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【从业必读】低剂量螺旋CT肺癌筛查专家共识

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发表于 2020-10-14 17:27:54 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <blockquote><p><span>让天下没有难找的医疗器械服务信息!</span></p><p><strong><span>“医疗器械助手”</span></strong><span>&nbsp;让一切触手可及!</span></p><p><p><img src="image/20201014/ac7c4c86bff3f0660e634292dc511095_1.jpg" /></p></p><p><span>点击图片</span><span><span></span><p><img src="image/20201014/c407fe90207c2622cc8e1dff32d28341_2.jpg" /></p><p><img src="image/20201014/c407fe90207c2622cc8e1dff32d28341_2.jpg" /></p><p><img src="image/20201014/c407fe90207c2622cc8e1dff32d28341_2.jpg" /></p></span></p></blockquote><p>&nbsp;</p><p><strong><span>肺癌是世界范围内患病率和病死率最高的恶性肿瘤</span></strong><span>。尽管近年来在治疗方面取得了一定进展,但是目前</span><strong><span>肺癌5年生存率仅为15%~16%[</span></strong><span>1-3],预后仍无明显改观。众所周知,如果能在早期阶段(尤其是Ⅰ期)进行手术切除,则肺癌的预后将显著改善。因此,多年来国内外一直致力于通过筛查来实现肺癌的早期诊断和早期治疗,并最终降低病死率。20世纪60至70年代开始的大样本随机对照研究表明,X线胸片虽能检出更多肺癌、提高手术切除率,但并未降低肺癌病死率,故目前不推荐X线胸片作为肺癌筛查工具[4-9]。自20世纪90年代起,随着胸部低剂量CT(low-dose computedtomography,LDCT)技术的发展,肺癌筛查研究进入LDCT时代,并成为近20余年来肺癌筛查研究的热点。</span><strong><span>2011&nbsp;年,美国国家肺癌筛查试验(NationalLung Screening Trial,NLST)的随机对照研究结果显示,与X线胸片相比,采用LDCT对肺癌高危人群进行筛查可使</span><span>肺癌病死率下降20%</span></strong><span>[10]。基于NLST令人振奋的获益结果,美国多家权威医学组织陆续推出了肺癌筛查指南,推荐在高危人群中进行LDCT肺癌筛查。近年来,我国越来越多的医疗机构已开展或拟开展LDCT肺癌筛查,但国内尚缺乏相应的诊疗规范,造成对LDCT肺癌筛查的认识和诊疗水平存在较大差异,临床实践不规范。为此,中华医学会放射学分会心胸学组参照国外最新版肺癌筛查指南,并结合国外大型肺癌筛查项目经验及我国目前实际情况,起草了本共识。</span></p><p><span><br  /></span></p><p><span>一、LDCT肺癌筛查现状</span></p><p><span><br  /></span></p><p><span>1.</span><span>全球较著名的肺癌筛查研究项目:(</span><span>1</span><span>)国际早期肺癌行动计划(</span><span>International Early Lung CancerProgram</span><span>,</span><span>I</span><span>-</span><span>ELCAP</span><span>)</span><span>[11</span><span>-</span><span>12]</span><span>,为非随机对照大型肺癌筛查项目;(</span><span>2</span><span>)美国国家癌症研究所(</span><span>National CancerInstitute</span><span>,</span><span>NCI</span><span>)发起的大型肺癌筛查随机对照研究——国家肺癌筛查试验(</span><span>National Lung ScreeningTrial</span><span>,</span><span>NLST</span><span>)</span><span>[10</span><span>,</span><span>13]</span><span>;(</span><span>3</span><span>)荷兰</span><span>-</span><span>比利时的多中心随机对照研究项目——荷兰</span><span>-</span><span>比利时随机对照肺癌筛查试验(</span><span>Dutch</span><span>-</span><span>BelgianRandomized Lung CancerScreening Trial</span><span>,</span><span>NELSON</span><span>)</span><span>[14</span><span>-</span><span>15]</span><span>;(</span><span>4</span><span>)意大利的</span><span>LDCT</span><span>肺癌筛查的随机对照研究项目(</span><span>ITALUNG&nbsp;</span><span>和</span><span>DANTE</span><span>)</span><span>[16</span><span>-</span><span>17]</span><span>。</span></p><p><span><br  /></span></p><p><span>2.</span><span>国外已发表的肺癌筛查指南或指导意见:(</span><span>1</span><span>)</span><span>2011&nbsp;</span><span>年美国国家综合癌症网络(</span><span>NationalComprehensive Cancer Network</span><span>,</span><span>NCCN</span><span>)率先发布了肺癌筛查指南(目前已更新至</span><span>2015</span><span>版</span><span>[18]</span><span>),推荐在高危人群中采用</span><span>LDCT</span><span>进行肺癌筛查;(</span><span>2</span><span>)美国胸外科协会(</span><span>American Association for Thoracic Surgery</span><span>,</span><span>AATS</span><span>)根据</span><span>NLST</span><span>的结果发表的肺癌筛查指南</span><span>[19</span><span>-</span><span>20]</span><span>,建议在</span><span>55</span><span>~</span><span>79</span><span>岁、吸烟</span><span>≥30</span><span>包</span><span>/</span><span>年的人群及</span><span>≥50</span><span>岁、吸烟</span><span>≥20</span><span>包</span><span>/</span><span>年且同时合并其他肺癌危险因素</span><span>[</span><span>如慢性阻塞性疾病(</span><span>chronic obstructivepulmonarydisease</span><span>,</span><span>COPD</span><span>)、环境或职业暴露、既往罹患癌症、接受过放射治疗、家族史等</span><span>]</span><span>的人群中进行肺癌筛查;(</span><span>3</span><span>)美国胸科医师学院(</span><span>AmericanCollege of Chest Physicians</span><span>,</span><span>ACCP</span><span>)及美国临床肿瘤协会(</span><span>American Society of Clinical Oncology</span><span>,</span><span>ASCO</span><span>)发布的临床指南</span><span>[21</span><span>-</span><span>22]</span><span>,推荐意见与</span><span>NCCN</span><span>指南相似,均建议在高危人群采用</span><span>LDCT&nbsp;</span><span>进行肺癌筛查;(</span><span>4</span><span>)美国癌症协会(</span><span>American Cancer Society</span><span>,</span><span>ACS</span><span>)发布的肺癌筛查指南</span><span>[23]</span><span>,支持在高危人群(</span><span>55</span><span>~</span><span>74&nbsp;</span><span>岁,吸烟史</span><span>≥30</span><span>包</span><span>/</span><span>年且戒烟不足</span><span>15</span><span>年)中进行</span><span>LDCT&nbsp;</span><span>肺癌筛查;(</span><span>5</span><span>)美国预防服务工作组(</span><span>U.S. Preventive Services Task Force</span><span>,</span><span>USPSTF</span><span>)发表的肺癌筛查建议</span><span>[24</span><span>-</span><span>25]</span><span>,建议在高危人群(</span><span>55</span><span>~</span><span>80&nbsp;</span><span>岁,吸烟</span><span>30</span><span>包</span><span>/</span><span>年,或符合上述条件的曾经吸烟者且戒烟不足</span><span>15</span><span>年)中采用</span><span>LDCT</span><span>筛查肺癌,但不建议在下述情况下采用</span><span>LDCT</span><span>筛查肺癌:戒烟已超过</span><span>15</span><span>年,或已有威胁寿命的健康问题,或者不能承受或不愿意进行肺部手术者。</span></p><p><span><br  /></span></p><p><span>国内学者也围绕</span><span>LDCT</span><span>肺癌筛查进行了一些研究</span><span>[26</span><span>-</span><span>40]</span><span>,但尚未形成具体的肺癌筛查指导意见或方案。目前国内医疗机构多根据国外已较成熟的方案来开展</span><span>LDCT</span><span>肺癌筛查工作。在国家层面上,已有多项肺癌筛查研究项目或惠民项目正在进行。省市级相关部门亦十分重视肺癌的早期诊治工作,也有很多相关研究课题陆续启动。</span></p><p><span><br  /></span></p><p><strong><span>肺癌筛查是一项系统性工程,涉及多学科、多组织的协同与合作。随着大型随机对照研究数据的更新、</span></strong><strong><span>CT&nbsp;</span></strong><strong><span>检查方法的进步及新技术的应用,</span></strong><strong><span>LDCT&nbsp;</span></strong><strong><span>肺癌筛查的方案、流程等将会不断完善、更新</span></strong><span>。</span></p><p><span><br  /></span></p><p><span>二、LDCT肺癌筛查方案</span></p><p><span><br  /></span></p><p><strong>(一)筛查人群及危险因素的评估</strong></p><p><strong><br  /></strong></p><p><span>吸烟和曾经吸烟是公认的最重要的高危因素,随着戒烟时间的延长,危险性逐步下降;年龄亦是一个重要因素,因肺癌患病率随年龄增加逐渐上升。其他危险因素包括慢性肺部疾病(</span><span>COPD</span><span>、肺纤维化)、环境或职业暴露、氡暴露、既往罹患癌症、接受过放射治疗、家族史等</span><span>[18</span><span>,</span><span>25]</span><span>。</span><span>NCCN</span><span>指南将人群分为高危、中危和低危:(</span><span>1</span><span>)高危人群:年龄范围为</span><span>55</span><span>~</span><span>74</span><span>岁,吸烟</span><span>≥30</span><span>包</span><span>/</span><span>年(并且戒烟</span><span>&lt;15</span><span>年);或者年龄</span><span>≥50</span><span>岁,吸烟</span><span>≥20</span><span>包</span><span>/</span><span>年,且合并上述另一项危险因素(不包括被动吸烟);(</span><span>2</span><span>)中危人群:年龄</span><span>≥50&nbsp;</span><span>岁,吸烟</span><span>≥20</span><span>包</span><span>/</span><span>年,或有被动吸烟,但不存在其他危险因素;(</span><span>3</span><span>)低危人群:年龄</span><span>&lt;50</span><span>岁和(或)吸烟</span><span>&lt;20</span><span>包</span><span>/</span><span>年。</span><span>NCCN</span><span>指南建议在高危人群进行</span><span>LDCT</span><span>筛查肺癌,并进行年度复查直至</span><span>74</span><span>岁</span><span>[18]</span><span>。而</span><span>AATS</span><span>则根据北美地区的预期寿命,建议筛查年龄延长至</span><span>79</span><span>岁,并推荐在长期存活的肺癌患者(治疗后</span><span>4</span><span>~</span><span>5</span><span>年)中进行</span><span>LDCT</span><span>筛查,以便检出新的原发肺癌并至</span><span>79</span><span>岁</span><span>[20]</span><span>。</span><span>I</span><span>-</span><span>ELCAP</span><span>同样选择高危人群作为筛查对象,并将高危人群定义为:年龄</span><span>≥40</span><span>岁,吸烟史</span><span>≥10</span><span>包</span><span>/</span><span>年,戒烟不超过</span><span>15</span><span>年,或有被动吸烟史、职业暴露史(石棉、铍、铀或氡)</span><span>[11</span><span>,</span><span>41]</span><span>。</span></p><p><span><br  /></span></p><p><span>近年来,大气污染与肺癌的关系日益受到重视,大气污染被认为是除吸烟之外的另一肺癌重要危险因素</span><span>[42</span><span>-</span><span>43]</span><span>。随着工业化、城市化进程的加快,我国已成为世界上大气污染严重的国家之一,多数国人(特别是城市居民)正普遍暴露于这一危险因素之中。因此,在进行国人肺癌危险因素评估时,大气污染暴露是一个不容忽视的危险因素,但有关大气污染健康危险度评价体系的建立尚需时日。另外,根据我们的初步研究,也要充分重视女性被动吸烟人群的肺癌筛查</span><span>[40]</span><span>。</span></p><p><span><br  /></span></p><p><strong><span>我们推荐在国内肺癌高危人群中进行</span></strong><strong><span>LDCT</span></strong><strong><span>肺癌筛查。建议将高危人群定义为:(</span></strong><strong><span>1</span></strong><strong><span>)年龄</span></strong><strong><span>50~75&nbsp;</span></strong><strong><span>岁;(</span></strong><strong><span>2</span></strong><strong><span>)至少合并以下一项危险因素:</span></strong><strong><span>①</span></strong><strong><span>吸烟</span></strong><strong><span>≥</span></strong><strong><span>20&nbsp;</span></strong><strong><span>包</span></strong><strong><span>/</span></strong><strong><span>年,其中也包括曾经吸烟,但戒烟时间不足</span></strong><strong><span>15&nbsp;</span></strong><strong><span>年者;</span></strong><strong><span>②</span></strong><strong><span>被动吸烟者;</span></strong><strong><span>③</span></strong><strong><span>有职业暴露史(石棉、铍、铀、氡等接触者);</span></strong><strong><span>④</span></strong><strong><span>有恶性肿瘤病史或肺癌家族史;</span></strong><strong><span>⑤</span></strong><strong><span>有</span></strong><strong><span>COPD&nbsp;</span></strong><strong><span>或弥漫性肺纤维化病史。</span></strong></p><p><strong><span><br  /></span></strong></p><p><strong>(二)CT扫描方案</strong></p><p><strong><br  /></strong></p><p><span>基线</span><span>LDCT</span><span>(</span><span>baseline LDCT</span><span>):第</span><span>1</span><span>次行</span><span>LDCT</span><span>筛查肺癌。年度复查(年度筛查)</span><span>LDCT</span><span>(</span><span>annual repeatLDCT</span><span>):基线</span><span>CT</span><span>扫描以后,每年</span><span>1</span><span>次的</span><span>LDCT</span><span>肺癌筛查。随诊</span><span>LDCT</span><span>(</span><span>follow</span><span>-</span><span>upLDCT</span><span>):检出的肺内结节需在</span><span>12</span><span>个月内进行</span><span>LDCT</span><span>复查。</span></p><p><span><br  /></span></p><p><strong><span>建议有条件的医疗机构尽可能使用</span></strong><strong><span>16&nbsp;</span></strong><strong><span>层或以上多层螺旋</span></strong><strong><span>CT&nbsp;</span></strong><strong><span>进行肺癌筛查。</span></strong></p><p><strong><span>扫描范围为肺尖至肋膈角尖端水平。患者仰卧,双手上举,采取吸气末单次屏气扫描;螺旋扫描模式,建议螺距设定</span></strong><strong><span>≤</span></strong><strong><span>1</span></strong><strong><span>,机架旋转时间</span></strong><strong><span>≤</span></strong><strong><span>1.0 s</span></strong><strong><span>,扫描矩阵设定不低于</span></strong><strong><span>512</span></strong><strong><span>′</span></strong><strong><span>512</span></strong><strong><span>(具体技术参数依不同机型而定),并采用大视野(</span></strong><strong><span>FOV=L</span></strong><strong><span>);没有迭代重建技术的可使用</span></strong><strong><span>120 kVp</span></strong><strong><span>、</span></strong><strong><span>30</span></strong><strong><span>~</span></strong><strong><span>50 mAs&nbsp;</span></strong><strong><span>的扫描参数,有新一代迭代重建技术的可使用</span></strong><strong><span>100~120 kVp</span></strong><strong><span>、低于</span></strong><strong><span>30 mAs&nbsp;</span></strong><strong><span>作为扫描参数;若重建层厚</span></strong><strong><span>≤</span></strong><strong><span>0.625 mm</span></strong><strong><span>可以无间隔重建,若重建层厚介于</span></strong><strong><span>0.625</span></strong><strong><span>~</span></strong><strong><span>1.250 mm</span></strong><strong><span>之间,则重建间隔</span></strong><strong><span>≤</span></strong><strong><span>层厚的</span></strong><strong><span>80%</span></strong><strong><span>;采用标准算法,或者肺算法和标准算法同时进行重建。建议扫描时开启“</span></strong><strong><span>dose report</span></strong><strong><span>(剂量报告)”功能,以便将机器自动生成的剂量报告进行常规存储。</span></strong></p><p><strong><span><br  /></span></strong></p><p><strong>(三)LDCT图像的分析与记录</strong></p><p><span><br  /></span></p><p><span>1.</span><span>阅片:(</span><span>1</span><span>)由于现在多采用多层螺旋</span><span>CT</span><span>,胶片已不足于承载如此多的信息,因此建议在工作站或</span><span>PACS</span><span>进行阅片,最好能使用专业显示器;(</span><span>2</span><span>)采用纵隔窗(窗宽</span><span>350~380 HU</span><span>、窗位</span><span>25</span><span>~</span><span>40 HU</span><span>)及肺窗(窗宽</span><span>1 500~1 600 HU</span><span>,窗位-</span><span>650</span><span>~-</span><span>600 HU</span><span>)分别进行阅片;(</span><span>3</span><span>)建议采用多平面重组(</span><span>MPR</span><span>)及最大密度投影(</span><span>MIP</span><span>)阅片,</span><span>MPR</span><span>多方位显示肺结节的形态学特征。</span></p><p><span><br  /></span></p><p><span>2.</span><span>结节分析与记录:结节按照密度分为实性、部分实性及非实性(即纯磨玻璃密度),实性结节(</span><span>solid nodule</span><span>)定义为病灶完全掩盖肺实质;部分实性结节(</span><span>part</span><span>-</span><span>solidnodule</span><span>)为病灶遮蔽部分肺实质;非实性结节(</span><span>nonsolid nodule</span><span>)为病灶没有遮盖肺实质,支气管和血管可以辨认</span><span>[41]</span><span>。</span></p><p><span><br  /></span></p><p><strong><span>要求标注结节所在图层编号,完整报告肺结节部位、密度、大小、形态等,并给出随诊建议。有随诊</span></strong><strong><span>CT&nbsp;</span></strong><strong><span>时需要比较结节变化,同时记录其他异常,如肺气肿、肺纤维化等肺部其他疾病,冠状动脉钙化,扫描范围内其他异常发现。</span></strong></p><p><strong><span><br  /></span></strong></p><p><span>三、LDCT检出肺内结节的处理策略</span></p><p><span><br  /></span></p><p><span>通常将筛查发现的结节分为</span><span>2</span><span>大类:(</span><span>1</span><span>)肯定良性结节或钙化性结节:边界清楚,密度高,可见弥漫性钙化、中心钙化、层状钙化或爆米花样钙化;(</span><span>2</span><span>)性质不确定结节:通常指非钙化结节,对于此类结节的随诊至少需要</span><span>2</span><span>年,对非实性结节的随诊则需要更长时间。非钙化结节的随诊方案是</span><span>LDCT</span><span>筛查中的重要环节,恰当的随诊可增加肺癌筛查的效益,节约有效的卫生资源,避免不必要的医源性辐射。</span></p><p><span><br  /></span></p><p><strong>(一)&nbsp;Fleischner学会推荐方案</strong></p><p><span><br  /></span></p><p><span>Fleischner</span><span>学会</span><span>2005</span><span>年发表了</span><span>CT</span><span>检出的肺小结节的处理推荐方案,已得到广泛认可与推行,</span><span>2012</span><span>年底根据结节性质又进一步补充发表了亚实性结节(纯磨玻璃结节及含实性成分的磨玻璃结节)的随诊推荐方案</span><span>[44</span><span>-</span><span>45]</span><span>(表1,2)</span><span>。许多筛查项目的结节随诊都是依照此方案再根据筛查项目的特点形成的。</span></p><p><span><p><img src="image/20201014/d0437efe829bb7c0f273cf6ef6690b5b_5.png" /></p><br  /></span></p><p><strong>(二)&nbsp;NCCN随诊方案</strong></p><p><span><br  /></span></p><p><span>NCCN</span><span>根据</span><span>Fleischner</span><span>学会指南提出了更详细的及更适合</span><span>LDCT</span><span>筛查的肺结节随诊方案</span><span>[18]</span><span>。</span></p><p><span><br  /></span></p><p><span>1.NCCN</span><span>指南推荐基线</span><span>CT</span><span>检出结节的随诊方案:(</span><span>1</span><span>)实性和部分实性结节:</span><span>①&lt;6 mm</span><span>:年度</span><span>LDCT</span><span>筛查至少</span><span>2</span><span>年,并建议持续至患者无法耐受有效的治疗时。</span><span>②6</span><span>~</span><span>8 mm</span><span>:</span><span>3</span><span>个月内复查</span><span>LDCT</span><span>,结节无增大,则建议</span><span>6&nbsp;</span><span>个月内复查</span><span>LDCT</span><span>,仍无增大,则进入年度</span><span>LDCT</span><span>;结节增大,建议外科手术。</span><span>③&gt;8 mm</span><span>:建议行</span><span>PET</span><span>-</span><span>CT</span><span>检查,如果</span><span>PET</span><span>-</span><span>CT</span><span>怀疑肺癌可能性小,则建议</span><span>3&nbsp;</span><span>个月后复查</span><span>LDCT</span><span>;如果</span><span>PET</span><span>-</span><span>CT</span><span>高度怀疑肺癌,则建议活检或外科手术。但</span><span>PET&nbsp;</span><span>对于实性成分</span><span>&lt;8 mm&nbsp;</span><span>的结节敏感度低。</span><span>④</span><span>支气管腔内实性结节:</span><span>1</span><span>个月后复查</span><span>LDCT</span><span>,如未消散,则建议支气管镜检查。(</span><span>2</span><span>)非实性结节:</span><span>①≤5 mm</span><span>:年度</span><span>LDCT</span><span>筛查至少</span><span>2</span><span>年,并建议持续至患者无法耐受有效的治疗时;如果增大或实性成分增加,则建议</span><span>3</span><span>~</span><span>6</span><span>个月后复查</span><span>LDCT</span><span>或考虑外科手术。</span><span>②&gt;5</span><span>~</span><span>10 mm</span><span>:</span><span>6</span><span>个月内复查</span><span>LDCT</span><span>,结节无增大,进入年度</span><span>LDCT</span><span>;结节增大</span><span>,</span><span>或变为实性或部分实性结节,建议外科手术。</span><span>③&gt;10 mm</span><span>:</span><span>3</span><span>~</span><span>6</span><span>个月内复查</span><span>LDCT</span><span>,结节无增大,则建议</span><span>6</span><span>~</span><span>12</span><span>个月内复查</span><span>LDCT</span><span>、活检或外科手术;结节增大,或变为实性或部分实性结节,建议外科手术。</span></p><p><span><br  /></span></p><p><span>2</span><span>.</span><span>NCCN</span><span>指南推荐年度</span><span>LDCT</span><span>或随诊</span><span>LDCT</span><span>新发现结节的随诊方案:(</span><span>1</span><span>)新病灶疑似炎性病变:抗炎治疗后</span><span>1</span><span>~</span><span>2</span><span>个月后</span><span>LDCT</span><span>复查:</span><span>①</span><span>复查时如果病灶吸收,进入年度</span><span>LDCT</span><span>;</span><span>②</span><span>复查时如果结节部分吸收,影像随诊至吸收或稳定,进入年度</span><span>LDCT</span><span>;</span><span>③</span><span>复查时如果病灶未吸收或增大,行</span><span>PET</span><span>-</span><span>CT</span><span>,此时如果怀疑肺癌可能性小则建议</span><span>3</span><span>个月后复查</span><span>LDCT</span><span>,如果怀疑肺癌可能性大则建议活检或外科手术。(</span><span>2</span><span>)新病灶不似炎性病变:</span><span>①</span><span>实性或部分实性结节,参考上述基线</span><span>LDCT</span><span>随诊方案;</span><span>②</span><span>非实性结节,参考上述基线</span><span>LDCT</span><span>随诊方案。</span></p><p><br  /></p><p><strong>(三)I-ELCAP推荐的随诊方案</strong></p><p><span><br  /></span></p><p><span>I</span><span>-</span><span>ELCAP</span><span>的</span><span>LDCT</span><span>肺癌筛查历经</span><span>20</span><span>余年,经过对大量数据的分析与研究,不断更新自己的随诊方案</span><span>[41</span><span>,</span><span>46]</span><span>,主要目的是尽可能降低假阳性率,提高筛查效能。目前该项目所采用的方法与</span><span>NCCN</span><span>不同点体现在以下几个方面:(</span><span>1</span><span>)提出半阳性(</span><span>semi</span><span>-</span><span>positive</span><span>)结果的概念:基线</span><span>LDCT</span><span>发现的任何大小的非实性结节或径线</span><span>&lt;6 mm</span><span>的非钙化实性结节及部分实性结节;年度</span><span>CT</span><span>或随诊</span><span>CT</span><span>新发现的任何非实性结节及径线</span><span>&lt;3 mm</span><span>非钙化实性结节及部分实性结节;半阳性结节的随诊策略与筛查阴性者相似,从而有效降低了复查的频度。(</span><span>2</span><span>)基线</span><span>LDCT</span><span>按阴性(无非钙化结节)、半阳性结节、</span><span>6</span><span>~</span><span>14 mm</span><span>实性及部分实性结节、</span><span>≥15 mm</span><span>实性及部分实性结节分别进行随诊。(</span><span>3</span><span>)年度</span><span>LDCT</span><span>按阴性(无新结节)、半阳性结节、</span><span>3</span><span>~</span><span>6 mm</span><span>新实性或部分实性结节、</span><span>≥6 mm</span><span>新实性或部分实性结节或者任何呈恶性趋势增长的上年度结节分别随诊。</span></p><p><span><br  /></span></p><p><span>I</span><span>-</span><span>ELCAP</span><span>的最新版(</span><span>2014</span><span>版)基线筛查流程图请参见</span><span>http://www.ielcap.org/sites/default/files/Flowchart</span><span>-</span><span>baseline.pdf</span><span>;年度复查流程图请参见</span><span>http://www.ielcap.org/sites/default/files/Flowchart-annual.pdf</span><span>。</span></p><p><span><br  /></span></p><p><strong>(四)对检出结节生长率的评估</strong></p><p><span><br  /></span></p><p><span>NCCN</span><span>指南指出,出现下列情况可确定结节增大:(</span><span>1</span><span>)结节径线(最大径与垂直横径的平均值)</span><span>&lt;15 mm</span><span>:结节增大或结节内部实性成分增大</span><span>≥2 mm</span><span>(与基线</span><span>CT</span><span>比较);(</span><span>2</span><span>)结节径线</span><span>≥15 mm</span><span>:结节径线增大率</span><span>≥15%</span><span>(与基线</span><span>CT</span><span>比较)</span><span>[18]</span><span>。</span></p><p><span><br  /></span></p><p><span>I</span><span>-</span><span>ELCAP</span><span>提出实性结节增长率符合以下条件提示恶性(检出结节短期复查:年度复查及随诊</span><span>CT</span><span>与基线比较):(</span><span>1</span><span>)结节径线</span><span>3</span><span>~</span><span>5 mm</span><span>:增长</span><span>≥65%</span><span>;(</span><span>2</span><span>)结节径线</span><span>6</span><span>~</span><span>7 mm</span><span>:增长</span><span>≥50%</span><span>;(</span><span>3</span><span>)结节径线</span><span>7~9 mm</span><span>,增长</span><span>≥40%</span><span>;(</span><span>4</span><span>)结节径线</span><span>≥10 mm</span><span>,增长</span><span>≥30%[51]</span><span>。</span></p><p><span><br  /></span></p><p><strong><span>建议根据各家医院的设备条件(包括图像存储条件)、经验和习惯参照选用或者综合运用。但应该特别注意的是:结节的细微变化,应该在软阅读条件下,连续阅读薄层</span></strong><strong><span>CT&nbsp;</span></strong><strong><span>上的图像,并与前后进行仔细地比较;磨玻璃密度是否增高、实性部分是否增多对于诊断尤为重要。</span></strong></p><p><strong><span><br  /></span></strong></p><p><strong>(五)计算机辅助诊断系统(computer-aideddiagnosis/detection systems,CAD)在结节检出及诊断中的应用</strong></p><p><span><br  /></span></p><p><span>CAD</span><span>在肺癌筛查中有积极意义。</span><span>CAD</span><span>三维体积测量技术在实性肺结节的随诊中可早期发现病变大小的变化,对鉴别结节良恶性具有重要价值,可作为难以定性的实性肺结节(尤其是径线</span><span>≤10mm</span><span>)随诊的常规方法。如果以结节倍增时间</span><span>≤400 d</span><span>作为恶性结节的诊断阈值,其敏感度、特异度、准确性分别为</span><span>92.3%</span><span>、</span><span>91.7%</span><span>及</span><span>94.6%[33,47]</span><span>。另外,利用</span><span>CAD</span><span>有利于肺结节的检出,减少漏诊率。有研究表明利用</span><span>CAD</span><span>检出肺结节的能力要高于医师阅片</span><span>[36]</span><span>。但目前</span><span>CAD</span><span>的主要局限性在于对非实性结节、较多毛刺肿物或贴邻胸膜及支气管血管束的病灶的检出及计算,尚不能取代放射医师</span><span>[48]</span><span>,但可作为“第二读片人”来协助医师诊断</span><span>[49]</span><span>。</span></p><p><span><br  /></span></p><p><strong>(六)PET-CT在检出肺结节中的使用</strong></p><p><span><br  /></span></p><p><span>PET</span><span>-</span><span>CT</span><span>对</span><span>LDCT</span><span>肺癌筛查中检出的肺结节的进一步定性有一定作用。</span><span>LDCT</span><span>发现的不确定结节的随诊中,采用</span><span>PET</span><span>及计算结节倍增时间能有效提高诊断准确性,但在许多筛查项目中,脱氧葡萄糖(</span><span>FDG</span><span>)</span><span>PET</span><span>-</span><span>CT</span><span>并非常规用于检出的肺结节的进一步诊断,而且其在非实性及较小的实性肺癌中常呈假阴性</span><span>[49]</span><span>。</span><span>FDG</span><span>-</span><span>PET</span><span>在肺癌筛查中的应用研究在日本小范围内进行,尚处于较初步的阶段</span><span>[50]</span><span>。</span></p><p><span><br  /></span></p><p><strong><span>根据国情和效能,不推荐将</span></strong><strong><span>PET</span></strong><strong><span>-</span></strong><strong><span>CT&nbsp;</span></strong><strong><span>作为人群肺癌筛查的方法。</span></strong></p><p><br  /></p><p><strong>(七)CT导引下穿刺活检术的应用</strong></p><p><span><br  /></span></p><p><span>对筛查检出的肺结节,</span><span>CT</span><span>导引下穿刺活检术已是进一步诊断的重要方法,其诊断准确性高,可减少不必要的进一步有创性方法的介入,在一些医疗机构已作为胸科手术前的必要程序</span><span>[51]</span><span>。</span></p><p><span><br  /></span></p><p><strong><span>综上,各医疗机构或研究项目的随诊方案虽然不尽一致,但通常都是根据以下几个方面提出随诊意见:(</span></strong><strong><span>1</span></strong><strong><span>)结节的大小;(</span></strong><strong><span>2</span></strong><strong><span>)结节的密度(实性、部分实性或非实性);(</span></strong><strong><span>3</span></strong><strong><span>)检出结节的时间点不同:基线</span></strong><strong><span>CT&nbsp;</span></strong><strong><span>或年度和随诊复查</span></strong><strong><span>CT</span></strong><strong><span>。参照上述指南或推荐方案,结合我国实际情况,对</span></strong><strong><span>LDCT&nbsp;</span></strong><strong><span>肺癌筛查检出的肺结节的处理策略建议如下:</span></strong></p><p><strong><span>1.</span></strong><strong><span>基线</span></strong><strong><span>CT&nbsp;</span></strong><strong><span>检出的实性结节随诊方案见</span></strong><strong><span>图</span></strong><strong><span>1</span></strong><strong><span>。</span></strong></p><p><strong><span>2.</span></strong><strong><span>年度复查</span></strong><strong><span>CT&nbsp;</span></strong><strong><span>检出的实性结节随诊方案见</span></strong><strong><span>图</span></strong><strong><span>2</span></strong><strong><span>。</span></strong></p><p><strong><span>3.LDCT&nbsp;</span></strong><strong><span>检出的非实性和部分实性结节的处理方案:建议按照肺亚实性结节影像处理专家共识进行处理</span></strong><strong><span>[52]</span></strong><strong><span>。</span></strong></p><p><strong><span><p><img src="image/20201014/8d147c55c7e33d1419c89ca499a5f2c3_6.png" /></p><br  /><p><img src="image/20201014/340150d70ae685ef20bee6895260a58e_7.png" /></p><br  /></span></strong></p><p><strong><span><br  /></span></strong></p><p><span>四、LDCT肺癌筛查的价值</span></p><p><span><br  /></span></p><p><strong>(一)检出更多更早的肺癌,降低肺癌病死率</strong></p><p><span><br  /></span></p><p><span>在参加筛查的人群中,基线</span><span>LDCT</span><span>的肺癌检出率为</span><span>0.4%</span><span>~</span><span>3.7%</span><span>,年度复查</span><span>LDCT</span><span>的肺癌检出率为</span><span>0.2%</span><span>~</span><span>2.2%[40</span><span>,</span><span>53]</span><span>。</span><span>LDCT&nbsp;</span><span>筛查检出的肺癌多为</span><span>&lt;20 mm</span><span>的周围型肺癌,检出的非小细胞肺癌的平均径线为</span><span>15 mm[54]</span><span>。</span><span>LDCT</span><span>检出的肺癌中,早期比例很高,</span><span>IA</span><span>期可达</span><span>50%~91%[55]</span><span>。</span><span>I</span><span>-</span><span>ELCAP</span><span>的研究结果显示,</span><span>LDCT</span><span>检出早期肺癌占</span><span>85%</span><span>;肺癌预期总</span><span>10&nbsp;</span><span>年生存率</span><span>80%</span><span>(不论临床分期和接受何种治疗);若及时手术,预期总</span><span>10&nbsp;</span><span>年生存率高达</span><span>92%[41,56]</span><span>。</span><span>NCI</span><span>的研究表明</span><span>LDCT</span><span>作为肺癌筛查方法优于乳腺癌及结直肠癌的筛查,在美国每年可能避免</span><span>18 000</span><span>人死于肺癌</span><span>[57]</span><span>。</span></p><p><span><br  /></span></p><p><strong>(二)可同时检出其他疾病</strong></p><p><span><br  /></span></p><p><span>在无症状人群中早期检出肺</span><span>COPD</span><span>的作用还存有争议。但通过对</span><span>COPD</span><span>的早期诊断和早期干预,可减低</span><span>CPOD</span><span>相关疾病的患病率及病死率,以及通过戒烟减缓相关疾病的进展等。吸气</span><span>CT</span><span>对</span><span>COPD</span><span>的评估更具价值</span><span>[58]</span><span>。冠状动脉钙化的发现与危险的评价也加强了</span><span>LDCT</span><span>筛查的意义,有研究表明冠状动脉钙化分数(</span><span>CAC Scoring</span><span>)可作为一个独立因素预测全因病死率及心血管疾病。筛查中还可发现其他异常如肺间质性病变、甲状腺病变、乳腺结节等,都会给被检者带来益处</span><span>[18</span><span>,</span><span>58</span><span>-</span><span>60]</span><span>,这也直接增加了</span><span>LDCT</span><span>筛查的应用价值。</span></p><p><span><br  /></span></p><p><span>五、LDCT肺癌筛查的争议</span></p><p><span><br  /></span></p><p><strong>(一)假阳性结果</strong></p><p><span><br  /></span></p><p><span>假阳性率是肺癌筛查研究的重要内容之一,</span><span>LDCT</span><span>筛查肺癌的主要争议是其较高的假阳性率</span><span>[61]</span><span>。非钙化结节的检出率在基线</span><span>LDCT&nbsp;</span><span>为</span><span>9%&nbsp;</span><span>~</span><span>66.7%&nbsp;</span><span>,年度复查</span><span>LDCT&nbsp;</span><span>为</span><span>8%</span><span>~</span><span>42%[40</span><span>,</span><span>52]</span><span>,而肺癌检出率在基线</span><span>CT&nbsp;</span><span>仅为</span><span>0.4%</span><span>~</span><span>3.7%</span><span>,年度复查</span><span>CT</span><span>为</span><span>0.2%</span><span>~</span><span>2.2%</span><span>。有效而准确定义阳性结节的阈值可降低假阳性率。对</span><span>LDCT</span><span>发现的结节采用恰当的随诊策略也是目前影像筛查降低其假阳性率的重要手段,并且是目前及将来仍需研究的重要内容。</span></p><p><span><br  /></span></p><p><strong>(二)过度诊断</strong></p><p><span><br  /></span></p><p><span>过度诊断是目前</span><span>LDCT</span><span>肺癌筛查的争议之一,可能产生额外的费用,影响筛查效率</span><span>[62]</span><span>。但现有结果显示,与胸部</span><span>X</span><span>线片比较,</span><span>LDCT</span><span>的过度诊断并不高,研究表明小于</span><span>17%</span><span>,与女性乳腺癌筛查相仿</span><span>[57</span><span>,</span><span>63]</span><span>。惰性生长的肺癌在筛查中约占</span><span>25%</span><span>,过度诊断是难以避免的,合理的随诊、应用损伤较小的介入性诊疗方法(如胸腔镜等)或非手术治疗方法等可有效降低其可能产生的风险</span><span>[64]</span><span>。</span></p><p><span><br  /></span></p><p><strong>(三)&nbsp;过度治疗</strong></p><p><span><br  /></span></p><p><span>人们依然十分关注由于假阳性率较高,可能会造成较多不必要的有创性诊疗手段,但如果严格按照随诊方案、根据结节形态及生长速度进行随诊,则良性结节进行穿刺活检的比率很低,进行活检的结节中仅</span><span>16%</span><span>为良性结节</span><span>[51]</span><span>。筛查中的良性结节的手术切除率(手术的良性结节</span><span>/</span><span>检出的结节)在</span><span>0.9</span><span>~</span><span>13.0%</span><span>之间,大部分在</span><span>2.0%</span><span>左右</span><span>[65]</span><span>,在筛查研究项目中均控制在合理范围内。</span></p><p><span><br  /></span></p><p><strong>(四)&nbsp;辐射剂量</strong></p><p><span><br  /></span></p><p><span>放射线的风险依然是</span><span>LDCT</span><span>肺癌筛查时需要重点关注的内容之一,仍需要不断研究和给予评估</span><span>[10]</span><span>。</span><span>LDCT</span><span>平均辐射剂量为</span><span>0.61</span><span>~</span><span>1.50 mSv</span><span>,美国医学物理师协会认为如果影像学检查的单次剂量在</span><span>50 mSv</span><span>以下、短期内多次累积剂量在</span><span>100 mSv</span><span>以下时被认为可能是安全的</span><span>[20</span><span>,</span><span>24</span><span>,</span><span>66]</span><span>。</span></p><p><span><br  /></span></p><p><span>六、LDCT肺癌筛查的成本-效益</span></p><p><span><br  /></span></p><p><span>筛查方法应有较好的成本</span><span>-</span><span>效益关系,肿瘤的筛查不能过度占用有限的卫生资源,特别是在中国这样的发展中国家,目前的数据显示在高危人群中进行</span><span>LDCT</span><span>筛查肺癌具有良好的效益</span><span>[20</span><span>,</span><span>67]</span><span>。研究证实在高危人群中筛查费用是合理的,其效益与结肠癌筛查相似,优于乳腺癌的筛查</span><span>[67]</span><span>。但筛查所产生的费用如</span><span>LDCT</span><span>费用、随诊费用、治疗费用等在我国还需进行严格的分析。</span></p><p><span><br  /></span></p><p><span>综上所述,</span><span>2011</span><span>年美国</span><span>NLST</span><span>的随机对照研究结果表明</span><span>LDCT</span><span>筛查可使肺癌病死率下降</span><span>20%[10]</span><span>,印证了</span><span>LDCT&nbsp;</span><span>在肺癌筛查方面的价值,平息了很多争议,很大程度上也决定了未来研究和发展的方向。中国的经济、文化及社会背景等明显不同于西方发达国家,决定了国内医疗机构不能完全照搬照抄西方发达国家的</span><span>LDCT&nbsp;</span><span>肺癌筛查方案,我们需要积极努力获得更多数据,探究</span><span>LDCT</span><span>在中国肺癌筛查方面的应用前景。国际肺癌研究协会(</span><span>IASLC</span><span>)在关于肺癌筛查的声明中指出:未来实施筛查项目的一个关键因素是必须有一支训练有素且由肺癌相关领域的多学科专家共同组成的团队</span><span>[68]</span><span>。我们建议具备综合实力的国内医疗机构积极地在肺癌高危人群中开展</span><span>LDCT</span><span>肺癌筛查,以推动中国肺癌筛查研究的不断前行以及筛查方案的不断完善。此外,在社会上积极推进戒烟教育也是我们每位从事筛查工作者的责任。对每位吸烟的筛查对象都应建议戒烟,并告知筛查不应被视为戒烟的替代措施。</span></p><p><span><br  /></span></p><p><span><strong><span>共识专家组成员</span></strong><strong><span>:</span></strong></span><span>第二军医大学长征医院影像医学与核医学科(刘士远、肖湘生);西安交通大学第一附属医院影像科(郭佑民);北京医院放射科(陈起航、潘纪戍);大连大学附属中山医院放射科(伍建林);中国医学科学院肿瘤医院影像诊断科(吴宁、黄遥、赵世俊);首都医科大学附属北京友谊医院放射科(马大庆、贺文);复旦大学附属华东医院放射科(张国桢);四川大学华西医院放射科(杨志刚);北京协和医院放射科(宋伟);复旦大学附属中山医院放射科(张志勇);解放军总医院放射科(赵绍宏);中南大学湘雅二院放射科(王云华);上海交通大学附属胸科医院放射科(叶剑定);宁夏医科大学总医院放射科(郭玉林);兰州大学第一医院放射科(郭顺林);内蒙古医科大学附属医院放射科(刘挨师);天津医科大学肿瘤医院放射科(叶兆祥);广东省人民医院放射科(赵振军);无锡市第一人民医院放射科(陈宏伟);首都医科大学附属北京世纪坛医院放射科(王仁贵);广州医学院第一附属医院放射科(曾庆思);上海交通大学上海肺科医院放射科(史景云);中国医科大学附属盛京医院放射科(侯阳);中国医科大学附属第一医院放射科(张立娜)</span></p><p><br  /></p><p><span>本文原载于《中华放射学杂志》2015年第5期</span></p><p><span></span></p><section 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