Objective:

To elucidate the synergistic mechanism of the 'Two flowers therapy' — a Behçet’s disease treatment regimen using Total Glucosides of Paeony (TGP) and colchicine, which has been used in China for over 30 years — and its efficacy and safety in BD with mucocutaneous involvement.

Approach:

• Study Design: A retrospective clinical cohort study integrated with computational biology was performed.
• Patient Groups: 355 BD patients were divided into combination group (CG, n=231) and monotherapy group (MG, n=124).
• Bioactive Components: Five bioactive components were chosen: four from TGP and one from colchicine.
• Target Identification: 31 overlapping BD-related targets were identified via multi-omics.
• Core Genes: 6 core genes were confirmed through analysis.
• Clinical Outcomes: Efficacy was assessed through ulcer prevalence and ESR measurements.

Key Findings:

• Four active components of TGP and colchicine formed five bioactive compounds.
• 31 overlapping BD-related targets were identified, leading to the construction of a PPI network.
• Core targets identified included MMP9, ICAM1, FGF2, TLR4, EGFR, NOS3.
• Combination group showed superior early efficacy in controlling mucocutaneous lesions, with oral ulcer prevalence of 0.0% vs. 21.0% (M1) and 0.0% vs. 100.0% (M2).
• No drug-associated cytopenia was reported in either group.

Interpretation:

TGP combined with colchicine exerts therapeutic effects on BD by regulating core targets and inflammatory pathways.

Limitations:

• The study is retrospective and may be subject to biases, including selection bias and recall bias.
• Long-term effects beyond the study duration were not assessed.

Conclusion:

The dual-drug regimen effectively controls early mucocutaneous lesion recurrence in BD patients.