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目的评价重组人白细胞介素-1受体拮抗剂(rhIL-1Ra)治疗活动性类风湿关节炎(RA)的24周疗效及对RA影像学的影响。方法采用多中心、随机、双盲、平行对照的临床试验研究,南方医院试验中心确诊的活动期RA受试者40例,依照方案以3:1比例,随机分为rhIL-1Ra组(治疗组)和MTX组(对照组),治疗组30例予rhIL-1Ra联合MTX治疗,对照组10例予MTX治疗,并进行随访观察,疗程均为24周。主要评价指标为12周和24周时较基线期达到RA疗效评价标准20(ACR20)的患者比例;次要评价指标包括随访12周及24周时较基线期达到RA疗效评价标准50、70(ACR50、ACR70)的患者比例、晨僵持续时间、关节肿胀和关节触痛计数、VAS评分、健康评估问卷(HAQ)、急性期反应物水平(ESR、CRP),并对患者治疗前后的双腕关节进行影像学Sharp评分。结果第12周时治疗组ACR20为73%、ACR50为37%、ACR70为13%,对照组ACR20为10%、ACR50为10%、ACR70为0%(P=0.000);第24周时治疗组ACR20为87%、ACR50为50%、ACR70为37%,对照组ACR20为50%、ACR50为10%、ACR70为0%(P=0.000);其他各项疗效指标也反映出相似的改善程度及趋势(P=0.000)。双腕关节Sharp评分:治疗组0周关节侵蚀评分平均值为2.33,治疗24周为2.23(P=0.795),0周关节狭窄评分的平均值为1.70,治疗24周为1.43(P=0.343);对照组0周关节侵蚀评分平均值为2.60,治疗24周为3.60(P=0.024),0周关节狭窄评分的平均值为1.70,治疗24周为2.50(P=0.019)。结论rhIL-1Ra联合MTX治疗RA24周的疗效明显优于单用MTX,能明显控制RA病程并提示rhIL-1Ra有可能阻止RA患者影像学的进展。
Objective To evaluate the efficacy and safety of recombinant human interleukin-1 receptor antagonist (rhIL-1Ra) in the treatment of active rheumatoid arthritis (RA) in RA for 24 weeks. Methods A multicenter, randomized, double-blind, parallel-controlled clinical trial was conducted. Forty patients with active RA diagnosed by Southern Hospital Test Center were randomly divided into three groups according to the protocol: rhIL-1Ra group ) And MTX group (control group) .30 cases in the treatment group were treated with rhIL-1Ra combined with MTX and 10 cases in the control group were treated with MTX. The patients were followed up for 24 weeks. The primary outcome measure was the proportion of patients who achieved RA efficacy 20 (ACR20) at baseline and baseline at weeks 12 and 24; the secondary outcome measures included achievement of RA efficacy criteria 50 and 70 (baseline) at 12 and 24 weeks of follow-up ACR50 and ACR70), duration of morning stiffness, joint swelling and tenderness of joints, VAS score, HAQ, ESR and CRP were measured before and after treatment Joint imaging sharp Sharp score. Results At the 12th week, the ACR20 in the treatment group was 73%, the ACR50 was 37%, the ACR70 was 13%, the ACR20 was 10%, the ACR50 was 10% and the ACR70 was 0% (P = 0.000) ACR20 was 87%, ACR50 was 50%, ACR70 was 37%, control group ACR20 was 50%, ACR50 was 10%, ACR70 was 0% (P = 0.000); other efficacy indicators also reflect a similar degree of improvement and Trend (P = 0.000). The wrist joint Sharp score was 0.33 for the 0-week joint erosion score, 2.23 for 24 weeks (P = 0.795), 1.70 for the 0-week joint stenosis score, and 1.43 for 24 weeks (P = 0.343) . The control group had an average score of 2.60 for the 0-week joint erosion score, 3.60 for 24 weeks (P = 0.024), an average of 1.70 for the 0-week joint stenosis score and 2.50 for 24 weeks (P = .019). Conclusion The therapeutic effect of rhIL-1Ra combined with MTX on RA for 24 weeks is better than that of MTX alone. It can significantly control the course of RA and suggest that rhIL-1Ra may prevent the imaging progress of RA patients.