尪痹片治疗膝骨关节炎的临床研究

Clinical Study on the Treatment of Knee Osteoarthritis by Wangbi Tablet

目的观察尪痹片治疗膝骨关节炎的临床疗效,探讨中西医结合治疗膝骨关节炎的治疗方案。方法采用随机、平行对照、多中心临床治疗观察方法将中医辨证为肝肾两虚合并瘀血痹阻证160例膝骨关节炎患者分为尪痹片治疗组(A组,72例)、扶他林治疗组(B组,42例)、尪痹片加扶他林治疗组(C组,46例)。3组分别采用尪痹片、扶他林片、尪痹片加扶他林片治疗两个月。观察记录各组治疗前后临床症状、膝关节功能活动及不良反应情况,并检测各组患者治疗前后血沉(ESR)、C反应蛋白(CRP)指标,进行统计分析比较。结果经临床治疗8周后,3组患者关节晨僵时间、关节压痛、肿胀、疼痛、关节功能活动及ESR、CRP与治疗前比较,均有明显改善(P<0.01),且C组改善明显优于A、B组(P<0.01);ESR、CRPA、B组比较,差异亦有统计学意义(P<0.01);3组显效率比较,C组明显优于A、B组(P<0.05)。结论尪痹片治疗膝骨关节炎临床效果良好,无明显的不良反应;尪痹片配合扶他林片治疗膝关节炎临床疗效明显优于单用尪痹片或扶他林片,两药联合使用可减少扶他林的应用剂量及避免胃肠道不良反应。

Objective To observe the clinical efficacy of Wangbi Tablet（WT） on the treatment of knee osteoarthritis（KOA）,and to study its treatment program by integrative medicine.Methods The randomized,parallel control,and multi-center clinical observation method was used.160 KOA patients of Gan-Shen deficiency complicated with stasis-blood blockade syndrome were assigned to three groups.Group A（72 cases） was treated by WT,Group B（42 cases） was treated by Votalin Tablet,and Group C（46 cases） was treated by WT＋Votalin Tablet.All patients were treated for two months.Before and after treatment the clinical symptoms,the knee function activity,adverse reactions were observed and recorded.Erythrocyte sedimentation rate（ESR） and C-reactive protein（CRP） of each patient were respectively detected,statistically analyzed and compared.Results After eight weeks of treatment significant difference was shown in the time of morning stiffness in joints,joint tenderness,swelling,pain,joint functional activities,ESR,and CRP between Group A and Group B（P0.01）.Besides,better effects were obtained in Group C（P0.01）.Improvement of ESR and CRP：They were obviously improved in the three groups after treatment（P0.01）.As for the markedly effective rate,better effects were obtained in Group C（P0.05）.Conclusions In the treatment of KOA,WT showed favorable effects with no obvious adverse reaction.The combination of WT and Voltaren Tablet was significantly superior to use of WT or Votalin Tablet alone.It could reduce the dosage of Voltaren Tablet and avoid adverse reactions of the gastrointestinal tract.