甘肃省县(区)级结核病定点医院病原学阴性肺结核诊断质量调查分析

Investigation and analysis of diagnostic quality of pathogenic negative pulmonary tuberculosis in county level tuberculosis designated hospitals in Gansu Province

目的:分析甘肃省县(区)级结核病定点医院病原学阴性肺结核诊断质量,以进一步提高病原学阴性肺结核诊断质量。方法:采用现况调查方法,从“结核病信息管理系统”中收集2021年甘肃省登记的活动性肺结核患者,采用分层整群抽样方法,从甘肃省中部、西部和东部各抽取3个市(州),每个市(州)选择患者数前三位的3家县(区)级结核病定点医院作为调查点,由调查员通过“甘肃省病原学检测阴性肺结核患者现场调查表”现场收集各调查点登记的信息资料完整的病原学阴性肺结核(除外气管支气管结核和结核性胸膜炎)患者资料,从诊断流程、诊断依据、实验室检查、影像学诊断和诊断性抗感染治疗等5个方面进行病原学阴性肺结核诊断质量评价。结果:共收集到26家县(区)级定点医院符合调查标准的1187例病原学阴性肺结核患者作为调查对象。其中,诊断流程规范者941例(79.28%);诊断依据符合要求者699例(58.89%);病原学检查者1176例(99.07%),其中,行痰涂片镜检、分枝杆菌培养、分子生物学检查和结核病灶组织病理检查者分别为1169例(98.48%)、368例(31.00%)、900例(75.82%)和103例(8.68%),痰涂片质量合格者1084例(91.32%);至少选择1项结核病免疫学检查者958例(80.71%),其中,行结核菌素试验、抗结核抗体和γ-干扰素释放试验检查者分别为724例(60.99%)、574例(48.36%)和382例(32.18%),阳性者分别为572例(79.01%)、187例(32.58%)和329例(86.13%);行支气管镜和胸腔积液检查者分别为198例(16.68%)和29例(2.44%),均未检出阳性者;影像学检查者1187例(100.00%),其中,胸部X线摄影(简称“胸片”)检查率[73.21%(869/1187)]和合格率[85.04%(739/869)]均明显低于CT检查[分别为99.16%(1177/1187)和92.78%(1092/1177)],差异均有统计学意义(χ^(2)=335.585,P=0.000;χ^(2)=31.829,P=0.000)。诊断小组讨论1166例(98.23%)患者,建议进行诊断性抗结核治疗者626例,实际治疗者563例(89.94%)。结论:甘肃省县(区)级结核病定点医院对病原学阴性肺结核相关实验室检查以痰涂片和分子生物学检查为主,CT检查率和合格率均较高,但分子生物学检查率、诊断流程规范率和诊断依据符合率仍有较大提升空间,建议加强县(区)级结核病定点医院检测规范和技术人员培训,严格执行结核病相关检查流程,以进一步提升病原学阴性肺结核诊断质量。

Objective:To analyze the diagnostic quality of pathogenic negative pulmonary tuberculosis in county level tuberculosis designated hospitals in Gansu Province,so as to further improve the diagnostic quality of pathogen negative pulmonary tuberculosis.Methods:The cross-sectional method was used to collect the data of active tuberculosis patients registered in Tuberculosis Information Management System in Gansu Province in 2021.The stratified cluster sampling method was used to select the clusters.Three cities were selected from the central,western and eastern parts of Gansu Province.Each city and prefecture selected three county level designated hospitals with the top three registered patients as the survey sites.The investigators collected the complete data of pathogenic negative pulmonary tuberculosis patients(except for tracheobronchial tuberculosis and tuberculous pleurisy)registered at each survey site through the“Field questionnaire of pathogenic negative pulmonary tuberculosis patients in Gansu Province”,and evaluated the diagnostic quality of pathogenic negative pulmonary tuberculosis from five aspects,including diagnostic process,diagnostic evidence,laboratory examination,imaging examination and diagnostic anti-infection treatment.Results:A total of 1187 pathogenic negative pulmonary tuberculosis patients who met the enrollment criteria from 26 designated hospitals were collected.Nine hundred and forty-one cases(79.28%)received standardized diagnostic procedures,and 699 cases(58.89%)diagnostic evidence met the requirements,1176 cases(99.07%)received bacteriological examination,of which 1169 cases(98.48%),368 cases(31.00%),900 cases(75.82%)and 103 cases(8.68%)were examined for sputum smear,mycobacterium culture,molecular biology,and tuberculosis pathology,respectively,1084(91.32%)had qualified sputum specimens.Nine hundred and fifty-eight cases(80.71%)received at least one tuberculosis immunological examination.Among them,724 cases(60.99%),574 cases(48.36%)and 382 cases(32.18%)were provided tuberculin test,anti-tuberculosis antibody test and interferon-γrelease test,respectively.The positive cases were 572 cases(79.01%),187 cases(32.58%)and 329 cases(86.13%),respectively.Bronchoscopy and pleural effusion examination were performed in 198 cases(16.68%)and 29 cases(2.44%),the positive cases were all 0 cases,respectively.In the 1187 cases(100.00%)underwent imaging examinations,the chest X-ray examination rate(73.21%(869/1187))and the qualification rate(85.04%(739/869))were significantly lower than CT examination(99.16%(1177/1187))and 92.78%(1092/1177),respectively),and the differences were statistically significant(χ^(2)=335.585,P=0.000;χ^(2)=31.829,P=0.000).The diagnostic team discussed 1166 patients(98.23%)and recommended diagnostic anti tuberculosis treatment for 626 patients,while 563 patients(89.94%)were actually treated.Conclusion:The sputum smear and the molecular biological examination of laboratory tests on pathogenic negative pulmonary tuberculosis were mainly used in the designated county(district)level tuberculosis hospitals in Gansu Province.The examination rate and pass rate of CT were relatively high,but molecular biology examination rate,diagnostic process rate and diagnostic rate still have larger space.It is suggested to strengthen the testing procedures and training of technical personnel at county level designated hospitals,and strictly implement the tuberculosis-related examination procedures,and further improve the quality of pathogenic negative pulmonary tuberculosis diagnosis.