Benefit-Risk Assessment of Tripterygium Glycosides Tablets in the Treatment of Rheumatoid Arthritis Based on an MCDA and Zebrafish Model

doi:10.19803/j.1672-8629.20250864

Abstract

Abstract: Objective To quantitatively evaluate the benefits and risks of Tripterygium Glycosides tablets (TGT) in the treatment of rheumatoid arthritis (RA) and to explore optimized medications. Methods A multi-criteria decision analysis (MCDA) model was used for a quantitative benefit-risk assessment (BRA) of the included randomized controlled trials (RCTs) before the effects of varied medication conditions on the overall benefit-risk profiles of TGT were simulated. Using zebrafish as an in vivo model, the response surface methodology (RSM) was employed to analyze the interactions of dosage, exposure durations, and combination therapies with drug-related risks. The parameter with the lowest toxicity was screened. Results A total of 60 RCTs were included in the analysis. MCDA results suggested that the therapeutic benefits of TGT against RA outweighed risks. The results of BRAs were the best when the prescribed dosage ranged from 60 to 90 mg·d^-1, the course of treatment was short (less than 2 months), and TGTs were combined with methotrexate (MTX). Zebrafish-based RSM analysis revealed that a triptolide concentration of 48.91 mg·L^-1, an exposure duration of 48.39 hours, and an MTX concentration of 109.35 μmol·L^-1 yielded a predicted SV-BA distance that was the closest to the reference value 1, indicating the minimal toxicity expressions.This optimal parameter set provided evidence for the clinically BRA derived strategies. Conclusion By combining clinical evaluation with biological experiments, this study has quantitatively identified “the prescribed dose, a short course of treatment, and combination with MTX” as the optimized usage of TGT against RA.

Key words: Tripterygium Glycosides Tablets, Rheumatoid Arthritis, Benefit-Risk Assessment, Multi-Criteria Decision Analysis, Zebrafish, Response Surface Methodology

CLC Number:

ZHANG Xiaomeng, YUAN Yueying, JI Yuxin, ZHAO Xuejing, LIN Zhijian, ZHANG Bing. Benefit-Risk Assessment of Tripterygium Glycosides Tablets in the Treatment of Rheumatoid Arthritis Based on an MCDA and Zebrafish Model[J]. Chinese Journal of Pharmacovigilance, 2026, 23(1): 19-25.

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