基于病证结合模式的腰痛中成药临床综合评价主题遴选路径探析OA

Objective:To construct a topic selection pathway for the clinical comprehensive evaluation of Chinese patent medicines for low back pain based on the disease-syndrome combination model,thereby providing methodological support and practical guidance for topic selection and policy recommendations in such evaluations.Methods:Taking low back pain as the research focus,literature review,semi-structured interviews,brainstorming sessions and a modified Delphi study to systematically screen diseases and traditional Chinese medicine syndromes for evaluation.A five-dimen-sional index system-comprising necessity,importance,fea-sibility,social benefit and equity-was adopted for quantita-tive topic selection to determine priority diseases and core syndromes.Results:A total of 15 experts from 12 regions and various professional fields across China were invited.The expert response rate in the Delphi consultation was 100.0％,the expert authority coefficient was 0.950,and Kendall's coefficient of concordance(W)was statistically significant(P＜0.001).Seven core diseases were ultimately identified,and lumbar disc herniation(LDH)was selected as the priority dis-ease.Three core syndromes were selected:Qi stagnation and blood stasis syndrome,cold-dampness obstruction syndrome,and liver-kidney deficiency syndrome.A full-chain clinical evaluation system-comprising"topic selection","variety screening"and"stratified evaluation"-was established.Conclusion:Taking low back pain as a case study,this study established a disease-syndrome combination-based topic selection pathway.This pathway provides a standardized approach to topic selection for the clinical comprehensive evaluation of Chinese patent medicines for low back pain and other similar orthopedic chronic orthopedic conditions,thereby supporting rational clinical medication use and evidence-informed health decision-making.