2015—2024年内蒙古自治区鄂尔多斯市结核病定点医院肺结核患者病原学阳性检出情况分析

doi:10.19983/j.issn.2096-8493.20250056

摘要/Abstract

摘要：

目的: 分析2015—2024年内蒙古自治区鄂尔多斯市肺结核患者病原学阳性检出情况,探究分子生物学诊断技术在肺结核早期诊断中的应用价值。方法: 从中国疾病预防控制中心“结核病信息管理系统”中导出2015—2024年鄂尔多斯市9家结核病定点医院上报的4394例有病原学阳性检测结果的肺结核患者相关资料,分析抗酸染色涂片镜检(简称“涂片法”)、分枝杆菌培养(简称“培养”)、结核分枝杆菌分子生物学等3种方法的使用率及病原学阳性检出情况。结果: 全市结核病定点医院在2015—2017年主要采用涂片法进行病原学诊断,自2018年起全部开始逐步联合使用分子生物学诊断方法,其中,涂片法的使用率除2018年为84.12%(445/529)外,其他年份均达到93.95%~100.00%,而培养和分子生物学方法的使用率分别从2018年的1.70%(9/529)和25.90%(137/529)上升至2024年的76.72%(356/464)和92.24%(428/464),均呈逐年上升趋势( $χ 趋势 2$ =1885.690,P<0.001; $χ 趋势 2$ =2150.208,P<0.001)。全市肺结核病原学阳性率从2015年的28.44%(128/450)上升至2024年的75.44%(344/456),呈逐年上升趋势( $χ 趋势 2$ =682.623,P<0.001);而分子生物学检测在2018—2024年的总阳性率[74.38%(1405/1889)]明显高于培养阳性率[54.85%(921/1679)]和涂片阳性率[33.40%(1425/4267)],差异有统计学意义(χ²=922.943,P<0.001);全市病原学阳性结果中,仅涂片法的阳性占比从2015年的98.44%(126/128)急剧下降至2024年的2.91%(10/344),仅培养的阳性占比始终介于0.45%(1/221)~5.71%(16/280),而有分子生物学检测的阳性占比由2018年之前的0.00%上升到2024年的90.41%(311/344),其中以仅分子生物学[从2019年的17.55%(43/245)上升至2024年的36.34%(125/344)]和3种方法联合检测[从2019年的10.20%(25/245)上升至2024年的27.62%(95/344)]最为明显。对于涂阴患者,全市、市级、旗(区)级定点医院分子生物学检测阳性率分别从2018年的0.33%(1/303)、0.54%(1/185)、0.00%(0/118)上升至2024年的60.00%(165/275)、53.37%(95/178)、72.16%(70/97),均呈逐年上升趋势( $χ 趋势 2$ =867.785,P<0.001; $χ 趋势 2$ =421.652,P<0.001; $χ 趋势 2$ =445.559,P<0.001),且旗(区)级定点医院在2024年超过市级,差异有统计学意义( $χ 趋势 2$ =9.240,P=0.002)。结论: 2015—2024年,鄂尔多斯市肺结核病原学阳性率和涂阴患者阳性检出率均逐年提高,虽然传统涂片法的使用率一直较高,但依靠其进行阳性诊断的主导地位已被逐步取代;培养和分子生物学方法的使用率逐年升高,但培养的阳性检出率一直较低,对临床贡献有限,使得分子生物学检测成为目前主要的诊断方法。因此,推荐分子生物学检测用于病原学阳性诊断,并应关注市级定点医院对涂阴患者阳性检出情况。

关键词: 分枝杆菌,结核, 诊断技术和方法, 分子诊断技术, 数据说明,统计, 小地区分析, 鄂尔多斯

Abstract:

Objective: To analyze the etiological positive rate among pulmonary tuberculosis (PTB) patients in Ordos City, Inner Mongolia Autonomous Region from 2015 to 2024, and to evaluate the application value of molecular diagnostic techniques in the early diagnosis of PTB. Methods: Data from 4394 PTB patients with laboratory testing results, reported by nine designated TB hospitals in Ordos City between 2015 and 2024, were extracted from the “Tuberculosis Information Management System” of Chinese Center for Disease Control and Prevention. The usage rates and positive rates of three diagnostic methods were assessed: acid-fast bacilli (AFB) smear microscopy, Mycobacterial culture, and molecular diagnostic assay. Results: From 2015 to 2017, AFB smear microscopy was the primary diagnostic method. Molecular diagnostic assays were gradually introduced begining in 2018. The utilization rate of smear microscopy remained 93.95%-100.00% in most years, except in 2018 (84.12%, 445/529). In contrast, the utilization rates of culture and molecular methods increased from 1.70% (9/529) and 25.90% (137/529) in 2018 to 76.72% (356/464) and 92.24% (428/464) in 2024, respectively, showing significant annual upward trend ( $χ t r e n d 2$ =1885.69, P<0.001; $χ t r e n d 2$ =2150.208, P<0.001).The overall etiological positive rate for PTB in Ordos significantly increased from 28.44% (128/450) in 2015 to 75.44% (344/456) in 2024 ( $χ t r e n d 2$ =682.623, P<0.001). Between 2018 and 2024, the overall positive rate of molecular methods (74.38% (1405/1889)) was significantly higher than that of culture (54.85% (921/1679)) and smear microscopy (33.40% (1425/4267)), with significant difference (χ²=922.943, P<0.001). Among all etiologically positive results, the proportion of positive cases only by smear microscopy decreased from 98.44% (126/128) in 2015 to 2.91% (10/344) in 2024, while the proportion detected only by culture consistently remained between 0.45% (1/221) and 5.71% (16/280). Conversely, the proportion of cases positive with molecular biological methods increased from 0.00% before 2018 to 90.41% (311/344) in 2024, with the most significant increase in cases detected only by molecular methods (rising from 17.55% (43/245) in 2019 to 36.34%(125/344) in 2024) and by all three methods combined (rising from 10.20% (25/245) in 2019 to 27.62% (95/344) in 2024). For smear-negative patients, the molecular detection positive rates at citywide, municipal-level, and county-level designated hospitals increased from 0.33% (1/303), 0.54% (1/185), and 0.00% (0/118) in 2018 to 60.00% (165/275), 53.37% (95/178), and 72.16% (70/97) in 2024, respectively, all showing significant annual upward trends ( $χ t r e n d 2$ =867.785, P<0.001; $χ t r e n d 2$ =421.652, P<0.001; $χ t r e n d 2$ =445.559, P<0.001). Notably, the positive rate at banner (district)-level hospitals surpassed that at municipal-level hospitals in 2024, with statistically significant difference ( $χ t r e n d 2$ =9.240, P=0.002). Conclusion: From 2015 to 2024, both the etiological positive rate of pulmonary tuberculosis and the positive rate among smear-negative patients in Ordos City showed continuous annual increases. Although the utilization rate of smear microscopy remained high, its dominant role in positive diagnosis has gradually diminished. While the utilization rates of both culture and molecular testing increased annually, the positive detection rate of culture has consistently been low, resulting in limited clinical impact. Consequently, molecular testing has become the primary diagnostic method. It is recommended to adopt molecular testing for etiological confirmation. Furthermore, attention should be paid to improving the positive detection rate among smear-negative patients in municipal-level designated hospitals.

Key words: Mycobacterium tuberculosis, Diagnostic techniques and procedures, Molecular diagnostic techniques, Data interpretation, statistical, Small-area analysis, Ordos

中图分类号:

祁丹, 王昇, 刘敏, 高美琴, 石峰, 李兵, 白俊, 郝瑞霞, 王东. 2015—2024年内蒙古自治区鄂尔多斯市结核病定点医院肺结核患者病原学阳性检出情况分析[J]. 结核与肺部疾病杂志, 2025, 6(4): 456-463. doi: 10.19983/j.issn.2096-8493.20250056

Qi Dan, Wang Sheng, Liu Min, Gao Meiqin, Shi Feng, Li Bing, Bai Jun, Hao Ruixia, Wang Dong. Analysis of the etiological positive rate among pulmonary tuberculosis patients in designated tuberculosis hospitals in Ordos,Inner Mongolia Autonomous Region, 2015—2024[J]. Journal of Tuberculosis and Lung Disease, 2025, 6(4): 456-463. doi: 10.19983/j.issn.2096-8493.20250056

图/表 9

表1

2015—2024年鄂尔多斯市不同级别结核病定点医院病原学阳性检出情况

年份	全市所有定点医院			市级定点医院			旗(区)级定点医院			χ²值	P值
年份	例数	阳性例数	阳性率 (%)	例数	阳性例数	阳性率 (%)	例数	阳性例数	阳性率 (%)	χ²值	P值
2015	450	128	28.44	146	21	14.38	304	107	35.20	20.993	<0.001
2016	475	104	21.89	204	21	10.29	271	83	30.63	28.138	<0.001
2017	442	120	27.15	233	40	17.17	209	80	38.28	24.824	<0.001
2018	523	224	42.83	315	131	41.59	208	93	44.71	0.499	0.480
2019	379	245	64.64	169	114	67.46	210	131	62.38	1.055	0.304
2020	414	280	67.63	217	141	64.98	197	139	70.56	1.469	0.225
2021	466	302	64.81	273	155	56.78	193	147	76.17	18.637	<0.001
2022	341	252	73.90	204	152	74.51	137	100	72.99	0.098	0.754
2023	448	350	78.13	269	207	76.95	179	143	79.89	0.542	0.461
2024	456	344	75.44	270	192	71.11	173	152	87.86	10.332	0.001
合计	4394	2349	53.46	2300	1174	51.04	2081	1175	56.46	12.904	<0.001
$χ 趋势 2$ 值			682.623			412.264			292.422
P值			<0.001			<0.001			<0.001

表1

图1

表2

2015—2024年鄂尔多斯市3种检测方法的病原学阳性率情况

年份	病原学阳性率	涂片阳性率	培养阳性率	分子生物学阳性率	χ²值	P值
2015	28.44(128/450)	28.22(127/450)	2/4	-	-	-
2016	21.89(104/475)	21.89(104/475)	-	-	-	-
2017	27.15(120/442)	27.15(120/442)	-	-	-	-
2018	42.83(224/523)	31.91(142/445)	3/9	89.05(122/137)	138.611	<0.001
2019	64.64(245/379)	45.91(174/379)	64.43(96/149)	85.06(107/125)	64.288	<0.001
2020	67.63(280/414)	40.10(166/414)	56.51(152/269)	71.24(161/226)	59.105	<0.001
2021	64.81(302/466)	30.54(142/465)	60.29(164/272)	73.04(214/293)	144.101	<0.001
2022	73.90(252/341)	35.28(115/326)	53.18(142/267)	73.53(200/272)	87.091	<0.001
2023	78.13(350/448)	39.72(172/433)	54.11(191/353)	72.86(290/398)	92.311	<0.001
2024	75.44(344/456)	37.21(163/438)	48.03(171/356)	72.66(311/438)	103.987	<0.001
合计	53.46(2349/4394)	33.40(1425/4267)	54.85(921/1679)	74.38(1405/1889)	922.943	<0.001
$χ 趋势 2$ 值	682.623	35.183	9.980	15.607
P值	<0.001	<0.001	0.002	<0.001

表2

表3

图2

表4

2015—2024年鄂尔多斯市结核病定点医院结核分枝杆菌检测方法使用情况

年份	总例数	痰涂片镜检		培养法		分子生物学
年份	总例数	使用患者例数	使用率(%)	使用患者例数	使用率(%)	使用患者例数	使用率(%)
2015	450	450	100.00	4	0.89	0	0.00
2016	476	475	99.79	0	0.00	0	0.00
2017	446	442	99.10	0	0.00	0	0.00
2018	529	445	84.12	9	1.70	137	25.90
2019	380	379	99.74	149	39.21	125	32.89
2020	415	414	99.76	269	64.82	226	54.46
2021	466	465	99.79	272	58.37	293	62.88
2022	347	326	93.95	267	76.95	272	78.39
2023	455	433	95.16	353	77.58	398	87.47
2024	464	438	94.40	356	76.72	428	92.24
$χ 趋势 2$ 值			11.147		1885.690		2150.208
P值			0.001		<0.001		<0.001

表4

图3

表5

2015—2024年鄂尔多斯市涂阴肺结核患者中分子生物学检测阳性情况

年份	全市所有定点医院			市级定点医院			旗(区)级定点医院			χ²值	P值
年份	例数	分子阳性例数	阳性率 (%)	例数	分子阳性例数	阳性率 (%)	例数	分子阳性例数	阳性率 (%)	χ²值	P值
2015	323	0	0.00	125	0	0.00	198	0	0.00
2016	371	0	0.00	183	0	0.00	188	0	0.00
2017	322	0	0.00	193	0	0.00	129	0	0.00
2018	303	1	0.33	185	1	0.54	118	0	0.00	-	1.000^a
2019	205	63	30.73	108	51	47.22	97	12	12.37	29.158	<0.001
2020	248	98	39.52	160	77	48.13	88	21	23.86	13.982	<0.001
2021	323	140	43.34	219	99	45.21	104	41	39.42	0.960	0.330
2022	211	117	55.45	128	75	58.59	83	42	50.60	1.302	0.250
2023	261	156	59.77	159	95	59.75	102	61	59.80	0.000	0.993
2024	275	165	60.00	178	95	53.37	97	70	72.16	9.240	0.002
合计	2842	740	26.04	1638	493	30.10	1204	247	20.51	33.089	<0.001
$χ 趋势 2$ 值			867.785			421.652			445.559
P值			<0.001			<0.001			<0.001

表5

图4

参考文献 18

[1]	王泽锦, 胡素侠, 戚应杰. 结核病实验室诊断方法的现状与进展. 大医生, 2024, 9(2): 119-123. doi:10.3969/j.issn.2096-2665.2024.02.040.
[2]	World Health Organization. Global tuberculosis report 2022. Geneva: World Health Organization, 2022.
[3]	李国莉, 邵燕, 李燕, 等. 2015—2018年江苏省结核病患者常规监测检测方法及阳性检出情况. 江苏预防医学, 2020, 31(2): 119-121, 129. doi:10.13668/j.issn.1006-9070.2020.02.001.
[4]	马燕, 王晓蓓, 马磊, 等. 结核分枝杆菌培养法与分子诊断技术联合对结核性脑膜炎患者的诊断价值. 热带医学杂志, 2024, 24(1):37-41. doi:10.3969/j.issn.1672-3619.2024.01.008.
[5]	中华人民共和国国家卫生和计划生育委员会. WS 196—2017结核病分类. 结核与肺部疾病杂志, 2024, 5 (4): 379-380. doi:10.19983/j.issn.2096-8493.2024055.
[6]	中华人民共和国国家卫生和计划生育委员会. WS 288—2017肺结核诊断. 结核与肺部疾病杂志, 2024, 5 (4): 376-378. doi:10.19983/j.issn.2096-8493.2024022.
[7]	来元春. 结核病实验室检测技术研究进展. 中国防痨杂志, 2024, 46(S1):322-324.
[8]	张杨文, 翁建盛. 肺结核患者痰涂片抗酸杆菌阳性检出率影响因素分析. 深圳中西医结合杂志, 2016, 26(23):63-65. doi:10.16458/j.cnki.1007-0893.2016.23.032.
[9]	黄银霞, 潘丽萍, 张宗德. 结核病实验室诊断技术研究进展. 北京医学, 2023, 45(10): 893-898. doi:10.15932/j.0253-9713.2023.10.013.
[10]	乐晓琴, 陈军, 沈银忠, 等. 结核分枝杆菌/利福平耐药实时荧光定量核酸扩增检测技术诊断艾滋病患者肺结核的临床应用评价. 中华传染病杂志, 2021, 39(1):21-24. doi:10.3760/cma.j.cn311365-20190729-00235.
[11]	李姗姗, 王玉峰, 舒薇, 等. 结核病实验室诊断技术研发新进展. 中国防痨杂志, 2023, 45(5):446-453. doi:10.19982/j.issn.1000-6621.20220535.
[12]	周林, 刘二勇. 结核病诊断标准解读. 寄生虫病与感染性疾病, 2019, 17(1):7-9.
[13]	王静, 刘立宾, 岳永宁, 等. 交叉引物扩增技术检测痰样本中结核分枝杆菌的应用价值. 中国预防医学杂志, 2016, 17(4): 265-268. doi:10.16506/j.1009-6639.2016.04.006.
[14]	王燕, 欧维正, 杨秀章, 等. 二代交叉引物恒温扩增技术对结核分枝杆菌检测的应用价值. 贵州医药, 2023, 47(11):1786-1787. doi:10.3969/j.issn.1000-744X.2023.11.064.
[15]	车佳璐, 刘子臣, 李琨, 等. 探针熔解曲线法检测石蜡包埋组织诊断耐药结核病的临床价值. 中华病理学杂志, 2023, 52(5):466-471. doi:10.3760/cma.j.cn112151-20230103-00004.
[16]	Schito M, Migliori GB, Fletcher HA, et al. Perspectives on Advances in Tuberculosis Diagnostics, Drugs, and Vaccines. Clin Infect Dis, 2015, 61Suppl 3(Suppl 3):S102-S118. doi:10.1093/cid/civ609.
[17]	Oommen S, Banaji N. Laboratory diagnosis of tuberculosis: Advances in technology and drug susceptibility testing. Indian J Med Microbiol, 2017, 35(3):323-331. doi:10.4103/ijmm.IJMM_16_204. pmid: 29063875
[18]	叶锦欣. 云南省15县区首诊涂阴肺结核“过诊”现况研究及影响因素分析. 昆明:昆明医科大学, 2021. doi:10.27202/d.cnki.gkmyc.2021.000466.