CAJ | 학술논문

目的：研究依托芬那酯凝胶联合口服布洛芬缓释胶囊治疗膝关节骨关节炎关节疼痛的临床疗效。方法采用前瞻性随机对照临床试验，将293例Kellgren-Lawrence分级为I～Ⅲ级的膝关节骨关节炎患者随机分为：A组联合使用依托芬那酯凝胶（外用，直径2 cm范围内，每次约3 g，每日3次，疗程2周）及布洛芬缓释胶囊（0.3 g，口服，每日2次，疗程2周），B组运用布洛芬缓释胶囊（0.3 g，口服，每日2次，疗程2周），C组则运用依托芬那酯凝胶（外用，直径2 cm内，每次约3 g，每日3次，疗程2周），分别于治疗后第0、1、2、4及8周采用视觉模拟评分法评估患者静息痛、运动痛及夜间痛，进行疗效评价。结果293例患者中275例完成有效随访。第0～1周A、B、C三组患者3项VAS疼痛评分均表现出下降趋势，而在第1～2周其下降速度进一步加快。 A组在第2周达到最佳临床疗效，而B组及C组在第4周达到最佳临床疗效，并且从第1周开始A组3项VAS疼痛评分始终低于B、C两组。第4周开始三组患者3项VAS疼痛评分均呈现上升趋势。本研究中口服药物的两组上消化道不良反应发生率无统计学差异（χ2＝0.354， P＞0.05），外用药物的两组皮肤不良反应的发生率无统计学差异（χ2＝0.334， P＞0.05）。三组患者均无肾功能损害及凝血功能障碍等不良反应发生。结论依托芬那酯凝胶联合口服布洛芬缓释胶囊治疗膝关节骨关节炎关节痛临床效果优于单用口服布洛芬缓释胶囊和单独外用依托芬那酯凝胶。起效时间短，作用强度高，不良反应发生率低，具有良好地临床应用价值。
목적：연구의탁분나지응효연합구복포락분완석효낭치료슬관절골관절염관절동통적림상료효。방법채용전첨성수궤대조림상시험，장293례Kellgren-Lawrence분급위I～Ⅲ급적슬관절골관절염환자수궤분위：A조연합사용의탁분나지응효（외용，직경2 cm범위내，매차약3 g，매일3차，료정2주）급포락분완석효낭（0.3 g，구복，매일2차，료정2주），B조운용포락분완석효낭（0.3 g，구복，매일2차，료정2주），C조칙운용의탁분나지응효（외용，직경2 cm내，매차약3 g，매일3차，료정2주），분별우치료후제0、1、2、4급8주채용시각모의평분법평고환자정식통、운동통급야간통，진행료효평개。결과293례환자중275례완성유효수방。제0～1주A、B、C삼조환자3항VAS동통평분균표현출하강추세，이재제1～2주기하강속도진일보가쾌。 A조재제2주체도최가림상료효，이B조급C조재제4주체도최가림상료효，병차종제1주개시A조3항VAS동통평분시종저우B、C량조。제4주개시삼조환자3항VAS동통평분균정현상승추세。본연구중구복약물적량조상소화도불량반응발생솔무통계학차이（χ2＝0.354， P＞0.05），외용약물적량조피부불량반응적발생솔무통계학차이（χ2＝0.334， P＞0.05）。삼조환자균무신공능손해급응혈공능장애등불량반응발생。결론의탁분나지응효연합구복포락분완석효낭치료슬관절골관절염관절통림상효과우우단용구복포락분완석효낭화단독외용의탁분나지응효。기효시간단，작용강도고，불량반응발생솔저，구유량호지림상응용개치。
Objective To evaluate the clinical results of combination of the etofenamate gel and the ibuprofen sustained release capsules in the treatment of knee osteoarthritis.Methods Two hundred and ninety-three patients with knee osteoarthritis that belonged to gradeⅠto gradeⅢof Kellgren-Lawrence grading scale were randomized divided into group A, B, C.Group A was treated with etofenamate gel ( external use, rang 2 cm, about 3 g each time, three times a day for two weeks ) and the ibuprofen sustained release capsules (0.3 g, twice a day for two weeks); group B was treated with the ibuprofen sustained release capsules (0.3 g, twice a day for two weeks) only, and group C was treated with the etofenamate gel ( external use, rang 2 cm, about 3 g each time, three times a day for two weeks) only.The clinical results were evaluate by the visual analogue scale ( VAS) of rest pain, sport pain and night pain in week 0, 1, 2, 4 and 8.Results There were 275 patients finished follow-up.In week 0 to 1 the three VAS pain scores of all the groups decreased, and in week 1 to 2 the decline of these scores accelerated. Group A got it’s best clinical effect in week 2, group B and C got their best clinical effects in week 4.All three VAS pain scores of group A were always lower than those of group B and C since week 1.In week 4, these scores began to increase.There was no significant difference between the two oral drug groups in the gastrointestinal adverse effects (χ2=0.354, P>0.05), and there was no significant difference between the topical drug groups in the skin adverse effects (χ2=0.334, P >0.05 ).There was no renal dysfunction or coagulation defect case in all the groups. Conclusion The joint pain of the knee osteoarthritis can be better relieved by the etofenamate gel combined with the ibuprofen sustained release capsules comparing to using either ibuprofen sustained release capsules or etofenamate gel alone.The combination of the drugs may provide shorter onset time, little side-effect, but greater effcts, which should be widely used.