OBJECTIVE:To evaluate the clinical efficacy of infliximab in the treatment of moderate and severe active rheumatoid arthritis (RA). METHODS:This randomized double-blind II/III clinical trial involved 30 patients with moderate and severe active RA, who were randomly allocated into 3 groups (groups A, B, and C) at the ratio of 3:1:1. At weeks 0, 2, 6, and 14, the patients in groups A and C received infliximab or placebo, and those in group B had placebo at week 14 with a stable background dose of methotrexate. The indicators for efficacy evaluation included the proportions of ACR20/50/70 of the responders and DAS28. The sharp scores of the hand joints were recorded before and after the treatment. RESULTS:Twenty-nine patients completed the clinical trial (18 in group A, 5 in group B, and 6 in group C). At week 14, the proportions of ACR20/50/70 in the 3 groups reached 83.33%, 60%, and 33.33%, respectively (P<0.05), as compared to 100%, 100%, and 33.33% at week 18 (P<0.05). The other indicators for clinical efficacy evaluation also suggested similar clinical improvement of the patients (P=0.000). The proportions of the patients with DAS28<3.2 and DAS28<2.6 were significantly different. Compared to the baseline, the Sharp scores in group A showed no significant changes at week 18 (P>0.930), while those in group C exhibited significant radiographic progression (P<0.044). CONCLUSION:Infliximab produces good short-term therapeutic effect against moderate and severe active RA and may help arrest the radiographic progression of the diseases, which can be more obvious in patients with moderate severity.

目的:对重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(依那西普)治疗幼年脊柱关节病(JSpA)的临床疗效与安全性进行评价。方法:所有患者均符合欧洲脊柱关节病研究组(ESSG)分类标准,年龄≤16岁,病情处于活动期,关节炎数≥2,肌腱端炎数≥3,总体疼痛VAS≥4(0～10),对NSAIDs和传统DMARDs疗效不佳,给予依那西普0.4mg/kg,每周2次(最大用量至50mg/w),疗程12周。评价指标为0、4、8、12周关节炎数、肌腱端炎数、总体疼痛评分VAS、晨僵时间及实验室炎症反应指标红细胞沉降率(ESR)和C反应蛋白浓度(CRP)等。并随访至48周,观察依那西普减量维持和停用依那西普后患者病情状况。随时记录观察期间不良事件。结果:26例患者完成了12周的观察。4周后,关节炎数和肌腱端炎数均减少,与各自基线水平比较差异有统计学意义(P<0.05),8、12周时这种情况继续改善;其他各项疗效指标也反映出相似的改善程度和趋势;实验室炎症反应指标12周后也明显下降(P<0.05)。随访过程中,16例患者降低依那西普剂量密度继续使用,病情维持稳定。停用依那西普的患者中,多数病情加重。不良反应均为轻度,未发现结核、严重感染等情况。结论:依那西普可以迅速改善JSpA的症状和体征,降低用药频率可维持疗效,安全性较好。

Objective To explore the clinical or laboratory parameters predictive of flare and determine whether Gulingtang can maintain remission after discontinuation of etanercept therapy in ankylosing spondylitis.Methods Sixty patients with ankylosing spondylitis(AS) were randomly divided into two groups.Treatment group 1(30 cases) received etanercept and Gulingtang.Treatment group 2(30 cases) received etanercept.After 12 weeks,patients stopping using etanercept,were followed up until relapse or 9 month after not using etanercept.The statistical tools used were the Cox proportionate hazard model and the logrank method.Results 53 patients who attained an improvement of ASAS20 at week 12 were followed using a definition of relapse.81.1% of these patients relapsed within 36 weeks afterwards.The duration of relapse of group1 was 20 weeks,however that in the group 2 was 14 weeks.The rates of relapse in the group1 and group 2 were 71.4%,92%,respectively.The differents betweent the two groups were significantly(P0.05).Higher BASDAI,CRP and hip joint damaged at baseline were the risk factors for the AS patients,and the therapeutic method was the protective factor(P0.05).Conclusion After discontinuing the etanercept keeping the initial medications almost patients completed disease relapsed within short times.Higher BASDAI,CRP and hip joint damaged were the risk factors for the relapse.Gulingtang could prolong the duration of remission.

Objective To evaluate the efficacy of using rhIL-1Ra for the treatment of active RA.Methods The study was based on the use of multi-center,randomized,double-blind,parallel-controlled clinical trial research.40 cases of active RA were obtained from Test Center of Nan-fang hospital.Based on the program 3:1 ratio,the patients were randomly divided into rhIL-1Ra group(treatment group) and the MTX group(control group).30 cases of treatment group were treated with rhIL-1Ra combined with MTX;10 cases of the control group were treated with MTX for 24 weeks.The main evaluation index was the comparison of the proportion of patients reached ACR20 after 12 weeks and 24 weeks to the baseline.The secondary evaluation was the comparison of the proportion of patients reached ACR50,ACR70 after 12 weeks and 24 weeks to the baseline.The index are duration of morning stiffness,joint swelling and joint tenderness count,VAS score,health assessment questionnaire(HAQ),the level of acute phase reactants(ESR,CRP),and the sharp score of dual wrist imaging at week 24.Results 30 cases of treatment group treated with rhIL-1Ra plus MTX,10 cases of the control group to MTX treatment,and follow-up observation,treatment of After the first 12 weeks of treatment the treatment group ACR20 reached 73%,ACR50 37%,and ACR70 13%,while the control group ACR20 reached 10%,ACR50 10%,and ACR70 0%(P = 0.000);after 24 weeks the treatment group ACR20 reached 87%,ACR50 50%,ACR70 37%,while for the control group ACR20 reached 50%,ACR50 10% and ACR70 0%(P = 0.000).The other indicators also reflects the effect of similar extent and trend of improvement(P = 0.000).The sharp score of dual wrist joint for(1) the treatment group:the average joint erosion score at week 0 was 2.33 and at week 24 was 2.23(P = 0.795);the average joint narrow score at week 0 was 1.70 and at 24 weeks was 1.43(P = 0.343),(2) the control group:the average joint erosion score at week 0 was 2.60 and at 24 weeks was 3.60(P = 0.024);the average joints narrow score at week 0 was 1.70 and at 24 weeks was 2.50(P = 0.019).Conclusion The efficacy of rhIL-1Ra combined with MTX was better than MTX alone.The treatment can significantly control the course of RA and prevent the progress of RA.