; height: 20px"> </div> <div style="width: 100%; height: 20px; text-align: center; margin:10px">  <script src="/html/js/share.js" type="text/javascript"></script>  </div> </div> </td> </tr> </table> </td> </tr> </table> <div style="line-height: 10px; height: 10px; clear: both;">  </div> <div style=" vertical-align: bottom; width: 100%; 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美国批准首个结直肠癌筛查血液检测，仍不能替代结肠镜检查—新闻—科学网