中国骨伤2026，Vol.39Issue(4)：336-342,7.DOI:10.12200/j.issn.1003-0034.20250486
肿意膏治疗伴有中重度疼痛K-L分级Ⅱ级膝骨关节炎的临床对照研究
Clinical controlled study of Zhongyi Ointment(肿意膏)in the treatment of Kellgren-Lawrence grade Ⅱ knee os-teoarthritis with moderate-to-severe pain
摘要
Abstract
Objective To evaluate the clinical efficacy and safety of Zhongyi Ointment(肿意膏)in the treatment of Kellgren-Lawrence grade(K-L)Ⅱ knee osteoarthritis with moderate-to-severe pain.Methods This study adopted a prospective,random-ized,double-blind,placebo-controlled design.Patients were recruited from November 2022 to October 2023.A total of 80 par-ticipants meeting the diagnostic criteria for K-L grade Ⅱ knee osteoarthritis at the acute exacerbation stage were enrolled and randomly assigned to the Zhongyi Ointment(肿意膏)group or the placebo group,with a uniform treatment course of 6 days.Two patients were lost to follow-up in the Zhongyi Ointment(肿意膏)group and three in the placebo group,resulting in a final sample of 75 patients included in the statistical analysis.The Zhongyi Ointment(肿意膏)group comprised 38 patients(15 males,23 females)aged from 55 to 80 years(70.97±5.05)years.The placebo group included 37 patients(12 males,25 fe-males)aged from 52 to 79 years(68.70±6.11)years.The primary outcome measures were the Western Ontario and McMaster Universities osteoarthritis index(WOMAC)scores,knee joint range of motion,and the occurrence of adverse events before and after treatment.Results On day 6 of treatment,the total WOMAC score in the Zhongyi Ointment(肿意膏)group decreased from(109.79±1 1.32)scores at baseline to(44.92±14.84)scores(P＜0.001),which was significantly lower than(56.78±9.33)scores in the placebo group(P＜0.001).Improvements in all WOMAC subscales(pain,stiffness,physical function)in the Zhongyi Ointment(肿意膏)group were superior to those in the placebo group(all P＜0.05),with more rapid symptom relief in the first 3 days.The knee joint range of motion in the Zhongyi Ointment(肿意膏)group was(127.21±15.87)°which was sig-nificantly higher than(117.11±13.44)° in the placebo group(P=0.028).No serious adverse events occurred in either group.Conclusion Zhongyi Ointment(肿意膏)can rapidly and significantly improve symptoms in patients with K-L grade Ⅱ knee os-teoarthritis with moderate-to-severe pain during the acute exacerbation stage,with definite short-term efficacy and favorable safety.Continuous treatment helps to consolidate the therapeutic effect and warrants further validation through multicenter studies with large sample sizes,as well as investigations into the underlying mechanisms.关键词
肿意膏/膝骨关节炎/中药软膏/中西医结合Key words
Zhongyi Ointment(肿意膏)/Knee osteoarthritis/Chinese herbal ointment/Intrgrative medicine分类
医药卫生引用本文复制引用
余柯晓,李传鸿,何震,何远航,金阳,邹瑜,卢卫忠,冉金伟..肿意膏治疗伴有中重度疼痛K-L分级Ⅱ级膝骨关节炎的临床对照研究[J].中国骨伤,2026,39(4):336-342,7.基金项目
重庆市中医名科中医重点专科建设项目(编号:渝中医[2022]4号) （编号:渝中医[2022]4号）
重庆市科卫联合医学创新科研项目(No.2022QNXM066) （No.2022QNXM066）
重庆市中青年医学高端人才项目(渝卫人[2023]10号) （渝卫人[2023]10号）
重庆市中医院青年拔尖人才项目(No.CQSZYY2020008)Chongqing Municipal Construction Project for Prestigious TCM Key Specialties(No.Chongqing TCM[2022]No.4) （No.CQSZYY2020008）
