外用洛索洛芬钠治疗人工全膝关节置换术后肢体肿胀效果的多中心Ⅳ期随机对照临床研究

A multicentre phase Ⅳ randomized controlled clinical study of loxoprofen sodium for topical treatment of limb swelling after total knee arthroplasty

目的:研究对接受人工全膝关节置换术后发生肢体肿胀的终末期膝关节骨性关节炎患者外用洛索洛芬钠凝胶膏进行治疗的有效性与安全性。方法:选取近年来在三个中心进行人工全膝关节置换术后发生肢体肿胀的90例终末期膝关节骨性关节炎患者作为研究对象。按照随机数表法将其分为观察组与对照组。术后为观察组患者外用洛索洛芬钠凝胶膏进行治疗,为对照组患者外用安慰剂凝胶贴膏进行治疗,然后比较两组患者的各项临床指标。结果:术后2 W和术后3 W,观察组患者患肢的肿胀值均小于对照组患者,其患膝活动时视觉模拟评分法(Visual analogue sca1es,VAS)的评分均低于对照组患者,其患膝的关节活动度(Range of motion,ROM)均大于对照组患者,P< 0.05。用药后,两组患者不良反应的发生率相比,P>0.05。结论:对接受人工全膝关节置换术后发生肢体肿胀的终末期膝关节骨性关节炎患者外用洛索洛芬钠凝胶膏进行治疗的效果显著,能有效地缓解其肢体肿胀的症状,减轻其患膝活动时的疼痛感,提高其患膝的ROM。

Objective:To investigate the efficacy and safety of topical loxoprofen sodium gel in the treatment of end-stage knee osteoarthritis patients with limb swelling after total knee arthroplasty.Methods:90 patients with end-stage knee osteoarthritis who developed limb swelling after total knee arthroplasty in three centers in recent years were selected as subjects.They were divided into observation group and control group according to random number table method.After surgery,the observation group was treated with loxoprofen sodium gel plaster,and the control group was treated with placebo gel plaster.Then,the clinical indexes of the two groups were compared.Results:Both 2 and 3 weeks after surgery,the swelling values of the affected limbs in the observation group were lower than those in the control group,the Visual analogue scales(VAS)scores of the affected knees were lower than those in the control group,and the Range of motion(Range of motion)of the affected knees was significantly higher than that in the control group.ROM was higher than control group(P<0.05).After medication,the incidence of ADR in 2 groups was compared with P>0.05.Conclusion:Topical application of loxoprofen sodium gel in the treatment of end-stage knee osteoarthritis patients with limb swelling after total knee arthroplasty has a significant effect,which can effectively relieve the symptoms of limb swelling,relieve the pain of the affected knee movement,and improve the ROM of the affected knee.