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吴文铭, 陈洁, 白春梅, 依荷芭丽·迟, 杜奕奇, 冯仕庭, 霍力, 姜玉新, 李景南, 楼文晖, 罗杰, 邵成浩, 沈琳, 王峰, 王理伟, 王鸥, 王于, 吴焕文, 邢小平, 徐建明, 薛华丹, 薛玲, 杨扬, 虞先濬, 原春辉, 赵宏, 朱雄增, 赵玉沛, 中华医学会外科学分会胰腺外科学组. 中国胰腺神经内分泌肿瘤诊疗指南(2020)[J]. 协和医学杂志, 2021, 12(4): 460-480. doi: 10.12290/xhyxzz.2021-0481
引用本文: 吴文铭, 陈洁, 白春梅, 依荷芭丽·迟, 杜奕奇, 冯仕庭, 霍力, 姜玉新, 李景南, 楼文晖, 罗杰, 邵成浩, 沈琳, 王峰, 王理伟, 王鸥, 王于, 吴焕文, 邢小平, 徐建明, 薛华丹, 薛玲, 杨扬, 虞先濬, 原春辉, 赵宏, 朱雄增, 赵玉沛, 中华医学会外科学分会胰腺外科学组. 中国胰腺神经内分泌肿瘤诊疗指南(2020)[J]. 协和医学杂志, 2021, 12(4): 460-480. doi: 10.12290/xhyxzz.2021-0481
WU Wenming, CHEN Jie, BAI Chunmei, YIHEBALI Chi, DU Yiqi, FENG Shiting, HUO Li, JIANG Yuxin, LI Jingnan, LOU Wenhui, LUO Jie, SHAO Chenghao, SHEN Lin, WANG Feng, WANG Liwei, WANG Ou, WANG Yu, WU Huanwen, XING Xiaoping, XU Jianming, XUE Huadan, XUE Ling, YANG Yang, YU Xianjun, YUAN Chunhui, ZHAO Hong, ZHU Xiongzeng, ZHAO Yupei, Chinese Pancreatic Surgery Association, Chinese Society of Surgery, Chinese Medical Association. The Chinese Guidelines for the Diagnosis and Treatment of Pancreatic Neuroendocrine Neoplasms (2020)[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(4): 460-480. doi: 10.12290/xhyxzz.2021-0481
Citation: WU Wenming, CHEN Jie, BAI Chunmei, YIHEBALI Chi, DU Yiqi, FENG Shiting, HUO Li, JIANG Yuxin, LI Jingnan, LOU Wenhui, LUO Jie, SHAO Chenghao, SHEN Lin, WANG Feng, WANG Liwei, WANG Ou, WANG Yu, WU Huanwen, XING Xiaoping, XU Jianming, XUE Huadan, XUE Ling, YANG Yang, YU Xianjun, YUAN Chunhui, ZHAO Hong, ZHU Xiongzeng, ZHAO Yupei, Chinese Pancreatic Surgery Association, Chinese Society of Surgery, Chinese Medical Association. The Chinese Guidelines for the Diagnosis and Treatment of Pancreatic Neuroendocrine Neoplasms (2020)[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(4): 460-480. doi: 10.12290/xhyxzz.2021-0481

中国胰腺神经内分泌肿瘤诊疗指南(2020)

doi: 10.12290/xhyxzz.2021-0481
基金项目: 

中国医学科学院医学与健康科技创新工程 2017-I2M-1-001

详细信息
    通讯作者:

    赵玉沛  电话:010-69155810,E-mail: zhao8028@263.net

    吴文铭、陈洁对本文同等贡献

    吴文铭、陈洁对本文同等贡献

  • 中图分类号: R58;R735.9;R61

The Chinese Guidelines for the Diagnosis and Treatment of Pancreatic Neuroendocrine Neoplasms (2020)

Funds: 

CAMS Innovation Fund for Medical Sciences 2017-I2M-1-001

More Information
    Corresponding author: ZHAO Yupei  Tel: 86-10-69155810, E-mail: zhao8028@263.net
  • 摘要: 胰腺神经内分泌肿瘤具有高度异质性,患者的临床管理存在一定难度。为了应对这一挑战,中华医学会外科学分会胰腺外科学组牵头成立了由肿瘤外科、消化内科、肿瘤内科、内分泌科、影像科、病理科、核医学科等多领域学者组成的专家委员会。该委员会回顾了与胰腺神经内分泌肿瘤诊断和治疗相关的重要问题,并基于循证医学证据提出了相应的诊疗建议,以期进一步改进中国胰腺神经内分泌肿瘤患者的诊疗流程。
    作者贡献:赵玉沛院士领导了指南更新项目、组织了指南编辑委员会(编委会)并任命吴文铭教授和陈洁教授全权负责编委会对指南的撰写工作。吴文铭教授和陈洁教授共同起草了指南初稿,并组织编委会其他成员依照指南编写流程对指南初稿进行审校;在吴文铭教授和陈洁教授的主持和参与下,白春梅教授、依荷芭丽·迟教授、杜奕奇教授、冯仕庭教授、霍力教授、姜玉新教授、李景南教授、楼文晖教授、罗杰教授、邵成浩教授、沈琳教授、王峰教授、王理伟教授、王鸥教授、王于教授、吴焕文教授、邢小平教授、徐建明教授、薛华丹教授、薛玲教授、杨扬教授、虞先濬教授、原春辉教授、赵宏教授、朱雄增教授共同参加了三轮指南修订会议,并根据各自专业对指南的相应章节进行了修订;吴文铭教授、陈洁教授、白春梅教授、霍力教授、姜玉新教授、邢小平教授、薛华丹教授、薛玲教授作为各自章节的负责人,参加或委派代表参加了指南定稿会并对指南终稿内容进行确认;吴文铭教授和陈洁教授对指南终稿全文进行了最终审校后,所有作者均通过了指南终稿并形成指南定稿,同时签署了作者贡献声明及版权转让协议。
    利益冲突:
    吴文铭、陈洁对本文同等贡献
  • 表  1  2019年世界卫生组织第5版胃肠胰神经内分泌肿瘤病理学分类和分级标准

    命名 分化程度 分级 核分裂象数a(/2 mm2) Ki-67指数(%)a
    神经内分泌瘤,G1级 高分化 <2 <3
    神经内分泌瘤,G2级 高分化 2~20 3~20
    神经内分泌瘤,G3级b 高分化 >20 >20
    神经内分泌癌,小细胞型 低分化c c >20 >20
    神经内分泌癌,大细胞型 低分化c c >20 >20
    混合性神经内分泌-非神经内分泌肿瘤 高或低分化 多样的d 多样的d 多样的d
    a核分裂象数表示为核分裂象计数/2 mm2(该面积等于40倍放大倍数及每个视野最大径0.5 mm情况下的10个高倍镜视野),计数50个0.2 mm2的视野;Ki-67增殖指数通过计数高染色区域(即热点区)至少500个细胞获得;最终分级采用两种增殖指数所对应分级中的较高者;bG3级神经内分泌瘤的核分裂数和Ki-67指数未设上限,其理由是G3级神经内分泌瘤(尤其G3级胰腺神经内分泌瘤)的Ki-67指数偶可高达70%~80%,故不能仅根据Ki-67指数的高低进行分级,还需结合其形态学分化良好的特点;对难以区分的G3级神经内分泌瘤和神经内分泌癌,需进行TP53、RB1、ATRX和DAXX染色协助鉴别诊断;c神经内分泌癌根据定义为高级别,无需再分级;d在大部分混合性神经内分泌-非神经内分泌肿瘤中,神经内分泌肿瘤和非神经内分泌肿瘤成分均为低分化,且神经内分泌肿瘤成分的增殖指数与其他神经内分泌癌一致,但该类型肿瘤亦允许这两种成分均为高分化,这种情况下,应分别对两种成分进行分级;胰腺的混合性神经内分泌-非神经内分泌肿瘤包括4个亚型:混合性导管癌-神经内分泌癌(小细胞或大细胞)、混合性导管癌-神经内分泌瘤、混合性腺泡细胞癌-神经内分泌癌和混合性腺泡细胞癌-导管癌-神经内分泌癌
    下载: 导出CSV

    表  2  2017年AJCC第8版胰腺神经内分泌肿瘤的TNM分期标准

    分期 特征 分期 特征
    T分期 原发肿瘤a M分期 远处转移
      TX 原发肿瘤无法评价   M0 无远处转移
      T1 局限于胰腺内b,且最大径<2 cm   M1 有远处转移
      T2 局限于胰腺内b,且最大径2~4 cm     M1a 仅存在肝脏转移
      T3 局限于胰腺内b,且最大径>4 cm;或侵犯十二指肠或胆管     M1b 仅存在至少一个肝脏外器官转移(如肺、卵巢、非区域淋巴结、腹膜、骨)
      T4 侵犯邻近器官(如胃、脾、结肠、肾上腺)或大血管壁(腹腔干或肠系膜上动脉)     M1c 同时存在肝脏和肝脏外器官转移
    N分期 区域淋巴结
      NX 区域淋巴结无法评价
      N0 无区域淋巴结转移
      N1 有区域淋巴结转移
    AJCC:美国癌症联合委员会;a若原发肿瘤为多发,则以最大的肿瘤进行T分期;若多发肿瘤数量已知,则记为T(#),如pT3(4)N0M0;若多发肿瘤数量未知或难以计数,则记为T(m),如pT3(m) N0 M0;b“局限于胰腺内”定义为无邻近器官(如胃、脾、结肠、肾上腺)或大血管壁(如腹腔干或肠系膜上动脉)侵犯,肿瘤对胰周脂肪的侵犯不作为分期依据
    下载: 导出CSV

    表  3  2017年AJCC第8版综合分期标准

    分期 T分期 N分期 M分期
    Ⅰ期 T1 N0 M0
    Ⅱ期 T2 N0 M0
    T3 N0 M0
    Ⅲ期 T4 N0 M0
    任何T N1 M0
    Ⅳ期 任何T 任何N M1
    AJCC:同表 2
    下载: 导出CSV

    表  4  pNEN的临床分类与特征[5, 10-11, 15, 20-21]

    类型 年发病率(/106) 分泌激素 常见部位 恶性比率(%) 主要症状
    功能性pNEN
      胰岛素瘤 1~32 胰岛素 胰腺 5~10 低血糖
      胃泌素瘤 0.5~21.5 胃泌素 十二指肠、胰腺 50~60 腹泻、腹痛、反酸
      胰高血糖素瘤 0.01~0.1 胰高血糖素 胰腺 50~80 坏死游走性红斑、贫血、葡萄糖不耐受、体质量下降
      生长抑素瘤 少见 生长抑素 胰腺、十二指肠、空肠 50~60 糖尿病、胆石症、腹泻
      产生ACTH的神经内分泌瘤 少见 ACTH 胰腺 >90 库欣综合征
      血管活性肠肽瘤 0.05~0.2 血管活性肠肽 胰腺 40~80 水样泻、低钾血症
    无功能性pNEN 可能有激素水平的升高但未引起相关临床症状 胰腺 60~90 无特异性症状,常为肿瘤压迫、侵袭、转移引起的相关症状,如消化道梗阻、出血、腹痛、黄疸等
    pNEN:胰腺神经内分泌肿瘤;ACTH:促肾上腺皮质激素
    下载: 导出CSV

    附表 1  本指南使用的指南证据特征分类

    类别 水平 来源 专家共识度
    1A 严谨的Meta分析、大型随机对照临床研究 一致共识
    1B 严谨的Meta分析、大型随机对照临床研究 基本一致共识,但争议小
    2A 稍低 一般质量的Meta分析、小型随机对照研究、设计良好的大型回顾性研究、病例对照研究 一致共识
    2B 稍低 一般质量的Meta分析、小型随机对照研究、设计良好的大型回顾性研究、病例对照研究 基本一致共识,但争议小
    3 非对照的单臂临床研究、病例报告、专家观点 无共识,且争议大
    下载: 导出CSV

    附表 2  本指南使用的指南证据等级分类

    推荐等级 标准
    Ⅰ级推荐 一般情况下,将1A类证据和部分专家共识度高且在中国可及性好的2A类证据作为Ⅰ级推荐。具体来说,Ⅰ级推荐具有如下特征:可及性好的普适性诊治措施(包括适应证明确),肿瘤治疗价值相对稳定,基本为国家医保所收录;Ⅰ级推荐的确定,不因商业医疗保险而改变,主要考虑的因素是患者的明确获益性
    Ⅱ级推荐 一般情况下,将1B类证据和部分专家共识度稍低或在中国可及性不太好的2A类证据作为Ⅱ级推荐。具体来说,Ⅱ级推荐具有如下特征:在国际或国内已有随机对照的多中心研究提供的高级别证据,但是可及性差或者效价比低,已超出平民经济承受能力的药物或治疗措施;对于获益明显但价格昂贵的措施,以肿瘤治疗价值为主要考虑因素,也可以作为Ⅱ级推荐
    Ⅲ级推荐 对于正在探索的诊治手段,虽然缺乏强有力的循证医学证据,但是专家组具有一致共识的,可以作为Ⅲ级推荐供医疗人员参考
    不推荐或反对 对于已有充分证据证明不能使患者获益的,甚至导致患者伤害的药物或者医疗技术,专家组具有一致共识的,应写明“专家不推荐”或者必要时“反对”。可以是任何类别等级的证据
    下载: 导出CSV
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  • 收稿日期:  2021-06-18
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