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

doi:10.19982/j.issn.1000-6621.20250480

Abstract

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

CLC Number:

R521

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

Figures/Tables 3

References 33

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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