重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗活动性类风湿性关节炎效果观察

目的研究重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（rhTNFR：Fc）对活动性类风湿关节炎（RA）的疗效。方法40例活动性RA随机分为两组,观察组皮下注射rhTNFR：Fc25mg,2次/周;对照组口服来氟米特（LEFT）20mg,1/d及甲氨蝶呤（MTX）15mg,1次/周。疗程为24周。治疗2、4、8、12、24周后,统计两组达到美国风湿病学会（ACR）20、ACR50、ACR70改善标准的情况。结果治疗2、4周后,观察组ACR20的比例明显高于对照组,差异有统计学意义（P〈0.05）;治疗8周后,观察组ACR20、50的比例均明显高于对照组,差异有统计学意义（P〈0.05）;治疗24周后,观察组ACR20、50、70的比例均显著高于对照组,差异有统计学意义（P〈0.05）。对照组中的消化道症状发生率明显高于观察组（P〈0.05）。结论 rhTNFR：Fc对活动性RA具有良好的疗效及安全性。

The Curative Effect of Recombinant Human Tumor Necrosis Factor (rhTNFR:Fc) Protein in the Treatment of Activity Rheumatoid Arthritis

Objective To study curative effect of recombinant human tumor necrosis factor（rhTNFR：Fc）protein in the treatment of activity rheumatoid arthritis（RA）.Methods 40 patients with activity RA were randomly divided into treatment group （n=20） and control group （n=20）.The treatment group was injected with rhTNFR：Fc 25 mg,subcutaneously,twice a week;the control group took LEFT 20 mg once a day and MTX 15 mg once a week orally;the course was 24 weeks.The United States Institute of Rheumatology（ACR） 20,ACR 50 and ACR 70 improvement criteria were statistically analyzed 2,4,8 and 12 weeks after treatment.Results ACR 20 of the treatment group was higher than that of the controls（P0.05） 2,4 weeks after treatment,ACR 20 and ACR 50 of the treatment group was higher than that of the controls（P0.05） 8 weeks after treatment,ACR 20,ACR 50 and ACR 70 of the treatment group was higher than that of the controls（P0.05） 24 weeks after treatment.but incidence rate of adverse events especially in digestive system of the control group was obviously higher than that of the treatment group（P0.05）.Conclusion Recombinant human tumor necrosis factor（rhTNFR：Fc）protein is safe and effective in the treatment of activity RA.