中和汤辅助治疗气血两虚证脓肿型淋巴结结核的随机对照研究短期疗效观察

doi:10.19982/j.issn.1000-6621.20250480

中国防痨杂志 ›› 2026, Vol. 48 ›› Issue (7): 1044-1050.doi: 10.19982/j.issn.1000-6621.20250480

中和汤辅助治疗气血两虚证脓肿型淋巴结结核的随机对照研究短期疗效观察

赵丽萍¹, 宗星煜², 曹玉清², 姜慧³, 蔡秋杰², 马艳², 穆婷婷², 刘晓明³, 刘斌³, 梁博文¹, 曹艳华¹, 李波¹, 罗敬月¹, 王桂荣⁴, 黄麦玲⁵()

¹ 首都医科大学附属北京胸科医院中医科, 北京 101149
² 中国中医科学院中医临床基础医学基础所疫病防治研究室, 北京 100700
³ 首都医科大学附属北京胸科医院科技处, 北京 101149
⁴ 首都医科大学附属北京胸科医院检验科, 北京 101149
⁵ 首都医科大学附属北京胸科医院结核科, 北京 101149

收稿日期:2025-12-04 出版日期:2026-07-10 发布日期:2026-07-02
通信作者: 黄麦玲,Email:huangmailing@163.com
基金资助:
首都卫生发展科研专项(2022-4-2164);北京研究型病房卓越计划(BRWEP2024W042160104)

Adjuvant therapy with Zhonghe Decoction for abscess lymph node tuberculosis with Qi and blood deficiency syndrome: a randomized controlled trial on short-term efficacy

Zhao Liping¹, Zong Xingyu², Cao Yuqing², Jiang Hui³, Cai Qiujie², Ma Yan², Mu Tingting², Liu Xiaoming³, Liu Bin³, Liang Bowen¹, Cao Yanhua¹, Li Bo¹, Luo Jingyue¹, Wang Guirong⁴, Huang Mailing⁵()

¹ Department of Traditional Chinese Medicine, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Institute, Beijing 101149, China
² Laboratory for Epidemic Disease Prevention and Control, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
³ Department of Scinese and Technology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Institute, Beijing 101149, China
⁴ Department of Clinical Laboratory, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Institute, Beijing 101149, China
⁵ Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Institute, Beijing 101149, China

Received:2025-12-04 Online:2026-07-10 Published:2026-07-02
Contact: Huang Mailing, Email: huangmailing@163.com
Supported by:
Capital’s Funds for Health Improvement and Research(2022-4-2164);Beijing Research Ward Excellence Program(BRWEP2024W042160104)

摘要/Abstract

摘要：

目的: 评价中和汤辅助治疗气血两虚证脓肿型淋巴结结核的短期疗效。方法: 采用前瞻性随机对照设计,纳入2022年1月至2024年12月首都医科大学附属北京胸科医院收治的非耐药性颈部脓肿型淋巴结结核(气血两虚证)患者80例,随机分为观察组与对照组各40例,脱落7例,最终观察组纳入36例,对照组纳入37例。两组均予异烟肼、利福平、吡嗪酰胺、乙胺丁醇(H-R-Z-E)方案抗结核治疗1年;观察组在此基础上加用中和汤,疗程6个月。分别于治疗前、治疗6周及24周评估两组患者的脓肿大小、中医证候积分、生活质量评分及不良反应发生情况。结果: 治疗6周时,观察组脓肿改善率为77.78%(28/36),显著高于对照组32.43%(12/37)(χ²=15.150,P<0.05);中医证候疗效总有效率为88.89%(32/36),优于对照组(27.03%,10/37)(χ²=28.590,P<0.05)。治疗24周时,观察组良好结局率为72.22%(26/36),显著高于对照组27.03%(10/37)(χ²=14.920,P<0.05)。生活质量方面,治疗6周后,观察组生理机能得分中位数(四分位数)为3.98 (-0.42,8.38)分,对照组为0.34(-4.86,5.53)分,差异有统计学意义(Z=226.290,P<0.05);观察组生理职能得分中位数(四分位数)为59.93(20.36,99.50)分,对照组为33.24(-26.76,93.23)分,差异有统计学意义(Z=212.203,P<0.05);观察组躯体疼痛得分中位数(四分位数)为24.50(-4.75,53.75)分,对照组为12.50(-4.12,24.50)分,差异有统计学意义(Z=224.837,P<0.05))。两组均未发生严重不良事件。结论: 中和汤可促进脓肿型淋巴结结核病灶吸收、加速症状缓解,并提高患者生活质量,疗效确切且安全性良好。

关键词: 结核,淋巴结, 药物,中草药, 随机对照试验

Abstract:

Objective: To evaluate the short-term efficacy of Zhonghe Decoction as an adjuvant therapy for abscess lymph node tuberculosis with Qi and blood deficiency syndrome. Methods: A prospective randomized controlled design was adopted. A total of 80 patients with non-drug-resistant cervical abscess lymph node tuberculosis (Qi and blood deficiency syndrome) admitted to Beijing Chest Hospital, Capital Medical University from January 2022 to December 2024 were enrolled and randomly divided into an observation group and a control group, with 40 cases in each group. After 7 dropouts, 36 cases were finally included in the observation group and 37 cases in the control group. Both groups received the H-R-Z-E (Isoniazid, Rifampicin, Pyrazinamide, Ethambutol) anti-tuberculosis regimen for one year. The observation group was additionally treated with Zhonghe Decoction for 6 months. Abscess size, Traditional Chinese Medicine (TCM) syndrome score, quality of life score, and adverse reactions were evaluated in both groups before treatment, at 6 weeks, and at 24 weeks of treatment. Results: At 6 weeks of treatment, the abscess improvement rate in the observation group was 77.78% (28/36), significantly higher than that in the control group (32.43%, 12/37)(χ²=15.150, P<0.05); the total effective rate for TCM syndrome efficacy was 88.89% (32/36) in the observation group, also superior to that in the control group (27.03%, 10/37)(χ²=28.590, P<0.05). At 24 weeks of treatment, the favorable outcome rate in the observation group was 72.22% (26/36), significantly higher than that in the control group (27.03%, 10/37)(χ²=14.920, P<0.05). Regarding quality of life,, after 6 weeks of treatment, the median (interquartile range) score for physical functioning in the observation group was 3.98 (-0.42, 8.38), while that in the control group was 0.34 (-4.86, 5.53), with a statistically significant difference (Z=226.290, P<0.05). The score for role-physical in the observation group was 59.93 (20.36, 99.50), compared to 33.24 (-26.76, 93.23) in the control group, showing a statistically significant difference (Z=212.203, P<0.05). The score for bodily pain in the observation group was 24.50 (-4.75, 53.75), while that in the control group was 12.50 (-4.12, 24.50), with a statistically significant difference (Z=224.837, P<0.05). No serious adverse events occurred in two groups. Conclusion: Zhonghe Decoction can promote the absorption of abscesses in lymph node tuberculosis, accelerate symptom relief, and improve patients’ quality of life, demonstrating definite efficacy and good safety.

Key words: Tuberculosis, lymph node, Drugs, Chinese herbal, Randomized controlled trial

中图分类号:

R521

赵丽萍, 宗星煜, 曹玉清, 姜慧, 蔡秋杰, 马艳, 穆婷婷, 刘晓明, 刘斌, 梁博文, 曹艳华, 李波, 罗敬月, 王桂荣, 黄麦玲. 中和汤辅助治疗气血两虚证脓肿型淋巴结结核的随机对照研究短期疗效观察[J]. 中国防痨杂志, 2026, 48(7): 1044-1050. doi: 10.19982/j.issn.1000-6621.20250480

Zhao Liping, Zong Xingyu, Cao Yuqing, Jiang Hui, Cai Qiujie, Ma Yan, Mu Tingting, Liu Xiaoming, Liu Bin, Liang Bowen, Cao Yanhua, Li Bo, Luo Jingyue, Wang Guirong, Huang Mailing. Adjuvant therapy with Zhonghe Decoction for abscess lymph node tuberculosis with Qi and blood deficiency syndrome: a randomized controlled trial on short-term efficacy[J]. Chinese Journal of Antituberculosis, 2026, 48(7): 1044-1050. doi: 10.19982/j.issn.1000-6621.20250480

图/表 3

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参考文献 33

[1]	屈燕, 李涛, 马文斌, 等. 世界卫生组织《2025年全球结核病报告》解读[J]. 结核与肺部疾病杂志, 2025, 6(6): 613-623. doi:10.19983/j.issn.2096-8493.20250178.
[2]	Park J H, Kim D W. Sonographic diagnosis of tuberculous lymphadenitis in the neck[J]. J Ultrasound Med, 2014, 33(9): 1619-1626. doi:10.7863/ultra.33.9.1619. pmid: 25154944
[3]	中国人民解放军总医院第八医学中心结核病医学部,《中国防痨杂志》编辑委员会, 中国医疗保健国际交流促进会结核病防治分会. 浅表淋巴结结核的诊断与治疗专家共识[J]. 中国防痨杂志, 2023, 45(6): 531-542. doi:10.19982/j.issn.1000-6621.20230120.
[4]	刘万里, 黄子慧. 淋巴结结核中西医诊疗学[M]. 北京: 中国中医药出版社, 2018.
[5]	李玥莹, 李群宝. 抗痨联合手术治疗淋巴结核的疗效分析[J]. 新疆医科大学学报, 2009, 32(6): 796-797. doi:10.3969/j.issn.1009-5551.2009.06.055.
[6]	唐神结. 耐药结核病的综合治疗[J]. 中华临床医师杂志(电子版), 2010, 4(7): 916-919. doi:10.3969/cma.j.issn.1674-0785.2010.07.003.
[7]	尚希钰, 张慧芳, 曹玉清, 等. 基于文献计量学的结核病中医药基础研究全球研究现状及热点分析[J]. 中国防痨杂志, 2025, 47(4): 482-497. doi:10.19982/j.issn.1000-6621.20240567.
[8]	中国中医科学院中医临床基础医学研究所, 浙江中医药大学附属丽水中医院, 中国防痨协会, 等. 结核分枝杆菌潜伏感染中医辨证分型及治法方药专家共识[J]. 中国防痨杂志, 2026, 48(1): 1-8. doi:10.19982/j.issn.1000-6621.20250421.
[9]	徐信义, 邱仕君. 《十药神书》临床用药特色[J]. 河南中医, 2006, 26(6): 21-23. doi:10.3969/j.issn.1003-5028.2006.06.014.
[10]	张旭阳, 穆婷婷, 马艳, 等. 从“火”探讨痨瘵中医病机及辨证治疗[J]. 中国防痨杂志, 2025, 47(12): 1535-1540. doi:10.19982/j.issn.1000-6621.20250328.
[11]	穆婷婷, 张旭阳, 马艳, 等. 基于《理虚元鉴》“三本二统”治虚理论论治肺痨[J]. 中国防痨杂志, 2025, 47(11): 1522-1527. doi:10.19982/j.issn.1000-6621.20250329.
[12]	戴志澄, 肖东楼, 万利亚. 中国防痨史[M]. 北京: 人民卫生出版社, 2012.
[13]	刘立伟, 曹玉清, 王倪, 等. 基于伏邪理论探讨结核分枝杆菌感染后肺络微环境的周期性动态演变及分期治疗策略[J/OL]. 中国实验方剂学杂志,1-13[2026-03-04].https://doi.org/10.13422/j.cnki.syfjx.20260237.
[14]	李波, 董雨萌, 曹玉清, 等. 《黄帝内经》“瘰疬”证治理论探析[J]. 中国防痨杂志, 2025, 47(11): 1416-1420. doi:10.19982/j.issn.1000-6621.20250326.
[15]	赵有利. 瘰疬与淋巴结结核名称溯源及释义[J]. 世界中医药, 2018, 13(8): 2059-2062. doi:10.3969/j.issn.1673-7202.2018.08.057.
[16]	陈广坤, 张宇, 高雅蓓, 等. 梁希曾内外兼治——扶正潜消法治疗瘰疬学术特色浅析[J]. 中国中医基础医学杂志, 2024, 30 (3): 379-383. doi:10.19945/j.cnki.issn.1006-3250.2024.03.004.
[17]	方木通, 杨倩婷, 王仲元, 等. 病理组织中的病原学检查对结核病的诊断价值[J]. 中华传染病杂志, 2021, 39(2): 92-96. doi:10.3760/cma.j.cn311365-20191124-00391.
[18]	黄伟强, 袁楚楚, 张欢, 等. 45例有创机械通气重症结核病患者静脉使用抗结核药物血药浓度分析[J]. 中国防痨杂志, 2025, 47(6): 798-807. doi:10.19982/j.issn.1000-6621.20250030.
[19]	王肯堂. 证治准绳-四-疡医证治准绳[M]. 北京: 人民卫生出版社, 2014.
[20]	中国疾病预防控制中心. 中国结核病预防控制工作指南[M]. 北京: 人民卫生出版社, 2021.
[21]	郑筱萸. 中药新药临床研究指导原则[M]. 北京: 中国医药科技出版社, 2004.
[22]	国家技术监督局. 中医病证诊断疗效标准: ZY/T 001.1-001.9-94[S]. 北京: 中国标准出版社, 1994.
[23]	李鲁, 王红妹, 沈毅. SF-36健康调查量表中文版的研制及其性能测试[J]. 中华预防医学杂志, 2002, 36(2): 109-113. doi:10.3760/j:issn:0253-9624.2002.02.011.
[24]	柳叶, 许费昀, 黄子慧. 基于真实世界中西医结合治疗淋巴结结核疗效观察[J]. 现代中西医结合杂志, 2024, 33(1): 42-47. doi:10.3969/j.issn.1008-8849.2024.01.007.
[25]	郭净, 刘忠达, 张尊敬, 等. 老年肺结核患者中医药诊治研究进展[J]. 中国防痨杂志, 2024, 46(11): 1406-1409. doi:10.19982/j.issn.1000-6621.20240192.
[26]	吴霞, 方小忠. 健脾润肺愈痨汤辅助治疗老年肺结核的疗效观察[J]. 中国中医药科技, 2021, 28 (6): 966-968.
[27]	李中梓. 雷公炮制药性解[M]. 北京: 人民军医出版社, 2013.
[28]	唐神结, 高文. 临床结核病学[M]. 北京: 人民卫生出版社, 2011.
[29]	孙文海, 刘华敏, 梁大鹏. 原发性颈淋巴结结核的临床特征与治疗[J]. 临床耳鼻咽喉科杂志, 2006, 20(12): 552-553. doi:10.3969/j.issn.1001-1781.2006.12.009.
[30]	杨澄清, 戴希勇, 李俭, 等. 210例颈部淋巴结结核的临床分析[J]. 中国防痨杂志, 2017, 39(2): 169-173. doi:10.3969/j.issn.1000-6621.2017.02.013.
[31]	顾宇人, 唐佩军. 抗结核药物性肝损伤相关危险因素研究进展[J]. 结核与肺部疾病杂志, 2021, 2(3): 283-288. doi:10.3969/j.issn.2096-8493.20210055.
[32]	中国防痨协会药学专业分会, 首都医科大学附属北京胸科医院/北京市结核病胸部肿瘤研究所. 抗结核药治疗药物监测临床应用专家共识(2025年更新版)[J]. 中国防痨杂志, 2026, 48(2): 167-186. doi:10.19982/j.issn.1000-6621.20250435.
[33]	戈启萍, 张立杰, 黄学锐, 等. 首次复治敏感肺结核治疗新方案疗效的验证性研究[J]. 中国防痨杂志, 2023, 45(11): 1078-1083. doi:10.19982/j.issn.1000-6621.20230192.

临床特征	合计(73例)	观察组(36例)	对照组(37例)	统计检验值	P值
年龄[岁,M(Q₁,Q₃)]	32.00 (27.00,48.00)	31.00 (27.00,44.50)	37.00 (27.00,53.00)	U=614.000	0.599
性别[例,构成比(%)]				χ²=0.006	0.939
男性	22(30.14)	11(30.56)	11(29.73)
女性	51(69.86)	25(69.44)	26(70.27)
并发肺结核[例,构成比(%)]				χ²=0.012	0.913
是	34(46.58)	17(47.22)	17(45.95)
否	39(53.42)	19(52.78)	20(54.05)

组别	患者例数	治疗前中医证候积分^a	治疗后中医证候积分^a	尼莫地平法疗效指数^a	显效 (例)	有效 (例)	无效 (例)	总有效率 (%)^b
观察组	36	10.00(8.00,12.50)	2.50(1.50,3.00)	78.17(58.17,87.50)	24	8	4	88.89
对照组	37	9.00(6.50,11.00)	5.00(3.00,8.00)	16.67(0.00,37.50)	4	6	27	27.03
统计检验值		U=666.435	U=283.932	U=1157.341				χ²=28.590
P值		0.465	<0.001	<0.001				<0.001

组别		生理机能					生理职能
组别		治疗6周得分差值		治疗24周得分差值			治疗6周得分差值		治疗24周得分差值
观察组		3.98(-0.42,8.38)		5.00(-1.88,11.88)			59.93(20.36,99.50)		100.00(89.14,110.86)
对照组		0.34(-4.86,5.53)		10.00(-2.50,22.50)			33.24(-26.76,93.23)		87.50(62.50,112.50)
Z值		226.290		41.367			212.203		58.473
P值		0.041		0.372			0.034		0.238
组别		躯体疼痛					健康状况
组别		治疗6周得分差值		治疗24周得分差值			治疗6周得分差值		治疗24周得分差值
观察组		24.50(-4.75,53.75)		40.00(28.00,52.00)			10.00(-3.50,23.50)		13.62(2.16,31.09)
对照组		12.50(-4.12,24.50)		38.00(14.00,62.00)			7.50(-6.00,21.50)		10.00(3.62,23.50)
Z值		224.837		28.845			161.891		167.370
P值		0.042		0.291			0.862		0.619
组别		精力					社会功能
组别		治疗6周得分差值		治疗24周得分差值			治疗6周得分差值		治疗24周得分差值
观察组		5.00(0.00,10.00)		7.50(0.00,12.50)			3.58(-9.03,16.19)		10.00(0.00,20.00)
对照组		0.00(-7.50,7.50)		5.00(0.00,12.50)			0.23(-10.16,9.70)		5.00(-10.00,20.00)
Z值		142.885		53.218			166.811		52.995
P值		0.293		0.647			0.959		0.665
组别	情感职能				精神健康			健康变化
组别	治疗6周得分差值		治疗24周得分差值		治疗6周得分差值	治疗24周得分差值		治疗6周得分差值		治疗24周得分差值
观察组	0.00 (-50.00,50.00)		100.00 (70.83,129.17)		0.00 (-7.50,7.50)	6.00 (1.62,10.38)		0.00 (-12.50,12.50)		50.00 (37.50,62.50)
对照组	0.00 (-33.30,33.33)		66.67 (45.83,87.50)		2.00 (-10.00,5.50)	6.00 (2.00,10.00)		0.00 (-21.88,21.88)		50.00 (21.88,78.12)
Z值	178.774		55.902		132.711	48.523		160.550		47.964
P值	0.537		0.421		0.130	0.939		0.804		0.887

中和汤辅助治疗气血两虚证脓肿型淋巴结结核的随机对照研究短期疗效观察

Adjuvant therapy with Zhonghe Decoction for abscess lymph node tuberculosis with Qi and blood deficiency syndrome: a randomized controlled trial on short-term efficacy

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