摘要目的:揭示中国肺癌外科病理诊断现状及存在问题，进一步提升中国肺癌病理规范和科研数据水平并构建中国肺癌病理结构化大数据库。方法:依据肺癌手术切除标本病理诊断规范内容要求，制定病例报告表，按照病例报告表指标内容要求，回顾性收集23家三甲医院2013年1月至2017年12月手术切除原发肺癌患者原始临床病理资料信息，包括患者基本信息、吸烟史、病理报告（包括分子检测）、治疗及预后等，经脱敏、滤过并利用自然语言处理，结合领域知识库实现原始文本信息结构化处理，进行数据管理分析以及构建结构化数据库。结果:共收集到153 817份原始病理报告，57 748份分子检测报告及13 295条治疗及随访信息，最终获得有效结构化病理报告75 941份（包含86 979个原发肺癌病灶信息）。整体治疗及随访数据质量不满意。患者男女比例为1.2∶1.0；吸烟史可及8 648例（11.39%），吸烟者与非吸烟者比例为0.92∶1.00；高发年龄为60~69岁，占38.76%。常见病理类型前5位依次为腺癌（74.58%），鳞状细胞癌（简称鳞癌，18.01%），小细胞癌（2.18%），腺鳞癌（1.71%），肉瘤样癌（0.82%）；组织学类型与性别、年龄及吸烟状态显著相关（ P<0.05）：男性患者以腺癌（58.5%）和鳞癌（31.6%）为主，女性患者腺癌占91.6%，鳞癌仅占3.4%；非吸烟患者以腺癌（85.6%）为主，吸烟患者腺癌和鳞癌分别占50.6%和37.7%；随年龄增长腺癌占比下降，鳞癌及小细胞癌占比上升。指标使用量呈逐年上升趋势，综合医院与肿瘤专科医院间差异无统计学意义（ P<0.05）；至2017年使用率较低的主要指标为周围肺病变、pTNM分期、沿气道播散、新辅助治疗反应病理评估。前5位常用免疫组织化学指标依次为甲状腺转录因子1（TTF1）、细胞角蛋白（CK）7、间变性淋巴瘤激酶（ALK）-Ventana、Napsin A及p63，免疫组织化学套餐指标数最常见7~9项。整体表皮生长因子受体（EGFR）突变率51.32%（10 335/20 139，均为PCR法）、ALK融合基因阳性率6.18%［2 084/33 726，PCR、荧光原位杂交（FISH）及免疫组织化学Ventana平台阳性率分别为3.01%、8.93%及6.58%］、KRAS突变率7.01%（662/9 441，均为PCR法）。腺癌中EGFR、ALK（总）、KRAS阳性率分为58.14%（9 986/17 175）、6.59%（1 791/27 176）、7.52%（607/8 068），鳞癌中分别为5.83%（113/1 939）、0.40%（1/251，仅PCR和FISH法）、1.76%（15/852）。由于预后数据质量问题，难以获得有效生存相关因素分析结果。 结论:国内肺癌病理报告规范化程度（包括分子检测）整体基础良好，但大部分模式仍处于非结构化连续文本状态；肿瘤术后病理分期、新辅助治疗反应病理评估及高质量预后数据需予以重视与完善；免疫组织化学指标套餐使用均衡但欠精确；有待采用基于信息系统的肺癌结构化报告模板及结构化数据整合存储模式，以整体提升我国肺癌病理诊断规范及临床数据共享能力。

abstractsObjective:To reveal the current status and problem of surgical pathological diagnosis and to construct a structured pathological database of lung cancer in China, and to further improve the level of pathological standards and scientific data.Methods:Case report form (CRF) was made according to the diagnostic criteria of radical resection specimens of lung cancer, including general information, smoking history, pathological report (including molecular data), treatment and prognosis, etc. The original clinicopathological data of patients with primary lung cancer who underwent surgical resection in 23 centers from January 2013 to December 2017 were retrospectively collected. After desensitization, filtering and natural language processing, combined with domain knowledge base, and the raw data in the form of continuous text were structured.Results:A total of 153 817 non-structured pathological reports, 57 748 molecular reports and 13 295 pieces of treatment and/or follow-up information were collected. Finally, 75 941 effective structured documents (including 86 979 primary lesions) were obtained. The quality of treatment and follow-up data was not satisfactory; Number of CRF index involved showed an increasing trend with time coursing, and had no significant difference between general hospitals and cancer hospitals ( P<0.05). The indexes with low use rate until 2017 were peripheral lung disease, pTNM stage, spread though air space, and pathological evaluation of neoadjuvant treatment response. The ratio of male to female was 1.2∶1.0; 8 648 cases (11.39%) had smoking history, and the ratio of smokers to non-smokers was 0.92∶1.00. Age group of the highest incidence was 60-69 years, accounting for 38.76%. The top five common pathological subtypes were adenocarcinoma (74.58%), squamous cell carcinoma (18.01%), small cell carcinoma (2.18%), adenosquamous carcinoma (1.71%) and sarcomatoid carcinoma (0.82%); histological subtypes were significantly correlated with gender, age and smoking status ( P<0.05): adenocarcinoma (58.5%) and squamous cell carcinoma (31.6%) were the main pathological types in male patients, while adenocarcinoma (91.6%) and squamous cell carcinoma (3.4%) were the main pathological types in female patients; adenocarcinoma (85.6%) was the main type of non-smoking patients, adenocarcinoma and squamous cell carcinoma accounted for 50.6% and 37.7% respectively in smoking patients; the proportion of adenocarcinoma decreased with age, while squamous cell carcinoma and small cell carcinoma increased. The top five common immunohistochemical (IHC) markers were TTF1, CK7, ALK-Ventana, Napsin A and p63 and the most common panel included 7-9 IHC markers. The overall EGFR mutation rate was 51.32% (all 10 335/20 139 by PCR), the total ALK positive rate was 6.18% (2 084/33 726, PCR, FISH and IHC-Ventana platform positive rates were 3.01%, 8.93% and 6.58%, respectively), the KRAS mutation rate was 7.01% (all 662/9 441 by PCR). The positive rates of EGFR, ALK and KRAS were 58.14% (9 986/17 175), 6.59% (1 791/27 176) and 7.52% (607/8 068) in adenocarcinoma, 5.83% (113/1 939), 0.40% (1/251) and 1.76% (15/852) in squamous cell carcinoma, respectively. Due to the poor quality of prognostic data, it was difficult to obtain effective survival analysis. Conclusions:The standardization of pathological reports (including molecular detection) of lung cancer in China is generally fine, but most of the models are still in the state of unstructured continuous text. The postoperative pathological staging, pathological evaluation of neoadjuvant therapy response and high-quality prognosis data need paying more attention and improvement. Panel of IHC markers is balanced although further precision. The use of lung cancer structured report template and intelligent structured database management mode to improve the degree of the pathologic diagnosis standardization and data quality is recommended.