外用洛索洛芬钠治疗慢性腰背痛有效性与安全性的多中心随机对照临床研究

A multicentre randomized controlled clinical study on the efficacy and safety of topical loxoprofen sodium in the treatment of chronic low back pain

目的:评价外用洛索洛芬钠治疗慢性腰背痛的有效性与安全性。方法:采取多中心、随机、开放性平行对照的方法选择近年来三个中心的240例慢性腰背痛患者作为研究对象。随机将其分为A组、B组和C组。对三组患者均进行常规康复治疗+核心稳定性训练,在此基础上分别采用安慰剂、洛索洛芬钠凝胶膏、氟比洛芬酯凝胶膏对A组、B组、C组患者进行治疗,然后比较其疗效及各项临床指标。结果:B组患者与C组患者治疗的总有效率均高于A组患者,P<0.05。B组患者与C组患者治疗的总有效率相比,P>0.05。治疗后,B组患者与C组患者视觉模拟评分法的评分、Oswestry功能障碍指数问卷表(0DI)的评分和竖脊肌中位频率(MF)均低于A组患者,其竖脊肌平均肌电值均高于A组患者,P<0.05。B组患者的ODI评分和竖脊肌MF均低于C组患者,P<0.05。用药后,三组患者不良反应的发生率相比,P>0.05。结论:在对慢性腰背痛患者进行常规康复治疗及核心稳定性训练的基础上,外用洛索洛芬钠进行治疗能显著减轻其腰背部疼痛的程度及功能障碍,且用药较为安全。

Objective:To evaluate the efficacy and safety of topical loxoprofen sodium in the treatment of chronic low back pain.Methods:A multi-center,randomized and open parallel control method was adopted to select 240 patients with chronic low back pain from three centers in recent years as the research object.They were randomly divided into groups A,B,and C.All patients in the three groups were treated with routine rehabilitation therapy+core stability training.On this basis,patients in group A,group B and group C were treated with placebo,loxoprofen sodium gel ointment and flurbiprofen ester gel ointment,and then the efficacy and various clinical indicators were compared.Results:The total effective rate of group B and group C was higher than group A(P<0.05).The total effective rate of patients in group B and group C was P>0.05.After treatment,the visual analogue scale score,Oswestry Disability Index(ODI)score and median frequency(MF)of the erector spinal muscle in group B and group C were lower than those in group A,and the mean EMG of the erector spinal muscle were higher than those in group A(P<0.05).ODI score and erector spinal muscle MF in group B were lower than those in group C(P<0.05).After medication,the incidence of ADR in three groups was compared with P>0.05.CONCLUSIONS:Based on routine rehabilitation therapy and core stability training for patients with chronic low back pain,topical loxoprofen sodium can significantly reduce the severity and dysfunction of low back pain and is relatively safe to use.