Investigation and analysis of the current situation of the combined use of immunomodulatory drugs in children with immunodeficiency diseases in a certain hospital
某院儿童免疫缺陷疾病中免疫调节药物联用的现状调查分析

摘要

儿童免疫缺陷疾病是一类由先天性或获得性因素导致的免疫系统功能异常，临床表现为反复感染、自身免疫现象及生长发育迟缓，严重影响患儿生存质量。治疗核心在于免疫调节而非单纯免疫抑制，以避免过度干预带来的感染风险或长期药物毒性。在儿童免疫调节治疗策略中，中药复方制剂因其“多靶点、温和调节”的特性，逐渐成为辅助治疗的重要选择。复方参芪维E胶囊相较于西药免疫抑制剂（如糖皮质激素、环孢素等），该药在儿童用药安全性方面具有显著优势，动物毒理学研究显示其30倍临床剂量长期应用未见器官损伤（《中药新药药理毒理研究指导原则》），且适口性良好，有助于提高患儿依从性。目前，复方参芪维E胶囊在儿童免疫缺陷疾病中的联用模式尚缺乏系统性总结，超说明书用药的合法性及风险管控亦需规范。本文基于政策法规、药典标准及国家不良反应监测数据，对其药物特性、联用政策及临床应用现状进行综述，以期为儿科合理用药提供参考。

Abstract

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 children's 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.