| Objective: This study aims to investigate the combined use of the modified "Wenfei Huayin Tongluo Chubi Decoction" with(ILD)glucocorticoids in the treatment of advanced lung cancer-related interstitial lung diseases through both clinical trials and basic experiments.The aim is to explore the clinical efficacy and therapeutic mechanisms of the Chinese herbal formula in treating pulmonary obstruction(syndromes of lung cold and phlegm stagnation,as well as lung collaterals obstruction),with the objective of identifying a more effective adjunctive therapeutic approach,and investigating biomarkers associated with treatment efficacy.This study seeks to deepen the understanding of novel therapeutic approaches for interstitial lung diseases and the role of related biomarkers in assessing treatment outcomes.Methods: In terms of clinical trials,patients from the Department of Thoracic Oncology at Jilin Cancer Hospital were selected as the study population.Between November 2021 and December 2023,a total of 72 patients with traditional Chinese medicine syndrome differentiation classified as lung cold and phlegm stagnation or lung collateral obstruction were screened based on strict inclusion criteria,including both outpatients and inpatients from the treatment area.According to the principle of random allocation,these patients were divided into two groups: the treatment group and the control group,with 36 cases in each group.The treatment group received the modified "Wenfei Huayin Tongluo Chubi Decoction" combined with glucocorticoids therapy,while the control group received glucocorticoids therapy alone.Both groups of patients underwent a 6-week treatment period followed by efficacy assessment.Outcome measures included interstitial lung disease regression rate,interstitial lung disease clinical assessment questionnaire scores,interstitial lung disease physiology scores,traditional Chinese medicine clinical symptom scores,Karnofsky Performance Status(KPS)scores,and modified Medical Research Council(m MRC)dyspnea scale scores,as well as efficacy assessments for interstitial lung disease grading,traditional Chinese medicine syndrome differentiation,and KPS functional status.In terms of basic experiments,blood specimens were collected from both groups of patients before and after treatment to determine the levels of Krebs von den Lungen-6(KL-6)and C-reactive protein(CRP)biomarkers in the blood specimens of patients with advanced lung cancer-related interstitial lung disease(ILD),and changes before and after treatment were observed.Results: In terms of clinical trials,at baseline,the two groups of patients exhibited similar baseline levels(P>0.05),indicating comparability.However,post-treatment,the treatment group demonstrated significant improvements over the control group in interstitial pneumonia grading,interstitial lung disease symptom assessment questionnaires(including symptoms such as dyspnea,cough,sputum,rales,and cyanosis),interstitial lung disease physiology scores,traditional Chinese medicine clinical symptom scores(such as cough,sputum,dyspnea,aversion to cold,cold limbs,and cyanosis of the lips),KPS scores,and m MRC scores(P<0.05).Additionally,the treatment group exhibited significantly higher effectiveness rates than the control group in terms of interstitial pneumonia grading efficacy,traditional Chinese medicine syndrome efficacy,and KPS score efficacy(P<0.05).It is noteworthy that in the subgroup analysis,the clinical efficacy of the treatment group in the ICI subgroup was significantly higher than that of the control group(P<0.05).In terms of basic experiments,at baseline,the two groups of patients exhibited similar baseline levels(P>0.05),indicating comparability.However,post-treatment,the treatment group showed significantly lower levels of KL-6 and CRP compared to the control group(P<0.05).Conclusion: The modified "Wenfei Huayin Tongluo Chubi Decoction" combined with glucocorticoids demonstrates favorable clinical efficacy in the treatment of advanced lung cancer-related interstitial lung disease.It significantly improves patients’ pulmonary inflammatory status and clinical symptoms,enhances lung function,and concurrently reduces serum biomarker levels of KL-6 and CRP.No significant adverse effects were observed,and patients exhibited good tolerance.These results are of significant importance for assessing disease severity,predicting disease progression,and guiding clinical practice. |