洛索洛芬与罗非昔布对照治疗膝骨关节炎57例

Comparison of the safety and efficacy of loxoprofen and rofecoxib in treatment of 57 patients with knee osteoarthritis

目的 :对比洛索洛芬和特异性环氧化酶 2 (COX 2 )抑制剂罗非昔布治疗膝骨关节炎 (OA)的疗效和安全性。方法 :入选 6 2例OA患者 ,随机口服洛索洛芬 (n =2 9) ,每次 6 0mg ,tid或罗非昔布 (n =33)每次 2 5mg ,qd ,疗程 4周。分别在治疗前后进行疗效和安全性评估。结果 :共 5 7例 (洛索洛芬组 2 6例 ,罗非昔布组 31例 )完成疗程 ,2组对膝OA休息时痛、活动痛、关节活动度、关节压痛和患者总评定等各项指标的有效率均超过 70 %。在对各指标的改善上 2组药物相比差异均无显著性 (P >0 .0 5 )。 2d内起效者洛索洛芬组显著高于罗非昔布组 (5 9.1%对2 5 .9% ,P =0 .0 19)。洛索洛芬和罗非昔布的不良反应发生率相当 (30 .8%对 4 8.4 % ,P >0 .0 5 ) ,而罗非昔布组的口腔溃疡发生率 (16 .1% )显著高于洛索洛芬组 (0 .0 % ,P =0 .0 19)。结论 :洛索洛芬与罗非昔布均有较强的消炎镇痛作用 ,而且起效快 ,不良反应轻 ,依从性较好。

Objective:To compare the safety and efficacy of loxoprofen and rofecoxib in treatment of knee osteoarthritis(OA).Methods:62 patients with OA in knee were randomly divided to receive oral loxoprofen(n=29) 60 mg,3 times daily for 4 weeks or oral rofecoxib(n=33) 25 mg,one time daily for 4 weeks.Clinical safety and efficacy were evaluated before and after treatment.Results:There were 57 patients(26 in loxoprofen group and 31 in rofecoxib group) who completed the study.A total effective rate of>70% were obtained in both groups and no significant difference in efficacy were observed between groups.But the number of patients who have an onset of action within 2 days in loxoprofen group were more than that of rofecoxib group(59.1% vs 25.9%,P=0.019).The incidence of ADRs was 30.8% for loxoprofen group vs 48.4% for rofecoxib group(P>0.05) but the oral ulceration rate was obviously higher in rofecoxib group.Conclusion:Loxoprofen is effective in treatment of knee OA with a quicker onset of action,a tolerable adverse reaction and a better compliance rate.