图29标本量充足,肿瘤组织颗粒丰富 A:肉眼观颗粒物丰富,血液成分较少;B:光镜下观乳头状癌肿瘤细胞的细胞核明显(×10)专家意见:充分发挥病理医师或受过专门训练的医护技人员的技术能力,于穿刺现场裸眼观察并初步判断标本中颗粒物是否丰富,以指导当场是否需要继续穿刺取材。但是,不应将标本的裸眼观察结果与其病理性质作等同关联。推荐强度:C,推荐。基于专家意见。5 穿刺后注意事项穿刺后应向患者和家属详细说明注意事项,患者按压进针处皮肤至少10 min,避免颈部剧烈运动;门诊观察30 min,并再次超声检查确认穿刺部位无出血方可让患者离院。患者离院后,如出现颈部肿胀、持续疼痛等体征应及时就医检查处理。专家意见:细针穿刺活检的主要并发症是局部出血,压迫止血法简单易行,效果确切。少数患者可存在迟发性活动性出血风险,术者应予高度重视。推荐强度:C,推荐。基于专家意见。6 并发症及处置6.1 出血出血是FNA术中最常见的并发症,发生率约8.6%[32]。血肿可出现于甲状腺周围间隙、甲状腺实质内、或穿刺路径上的肌肉内,通常症状轻微,吸收较快。在患者无明显呼吸困难的情况下,局部压迫止血20 min,可不作其他处理。若颈动脉管壁被刺伤,发生管壁内血肿时需局部压迫止血1~2 h,以防出血沿动脉壁大范围扩散。极少情况下,当出现大血肿或假性动脉瘤时[33,34],需留院观察,作进一步处置。FNA损伤结节滋养动脉尚可导致甲状腺结节内假性动脉瘤,须要外科干预[35]。6.2 感染FNA导致皮肤穿刺点或穿刺路径感染者较为罕见,轻微感染者无需处理或仅作口服抗生素处理,感染较明显甚至形成脓肿时需外科处理。6.3 针道种植FNA术后肿瘤细胞沿穿刺针道种植的发生率极低,文献报告其发生率约为1.2/106[36]。6.4 休克极少数患者于穿刺时可发生“休克“,其多数为“晕针“反应。此时,应立即停止操作,患者仰卧,吸氧,监测心率、血压,密切观察生命体征。必要时,应及时联系急诊科、麻醉科等相关科室紧急会诊,根据具体情况进一步处置。6.5 其他FNA导致气管、食管及喉返神经等结构的损伤较罕见。专家意见:FNA创伤微小,并发症少、症状轻,但仍应遵守无菌操作原则,保持安全意识,制定应急预案与措施,防范严重并发症。推荐强度:C,推荐。基于专家意见。7 细胞学评估结果与处理意见目前,使用较广泛的甲状腺细胞学报告系统主要有意大利内分泌协会共识、英国皇家病理学家学会和甲状腺细胞病理学Bethesda报告系统(The Bethesda System for Reporting
Thyroid Cytopathology,TBSRTC),其内容存在微小差异[37,38,39,40]。专家意见:使用TBSRTC诊断总体分类[40,41]推荐强度:A,强烈推荐。循证证据肯定,能够改善临床结局,利大于弊。7.1 标本无法诊断或不满意建议每隔6~12个月进行超声随访或重复FNA。如果超声疑似恶性结节,尤其是短期内结节的实性成分增大,建议3个月内再次行FNA[42,43,44,45]。若结节最大径<5mm或囊性部分>50%,再次穿刺的无诊断率依然较高,建议随访超声检查,根据具体情况进一步处置[46]。推荐强度:B,推荐。循证证据肯定,能够改善临床结局,利大于弊。7.2 良性病变一般无需进一步诊断和处理,按12~24个月的时间间隔作随访超声检查。但当结节大于4 cm时,建议行超声引导下粗针穿刺活检(core-needle biopsy,CNB)或外科诊治。对于结节实性成分增长>50%或结节出现疑似恶性超声影像特征时,建议再次FNA或加行基因检测。推荐强度:B,推荐。循证证据良好,能够改善临床结局,利大于弊。7.3 意义不明确的细胞非典型性病变,或意义不明确的滤泡性病变建议再次FNA,若多次FNA均无结果,根据结节超声影像疑似恶性的程度,提高随访检查频度。超声影像上出现明显恶性特征者可在FNA基础上行基因检测,也可经评估后实行超声引导下CNB或诊断性外科手术。推荐强度:B,推荐。循证证据良好,能够改善临床结局,利大于弊。7.4 滤泡性肿瘤或可疑滤泡性肿瘤超声检查及FNA结果均难以判断其良恶性,一般建议外科诊治,不建议重复穿刺[47]。或在重复FNA基础上行基因检测。推荐强度:C,推荐。基于专家意见。7.5 恶性或可疑恶性结节一般建议积极处理。其中,可疑恶性者需结合临床危险因素、超声危险分类和基因检测结果。推荐强度:B,推荐。循证证据良好,能够改善临床结局,利大于弊。8 穿刺洗脱液分子标记物检测FNA穿刺物洗脱液可用于检测甲状腺癌特异性分子标记物。目前,研究比较成熟的分子标记物包括:RET/PTC、RAS、PAX8/PPARγ和BRAF,与甲状腺癌的发生相关[48,49,50,51,52,53,54]。其中,BRAF突变、RET/PTC重排与甲状腺乳头状癌高度相关;RAS突变、PAX8/PPARγ重排可能与甲状腺滤泡癌有关;甲状腺髓样癌可进行降钙素测定[55,56,57,58]。最近来自上海的一组病例发现,术前单纯FNA的敏感性和准确性分别为76%和79%,如联合应用术前BRAF基因检测,可分别上升至92%和91%[58]。专家意见:分子标记物的检测能有效提高诊断的敏感性和准确性,尤其是在细胞学阴性、不能诊断或细胞学结果不典型结果中,阳性表达有助于诊断。推荐强度:B,推荐。循证证据良好,能够改善临床结局,利大于弊。9 准入与培训[59]9.1 资质准入9.1.1 相关医疗机构在其核准的执业诊疗科目中有超声诊疗登记许可,取得诊疗许可证。9.1.2 相关科室的业务范围内应含有介入超声项目,超声引导下甲状腺结节穿刺技术管理符合上级主管部门或机构的相关管理规定要求。9.1.3 穿刺操作者取得中华人民共和国《医师资格证书》和《医师执业证》,执业范围应为“医学影像和放射治疗专业“。穿刺操作者如系从事其它执业范围,则须参加相关培训并取得大型医用设备CDFI医师上岗合格证。9.2 人员培训9.2.1 开展甲状腺结节细针穿刺需参加经国家级或省市级主管部门批准举办的介入超声和(或)甲状腺超声学习班培训学习,并经考核合格。9.2.2 实施穿刺操作者需接受介入超声丰富经验、副高及以上医师,临床带教1年及以上培训学习经历,参与甲状腺结节细针穿刺50例及以上。9.2.3 从事甲状腺穿刺辅助工作的护士应具备一定临床工作经验,接受介入超声专业培训学习,并经考核合格。专家意见:介入超声技术属于外科手术操作范畴。为减少医疗差错与事故,保障医疗安全,开展甲状腺结节细针穿刺细胞学检查时必须严格执行准入与培训制度。推荐强度:A.强烈推荐。循证证据肯定,能够改善临床结局,利大于弊。执笔专家 沈理、章建全、周伟编写组成员(按姓氏汉字拼音排序):陈磊(上海交通大学附属第六人民医院);崔峥(同济大学附属东方医院);方超(复旦大学附属中山医院徐汇医院);何峥(上海中医药大学附属曙光医院);季正标(复旦大学附属中山医院);李萍(上海交通大学医学院附属仁济医院);盛建国(上海中医药大学附属曙光医院);沈理(上海交通大学医学院附属新华医院崇明分院);孙丽萍(同济大学附属第十人民医院);施倩(上海中医药大学附属第七人民医院);王雷(上海交通大学附属胸科医院);徐彬(复旦大学附属上海市第五人民医院);徐辉雄(同济大学附属第十人民医院);詹维伟(上海交通大学医学院附属瑞金医院);章建全(海军军医大学附属长征医院、上海国际医学中心);周伟(上海交通大学医学院附属瑞金医院)审校 沈理致谢 文中插图由上海三月泉医院管理有限公司、江苏省苏州市立普医疗科技有限公司、上海交通大学医学院附属瑞金医院病理科制作、提供,谨致衷心感谢!参考文献[1]YipL,WharryLI, ArmstrongMJ,et al.A clinical
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