虎力散胶囊外敷治疗膝骨关节炎的有效性与安全性研究

Efficacy and safety of external application of Hulisan capsule for knee osteoarthritis

目的评价虎力散外用治疗膝骨关节炎(OA)的有效性和安全性。方法研究采用多中心合作,随机对照的方法将500例诊断为膝OA的患者分为两组。试验组350例,采用中药虎力散胶囊外敷,Qd;对照组150例,采用双氯芬酸二乙胺乳胶剂外用,Tid;这些患者连续用药14 d,观察两组患者的疗效和不良反应。结果共有442例患者完成了试验,其中试验组306例,对照组136例。(1)治疗14 d后,两组患者VAS疼痛评分和关节功能评分较治疗前均有明显改善(P<0.01);(2)虎力散外敷组在降低VAS疼痛评分和改善关节功能评分方面显著优于双氯芬酸二乙胺乳胶剂组(P<0.01);(3)出现的可能与试验药物相关的不良事件的比例在虎力散组和对照组分别为1.63%和0.74%,主要为皮肤过敏,停药后均能消失,不良反应发生率两组之间无统计学差异(P>0.05)。结论虎力散胶囊外敷治疗膝关节OA,可使关节疼痛症状在2周内消失或好转,并在一定程度上改善关节功能,不良反应少,安全性好。

Objective To evaluate the efficacy and safety of the external application of traditional Chinese medicine Hulisan capsule for the treatment of knee osteoarthritis ( OA ) . Methods A randomized, positive-controlled and multi-center clinical trial was carried out.Five-hundred patients with knee OA were recruited and randomly divided into two groups:the treatment group and the control group. Each patient of the treatment group ( n=350 ) was given eight Hulisan capsules for external application once a day, while the patients of the control group ( n=150) adopted diclofenac emulsion three times per day.Both the groups were treated for 14 days.The changes of symptoms and signs before and after the treatment and the incidence of adverse events were observed.Results A total of 442 patients completed the trial.After 14 days treatment, the visual analog scale (VAS) pain score and the joint function score of the two groups were significantly improved ( P<0.01 ) compared with those before the treatment; but the VAS score and the joint function score were improved better in the treatment group than in the control group (P<0.01).The incidences of related side effects (mainly as skin allergies) of the Hulisan capsule and the diclofenac emulsions were 1.63% and 0.74% respectively, and no statistical difference between the two groups ( P>0.05) .Conclusion External application of Hulisan capsule can significantly reduce the joint pain and improve joint function within two weeks with a good safety profile of low incidence of adverse reaction.