Investigating the Clinical Efficacy of a self-formulated Jianpi Chuji Formula in Alleviating Toxic Side Effects Following Immune Checkpoint Inhibitor (ICI) Therapy in Advanced Non-Small Cell Lung Cancer Patients.

A total of 98 patients with advanced non-small cell lung cancer (NSCLC) who received immunotherapy (ICIs) at Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine in Hebei Province from May 2019 to May 2021 were enrolled as study subjects. They were randomly divided into a control group (n=49) and a treatment group (n = 49). The control group received immune checkpoint inhibitor therapy combined with a platinum-based dual-drug regimen. The treatment group received the same regimen supplemented with self-formulated Jianpi Chuji Formula. Changes in thyroid function indicators, Traditional Chinese Medicine (TCM) syndrome scores, Karnofsky Performance Status (KPS), carcinoembryonic antigen (CEA), cytokeratin 19 fragment (CYFRA21-1), adverse reaction incidence, and clinical efficacy were compared between the two groups.

Following treatment, both groups exhibited elevated levels of thyroid-stimulating hormone (TSH) and KPS scores. Symptoms including fatigue, skin keratosis, pain, limb numbness, sallow complexion, pulse, dark tongue, total score, total thyroxine (TT₄), free triiodothyronine (FT₃), free thyroxine (FT₄), CYFRA21-1, and CEA levels decreased in both groups, with greater improvement observed in the treatment group compared to the control group (P < 0. 01). There was no statistically significant difference in the incidence of adverse reactions between the two groups (P >0. 05). Compared to the control group, the treatment group demonstrated higher objective response rates (ORR) and disease control rates (DCR) (P <0. 01). Multivariate analysis showed that age and pathological type had no significant effect on treatment response (P >0. 05) ; After 6 months of follow-up, progression-free survival was better in the treatment group than that in the control group (P <0.05).

Treatment with self-formulated Jianpi Chuji Formula in non-small cell lung cancer patients following ICIs therapy demonstrated significant efficacy. This approach effectively improved patients' quality of life, reduced tumor marker levels, enhanced thyroid function, and decreased the incidence of toxic side effects.