International Journal of Clinical Research

Pediatric immunodeficiency diseases are a group of immune system disorders caused by congenital or acquired factors, clinically manifested as recurrent infections, autoimmune phenomena, and growth retardation, significantly compromising childrens quality of life. The therapeutic focus lies in immunomodulation rather than pure immunosuppression to avoid excessive intervention that may lead to infection risks or long-term drug toxicity. In pediatric immunomodulatory treatment strategies, traditional Chinese medicine (TCM) compound preparations have emerged as important adjuvant therapies due to their "multi-target, mild regulatory" characteristics. Compound Ginseng/Astragalus/VitaminE Capsule, compared to Western immunosuppressants (e.g., glucocorticoids, cyclosporine), this preparation demonstrates notable safety advantages in pediatric use. Animal toxicology studies have shown no organ damage even at 30 times the clinical dose (*Guidelines for Pharmacological and Toxicological Research of New TCM Drugs*), while its palatability enhances treatment compliance in children. Currently, there remains a lack of systematic summarization regarding the combination patterns of Compound Ginseng/Astragalus/VitaminE Capsule in pediatric immunodeficiency diseases, and the legal status and risk management of off-label use require standardization. This review synthesizes its pharmacological characteristics, combination policies, and clinical application status based on regulatory policies, pharmacopoeia standards, and national adverse drug reaction monitoring data, aiming to provide references for rational pediatric medication use.

Compound Ginseng/Astragalus/VitaminE Capsule; Childhood immunodeficiency diseases; Immunoregulation