中文摘要：

目的 评价单次膝关节腔内注射依那西普对类风湿关节炎（RA）和脊柱关节病（SpA）所致的膝关节炎的疗效与安全性.方法 随机、单盲、平行、阳性药（复方倍他米松）对照的临床试验.受试者为确诊RA或SpA并伴有至少一侧膝关节肿胀及积液,但X线显示膝关节无变形、无中重度骨破坏及关节间隙明显狭窄,入组前经常规改善病情的抗风湿药（DMARDs）治疗至少6周.受试者按2∶1比例随机分为试验组和对照组,分别予以目标膝关节腔穿刺,吸净关节积液后注射1次依那西普（25 mg）或复方倍他米松（2 ml）.注射后第4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.结果 （1）试验组47例、对照组23例受试者入选本研究.（2）改良HSS膝关节评分试验组基线值为（65.6±14.0）分,治疗4周后为（84.3±11.1）分,治疗前后比差异有统计学意义（P＜0.0001）;对照组基线值为（68.2±11.4）分,治疗4周后为（79.4±15.5）分,治疗前后比,差异有统计学意义（P=0.0015）;试验组改良HSS膝关节评分改善率为（34.9±38.9）%,对照组为（17.9±24.5）%,2组比较差异有统计学意义（P=0.0467）.（3）试验组有8例（19.0%）、对照组有8例（44.4%）受试者发生不良事件,有7例次被研究者判断为与使用研究药物有相关性,试验组有2例次（4.8%）,分别为注射点轻度疼痛和月经提前;对照组有5例次（27.8%）,分别为面部潮红,失眠,耳鸣,头昏、困倦,口干、口苦;2组比较差异有统计学意义（P=0.0352）.无1例受试者因不良事件而退出试验,未发生结核感染和关节腔内感染,未发生严重不良事件.结论 单次膝关节腔内注射25 ng依那西普对X线改变不明显的炎性膝关节炎是一种有效、安全的治疗选择,其疗效优于2 ml复方倍他米松.

英文摘要：

Objective To evaluate the efficacy and safety of single intra-articular etanercept injection in patients with rheumatoid arthritis （RA） and spondyloarthropathy （SpA） who had knee arthritis.Methods This was a randomized, single-blind, parallel, controlled clinical trial. The subjects were the RA or SpA patients with the knee arthritis without deformity, 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 2：1 ratio to receive either single intra-articular 25 mg etanercept injection or 2 ml compound betamethasone to the target knees joint after their synovial fluid being drawn away at baseline. They were followed up four weeks after injection. 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 controlled group were included in the trial. The modified HSS knee score for the experimental group was baseline mean 65.6 ± 14.0, follow-up 84.3 ±11.1 （P 〈0.0001 ）, the controlled group baseline mean 68.2 ± 11.4, follow-up 79.4 ± 15.5（P =0.0015）. A mean （34.9 ±38.9）% improvement on the modified HSS knee score was achieved in the experimental group, while （ 17.9 ±24.5）% improvement on the modified HSS knee score was achieved in the controlled group （P =0.0467）. Adverse events were observed in eight patients （19.0% ） in the experimental group and eight patients （44.4%） in the controlled group. No serious adverse event had been observed. Conclusions Single intra-articular 25 mg etanercept injection had a better efficacy than 2 ml compound betamethasone. It was an effective and safe therapeutic option for SpA and RA patients who had knee arthritis without obvious change in radiography.