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目的:评价类风湿关节炎患者连续多次静脉滴注重组人CTLA4-抗体融合蛋白(rhCTLA4-Ig)的耐受性和安全性。方法:选取9例类风湿关节炎患者,于0,2,4,8,12,16周连续静脉滴注,剂量为10 mg.kg-1,观察临床症状体征并严密观察记录试验期间发生的不良反应事件。结果:9例受试者均无严重不良反应发生。未检查到肝肾功能损害、消化道及心血管系统毒性。免疫实验室指标呈下降趋势。结论:类风湿关节炎患者对连续静脉滴注10 mg.kg-1rhCTLA4-Ig耐受性良好,无明显毒副作用,该剂量可作为Ⅱ期临床研究剂量。
Objective: To evaluate the tolerability and safety of continuous intravenous infusion of recombinant human CTLA4-Ig fusion protein (rhCTLA4-Ig) in patients with rheumatoid arthritis. Methods: Nine patients with rheumatoid arthritis were selected and treated with continuous intravenous drip at 0, 2, 4, 8, 12, and 16 weeks at a dose of 10 mg.kg-1. Clinical signs and symptoms were observed and closely observed during recording test Adverse reaction events. Results: None of the 9 subjects experienced serious adverse reactions. Liver and kidney dysfunction, gastrointestinal and cardiovascular toxicity were not detected. Immunological laboratory indicators showed a downward trend. CONCLUSIONS: Rheumatoid arthritis patients are well tolerated with continuous intravenous infusion of 10 mg.kg-1 rhCTLA4-Ig with no significant side effects. This dose can be used as a phase II clinical study dose.