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OA

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.