目的 评估重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白（rhTNRF：Fc）治疗难治性慢性痛风性关节炎的临床疗效及安全性。方法 选取2022年1月一2023年12月广州中医药大学顺德医院风湿科门诊收治的46例难治性痛风性关节炎患者,分为观察组和对照组两组,对照组规范使用降尿酸药物治疗,观察组在对照组治疗的基础上联合使用rhTNRF：Fc至少12周,在0、12、24、48周观察两组的血尿酸（sUA）、肿瘤坏死因子-α（TNF-α）、关节肌肉骨骼超声变化、痛风发作例数、肝肾功能等指标。结果 观察组与对照组sUA无明显差别（P>0.05）,TNF-α水平明显下降（P<0.05）,滑膜炎、关节积液影像表现减少（P<0.05）,痛风发作例数明显减少（P<0.05）,观察期间肝肾功能正常,无患者因不良反应退出研究。结论 rhTNRF：Fc对难治性慢性痛风性关节炎安全有效。

Objective To explore the efficacy and safety of recombinant human type II tumor necrosis factor receptor-antibody fusion protein（rhTNRF：Fc）in refractory chronic gouty arthritis. Methods From January 2022 to December 2023, 46 cases of refractory chronic gouty arthritis in the Rheumatology Outpatient Department,Shunde Hospital Guangzhou University of Chinese Medicine were selected and divided into an observation group and a control group. The control group received routine treatment,while the observation group received rhTNRF：Fc treatment additionally for at least 12 weeks, two groups of indicators such as serum urine acid（sUA）, TNF-α, changes in musculoskeletal ultrasound,number of gout attacks,hepatic and renal function at 0, 12, 24, and 48 weeks were observed. Results There was no significant difference in sUA between the observation group and the control group（P>0. 05）, TNF-α significantly decreased（P<0. 05）, synovitis and joint effusion imaging manifestations reduced（P<0. 05）, number of gout attacks decreased（P<0. 05）. During the observation period, liver and kidney function were normal, and no patients withdrew from the study due to adverse reactions. Conclusions Using rhTNRF：Fc is safe and effective in treating refractory chronic gouty arthritis.