Effect of compound kushen injection on immune function in patients with lung cancer: a systematic review and meta-analysis

Abstrakt

Background Lung cancer remains a major global public health burden, characterized by high morbidity and mortality. The tumor immune microenvironment of lung cancer displays complex and dynamically changing immune landscapes, where diverse cell types collectively construct an immunosuppressive tumor ecosystem. Accordingly, boosting host immune function represents a promising therapeutic strategy to improve clinical outcomes and alleviate treatment-related adverse reactions in patients with lung cancer. Objective To systematically analyze the effects, efficacy, and safety of Compound Kushen Injection (CKI) combined with conventional treatment on improving immune function in lung cancer patients, providing evidence-based medical evidence for clinical practice. Methods A systematic search was conducted in major Chinese and English databases from their inception to 25 March 2026. Randomized controlled trials (RCTs) evaluating the impact of CKI on immune function in lung cancer patients were included. Quality assessment and data extraction were performed, and statistical analyses were conducted using Review Manager 5.4 and Stata 18.0 software. Results A total of 3846 patients from 39 RCTs were included (1971 in the experimental group and 1875 in the control group). Compared with conventional treatment alone, CKI combined with conventional treatment significantly enhanced immune function, as evidenced by increased levels of CD3 + , CD4 + , CD4 + /CD8 + ratio, and natural killer (NK) cells, and decreased levels of CD8 + cells. Additionally, this combination improved the objective response rate (ORR) and disease control rate (DCR), reduced carcinoembryonic antigen (CEA) levels, improved Karnofsky Performance Status (KPS) scores, prolonged 1-year overall survival, and effectively reduced treatment-related adverse reactions such as gastrointestinal reactions, myelosuppression, hepatorenal toxicity, and fatigue. Conclusion Current evidence indicates that CKI combined with conventional treatment provides multiple clinical benefits for lung cancer patients. However, the limited available evidence may compromise the reliability of our conclusions. Rigorously designed multicenter double-blind randomized controlled trials with staged analyses and long-term follow-up are needed to validate these findings. All findings should be interpreted as exploratory. Systematic Review Registration https://www.crd.york.ac.uk/PROSPERO/view/CRD420261384207 , identifier CRD420261384207.