目的 探討重組人Ⅱ型腫瘤壞死因子受體–抗體融合蛋白治療非全身型幼年特發(fā)性關節(jié)炎的臨床療效。方法 選擇2010年9月—2013年9月湖北醫(yī)藥學院附屬東風醫(yī)院收治的非全身型幼年特發(fā)性關節(jié)炎患兒100例,隨機分為對照組和治療組,每組各50例。對照組給予常規(guī)藥物治療。治療組在對照組基礎上皮下注射注射用重組人Ⅱ型腫瘤壞死因子受體–抗體融合蛋白,0.4 mg/kg,2次/周。治療3個月后根據(jù)患兒病情進行劑量調(diào)整,若患兒效果較好,則重組人Ⅱ型腫瘤壞死因子受體–抗體融合蛋白改為1次/周。兩組均連續(xù)治療6個月。觀察兩組的臨床療效,同時比較兩組治療前后腫瘤壞死因子α(TNF-α)、C反應蛋白(CRP)、白細胞介素-1β(IL-1β)、基質(zhì)金屬蛋白酶-3(MMP-3)、β膠原分解片斷(β-CTx)、堿性磷酸酶(ALP)、白細胞計數(shù)(WBC)、血沉(ESR)和血小板計數(shù)(PLT)的變化。監(jiān)測兩組前臂、L2～4腰椎正側(cè)位和股骨Ward's三角骨密度的變化情況。結(jié)果 治療后,對照組和治療組的總有效率分別為68.0%、88.0%,兩組比較差異有統(tǒng)計學意義(P< 0.05)。治療后,兩組患兒TNF-α、CRP、IL-1β、MMP-3、WBC、ESR、PLT水平均顯著下降,ALP顯著升高,同組治療前后差異有統(tǒng)計學意義(P< 0.05);且治療組的改善程度優(yōu)于對照組,兩組比較差異有統(tǒng)計學意義(P< 0.05)。治療后,兩組患兒腰椎正位、腰椎側(cè)位骨密度顯著上升,與治療前相比差異有統(tǒng)計學意義(P< 0.05);且治療組治療后腰椎正位、腰椎側(cè)位骨密度顯著高于對照組,兩組比較差異有統(tǒng)計學意(P< 0.05)。結(jié)論 重組人Ⅱ型腫瘤壞死因子受體–抗體融合蛋白治療非全身型幼年特發(fā)性關節(jié)炎具有較好的臨床療效,可改善患兒骨質(zhì)疏松狀況,其作用機制可能與降低患兒血清炎癥因子水平有關。

Objective To investigate the clinical effect of Recombinant Human Tumor Necrosis Factor-α ReceptorⅡ: IgG Fc Fusion Protein for injection in treatment of non systemic juvenile idiopathic arthritis. Methods Patients (100 cases) with non systemic juvenile idiopathic arthritis in Dongfeng Hospital, Hubei University of Medicine from September 2010 to September 2013 were randomly divided into control and treatment groups, and each group had 50 cases. The patients in the control group were given routine drug. The patients in the treatment group were sc administered with Recombinant Human Tumor Necrosis Factor-α ReceptorⅡ: IgG Fc Fusion Protein for injection, 0.4 mg/kg, twice weekly. After three months, the dosage was adjusted according to the state of illness. If clinical effect was better, the dosage was adjusted once weekly. The patients in two groups were treated for 6 months. After treatment, the efficacy was evaluated, and the changes of TNF-α, CRP, IL-1β, MMP-3, β-CTx, ALP, WBC, ESR, and PLT in two groups before and after treatment were compared. The changes of bone mineral density about forearm, L2-L4 lumbar normotopia and side position and the femoral Ward's triangle in two groups were monitored. Results After treatment, the efficacies in the control and treatment groups were 68.0% and 88.0%, respectively, and there was difference between two groups (P < 0.05). After treatment, the levels of TNF-α, CRP, IL-1β, MMP-3, WBC, ESR, and PLT in two groups were significantly reduced, and ALP was significantly increased, and the difference was statistically significant in the same group (P < 0.05). And these indicators in treatment group improved better than those in the control group, with significant difference between two groups (P < 0.05). After treatment, bone mineral density about lumbar spine normotopia and side position were significant increase, and the difference was statistically significant in the same group (P < 0.05). After treatment, bone mineral density about lumbar spine normotopia and side position in treatment group were significant higher than those in the control group, with significant differences between two groups (P < 0.05). Conclusion Recombinant Human Tumor Necrosis Factor-α ReceptorⅡ: IgG Fc Fusion Protein for injection has good clinical efficacy in treatment of non systemic juvenile idiopathic arthritis, and can improve osteoporosis, whose mechanism may be associated with lower levels of serum inflammatory factors.