"6+1 Dimension"Clinical Comprehensive Evaluation of Hulisan Capsule in Treatment of Knee Osteoarthritis with Wind-Cold-Dampness Obstruction Syndrome

XU Xiaohan; HUANG Yanli; CUI Xin; LIU Hongxiao; XIE Yanming

doi:10.3969/j.issn.1006-3250.2026.02.026

Abstract：Objective This study aims to systematically sort out and scientifically evaluate the comprehensive clinical value of Hulisan capsule in the treatment of knee osteoarthritis of wind-cold-dampness obstruction syndrome,so as to provide valuable data and clues for national medical policy formulation,pharmaceutical market promotion,pharmacy administration services,as well as clinical and basic medical research.Methods Based on the multi-criteria decision analysis model(MCDA),and by using the Chinese Patent Medicine Clinical Evidence and Value Evaluation Software CSC v2.0,a combined comprehensive clinical evaluation of Hulisan capsule was conducted from six dimensions of effectiveness,safety,economy,innovation,suitability,accessibility and characteristics of traditional Chinese medicine in accordance with the"6+1"evaluation framework.Results In terms of safety and effectiveness,Hulisan capsule was associated with mild adverse drug reactions(ADR),with rare severe ADRs,indicating good safety.Combination therapy with Hulisan capsule and Western medicine showed superior outcomes to monotherapy with Western medicine in terms of the Visual Analogue Scale(VAS)score,Lysholm Knee Function Scale score,and overall clinical effective rate.Regarding economy,incremental effectiveness analysis demonstrated that the treatment cost of Hulisan capsule was acceptable,reflecting favorable economic efficiency.The product exhibited high innovation in terms of dosage form and preparation technology.Hulisan capsule required no special technical or management requirements,featured simple drug supply,storage and transportation,and had a reasonable price,with high coverage and availability rates in hospitals at all levels,thus showing good suitability and accessibility.As a traditional Yi ethnic medicine,Hulisan capsule had an elaborate formulation with a small number of medicinal ingredients but significant efficacy,and was supported by abundant real-world studies,representing distinct TCM characteristics.Conclusion Based on the evidence from the"6+1"evaluation dimensions,Hulisan capsule obtain a favorable clinical value assessment.It is recommended that Hulisan capsule be conditionally included in the consideration scope of essential clinical medication management policies in accordance with standardized procedures,so as to form relevant policy outcomes.