Mechanistic and safety evaluation of standardized traditional chinese medicine formulations and their bioactive constituents in ICD-11-classified inflammatory skin diseases: A structured narrative review

Abstract

Background

Inflammatory skin diseases, under the International Classification of Diseases 11th Revision (ICD-11), such as atopic dermatitis, psoriasis, and contact dermatitis, are highly prevalent worldwide and are associated with dysregulation of the immune system, impaired epidermal barrier function, and oxidative stress. Existing therapies are imperfect, including being expensive and having long-term safety risks, so other multi-target treatment methods are needed.

Methods

The structured literature review was conducted using PubMed, Scopus, Web of Science, and Google Scholar, covering the period from January 2000 to March 2025. The systematic search strategy used predetermined keywords. The initial identification of 620 records was followed by the selection of 157 studies, which were screened by two independent researchers in line with the PRISMA selection principles.

Results

Multi-component, multi-target TCM preparations modulate inflammatory pathways (NF-κB, JAK-STAT, PI3K/Akt, MAPK), reduce pro-inflammatory cytokines, promote Th17/Th2 immunity, activate NRF2 and improve epidermal integrity through filaggrin upregulation. At the formulation level, activation of NF-κB/MAPK, STAT3/Th17 and Nrf2-mediated defense activity alleviates inflammation, oxidative stress and barrier dysfunction in ICD-11 disease phenotypes. Network pharmacology and multi-omics data show that formulation effects are synergistic and coordinated, indicating an integrative therapeutic effect.

Discussion

Standardized TCM formulations show promising mechanistic plausibility and generally favorable safety profiles in controlled experimental and preliminary clinical settings with quality control. However, lack of large-scale randomized controlled trials, inconsistent formulation standardization, and global regulatory heterogeneity leave significant translational gaps. These therapies can be used in clinical settings to treat mild-to-moderate inflammatory skin diseases. Translationally, chemical analysis, ICD-11 disease stratification, and biomarker-based therapy selection can generate a rational precision dermatology model that increases clinical predictability. Research should be focused on biomarker patient stratification, machine learning and precision dermatology module integration to increase clinical predictability and regulatory approval.