A randomized controlled study of juvenile idiopathic arthritis treated with recombinant human Ⅱ tumor necrosis factor-Fc function protein / 国际儿科学杂志

ABSTRACT

Objective Through the application of recombinant human Ⅱ tumor necrosis factor-Fc function protein (rhTNFRFc) in the treatment of juvenile idiopathic arthritis (JIA) with randomized control study,clinical characteristic and clinical effect were summarized.Methods According to the randomized controlled principle,124 patients with JIA were divided into control group and treatment group.The basic treatment in two groups were one antirheumatic slow-acting drug,nonsteroidal drug,adrenal cortical hormone.There were no significant differences between clinical type and basic treatment in two groups (P ＞ 0.05).Sixty-two patients of JIA treated with rhTNFRFc by subcutaneous injection.The doses was 0.8mg /kg per week.There were 17 cases of oligoarthritis,15 cases of polyarthritis,30 cases of systemic arthritis in the treatment group and control group respectively.The basic antirheumatic drugs,nonsteroidal anti-inflamatory drugs ( NSAIDs),adrenal cortex hormone were allowed to continued.Clinical evaluation index included ACR Pedi 30,ACR Pedi 50 and ACR Pedi 70.The adverse drug reactions were recorded.Results The remission rate of ACR Pedi 30,50,70 in 2 weeks,one month,three monthes and six monthes were different in types of JIA patients in the treatment group ( P ＜ 0.05 ).The remission rate of systemic arthritis was lower than the other two groups of arthritis ( P ＜ 0.05 ).Only 44％ ACR Pedi 50 remission was achieved after three monthes medication in systemic arthritis and 41.7％ ACR Pedi 50,29.2％ ACR Pedi 70 were achieved after six monthes.The remission rate in the types of oligoarthritis and polyarthritis at different time points (2 weeks,one month,three monthes,six monthes) of ACR Pedi 30,50,70 were similar.After six monthes,more than 80％ reached ACR Pedi 50 remission,more than half of patients reached ACR Pedi 70 remission.Three cases of macrophage activation syndrome in systemic arthritis group was effective treated with rhTNFRFc.In the treatment group,2 cases of systemic arthritis appeared ache and discomfort after one week treatment,3 cases appeared repeated mild upper respiratory tract infection and diarrhea during treatment,including one varicella infection.The incidence of adverse reactions in the treatment group of systemic arthritis were 16.7％,Other 2 types of patients did not show adverse reaction during rhTNFRFc treatment.Conclusion rhTNFRFc has good effect on oligoarthritis and polyarthritis of JIA.The adverse reactions of six monthes were rare.The cases of systemic arthritis could reach some clinical remission,but need to guard against infection and the occurrence of adverse reactions.To whom did not respond to conventional therapy in systemic arthritis or systemic arthritis combined with macrophage activation syndrome,it could be considered with rhTNFRFc.