依那西普、甲氨蝶呤关节腔注射治疗膝关节炎临床观察  

A randomized,controlled clinical study on single intra-articular injection of etanercept and methotrexate in treatment of inflammatory knee arthritis

作　　者：尚桂莲 刘建华[1] 宋艳红[1] 

机构地区：[1]武汉科技大学附属天佑医院,湖北武汉430064

出　　处：《中国医院药学杂志》2013年第9期722-725,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:评价依那西普、甲氨蝶呤关节腔内注射治疗类风湿关节炎(RA)和脊柱关节病(SpA)所致的膝关节炎的疗效及安全性。方法:确诊为RA或SpA患者64例,均伴有至少一侧膝关节肿胀及积液,但X线片显示膝关节无显著骨破坏,研究前经相同的常规改善病情的抗风湿药(DMARDs)治疗至少6周。随机分为治疗组和对照组各32例,分别予膝关节腔穿刺注射术1次,治疗组应用依那西普(25mg),对照组应用甲氨蝶呤(10mg)。注射后第4周、第8周随访,评价疗效和不良反应。主要疗效指标为改良(纽约)特种外科医院(HSS)膝关节评分,次要疗效指标包括:医、患对膝关节健康状况评价等。结果:2组间人口学特征、疾病基线状况比较差异无统计学意义,对照组患者治疗4周,除患者对膝关节健康状况评价、行走或站立时膝关节疼痛有明显改善(P<0.05)外,大多数疗效评价指标较治疗前无明显改善(P>0.05);治疗8周后,主要疗效指标和所有次要疗效指标均较治疗前明显改善,差异有统计学意义(P<0.05)。治疗组患者治疗4周,主要疗效指标和所有次要疗效指标与治疗前及与对照组比较均明显改善,差异有统计学意义(P<0.05);治疗8周后,各指标较治疗前明显改善,差异有统计学意义(P<0.05),与对照组比较,改良HSS关节评分、行走或站立时膝关节疼痛、膝关节屈曲范围、CRP仍有明显优势(P<0.05)。观察期间2组不良反应比较差异有统计学意义(P<0.05)。2组出现消化道症状和肝功能酶学异常方面比较,治疗组的发生率明显低于对照组。结论:依那西普关节腔内注射治疗X线改变不明显的类风湿关节炎(RA)和/或脊柱关节病(SpA)所致的膝关节炎的疗效明显优于甲氨蝶呤注射液,且不良反应小,是一种快速、有效、安全的方法。OBJECTIVE To evaluate the efficacy and safety of single intra-artieular injection of etanereept and methotrexate in patients suffering from knee arthritis with rheumatoid arthritis（RA）and spondyloarthropathy（SpA）. METHODS The study was a randomized, parallel, controlled clinical trial. The subjects were the RA or SpA patients with the knee arthritis without de- formity, moderate or severe bone erosion and obvious joint space narrowing in radiography in the target knees, who had taken at least 6-week therapy with routine dosage of disease modifying anti-rheumatic drugs （DMARDs） before the study. The subjects were randomized in 1：1 ratio to receive single intra-articular 25 mg etanercept injection or 2 mL compound methotrexate 10 mg to the target knee joint after their synovial fluid being drawn away at baseline. They were followed up four weeks after injec- tion. The primary end point was the 4 week change in the modified Hospital for Special Surgery（HSS） knee score for the target knee. RESULTS Forty-seven subjects in the experimental group and twenty three subjects in the control group were included in the trial. The modified HSS knee score for the experimental group was baseline mean 65.64- 14. 0,follow-up 84. 3 ± 0. 1 （P ~0.01 ）, the control group baseline mean 68. 24 - 11.4, follow-up 79. 4 ± 15.5 （P = 0. 001 ）. A mean（34. 940± 38. 90 G） im- provement on the modified HSS knee score was achieved in the experimental group. While （17. 9± 24. 5） G improvement on the moditied HSS knee score was achieved in the control group （P = 0. 046 7）. Adverse events were observed （19. 0%） in the ex- perimental group and （44. 4%） in the control group. No serious adverse event had been observed. CONCLUSION Single intra- articular 25 rag etanercept injection had a better efficacy than methotrexate. It was an effective and safe therapeutic option for sDA and RA patients who had knee arthritis without obvious change in radiography.

关 键 词：依那西普 甲氨蝶呤 关节腔注射 炎性膝关节疾病 

分 类 号：R977.3[医药卫生—药品]