三色膏治疗早中期原发性膝骨关节炎的临床研究

目的:观察三色膏外敷治疗早中期膝骨关节炎(KOA)的疗效,比较三色膏外敷与美洛昔康口服治疗早中期KOA的临床疗效差异。方法:纳入136例早中期KOA患者,随机分为治疗组和对照组,每组各68例。治疗组采用三色膏外敷治疗,对照组给予美洛昔康片口服,两组均治疗6周。分别于治疗前及治疗3周、6周、12周、24周时,评定患者的WOMAC(Western Ontario and Mc Master Universities Arthritis Index)量表评分、膝关节疼痛视觉模拟评分(visual analog score,VAS)、5次坐-立试验时间及健康调查简表(SF-36)评分;比较两组患者的临床疗效。结果:治疗后,两组患者的WOMAC各项评分、疼痛VAS评分均明显降低,SF-36量表评分明显升高,5次坐-立试验时间明显缩短,与治疗前比较差异均有统计学意义(P0.05,P0.01)。治疗3周、6周、12周、24周时,治疗组患者的WOMAC各项评分均低于对照组(P0.05,P0.01);治疗6周、12周、24周时,治疗组患者的VAS评分均低于对照组(P0.05),5次坐-立试验时间较对照组明显缩短(P0.05,P0.01),SF-36量表评分高于对照组(P0.05,P0.01)。治疗3周、6周、12周、24周时,治疗组的临床总有效率分别为71.21%、90.91%、80.30%、74.24%,对照组分别为61.76%、76.47%、72.06%、64.71%;各时间点的临床疗效比较,治疗组均优于对照组(P0.05)。结论:三色膏与美洛昔康治疗早中期KOA均有效,三色膏既可明显缓解患者的疼痛症状,又可改善其膝关节活动度,提高生活质量,在恢复膝关节的力学平衡方面疗效优于美洛昔康。

Clinical study on three-color paste in the treatment of primary knee osteoarthritis at early and middle stages

  Objective: To observe the effects of three-color paste in the treatment of knee osteoarthritis(KOA) at early and middle stages;and compare the clinical efficacy on KOA at early and middle stages between external application of three-color paste and oral administration of meloxicam.   Methods: 136 patients with knee osteoarthritis at the early and middle stages were selected and randomly divided into the treatment group and the control group,68 cases in each group. The patients in the treatment group were treated with three-color paste for external application and the patients in the control group were orally treated with meloxicam,with a course of 6 weeks. Before treatment and 3 weeks,6 weeks,12 weeks and 24 weeks after treatment,the Western Ontario and McMaster University Arthritis Index(WOMAC) score,visual analog scale(VAS) score for knee pain,5-time sit-to-stand test and the quality of life score(36-item short form health survey,SF-36) were evaluated,and the clinical effects of both groups were compared.   Results: After treatment,all items scores of WOMAC and the VAS score in both groups were obviously decreased,the SF-36 score was increased,and the time of 5-time sit-to-stand test was shortened,compared with before treatment there were statistically significant differences(P<0.05,P<0.01). Three weeks,6 weeks,12 weeks and 24 weeks after treatment,all items scores of WOMAC in the treatment group were lower than those in the control group(P<0.05,P<0.01);6 weeks,12 weeks and 24 weeks after treatment,the VAS scores in the treatment group were lower than those in the control group(P<0.05),the time of 5-time sit-to-stand test was shorter than that in the control group(P<0.05,P<0.01),and the SF-36 scores were higher than those in the control group(P<0.05,P<0.01). Three weeks,6 weeks,12 weeks and 24 weeks after treatment,the total clinical effective rates of the treatment group were 71.21%,90.91%,80.30% and 74.24% respectively,and the total clinical effective rates of the control group were 61.76%,76.47%,72.06% and 64.71% respectively;the effects of the treatment group were better than those of the control group at different time points(P<0.05).   Conclusion: Both three-color paste and meloxicam are effective in the treatment of KOA at the early and middle stages. The three-color paste can obviously relieve the pain,improve the knee motion range and enhance the quality of life for patients with KOA. The efficacy of three-color paste on recovering the mechanics balance of knee is better than that of meloxicam.