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研究

Clinical trial of methotrexate tablets combined with recombinant human tumor necrosis factor-α receptor Ⅱ: immunoglobulin G Fc fusion protein for injection in the treatment of systemic juvenile idiopathic arthritis

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 metho- trexate tablets combined with recombinant human tumor necrosis factor-α receptor Ⅱ： immunoglobulin G Fc fusion protein for injection in the treatment of systemic juvenile idiopathic arthritis. Methods Fifty- six children with systemic juvenile idiopathic arthritis were randomly divided into control group （n = 28 cases） and treatment group （n=28 cases）. Control group was given oral methotrexate 10 -2 mg＂ m per week. Treatment group was given recombinant human tumor necrosis factor -α receptor Ⅱ： immunoglobulin G Fc fusion pro- tein for injection 0. 4 mg·kg^-1, subcutaneous injection, twice a week, and after three months, turning to once a week： Two groups were treated for 6 months. The clinical efficacy, serum C reactive protein （CRP）, erythrocyte sedimentation rate （ESR） and adverse drug reactions were compared between the two groups. Results After treatment, the total effective rates in treatment and control groups were 82. 14% （23/28 cases） and 53.57% （15/28 cases）, with statistically significant difference （P 〈 0.05 ）. After treatment, CRP in treatment and control groups were （ 10. 28 ± 4. 17）, （ 15.02 ± 4. 19） mg·L^-1 ; ESR in treatment and control groups were （29. 11 ± 7. 93）, （ 39. 74 ±8. 12 ）mm·h^-1, with statistically significant differences （ P 〈 0.05 ）. Adverse drug reactions in two groups were based on low fever, sore throat and runny nose. The incidences of adverse drug reactions in treatment and control groups were 25. 00% and 17. 86%, without significant difference （P 〉 0. 05 ）. Conclusion Methotrexate tablets combined with recombinant human tumor necrosis factor -α receptor Ⅱ： immunoglobu- lin G Fc fusion protein for injection has a definitive clinical efficacy in the treatment of systemic juvenile idiopathic arthritis, which can improve CRP and ESR, without increasing the incidence of adverse drug reactions.