基于《备急千金要方》辛味药"辛能行散"理论透皮给药治疗膝骨关节炎寒湿痹阻证临床观察OA

Objective To investigate the clinical efficacy of transdermal delivery of pungent herbs for knee osteoarthritis(KOA)with cold-dampness bi syndrome based on the theory of pungent flavor promoting movement and dissipation in Beiji Qianjin Yaofang(Essential Prescriptions Worth a Thousand in Gold for Every Emergency).Methods A total of 128 patients with KOA admitted from September 2021 to September 2024 were selected and divided into Western medicine group and pungent herbs group using random number table,with 64 patients in each group.The Western medicine group received conventional Western medicine treatment,while the pungent herbs group received transdermal delivery of pungent herbs based on the theory of pungent flavor promoting movement and dissipation in Beiji Qianjin Yaofang on the basis of the Western medicine group.The clinical efficacy,traditional Chinese medicine(TCM)syndrome score,knee joint pain degree[visual analogue scale(VAS)],disease severity[Western Ontario and McMaster University Osteoarthritis Index(WOMAC)],inflammatory factor levels[interleukin-6(IL-6),tumor necrosis factor-α(TNF-α),prostaglandin E2(PGE2)],disease-related indicators[relative expression of Toll-like receptor-4(TLR-4),myeloid differentiation factor 88(MyD88)mRNA],safety and recurrence rate were compared between the two groups.Results The total effective rate in the pungent herbs group was[95.31％(61/64)],which was higher than that in the Western medicine group[84.38％(54/64)](P＜0.05).After treatment,the various TCM syndrome scores and total scores,WOMAC and VAS scores in the pungent herbs group were lower than those in the Western medicine group(P＜0.01).After treatment,the relative expression levels of TNF-α,PGE2,IL-6,TLR-4 and MyD88 mRNA in the pungent herbs group were lower than those in the Western medicine group(P＜0.01).There was no significant difference in the incidence of adverse reactions between groups(P＞0.05).At 3 and 6 months after treatment,the recurrence rate in the pungent herbs group[1.64％(1/61),3.45％(2/58)]was lower than that in the Western medicine group[12.96％(7/54),18.18％(8/44)](P＜0.01).Conclusion Transdermal delivery of pungent herbs for KOA with cold-dampness bi syndrome based on the theory of pungent flavor promoting movement and dissipation in Beiji Qianjin Yaofang has a significant efficacy,which can reduce knee pain,improve clinical symptoms,regulate TLR-4/MyD88 signaling pathway,inhibit inflammatory response,reduce the risk of recurrence,and has high safety.