成都中医药大学学报2026，Vol.49Issue(4)：67-76,10.DOI:10.13593/j.cnki.51-1501/r.2026.04.011
艾灸与双氯芬酸钠凝胶治疗膝骨关节炎的即时效应和后效应:一项双盲双模拟随机对照试验
Immediate and Sustained Effects of Moxibustion Versus Diclofenac Sodium Gel for Knee Osteoarthritis:A Double-Blind,Double-Dummy Randomized Controlled Trial
摘要
Abstract
Objective:To evaluate the immediate and sustained effects of moxibustion versus diclofenac sodium gel(DSG)in the treatment of knee osteoarthritis(KOA),and to provide evidence-based support for moxibustion in KOA management.Methods:A multicenter,doub-le-blind,double-dummy,randomized controlled trial was conducted.A total of 139 KOA patients aged 40-75 years were randomly assigned 1∶1 to the moxibustion group or the DSG control group.All patients received 4 weeks of intervention and 8 weeks of follow-up.Moxibustion group:real moxibustion plus a placebo gel for external use;DSG control group:sham moxibustion plus active diclofenac sodium gel for exter-nal use.The primary outcome was the total score of the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC).The secondary outcomes included the Visual Analog Scale(VAS)and Patient Global Assessment(PGA).The efficacy,response rate,and safety were compared between the two groups.Treatment parameters were set as follows:Moxibustion was applied to Dubi(ST35),Neixiyan(EX-LE5),and Zusanli(ST36),with each moxa cone burning for 30 minutes per acupoint,administered three times a week on alternate days.A total of 4 g gel was applied topically to each affected knee three times daily.Results:At 2 and 4 weeks of treatment,the WOMAC and VAS scores of both groups decreased significantly,with no statistically significant differences between groups(P＞0.05),indicating comparable short-term immediate efficacy.At the 8-week follow-up,scores in both groups continued to decline;the DSG control group achieved better WOMAC scores than the moxibustion group(P＜0.05).At the 12-week follow-up,the proportion of patients with marked improvement in PGA was higher in the moxibustion group,though the difference between groups was not statistically significant(P＞0.05).Only mild local adverse reactions occurred in both groups,indicating good safety.Conclusion:Both moxibustion and DSG are safe and effective for KOA.Moxibustion yields short-term immediate efficacy comparable to DSG.It shows potential advantages in long-term patient global assessment with milder efficacy decline and more sustained late effects,and can be recommended as a preferred long-term non-pharmacological interven-tion for KOA.关键词
艾灸/膝骨关节炎/双氯芬酸钠凝胶/双盲/双模拟/随机对照试验/效应/后效应Key words
Moxibustion/Knee osteoarthritis/Diclofenac sodium gel/Double-blind/Double-dummy/Randomized controlled trial/Immedi-ate effect/Sustained effect分类
医药卫生引用本文复制引用
罗玲,周建英,陈薏凤,张彩荣,郭玲玲,韩晓霞,左甲,尹海燕,余曙光..艾灸与双氯芬酸钠凝胶治疗膝骨关节炎的即时效应和后效应:一项双盲双模拟随机对照试验[J].成都中医药大学学报,2026,49(4):67-76,10.基金项目
中医药高层次人才培育工程-四川省名中医罗玲传承工作室(600008241006) （600008241006）
