真实世界肺结节诊断与治疗现状的探索与分析

Exploration and analysis of diagnosis and treatment of pulmonary nodules in using real-world data

目的分析真实医学数据中肺结节患者的诊疗现状, 探索肺结节的最佳诊疗路径。方法本研究为观察性研究, 借助首都医科大学附属北京朝阳医院嘉禾大数据临床研究平台, 从影像档案系统(PACS)检索筛选出胸部CT扫描报告中含有"结节"字段的病例, 建立所有患者(2013年7月至2021年11月门诊和住院)的基础数据库, 在研究前删除患者隐私信息。进一步分析肺结节患者经随访、手术、支气管镜或肺穿刺活检获得的病理诊断结果, 探讨肺结节患者的诊疗过程。结果共检测到233 305例肺结节病例, 其中男114 378例, 女118 927例;肺结节检出率逐年增高, 2017-2018年增长速度(30.41%~41.42%)高于2014-2016年(17.00%~26.03%);2013-2018年肺结节检出患者中男性多于女性, 2019-2021年女性多于男性;2013-2019年肺结节检出较高的集中在55~85岁年龄段, 2020-2021年肺结节检出显现年轻化趋势, 高检出集中在35~85岁年龄段。其中104 458例进行了2次以上的随访, 在随访数据库中以"支气管镜"和(或)"CT引导(肺部)"为条件检索出内科系统住院患者7 286例(做过肺部活组织检查), 以"肺叶切除术"为条件检索出外科系统住院患者2 896例。恶性肿瘤检出率为2.35%(5 483/233 305)(内科2 791例, 外科2 691例), 其中腺癌3 279例, 鳞癌1 028例, 小细胞癌421例, 非小细胞癌398例, 未分型357例。非恶性病理4 698例, 大部分病理为非特异性炎症[3 884例(82.67%)], 肉芽肿506例, 结核(抗酸染色阳性)104例, 真菌(PAS/GMS染色阳性)70例, 机化134例。有104 458例次(44.77%)患者进行了CT影像检查的随访, 其中内科系统肺恶性肿瘤患者介入检查前随访时间为6(3, 18)个月, 最长跨年度随访48个月。外科系统肺恶性肿瘤患者术前随访时间为6(3, 18)个月, 最长跨年度随访42个月。结论肺结节的检出率逐年增长, 并呈现年轻化的趋势, 恶性肿瘤检出率较低。检出结节后的最佳诊疗流程, 应按照随访、影像学检查、组织活检、手术来进行。合理随访肺结节, 避免过度诊断和治疗。

Objective Analyze the diagnosis and treatment status of patients with pulmonary nodules in real medical data,and explore the best diagnosis and treatment path of pulmonary nodules.Methods It was an observational study by extracting clinical data from chest CT scans involving the fields of"nodules"in the picture archiving and communication systems(PACS)of the JiaHe clinical data research platform,Beijing Chao-Yang Hospital,Capital Medical University.A database involving qualified outpatient and impatient data from July 2013 to November 2021 was created.All raw data obtained from the hospital were cleaned and desensitized,and the patient privacy information was deleted before the research.The pathological diagnosis results of patients with pulmonary nodules obtained by follow-up,operation,bronchoscopy or lung biopsy were further analyzed,and the diagnosis and treatment of patients with pulmonary nodules was explored.Results A total of 233,305 cases of pulmonary nodules were detected,including 114,378 males and 118,927 females.The detection rate of pulmonary nodules annually increased,and the growing rate from 2017 to 2018(30.41%-41.42%)was higher than that from 2014 to 2016(17.00%-26.03%).From 2013 to 2018,males had a higher detection rate of pulmonary nodules than females,while an opposite trend was detected from 2019 to 2021.From 2013 to 2019,a higher detection rate of pulmonary nodules was concentrated in the age group of 55-85 years,and from 2020 to 2021,the detection rate showed a younger trend,with a high detection rate concentrated in the age group of 35-85 years.Among them,104,458 cases have been followed up more than twice.In the follow-up database,7,286 inpatients of the internal medicine system,who have received lung tissue examinations were retrieved based on the conditions of"bronchoscopy"and/or"CT-guided(for the lung),"and 2,896 inpatients of the surgical system were retrieved based on the condition of"lobectomy."The malignant tumor detection rate was 2.35%(5,483/233,305),including 2,791 cases in internal medicine,and 2,691 cases in surgery.There were 3,279 cases of adenocarcinoma,1,028 cases of squamous cell carcinoma,421 cases of small cell carcinoma,398 cases of non-small cell carcinoma,and 357 cases of unspecified type.Non-malignant nodules were detected in 4,698 cases,most of which were non-specific inflammation(3,884 cases,82.67%),granuloma(506 cases),tuberculosis(positive acid-fast staining)(104 cases),fungus(positive PAS/GMS staining)(70 cases),and mineralization(134 cases).A total of 104,458 cases(44.77%)have been followed up for CT examinations.The follow-up time before interventional examination for pulmonary malignant tumors in the internal medicine system was 6(3,18)months,and the longest follow-up across years was 48 months.The preoperative follow-up time for pulmonary malignant tumors in the surgical system was 6(3,18)months,and the longest follow-up across years was 42 months.Conclusions The detection rate of pulmonary nodules is annually on the rise and getting younger,and the detection rate of malignant tumors is relatively low.The optimal diagnosis and treatment process after the detection of nodules should be conducted through follow-up visits,imaging examinations,biopsies and surgeries.An over-diagnosis and over-treatment should be avoided.