消瘰散结散联合常规抗结核药物治疗浸润型淋巴结结核的疗效观察

doi:10.19983/j.issn.2096-8493.20230014

摘要/Abstract

摘要：

目的: 观察消瘰散结散联合常规抗结核药物治疗浸润型浅表淋巴结结核临床疗效及对免疫水平影响。方法: 采用前瞻性研究的方法,参照入组标准选择2019年3月至2021年3月于河北省胸科医院住院治疗的80例确诊为浸润型浅表淋巴结结核患者,按照随机数字表法将80例患者平均分为观察组40例(常规抗结核治疗+消瘰散结散组)和对照组40例(常规抗结核治疗组)。观察两组患者治疗2个月时的临床有效率、中医证候(疼痛、低热、乏力、盗汗)积分变化、免疫水平(CD3⁺、CD4⁺、CD8⁺水平和CD4/CD8比值),以及治疗10个月疗程结束时的治愈率、随访情况及不良反应。在2个月强化期治疗结束时,观察组和对照组分别脱落1例和3例。结果: 两组患者治疗2个月时,观察组总有效率[97.4%(38/39)]明显高于对照组[83.8%(31/37)],差异有统计学意义(χ²=4.232,P=0.040);观察组在疼痛、低热、乏力、盗汗等中医证候的积分改善情况[分别为(0.38±0.08)、(0.38±0.08)、(0.56±0.08)、(0.41±0.08)分]和CD3⁺、CD4⁺水平及CD4/CD8比值[分别为(66.89±3.58)%、(39.92±3.73)%和1.47±0.23]均优于对照组[分别为(0.76±0.10)、(0.68±0.09)、(0.92±0.09)和(0.68±0.08)分;(62.68±3.61)%、(32.19±2.96)%和1.06±0.12],而CD8⁺水平[(26.81±2.99)%]低于对照组[(30.81±2.56)%],差异均有统计学意义(t=-2.971,P=0.040;t=-2.481,P=0.015;t=-2.948,P=0.004;t=-2.375,P=0.020;t=5.101,P<0.001;t=9.989,P<0.001;t=9.447,P<0.001;t=-6.245,P<0.001)。治疗10个月疗程结束时,观察组治愈率[100.0%(39/39)]明显高于对照组[86.5%(32/37)],差异有统计学意义(χ²=5.641,P=0.024);且前者皮肤无破溃,后者3例(8.1%)皮肤破溃、2例(5.4%)未愈持续用药。观察组治疗期间不良反应发生率[5.1%(2/39)]与对照组[8.1%(3/37)]差异无统计学意义(χ²=0.274 P=0.671)。结论: 消瘰散结散联合常规抗结核药物可提高浸润型浅表淋巴结结核患者免疫水平、临床疗效、治愈率、改善中医证候,且安全性较好,可临床广泛应用。

关键词: 结核,淋巴结, 药物疗法,联合, 抗结核药, 中草药, 消瘰散结散

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

中图分类号:

R522
R283

王国卫, 梁亚充, 刘宇飞, 李翠乔, 何萍. 消瘰散结散联合常规抗结核药物治疗浸润型淋巴结结核的疗效观察[J]. 结核与肺部疾病杂志, 2023, 4(1): 60-65. doi: 10.19983/j.issn.2096-8493.20230014

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

图/表 3

表1

一般临床资料在两组淋巴结结核患者中的分布

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

表1

表2

不同中医证候积分在两组患者治疗前后的分布情况

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

表2

表3

两组患者治疗前后 CD3+、CD4+、CD8+水平及CD4/CD8比值情况

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

表3

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