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.