实时荧光RNA恒温检测在气管支气管结核疗效监测中的应用价值

doi:10.19982/j.issn.1000-6621.20220337

摘要/Abstract

摘要：

目的: 分析实时荧光RNA恒温检测技术(SAT-TB)和实时荧光定量PCR检测技术(qRT-PCR)在气管支气管结核患者治疗早期对抗结核治疗效果的监测作用。方法: 收集2021年1—12月在西安市胸科医院完成治疗的168例初治气管支气管结核患者,分析其中每2周做1次气管镜的94例病原学阳性患者的初入院(基线)及治疗2、4、6、8、10和12周时支气管肺泡灌洗液标本的分枝杆菌MGIT 960培养、SAT-TB和qRT-PCR的检测结果;并以MGIT 960培养结果为参照标准,分析SAT-TB和qRT-PCR检测结果的动态变化规律及检测效能。最后对168例患者培养阴转时间与首次SAT-TB法测定的探测时间(dt值)之间的关系进行分析。结果: 分析每2周做1次气管镜检查的94例患者检测结果显示,MGIT 960培养在基线至治疗12周检测的阳性率从87.23%(82/94)下降至1.06%(1/94),下降幅度为98.78%(81/82);qRT-PCR从92.55%(87/94)下降至29.79%(28/94),下降幅度为67.81%(59/87);SAT-TB法从93.62%(88/94)下降至15.96%(15/95),下降幅度为82.95%(73/88)。qRT-PCR和SAT-TB下降幅度均低于MGIT 960培养(χ² 值分别为28.472和12.469,P值均<0.001)。以MGIT 960培养结果为参照标准,qRT-PCR法在各检测点的Kappa值介于0.044~0.416、ROC曲线下面积(AUC)介于0.553~0.715,均明显低于SAT-TB法(Kappa值介于0.107~0.620,AUC值介于0.642~0.814)。168例患者阴转时间在1~4周时首次SAT-TB法检测的dt值[7.264(4.891,10.990)]明显长于5~8周[5.113(3.520,6.390)]和9周及以上[5.222(4.068,6.886)],差异均有统计学意义(Z=-4.318,P<0.001;Z=-2.017,P=0.044)。结论: SAT-TB法用于病原学阳性的气管支气管结核患者的早期疗效监测时效果优于qRT-PCR。

关键词: 结核,支气管, 核酸扩增技术, 治疗结果, 监测, 对比研究

Abstract:

Objective: To analyze the monitoring effect of real-time fluorescent RNA isothermal detection (SAT-TB) and real-time fluorescent quantitative PCR (qRT-PCR) in the early antituberculosis chemotherapy of patients with tracheobronchial tuberculosis. Methods: Data of 168 patients with initial treatment tracheobronchial tuberculosis who had been treated in Xi’an Chest Hospital were collected from January to December, 2021. We analyzed the results of mycobacterium MGIT 960 liquid culture, SAT-TB and qRT-PCR of 94 etiologically positive patients who had been treated with tracheoscopy and had alveolar lavage fluid sample collected every 2 weeks (2nd, 4th, 6th, 8th, 10th and 12th week) after admission (baseline), and the dynamic changes of SAT-TB, qRT-PCR and their detection efficiency using the MGIT 960 liquid culture test as reference. Then the relationship between the negative conversion time of MGIT 960 culture and the dt value of the first SAT-TB results of the 168 patients was analyzed. Results: For the 94 patients who undertook tracheoscopy every 2 weeks, the positive rates of MGIT 960 culture at baseline, 2nd, 4th, 6th, 8th, 10th and 12th week declined by 98.78% (81/82), from 87.23% (82/94) to 1.06% (1/94); and the results of qRT-PCR test decreased by 67.81% (59/87), from 92.55% (87/94) to 29.79% (28/94). In addition, the positive rates of SAT-TB decreased by 82.95% (73/88), from 93.62% (88/94) to 15.96% (15/95). The declines of positive rates of qRT-PCR and SAT-TB were less than MGIT 960 culture, the differences were statistically significant (χ²=28.472, 12.469; Ps<0.001). Taking MGIT 960 test as the reference standard, the consistency (Kappa values) of qRT-PCR and MGIT 960 test were 0.044-0.416, and the area under curve (AUC) were 0.553-0.715 at different test points, these were significantly lower than that of SAT-TB and MGIT 960 test at every test point (Kappa values were 0.107-0.620, AUC were 0.642-0.814). For all 168 patients, the average dt values of patients in the negative conversion time within 1-4 weeks group (7.264 (4.891, 10.990)) was longer than the 5-8 weeks group(5.113 (3.520, 6.390)) and the 9-weeks and above group (5.222 (4.068, 6.886)), respectively. The differences were statistically significant (Z=-4.318, P<0.001; Z=-2.017, P=0.044). Conclusion: SAT-TB did better than qRT-PCR in monitoring the early curative effect of etiologically positive tracheobronchial tuberculosis patients.

Key words: Tuberculosis,bronchus, Nucleic acid amplification technology, Treatment outcome, Monitoring, Comparative study

中图分类号:

R523

徐银娟, 赵国连, 崔晓利, 党丽云, 康磊, 周永. 实时荧光RNA恒温检测在气管支气管结核疗效监测中的应用价值[J]. 中国防痨杂志, 2023, 45(1): 79-84. doi: 10.19982/j.issn.1000-6621.20220337

Xu Yinjuan, Zhao Guolian, Cui Xiaoli, Dang Liyun, Kang Lei, Zhou Yong. The application value of SAT-TB in monitoring the curative effect of patients with tracheobronchial tuberculosis[J]. Chinese Journal of Antituberculosis, 2023, 45(1): 79-84. doi: 10.19982/j.issn.1000-6621.20220337

图/表 3

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参考文献 14

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检测方法	基线	治疗2周	治疗4周	治疗6周	治疗8周	治疗10周	治疗12周
MGIT 960培养	82(87.23)	61(64.89)	45(47.87)	23(24.47)	9(9.57)	3(3.19)	1(1.06)
qRT-PCR	87(92.55)	79(84.04)	69(73.40)	65(69.15)	47(50.00)	37(39.36)	28(29.79)
SAT-TB	88(93.62)	74(78.72)	57(60.64)	51(54.26)	27(28.72)	20(21.28)	15(15.96)
χ²值	2.500	8.471	6.722	21.441	12.042	12.071	13.474
P值^a	0.302	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001
χ²值	1.067	12.042	18.893	35.021	34.225	25.037	30.250
P值^b	0.109	0.002	0.008	<0.001	<0.001	<0.001	<0.001

检测时间	检测方法结果	MGIT 960培养		敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)	Kappa值	符合率 (%)	AUC值
检测时间	检测方法结果	阳性 (例)	阴性 (例)	敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)	Kappa值	符合率 (%)	AUC值
基线	qRT-PCR			93.90	16.67	88.51	28.57	0.129	84.04	0.553
	阳性	77	10
	阴性	5	2
	SAT-TB			97.56	33.33	90.91	66.67	0.393	89.36	0.642
	阳性	80	8
	阴性	2	4
治疗2周	qRT-PCR			95.08	36.36	73.42	80.00	0.359	74.47	0.657
	阳性	58	21
	阴性	3	12
	SAT-TB			96.72	54.55	79.73	90.00	0.564	81.91	0.756
	阳性	59	15
	阴性	2	18
治疗4周	qRT-PCR			95.56	46.94	62.32	92.00	0.416	70.21	0.707
	阳性	43	26
	阴性	2	23
	SAT-TB			93.33	69.39	73.68	91.89	0.620	80.85	0.814
	阳性	42	15
	阴性	3	34
治疗6周	qRT-PCR			86.96	36.62	30.77	89.66	0.146	48.94	0.680
	阳性	20	45
	阴性	3	26
	SAT-TB			86.96	56.34	39.22	93.02	0.307	63.83	0.725
	阳性	20	31
	阴性	3	40
治疗8周	qRT-PCR			88.89	54.12	17.02	97.87	0.149	57.45	0.715
	阳性	8	39
	阴性	1	46
	SAT-TB			66.67	75.29	22.22	95.52	0.222	74.47	0.779
	阳性	6	21
	阴性	3	64
检测时间	检测方法结果	MGIT 960培养		敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)	Kappa值	符合率 (%)	AUC值
检测时间	检测方法结果	阳性 (例)	阴性 (例)	敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)	Kappa值	符合率 (%)	AUC值
治疗10周	qRT-PCR			66.67	61.54	5.41	98.25	0.044	61.70	0.641
	阳性	2	35
	阴性	1	56
	SAT-TB			66.67	80.22	10.00	98.65	0.125	79.79	0.723
	阳性	2	18
	阴性	1	73
治疗12周	qRT-PCR			100.00	70.97	3.57	100.00	0.049	71.28	0.605
	阳性	1	27
	阴性	0	66
	SAT-TB			100.00	84.95	6.67	100.00	0.107	85.11	0.675
	阳性	1	14
	阴性	0	79

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