不同剂量重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎疗效分析

Therapeutic effects of different doses of recombinant human tumor necrosis factor-receptor Ⅱ:IgG Fc fusion protein on rheumatoid arthritis

目的观察不同剂量重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR:Fc)对类风湿关节炎患者的治疗效果。方法76例类风湿关节炎患者根据治疗方案分为rhTNFR:Fc治疗A组22例(rhTNFR:Fc25mg/次,2次/周;甲氨蝶呤10mg/周)、rhTNFR:Fc治疗B组24例(rhTNFR:Fc12.5mg/次,2次/周;甲氨蝶呤10mg/周)和对照组30例(甲氨蝶呤10mg/周)。所有患者均于治疗前及治疗开始后不同时间点(2、4、6、8、12、16、24周)进行关节功能相关指标检测,包括关节肿胀数、压痛数、疼痛程度、晨僵时间、健康评价问卷(HAQ)评分、红细胞沉降率、C反应蛋白、类风湿因子。疗程3个月,观察治疗前后患者关节功能指标的变化,比较治疗后各组关节功能改善情况,以达到ACR20、ACR50、ACR70改善标准来评价疗效。结果治疗前三组患者关节功能相关指标检测结果比较,差异无统计学意义(P>0.05)。治疗结束后,三组患者各项关节功能指标均较治疗前明显改善(P<0.05);其中rhTNFR:Fc治疗A、B组均优于对照组(P<0.05)。在治疗后第2、4周,rhTNFR:Fc治疗A组达到ACR50改善标准的患者比例明显高于B组(P<0.05);在治疗后第8、12、16、24周,A、B两组总体疗效比较,差异无统计学意义(P>0.05)。结论小剂量rhTNFR:Fc联合甲氨蝶呤治疗类风湿关节炎是一个有效且经济的备选方案。

Objective To observe the therapeutic effects of different doses of recombinant human tumor necrosis factor-receptor Ⅱ：IgG Fc fusion protein （rhTNFR：Fc） on rheumatoid arthritis （RA）. Methods Seventy-six patients with RA were randomly divided into rhTNFR：Fc treatment group A （n=22; rhTNFR：Fc 25 mg, twice/week and methotrexate 10 mg/week）, rhTNFR：Fc treatment group B （n=24; rhTNFR：Fc 12.5mg, twice/week and methotrexate 10 mg/week） and control group （n=30; methotrexate 10 mg/week）. Joint function related parameters including number of swollen joints, number of tenderness, pain degree, time of morning stiffness, Health Assessment Questionnaire （HAQ） score, erythrocyte sedimentation rate, C-reactive protein and rheumatoid factor were detected before and 2, 4, 6, 8, 12, 16 and 24 weeks after treatment in all the patients. After being treated for 3 months, the changes of joint function related paramters were evaluated and compared among groups. ACR20, ACR50 and ACR70 criteria were employed to evaluate the therapeutic effects. Results There was no significant difference in joint function related parameters among three groups before treatment （P〉0.05）, while those improved significantly after treatment for 3 months （P〈0.05）, with more favorable results in rhTNFR：Fc treatment group A and B than in control group （P〈0.05）. The percent of patients with ACR50 in rhTNFR：Fc treatment group A was significantly higher than that in rhTNFR：Fc treatment group B 2 and 4 weeks after treatment （P〈0.05）, while there was no significant difference in total effect between these two groups 8, 12, 16 and 24 weeks after treatment（P〉0.05）. Conclusion Small dose of rhTNFR：Fc in combination with methotrexate may yield effective and economical results for treatment of RA.