洛索洛芬钠贴剂治疗外伤导致肿胀疼痛的随机双盲双模拟临床试验

A randomized,controlled,double-blind,double-dummy,parallel-group,non-inferiority clinical study of loxoprofen sodium hydrogel patch versus loxoprofen tablet in treating swelling and pain caused by trauma

目的:评价洛索洛芬钠贴剂治疗外伤导致肿胀、疼痛的有效性和安全性。方法:采用多中心、随机、双盲、双模拟、平行组对照研究。共入组外伤后肿胀或疼痛患者162例,其中试验组80例,采用洛索洛芬钠贴剂qd,1次1贴(100 mg)贴敷于患处同时口服洛索洛芬钠片安慰剂1次1片,tid;对照组82例,采用洛索洛芬钠贴剂安慰剂1次1贴(qd)贴敷于患处+口服洛索洛芬钠片剂1次1片(60 mg) tid。两组疗程均为7 d。主要评价指标为用药终点时全分析集的整体改善度和总有效率,其他评价指标包括疼痛、肿胀等单项症状改善度和有效率、患者自我评价和不良反应情况。结果:治疗7 d后,试验组和对照组的总有效率分别为91. 3%和89. 0%,两组比较无统计学差异(P=0. 617),两组有效率的差值(试验组-对照组)及其95%可信区间为2. 2%(-6. 9%～11. 4%),结果提示试验组疗效不劣于对照组。疼痛(静止痛、压痛和运动痛)、炎症症状(肿胀、局部烧灼感)、运动受限等单项症状的有效率两组间没有差异。试验组与对照组的不良反应发生率分别为8. 8%和12. 2%,两组间比较差异无统计学意义(P=0. 47),两组均没有严重不良反应发生。结论:洛索洛芬钠贴剂治疗外伤导致的肿胀或疼痛的有效性和安全性不劣于洛索洛芬钠片剂。

Objective:The goal of this study was to evaluate the efficacy and safety of loxoprofen sodium hydrogel patch (LOX-P)compared to loxoprofen sodium tablet (LOX-T)in the treatment of swelling and pain caused by trauma.Methods:In this randomized,controlled,multicenter,parallel-group,double-blind,doubledummy,non-inferiority clinical study,162patients were enrolled with swelling and pain caused by trauma.Patients were randomly assigned in a 1:1ratio to receive LOX-P (100mg)plus tablet placebo or LOX-T (60mg) plus patch placebo for 7days.The primary efficacy endpoint was overall improvement rate and total effective rate at final visit using full analysis set.Other evaluation indexes included single symptom improvement,such as pain and swelling,and self-evaluation and adverse reactions in patients.Results :Average improvement rate at final visit was 91.3%in the LOX-P group (n =80)and 89.0%in the LOX-T group (n =82),and there was no statistical difference between the two groups (P =0.617).It indicated that LOX-P was non-inferior to LOX-T (the difference between both groups:2.2%,95%CI -6.9%to 11.4%).There was no significant difference in the improvement rates of clinical symptoms,including pain (pain at rest,tenderness,kinesalgia),inflammatory symptoms (swelling,local burning sensation),and limited movement respectively between two groups.There were a lower incidences of adverse events (AE)in the LOX-P group than in the LOX-T group,but not significant difference (8.8%vs 12.2%,P =0.47).No serious AEs were reported during the study.Conclusions:This study demonstrated non-inferiority of LOX-P to LOX-T in reducing swelling and pain caused by trauma.