Effects of Kang'ai injection combined with chemotherapy on immune function in advanced non-small cell lung cancer: a meta-analysis.

[BACKGROUND] Systematically evaluate the effects of Kang'ai Injection (KAI) combined with platinum-based chemotherapy on immune function, clinical efficacy, and safety in patients with advanced non-small cell lung cancer.

[MATERIALS AND METHODS] Relevant literature published from the inception of each database through September 2025 will be identified through systematic searches of Chinese and English electronic databases. Randomized controlled trials (RCTs) evaluating Kang'ai injection combined with chemotherapy for advanced non-small cell lung cancer will be screened against predefined inclusion and exclusion criteria. Two investigators will independently perform data extraction and quality assessment. Meta-analyses will be conducted using RevMan 5.3 and Stata 18.0 software. Publication bias will be assessed using funnel plots and Egger's test, while the robustness of findings will be examined through trial sequential analysis (TSA). The quality of evidence for critical outcomes will be evaluated using the GRADE approach.

[RESULTS] A total of 14 randomized controlled trials involving 1,214 patients were included. The meta-analysis demonstrated that compared with chemotherapy alone, KAI combined with chemotherapy significantly improved the objective response rate and enhanced immune function parameters, including increased CD3 and CD4 T-cell counts, elevated CD4/CD8 ratio, and higher natural killer cell percentage, while reducing CD8 T-cell percentage. The combination therapy group also showed superior outcomes in reducing tumor marker and vascular endothelial growth factor levels compared to the chemotherapy-alone group. Furthermore, combination treatment significantly reduced the incidence of chemotherapy-related adverse reactions including leukopenia, myelosuppression, nausea and vomiting, and gastrointestinal reactions.

[CONCLUSION] As an adjunctive therapy, KAI can enhance immune function (low-quality evidence), improve the objective response rate to chemotherapy (moderate-quality evidence), and alleviate chemotherapy-related toxicities (predominantly moderate-quality evidence) in patients with advanced NSCLC, providing an evidence-based reference for comprehensive clinical management.

[SYSTEMATIC REVIEW REGISTRATION] https://www.crd.york.ac.uk/PROSPERO/view/CRD420251168090.