Efficacy observation of Xiaoluo Sanjie Powder combined with conventional anti-tuberculosis drugs in the treatment of infiltrating lymph node tuberculosis

doi:10.19983/j.issn.2096-8493.20230014

Abstract

Abstract:

Objective: To observe the efficacy of Xiaoluo Sanjie Powder combined with conventional anti-tuberculosis drugs in the treatment of infiltrating superficial lymph node tuberculosis and the effect on immunity. Methods: According to the inclusion criteria, a prospective study was conducted in 80 patients with infiltrating cervical superficial lymph node tuberculosis from Hebei Chest Hospital between March 2019 and March 2021. They were divided into observation group (n=40, conventional anti-tuberculosis treatment+Xiaoluo Sanjie Powder groups) and control group (n=40,conventional anti-tuberculosis treatment group) according to the random number table method. The clinical effective rate, integral changes of traditional chines medicine (TCM) syndrome (pain, low fever, fatigue, night sweats), immune levels (CD3⁺, CD4⁺, CD8⁺, CD4/CD8) 2 months after treatment, and the cure rate, follow-up and adverse reactions at the end of the 10-month-treatment were observed. At the end of the 2-month intensive period treatment, 1 and 3 cases were off in the observation group and control group, respectively. Results: Two months after treatment, the total effective rate in the observation group (97.4% (38/39)) was significantly higher than that in the control group (83.8% (31/37)), the difference was statistically significant (χ²=4.232, P=0.040).The scores of TCM syndromes such as pain, low fever, fatigue, and night sweats in the observation group were all improved (0.38±0.08, 0.38±0.08, 0.56±0.08, and 0.41±0.08, respectively), significantly higher than those in the control group (0.76±0.10, 0.68±0.09, 0.92±0.09, and 0.68±0.08, respectively; t=-2.971, P=0.040; t=-2.481, P=0.015; t=-2.948, P=0.004; t=-2.375, P=0.020, respectively),and the levels of CD3⁺, CD4⁺, CD4/CD8 in the observation group were also significantly higher than those in the control group ((66.89±3.58) % vs. (62.68±3.61) %, t=5.101, P<0.001; (39.92±3.73) % vs. (32.19±2.96) %, t=9.989, P<0.001; 1.47±0.23 vs. 1.06±0.12, t=9.447, P<0.001, respectively);while CD8⁺ was significantly lower than those in the control group ((26.81±2.99) % vs. (30.81±2.56) %, t=-6.245, P<0.001, respectively). After the 10-month-treatment, the cure rate in the observation group (100.0% (39/39)) was significantly higher than that in the control group (86.5% (32/37)) (χ²=5.641, P=0.024); and no skin ulceration was found in the observation group,however, in the control group 3 cases (8.1%) had ulceration and 2 cases (5.4%) were not healed and needed continuous medication. There was no significant difference in the incidence of adverse reactions between the two groups (5.1% (2/39) vs. 8.1% (3/37),χ²=0.274, P=0.671). Conclusion: Xiaoluo Sanjie Powder combined with conventional anti-tuberculosis drugs can improve the immunity, clinical effective, curative effect, and TCM syndromes in patients with infiltrating superficial lymph node tuberculosis. It has good safety and can be widely used in clinic.

Key words: Tuberculosis, lymph node, Drug therapy, combination, Antituberculosis drugs, Chinese herbal medicine, Xiaoluo Sanjie Powder

CLC Number:

R522
R283

Wang Guowei, Liang Yachong, Liu Yufei, Li Cuiqiao, He Ping. Efficacy observation of Xiaoluo Sanjie Powder combined with conventional anti-tuberculosis drugs in the treatment of infiltrating lymph node tuberculosis[J]. Journal of Tuberculosis and Lung Disease , 2023, 4(1): 60-65. doi: 10.19983/j.issn.2096-8493.20230014

Figures/Tables 3

一般资料	观察组(40例)	对照组(40例)	统计检验值	P值
性别[例,构成比(%)]			χ²=0.213	0.818
男性	14(35.0)	16(40.0)
女性	26(65.0)	24(60.0)
年龄(岁, $x ˉ$ ±s)	36.85±2.12	34.25±2.03	t=0.883	0.380
病程(d, $x ˉ$ ±s)	20.80±1.48	19.82±1.44	t=0.471	0.639
病变部位[例,构成比(%)]			t=0.349	0.840
颈部	34(85.0)	32(80.0)
腹股沟	2(5.0)	2(5.0)
腋窝	4(10.0)	6(15.0)
淋巴结面积(cm², $x ˉ$ ±s)	7.90±0.74	8.80±0.76	t=0.852	0.397
Xpert检测阳性[例,阳性率(%)]	0(0.0)	1(2.5)	χ²=1.013	0.500
皮肤异常[例,发生率(%)]	0(0.0)	1(2.5)	χ²=1.013	0.500

中医证候	治疗前(分, $x ˉ$ ±s)		t值	P值	治疗后(分, $x ˉ$ ±s)		t值	P值	t值	P值^a	t值	P值^b
中医证候	观察组 (39例)	对照组 (37例)	t值	P值	观察组 (39例)	对照组 (37例)	t值	P值	t值	P值^a	t值	P值^b
疼痛	1.78±0.12	1.65±0.13	0.727	0.469	0.38±0.08	0.76±0.10	-2.971	0.040	-13.818	0.000	-6.112	<0.001
低热	1.75±0.12	1.50±0.12	1.497	0.138	0.38±0.08	0.68±0.09	-2.481	0.015	-13.658	0.000	-7.474	<0.001
乏力	1.70±0.12	1.60±0.12	0.582	0.562	0.56±0.08	0.92±0.09	-2.948	0.004	-11.658	0.000	-6.144	<0.001
盗汗	1.30±0.12	1.35±0.13	0.293	0.770	0.41±0.08	0.68±0.08	-2.375	0.020	-7.458	0.000	-4.988	<0.001

免疫指标	治疗前		t值	P值	治疗后		t值	P值	t值	P值^a	t值	P值^b
免疫指标	观察组 (39例)	对照组 (37例)	t值	P值	观察组 (39例)	对照组 (37例)	t值	P值	t值	P值^a	t值	P值^b
CD3⁺(%, $x ˉ$ ±s)	60.21± 6.01	60.17± 4.59	-0.044	0.965	66.89± 3.58	62.68± 3.61	5.101	0.000	8.164	0.000	7.038	<0.001
CD4⁺(%, $x ˉ$ ±s)	28.03± 5.90	28.89± 3.96	-0.759	0.450	39.92± 3.73	32.19± 2.96	9.989	0.000	12.648	0.000	8.814	<0.001
CD8⁺(%, $x ˉ$ ±s)	33.82± 3.29	33.07± 2.63	1.133	0.260	26.81± 2.99	30.81± 2.56	-6.245	0.000	10.270	0.000	-5.014	<0.001
CD4/CD8	0.84± 0.21	0.88± 0.14	-1.027	0.308	1.47± 0.23	1.06± 0.12	9.447	0.000	13.941	0.000	7.968	<0.001

References 26

[1]	何益平, 钟骏慧. 肿意膏外敷治疗颈淋巴结结核400例临床观察. 中国药业, 2017, 26(22):37-39. doi:10.3969/j.issn.1006-4931.2017.22.012. doi: 10.3969/j.issn.1006-4931.2017.22.012.
[2]	杨国强, 张靳, 张绿浪, 等. 夏枯草膏联合常规疗法治疗颈部淋巴结结核的疗效及对免疫功能和炎症因子水平的影响. 中国中西医结合杂志, 2020, 40(8):914-918. doi:10.7661/j.cjim.20200704.078. doi: 10.7661/j.cjim.20200704.078.
[3]	Etna MP, Giacomini E, Severa M, et al. Pro-and anti-inflammatory cytokines in tuberculosis:a two-edgedsword in TB pathogenesis. Semin Immunol, 2014, 26(6):543-551. doi:10.1016/j.smim.2014.09.011. doi: 10.1016/j.smim.2014.09.011. URL
[4]	Lyon SM, Rossman MD. Pulmonary tuberculosis. Microbiol Spectr, 2017, 5(1):5.1.24. doi:10.1128/microbiolspec.TNMI7-0032-2016. doi: 10.1128/microbiolspec.TNMI7-0032-2016.
[5]	段美英, 赵卉. 中药夏枯草膏口服加外敷联合西药化疗治疗颈淋巴结结核48例. 中医外治杂志, 2019, 28(1):36-37.
[6]	钮晓红, 黄子慧, 杨春睿. 瘰疬宁治疗淋巴结结核临床研究. 中医学报, 2014, 29(3):399-401.
[7]	唐神结, 高文. 临床结核病学. 北京: 人民卫生出版社, 2011:310,314-478.
[8]	国家技术监督局. 中医临床诊疗术语(症候部分). 1997-03-04.
[9]	中华医学会. 临床诊疗指南:结核病分册. 北京: 人民卫生出版社, 2005:64-86.
[10]	中华中医药学会. 中医外科常见病诊疗指南. 北京: 中国中医药出版社, 2012:20-25.
[11]	杨春睿. 滋阴降火糊辅助化疗治疗颈淋巴结结核临床观察. 山西中医, 2021, 37(9):47-48. doi:10.3969/j.issn.1000-7156.2021.09.020. doi: 10.3969/j.issn.1000-7156.2021.09.020.
[12]	国家中医药管理局. 中医病证诊断疗效标准. 南京: 南京大学出版, 1994:7.
[13]	Glaziou P, Floyd K, Raviglione MC. Global Epidemiology of Tuberculosis. Semin Respir Crit Care Med, 2018, 39(3): 271-285. doi:10.1055/s-0038-1651492. doi: 10.1055/s-0038-1651492 pmid: 30071543
[14]	Faksri K, Xia E, Ong RT, et al. Comparative whole-genome sequence analysis of Mycobacterium tuberculosis isolated from tuberculous meningitis and pulmonary tuberculosis patients. Sci Rep, 2018, 8 (1):4910.doi:10.1038/s41598-018-23337-y. doi: 10.1038/s41598-018-23337-y. URL
[15]	Satti H, Mafukidze A, Jooste PL, et al. High rate of hypothyroidism among patients treated for multidrug-resistant tuberculosis in Lesotho. Int J Tuberc Lung Dis, 2012, 16(4):468-472. doi:10.5588/ijtld.11.0615. doi: 10.5588/ijtld.11.0615 pmid: 22326109
[16]	陈丹, 刘光陵, 吴雪琼. 具有抗结核作用中药及其成分研究进展. 辽宁中医药大学学报, 2015, 17(1):128-131. doi:10.13194/j.issn.1673-842x.2015.01.045. doi: 10.13194/j.issn.1673-842x.2015.01.045.
[17]	赵有利. 瘰疬与淋巴结结核名称溯源及释义. 世界中医药, 2018, 13(8): 2059-2062. doi:10.3969/j.issn.1673-7202.2018.08.057. doi: 10.3969/j.issn.1673-7202.2018.08.057.
[18]	薛倩一, 靳汝辉, 钮晓红, 等. 消疬膏治疗脾胃虚弱证淋巴结结核临床疗效观察. 中医临床研究, 2019, 11(16): 8-11. doi:10.3969/j.issn.1674-7860.2019.16.003. doi: 10.3969/j.issn.1674-7860.2019.16.003.
[19]	傅良杰, 钮晓红. 内消瘰疬片辅助治疗初治肺结核并发颈部淋巴结结核患者的临床疗. 中国防痨杂志, 2019, 41(10): 1127-1131. doi:10.3969/j.issn.1000-6621.2019.10.012. doi: 10.3969/j.issn.1000-6621.2019.10.012.
[20]	刘媛, 陈洁, 孙辉, 等. 基于网络药理学的猫爪草治疗结核病作用机制研究. 山东科学, 2021, 34(6):52-61.
[21]	杨甫臣, 张世超. 基于网络药理学的“海藻-昆布”治疗甲状腺肿的作用机制研究. 中国医药导报, 2021, 18(5):133-138.
[22]	欧小龙, 黄涛阳. 柴胡属植物化学成分研究进展. 中药材, 2021, 44(3): 749-755.
[23]	李营. 胸腺五肽联合抗结核药物治疗复治涂阳肺结核对机体免疫功能的影响及疗效观察. 临床肺科杂志, 2017, 22(1):32-35. doi:10.3969/j.issn.1009-6663.2017.01.010. doi: 10.3969/j.issn.1009-6663.2017.01.010.
[24]	梁艳辉, 赵磊. 胸腺五肽辅助治疗颈部淋巴结结核对T淋巴细胞亚群及INF-γ和IL-10水平的影响. 现代中西医结合杂志, 2016, 25(12):1336-1338. doi:10.3969/j.issn.1008-8849.2016.12.030. doi: 10.3969/j.issn.1008-8849.2016.12.030.
[25]	Mustafa T, Brokstad KA, Mfinanga SG, et al. Multiplex Analysis of Pro- or Anti-Inflammatory Serum Cytokines and Chemokines in relation to Gender and Age among Tanzanian Tuberculous Lymphadenitis Patients. Tuberc Res Treat, 2015, 2015:561490. doi:10.1155/2015/561490. doi: 10.1155/2015/561490.
[26]	窦慧, 朱珠, 钮晓红. 瘰疬宁对淋巴结结核患者免疫细胞及细胞因子的影响研究. 江苏中医药, 2020, 52(8):33-36. doi:10.19844/j.cnki.1672-397X.2020.08.012. doi: 10.19844/j.cnki.1672-397X.2020.08.012.