艾瑞昔布治疗膝骨关节炎的Ⅲ期多中心随机双盲临床试验

A Multicenter Double Blind and Randomized Controlled Phase Ⅲ Trial of Imrecoxib in the Treatment of Knee Osteoarthritis

目的评价艾瑞昔布治疗膝骨关节炎(osteoarthritis,OA)的疗效和安全性。方法采用多中心、随机、双盲、阳性药物平行对照研究。试验组口服艾瑞昔布100 mg,2次/d,对照组口服塞来昔布200 mg,1次/d,疗程8周。以平地行走疼痛、受试者疼痛疗效等指标改善程度为评价指标观察患者治疗前及服药后2、4、8周情况。同时在治疗前后对部分患者进行胃镜检查,观察药物不良事件。结果本研究共人组469例患者(试验组351例、对照组118例),461例(试验组344例、对照组117例)进入全分析集。治疗后2、4及8周,平地行走疼痛程度两组差异无统计学意义(P>0.05)。试验组治疗2、4和8周后平地行走疼痛程度评分下降值分别为(1.64±1.68)、(2.35±1.84)和(2.85±2.01),对照组分别为(1.34±1.41)、(2.01±1.71)和(2.55±2.01);试验组治疗2、4和8周后平地行走疼痛程度评分下降率分别为(29.27%±29.16%)、(41.79%±30.56%)和(50.45%±34.09%),对照组分别为(24.21%±26.13%)、(36.61%±30.89%)和(45.19%±34.50%);两组治疗后平地行走疼痛程度评分下降值和下降率较治疗前明显降低,差异均有统计学意义(P<0.000 1),组间比较差异无统计学意义(P>0.05)。治疗2、4及8周,两组显效率、有效率差异均无统计学意义(P>0.05)。采用考虑中心分层的CMH-x^2检验进行比较,试验组非劣于对照组。临床不良反应发生率试验组7.85%,对照组10.26%,两组间差异无统计学意义(P=0.443 0)。结论艾瑞昔布和塞来昔布均可有效、安全地治疗膝OA,艾瑞昔布的疗效不劣于塞来昔布,安全性相似,值得推广应用于膝OA治疗。

Objective To evaluate the efficacy and safety of imrecoxib in the treatment of knee osteoarthritis （OA）.Methods A multicenter,double-blind,randomized and controlled trial was designed.Patientswere divided into the trial group （Imrecoxib 100 mg bid）,and the control group（celecoxib 200mg qd）for 8 wk.The following parameters,including walking pain score,effective rate,etc,were used to assess the efficacy of inrecoxib.At the same time,some patients had the gastroscopy examinations.Results 469 patients were enrolled in the trial.FAS（full analysis set）analysis included 461 patients（344 of the trial group,117 of the control group）.There were no significant differences in walking pain scores in the 2nd, 4th and 8th week of treatment between the two groups （P 〉0.05）.The scores of walking pain decreased after treatment.The walking pain scores decreased after 2,4,and 8 weeks of therapy were （1.64 ±1.68）, （2.35 ±1.84）,and（2.85 ±2.01 ）respectively in the trial group;and were （1.34 ±1.41 ）,（2.01 ± 1.71）,and （2.55 ±2.01 ）respectively in the control group.The decreasing rates of walking pain scores after 2,4,and 8 weeks of therapy were （29.27% ±29.16%）,（41.79% ±30.56%）,and （50.45% ± 34.09%）respectively in the trial group;and were （24.21% ±26.13%）,（36.61% ±30.89%）,and （45.19% ±34.50%）respectively in the control group.There were significant differences in the decreasing of walking pain scores between different treatment time points in each group （P 〈0.0001 ）,but no significant differences at each treatment point between the two groups （P 〉0.05）.There were no significant differences in the effective rate and markedly effective rate between the two groups in the 2nd,4th and 8th week（P 〉0.05）.Center stratification CMH-χ2 test showed that the trial group was not inferior to the control group.There were no significant differences in adverse reactions between trial group （7.85%）and control group（10.26%）.Conclusions Imrecoxib and celecoxib are effective and safe in the treatment of OA.It is worth to be recommended to be used in the treatment of knee OA.