2010—2023年中国肺结核合并症患者治疗依从性及治疗结局影响因素分析

doi:10.19982/j.issn.1000-6621.20250237

中国防痨杂志 ›› 2025, Vol. 47 ›› Issue (10): 1268-1278.doi: 10.19982/j.issn.1000-6621.20250237

2010—2023年中国肺结核合并症患者治疗依从性及治疗结局影响因素分析

严天心¹, 马文斌², 王嘉¹, 李涛¹, 张慧¹, 赵雁林¹(), 屈燕¹(), 罗小峰²()

¹中国疾病预防控制中心(中国预防医学科学院)结核病预防控制中心,北京 102206
²兰州大学公共卫生学院,兰州 730000

收稿日期:2025-06-03 出版日期:2025-10-10 发布日期:2025-09-29
通信作者: 赵雁林,Email: zhaoyl@chinacdc.cn;屈燕,Email: quyan@chinacdc.cn;罗小峰,Email: luoxiaof@lzu.edu.cn
作者简介:注:马文斌与严天心对本研究具有同等贡献,为并列第一作者
基金资助:
结核病预防控制项目(2428)

Analysis of the factors influencing adherence and treatment outcomes among pulmonary tuberculosis patients with comorbidities in China from 2010 to 2023

Yan Tianxin¹, Ma Wenbin², Wang Jia¹, Li Tao¹, Zhang Hui¹, Zhao Yanlin¹(), Qu Yan¹(), Luo Xiaofeng²()

¹National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention (Chinese Academy of Preventive Medicine), Beijing 102206, China
²School of Public Health, Lanzhou University, Lanzhou 730000, China

Received:2025-06-03 Online:2025-10-10 Published:2025-09-29
Contact: Zhao Yanlin, Email: zhaoyl@chinacdc.cn; Qu Yan, Email: quyan@chinacdc.cn; Luo Xiaofeng, Email: luoxiaof@lzu.edu.cn
Supported by:
National Tuberculosis Control and Prevention Programme(2428)

摘要/Abstract

摘要：

目的: 分析2010—2023年中国肺结核合并症患者的治疗依从性、治疗结局及相关影响因素,为进一步提升肺结核合并症患者治疗效果提供科学依据。方法: 采用回顾性研究方法,从“中国疾病预防控制信息系统”子系统“结核病管理信息系统”中提取2010—2023年登记的合并单一疾病的肺结核患者病案信息,剔除重复登记、无完整治疗记录、菌种鉴定为非结核分枝杆菌感染、药物敏感性试验结果为非利福平耐药的耐药肺结核患者,最终纳入339411例肺结核合并症患者,计算其不规则服药和不良治疗结局的发生率,并采用多因素logistic回归模型分析影响患者治疗依从性和治疗结局的相关因素。结果: 2010—2023年,中国肺结核合并症患者的不规则服药率为4.26%(14463/339411),不良治疗结局发生率为9.86%(33456/339411)。多因素logistic回归分析显示,男性、职业为商业及服务业和其他职业、被动就诊、合并HIV/AIDS或其他疾病、复治、病原学检测阳性、自服药,以及耐药结核病均是影响肺结核合并症患者治疗依从性的独立危险因素[OR(95%CI)值分别为1.153(1.107~1.201)、1.269(1.102~1.455)、1.135(1.086~1.186)、1.214(1.166~1.265)、1.568(1.419~1.730)、1.173(1.130~1.217)、1.261(1.198~1.327)、1.138(1.096~1.181)、1.440(1.390~1.492)、4.100(3.811~4.409)];男性、被动就诊、复治、病原学检测阳性、自服药、未使用固定剂量复合剂(FDC)、耐药结核病及治疗依从性低均是肺结核合并症患者发生不良治疗结局的独立危险因素[OR(95%CI)值分别为1.264(1.224~1.306)、1.076(1.043~1.111)、1.128(1.083~1.173)、1.585(1.531~1.642)、1.057(1.027~1.088)、1.046(1.017~1.075)、23.811(22.341~25.385)、28.468(27.329~29.659)]。结论: 中国肺结核合并症患者的治疗依从性和治疗结局受到合并相关疾病的明显影响,应结合影响肺结核合并症患者治疗依从性和治疗结局的人群特征与合并症类型,制定有针对性的措施,强化男性、公共服务人员患者的主动发现,加强复治、病原学阳性和耐药合并症患者的精准治疗管理,推广方便智能的服药管理工具,进一步促进患者完成全程服药治疗、降低不良治疗结局、提高治疗康复水平。

关键词: 结核,肺, 合并症, 治疗依从性, 治疗结局

Abstract:

Objective: To analyse the treatment adherence, treatment outcomes, and associated influencing factors among pulmonary tuberculosis (PTB) patients with comorbidities in China from 2010 to 2023 and provide a scientific basis for improving treatment effectiveness in these patients. Methods: Using a retrospective research method, medical records of PTB patients with single comorbidity registered between 2010 and 2023 was extracted from “China Tuberculosis Information Management System” subsystem of the “China Center for Disease Control and Prevention Information System”. The study excluded patients with duplicate registrations, incomplete treatment records, mycobacterial species identification indicating non-tuberculosis mycobacterial infections, and drug-resistant PTB cases other than rifampin resistance. Finally, a cohort of 339411 PTB patients with comorbidities was obtained. The incidence rates of non-adherence and unfavorable treatment outcomes were calculated. Multivariable logistic regression models were conducted to identify factors associated with treatment adherence and treatment outcomes. Results: The incidence rate of irregular medication adherence among PTB patients with comorbidities was 4.26% (14463/339411), while the incidence rate of unfavorable treatment outcomes was 9.86% (33456/339411). Multivariable logistic regression models revealed that male gender, occupations in commercial and other services, and other unspecified categories, passive healthcare-seeking behavior, co-infection with HIV/AIDS or other comorbidities, re-treatment status, bacteriologically positive results, self-medication practices, and the diagnosis of drug-resistant PTB were all independent risk factors influencing treatment non-adherence (odds ratio (OR) with 95% confidence intervals (CI): 1.153 (1.107-1.201), 1.269 (1.102-1.455), 1.135 (1.086-1.186), 1.214 (1.166-1.265), 1.568 (1.419-1.730), 1.173 (1.130-1.217), 1.261 (1.198-1.327), 1.138 (1.096-1.181), 1.440 (1.390-1.492), and 4.100 (3.811-4.409), respectively). Additionally, male gender, passive healthcare-seeking behavior, re-treatment status, positive etiological detection, self-medication, non-use of fixed-dose combination (FDC) drugs, a diagnosis of drug-resistant PTB, and low treatment adherence were identified as independent risk factors for unfavorable treatment outcomes (OR (95%CI): 1.264 (1.224-1.306), 1.076 (1.043-1.111), 1.128 (1.083-1.173), 1.585 (1.531-1.642), 1.057 (1.027-1.088), 1.046 (1.017-1.075), 23.811 (22.341-25.385), and 28.468 (27.329-29.659), respectively). Conclusion: The treatment adherence and treatment outcomes of patients with PTB complicated by other diseases in China are influenced by the co-existing related diseases, targeted measures should be developed by integrating an analysis of population characteristics and the types of comorbidities that influence treatment adherence and outcomes among PTB patients with comorbid conditions. Efforts should be strengthened to actively detect cases of male and public service personnel, and enhance precise treatment management for re-treated, bacteriologically positive patients, and individuals with drug resistant comorbidities. To encourage patients to complete their full course of treatment, such that it reduces unfavorable treatment outcomes and improve overall treatment efficacy and rehabilitation levels, convenient and intelligent medication management tools should be promoted.

Key words: Tuberculosis, pulmonary, Comorbidity, Treatment adherence, Treatment outcomes

中图分类号:

严天心, 马文斌, 王嘉, 李涛, 张慧, 赵雁林, 屈燕, 罗小峰. 2010—2023年中国肺结核合并症患者治疗依从性及治疗结局影响因素分析[J]. 中国防痨杂志, 2025, 47(10): 1268-1278. doi: 10.19982/j.issn.1000-6621.20250237

Yan Tianxin, Ma Wenbin, Wang Jia, Li Tao, Zhang Hui, Zhao Yanlin, Qu Yan, Luo Xiaofeng. Analysis of the factors influencing adherence and treatment outcomes among pulmonary tuberculosis patients with comorbidities in China from 2010 to 2023[J]. Chinese Journal of Antituberculosis, 2025, 47(10): 1268-1278. doi: 10.19982/j.issn.1000-6621.20250237

图/表 4

表1

表2

2010—2023年中国肺结核合并症患者治疗依从性和抗结核治疗结局的单因素分析

特征	治疗依从性 [例(构成比,%)]		χ²值	P值	OR(95%CI)值	治疗结局 [例(构成比,%)]		χ²值	P值	OR(95%CI)值
特征	高 (324948例)	低 (14463例)	χ²值	P值	OR(95%CI)值	完成治疗结局 (305955例)	不良治疗结局 (33456例)	χ²值	P值	OR(95%CI)值
性别
男性	243366 (95.60)	11203 (4.40)	6.968	<0.001	1.152 (1.107~1.199)	228043 (89.58)	26526 (10.42)	19.010	<0.001	1.308 (1.272~1.345)
女性	81582 (96.16)	3260 (3.84)		1.000		77912 (91.83)	6930 (8.17)		1.000
年龄组(岁)
<15	896 (96.55)	32 (3.45)	-1.809	0.070	0.722 (0.497~1.009)	891 (96.01)	37 (3.99)	-7.315	<0.001	0.293 (0.207~0.401)
15~29	18110 (96.86)	588 (3.14)	-9.691	<0.001	0.656 (0.602~0.714)	17849 (95.46)	849 (4.54)	-30.416	<0.001	0.335 (0.312~0.360)
30~45	40769 (95.92)	1733 (4.08)	-5.601	<0.001	0.859 (0.814~0.906)	39368 (92.63)	3134 (7.37)	-28.845	<0.001	0.561 (0.540~0.584)
46~59	109081 (96.14)	4385 (3.86)	-10.764	<0.001	0.812 (0.782~0.844)	104375 (91.99)	9091 (8.01)	-36.770	<0.001	0.614 (0.598~0.630)
≥60	156092 (95.28)	7725 (4.72)		1.000		143472 (87.58)	20345 (12.42)		1.000
职业
农业	208842 (95.79)	9189 (4.21)		1.000		195817 (89.81)	22214 (10.19)		1.000
企业	9375 (95.93)	398 (4.07)	-0.684	0.494	0.965 (0.870~1.067)	9095 (93.06)	678 (6.94)	-10.384	<0.001	0.657 (0.607~0.711)
商业服务业	4540 (95.32)	223 (4.68)	1.586	0.113	1.116 (0.972~1.276)	4470 (93.85)	293 (6.15)	-9.034	<0.001	0.578 (0.512~0.650)
在校学生	4704 (97.69)	111 (2.31)	-6.449	<0.001	0.536 (0.441~0.645)	4676 (97.11)	139 (2.89)	-15.534	<0.001	0.262 (0.220~0.309)
机关事业单位	7023 (97.08)	211 (2.92)	-5.398	<0.001	0.683 (0.593~0.782)	6881 (95.12)	353 (4.88)	-14.422	<0.001	0.452 (0.405~0.503)
离退人员	29057 (95.43)	1392 (4.57)	2.890	0.004	1.089 (1.027~1.153)	26754 (87.86)	3695 (12.14)	10.397	<0.001	1.217 (1.173~1.263)
其他	61407 (95.43)	2939 (4.57)	3.879	<0.001	1.088 (1.042~1.135)	58262 (90.54)	6084 (9.46)	-5.442	<0.001	0.921 (0.893~0.948)
患者来源
主动筛查	81443 (96.17)	3242 (3.83)		1.000		76750 (90.63)	7935 (9.37)		1.000
被动就诊	243505 (95.59)	11221 (4.41)	7.194	<0.001	1.158 (1.113~1.205)	229205 (89.98)	25521 (10.02)	5.488	<0.001	1.077 (1.049~1.106)
合并疾病
糖尿病	132572 (96.08)	5402 (3.92)		1.000		125026 (90.62)	12948 (9.38)		1.000
HIV/AIDS	9021 (95.09)	466 (4.91)	4.793	<0.001	1.268 (1.149~1.395)	8242 (86.88)	1245 (13.12)	11.879	<0.001	1.459 (1.370~1.552)
尘肺病	13604 (96.51)	492 (3.49)	-2.488	0.013	0.888 (0.807~0.974)	12655 (89.78)	1441 (10.22)	3.238	0.001	1.100 (1.038~1.164)
精神疾病	4079 (96.18)	162 (3.82)	-0.316	0.752	0.975 (0.828~1.139)	3882 (91.54)	359 (8.46)	-2.024	0.043	0.893 (0.799~0.995)
其他疾病	165672 (95.43)	7941 (4.57)	9.013	<0.001	1.176 (1.136~1.219)	156150 (89.94)	17463 (10.06)	6.298	<0.001	1.080 (1.054~1.106)
治疗分类
初治	292884 (95.94)	12391 (4.06)		1.000		277732 (90.98)	27543 (9.02)		1.000
复治	32064 (93.93)	2072 (6.07)	17.323	<0.001	1.527 (1.456~1.602)	28223 (82.68)	5913 (17.32)	47.836	<0.001	2.113 (2.049~2.178)
病原学结果
阴性或未知	110176 (96.25)	4295 (3.75)		1.000		105887 (92.50)	8584 (7.50)		1.000
阳性	214772 (95.48)	10168 (4.52)	10.462	<0.001	1.214 (1.171~1.260)	200068 (88.94)	24872 (11.06)	32.682	<0.001	1.534 (1.495~1.573)
服药管理方式
监督服药	180682 (96.30)	6939 (3.70)		1.000		168652 (89.89)	18969 (10.11)		1.000
自服药	144266 (95.04)	7524 (4.96)	19.135	<0.001	1.363 (1.315~1.401)	137303 (90.46)	14487 (9.54)	-4.299	<0.001	0.940 (0.924~0.963)
耐药情况
敏感	319359 (95.96)	13430 (4.04)		1.000		304097 (91.38)	28692 (8.62)		1.000
耐药	5589 (84.40)	1033 (15.60)	42.307	<0.001	4.395 (4.102~4.705)	1858 (28.06)	4764 (71.94)	117.770	<0.001	27.176 (25.727~28.717)
是否使用FDC
是	205868 (95.88)	8849 (4.12)		1.000		194927 (90.78)	19790 (9.22)		1.000
否	119080 (95.50)	5614 (4.50)	5.296	<0.001	1.097 (1.060~1.135)	111028 (89.04)	13666 (10.96)	16.403	<0.001	1.212 (1.185~1.241)
治疗依从性	-	-	-	-	-
高治疗依从性	-	-	-	-	-	301085 (92.66)	23863 (7.34)		1.000
低治疗依从性	-	-	-	-	-	4870 (33.67)	9593 (66.33)	170.575	<0.001	24.854 (23.954~25.790)

表2

表3

表4

2010—2023年中国肺结核合并症患者治疗依从性和抗结核治疗结局影响因素的多因素分析

因素	治疗依从性					抗结核治疗结局
因素	$s x ˉ$ 值	β值	Z值	P值	OR(95%CI)值	$s x ˉ$ 值	β值	Z值	P值	OR(95%CI)值
男性	0.021	0.142	6.881	<0.001	1.153 (1.107~1.201)	0.017	0.234	14.076	<0.001	1.264 (1.224~1.306)
<15岁	0.199	-0.006	-0.031	0.976	0.994 (0.662~1.446)	0.201	-0.825	-4.098	<0.001	0.438 (0.291~0.642)
15~29岁	0.048	-0.437	-9.080	<0.001	0.646 (0.587~0.709)	0.045	-1.145	-25.173	<0.001	0.318 (0.291~0.348)
30~45岁	0.029	-0.230	-7.995	<0.001	0.795 (0.751~0.840)	0.025	-0.817	-32.564	<0.001	0.442 (0.420~0.464)
46~59岁	0.020	-0.232	-11.344	<0.001	0.793 (0.762~0.825)	0.016	-0.630	-38.355	<0.001	0.533 (0.516~0.550)
商业服务业	0.071	0.239	3.373	0.001	1.269 (1.102~1.455)	0.072	-0.435	-6.060	<0.001	0.647 (0.561~0.744)
机关事业单位	0.072	-0.240	-3.345	0.001	0.787 (0.682~0.903)	0.064	-0.523	-8.173	<0.001	0.593 (0.522~0.671)
在校学生	0.113	-0.361	-3.183	0.002	0.697 (0.556~0.867)	0.110	-0.497	-4.514	<0.001	0.608 (0.488~0.752)
离退人员	0.031	0.010	0.314	0.754	1.010 (0.951~1.072)	0.023	-0.008	-0.346	0.729	0.992 (0.949~1.037)
企业	0.053	0.055	1.021	0.307	1.056 (0.950~1.171)	0.049	-0.362	-7.450	<0.001	0.696 (0.632~0.765)
其他职业	0.022	0.127	5.667	<0.001	1.135 (1.086~1.186)	0.019	-0.123	-6.637	<0.001	0.884 (0.853~0.917)
被动就诊	0.021	0.194	9.364	<0.001	1.214 (1.166~1.265)	0.016	0.073	4.537	<0.001	1.076 (1.043~1.111)
合并尘肺病	0.049	-0.114	-2.348	0.019	0.892 (0.810~0.980)	0.034	0.125	3.684	<0.001	1.133 (1.060~1.211)
合并精神疾病	0.082	0.119	1.445	0.149	1.126 (0.955~1.318)	0.065	0.518	7.989	<0.001	1.679 (1.476~1.903)
合并HIV/AIDS	0.051	0.450	8.885	<0.001	1.568 (1.419~1.730)	0.038	0.805	21.223	<0.001	2.237 (2.076~2.409)
其他合并症	0.019	0.159	8.406	<0.001	1.173 (1.130~1.217)	0.015	0.319	21.156	<0.001	1.375 (1.335~1.417)
复治	0.026	0.232	8.893	<0.001	1.261 (1.198~1.327)	0.020	0.120	5.903	<0.001	1.128 (1.083~1.173)
病原学阳性	0.019	0.129	6.731	<0.001	1.138 (1.096~1.181)	0.018	0.461	26.019	<0.001	1.585 (1.531~1.642)
自服药	0.018	0.365	20.241	<0.001	1.440 (1.390~1.492)	0.014	0.055	3.721	0.001	1.057 (1.027~1.088)
耐药	0.037	1.411	37.944	<0.001	4.100 (3.811~4.409)	0.032	3.170	97.275	<0.001	23.811 (22.341~25.385)
未使用FDC	0.018	-0.001	-0.068	0.946	0.999 (0.964~1.035)	0.014	0.045	3.160	0.002	1.046 (1.017~1.075)
低治疗依从性	-	-	-	-	-	0.021	3.349	160.453	<0.001	28.468 (27.329~29.659)

表4

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特征	例数	构成比 (%)	χ²值	P值	特征	例数	构成比 (%)	χ²值	P值
性别			24980.004	<0.001	治疗分类			64169.712	<0.001
男性	254569	75.00			初治	305275	89.94
女性	84842	25.00			复治	34136	10.06
年龄组(岁)			81301.867	<0.001	病原学检测结果			10365.824	<0.001
<15	928	0.27			阴性或未知	114471	33.73
15~29	18698	5.51			阳性	224940	66.27
30~45	42502	12.52			服药管理方式			1141.479	<0.001
46~59	113466	33.43			监督服药	187621	55.28
≥60	163817	48.27			自服药	151790	44.72
职业			219444.540	<0.001	耐药情况			92513.619	<0.001
农业	218031	64.24			敏感	332789	98.05
企业	9773	2.88			耐药	6622	1.95
机关事业单位	7234	2.13			治疗依从性			83788.393	<0.001
商业服务业	4763	1.40			高	324948	95.74
在校学生	4815	1.42			低	14463	4.26
离退人员	30449	8.97			是否使用FDC			6987.564	<0.001
其他	64346	18.96			是	214717	63.26
患者来源			25212.449	<0.001	否	124694	36.74
被动就诊	254726	75.05			治疗结局			64924.918	<0.001
主动筛查	84685	24.95			完成治疗	305955	90.14
合并疾病			115044.166	<0.001	死亡	15614	4.60
糖尿病	137974	40.65			失败	13074	3.85
尘肺病	14096	4.15			失访	2478	0.73
HIV/AIDS	9487	2.80			其他	2290	0.68
精神疾病	4241	1.25			合计	339411	100.00
其他疾病	173613	51.15

变量	赋值	变量	赋值
因变量		合并疾病	糖尿病=0;尘肺病=1;HIV/AIDS=2;精神疾病=3;其他合并症=4
(1)治疗依从性 (2)治疗转归	(1)低治疗依从性=0;高治疗依从性=1 (2)不良治疗结局=0;完成治疗=1	治疗分类	初治=0;复治=1
自变量		病原学检测结果	阴性或未知=0;阳性=1
性别	女性=0;男性=1	服药管理方式	监督服药=0;自服药=1
年龄组	≥60岁=0;<15岁=1;15~29岁=2;30~45岁=3;46~59岁=4	耐药情况	敏感=0;耐药=1
职业	农业=0;机关事业单位=1;企业=2;商业服务业=3;在校学生=4;离退人员=5;其他=6	是否使用固定剂量复合剂	是=0;否=1
患者来源	主动发现=0;被动就诊=1	治疗依从性	高治疗依从性=0;低治疗依从性=1

2010—2023年中国肺结核合并症患者治疗依从性及治疗结局影响因素分析

Analysis of the factors influencing adherence and treatment outcomes among pulmonary tuberculosis patients with comorbidities in China from 2010 to 2023

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