Abstract:【】 Objective To investigate the effects of levothyroxine sodium combined with Qingkailing granules on serum monocyte chemoattractant protein-1 (MCP-1), the Th17/Treg axis, and autoantibody levels in patients with Hashimoto"s thyroiditis (HT) and subclinical hypothyroidism (SCH). Methods A total of 125 patients with HT and SCH admitted to our hospital between December 2023 and December 2024 were selected for the study. According to a randomized grouping method, the patients were divided into two groups: an observation group (62 cases) and a control group (63 cases). The control group was treated with levothyroxine sodium, while the observation group received additional Qingkailing granules on top of the control group"s treatment. The clinical efficacy, total traditional Chinese medicine (TCM) syndrome score, thyroid hormone levels, thyroid autoantibody indicators, serum MCP-1, Th17/Treg axis, thyroid size, indicators of thyroid disease symptom clusters and adverse reactions were compared between the two groups. Results Compared with the control group, the overall effectiveness rate of the observation group was significantly higher (P<0.05). Following treatment, the observation group demonstrated a significantly lower total TCM syndrome score compared to the control group (P<0.05). Regarding thyroid function, the observation group exhibited lower TSH but higher FT3 and FT4 levels (P<0.05). Additionally, their TPOAb and TGAb levels were also significantly reduced (P<0.05). The MCP-1 level, Th17 cell count, Th17/Treg ratio, and IL-17 level in the observation group were lower than those in the control group, while the Treg cell count and IL-10 level were higher (P<0.05). The right lobe thickness, left lobe thickness, and isthmus thickness of the observation group were smaller than those of the control group (P<0.05). The observation group demonstrated significantly lower scores in HAMA, HAMD, PSQI, and FSS compared to the control group(P<0.05). There was no statistically significant difference in the incidence of adverse reactions between the two groups (P>0.05). Conclusion Levothyroxine sodium combined with Qingkailing granules has a significant effect in treating patients with HT and SCH, improving TCM syndrome scores, thyroid function, and reducing thyroid enlargement. The mechanism may be related to the regulation of immune-inflammatory responses via the Th17/Treg axis.