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目的观察甲氨蝶呤片联合注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗全身型幼年特发性关节炎的临床疗效和安全性。方法将56例全身型幼年特发性关节炎患儿随机分为对照组28例和试验组28例。对照组予以口服甲氨蝶呤每周10 mg·m~(-2);试验组在对照组治疗的基础上,予以皮下注射注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白0.4 mg·kg~(-1),每周2次,治疗3个月后改为每周1次。2组患者均治疗6个月。比较2组患儿的临床疗效、血清C反应蛋白(CRP)、红细胞沉降率(ESR),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为82.14%(23/28例)和53.57%(15/28例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血清CRP分别为(10.28±4.17),(15.02±4.19)mg·L~(-1);ESR分别为(29.11±7.93),(39.74±8.12)mm·h~(-1),差异均有统计学意义(P<0.05)。2组患儿药物不良反应主要有低热、咽痛、流鼻涕,且试验组和对照组的药物不良反应发生率分别为25.00%和17.86%,差异无统计学意义(P>0.05)。结论甲氨蝶呤片联合注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗全身型幼年特发性关节炎的临床疗效显著,能显著改善患儿的CRP和ESR水平,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of methotrexate combined with recombinant human type Ⅱ tumor necrosis factor receptor-antibody fusion protein in the treatment of systemic juvenile idiopathic arthritis. Methods Fifty-six children with idiopathic juvenile idiopathic juvenile arthritis were randomly divided into control group (n = 28) and experimental group (n = 28). The control group was treated with oral methotrexate 10 mg · m -2 weekly. On the basis of the control group, the experimental group was given subcutaneous injection of recombinant human type Ⅱ tumor necrosis factor receptor-antibody fusion protein 0.4 mg · Kg ~ (-1), 2 times a week, 3 months after the treatment changed to once a week. Two groups of patients were treated for 6 months. The clinical efficacy, serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and the incidence of adverse drug reactions were compared between the two groups. Results After treatment, the total effective rates of the experimental group and the control group were 82.14% (23/28 cases) and 53.57% (15/28 cases), respectively, with statistical significance (P <0.05). After treatment, the serum CRP in the test group and the control group were (10.28 ± 4.17) and (15.02 ± 4.19) mg · L -1, respectively; the ESR were (29.11 ± 7.93) and (39.74 ± 8.12) mm · h ~ (-1), the differences were statistically significant (P <0.05). Adverse drug reactions in the two groups were mainly fever, sore throat and runny nose. The incidences of adverse drug reactions in the two groups were 25.00% and 17.86%, respectively, with no significant difference (P> 0.05). Conclusion The clinical efficacy of methotrexate combined with recombinant human type Ⅱ tumor necrosis factor receptor-antibody fusion protein in the treatment of systemic juvenile idiopathic arthritis is significant and can significantly improve the level of CRP and ESR in children without increasing The incidence of adverse drug reactions.