白芍总苷胶囊联合注射用重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白治疗幼年特发性关节炎23例及对T淋巴细胞免疫、Th1/Th2漂移及红细胞沉降率的影响

Curative effect of total glucosides of paeony capsules combined with rhTNFR:Fc on JIA children and their influences on T lymphocyte immunity,Th1/Th2 drift and ESR level

目的分析白芍总苷胶囊联合注射用重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白(rhTNFR:Fc,益赛普)治疗幼年特发性关节炎(JIA)病儿的临床效果及对T淋巴细胞免疫、Th1/Th2漂移及红细胞沉降率(ESR)水平的影响。方法选取2015年1月至2018年6月郑州儿童医院收治的JIA病儿46例,采用随机数字表法分为对照组与观察组每组23例,对照组单用益赛普治疗,观察组加用白芍总苷胶囊治疗,比较两组疗效,采用幼年关节炎疾病活动性评分表(JADAS27)评定病儿临床症状及体征的改善,并测定病儿治疗前后外周血T淋巴细胞免疫(CD4+、CD8+、CD4+/CD8+)、免疫球蛋白(IgA、IgG、IgM)、Th1、Th2细胞比例、Th1/Th2比值及红细胞沉降率、肿瘤坏死因子-α(TNF-α)水平的变化,统计治疗不良反应发生率。结果观察组总有效率86.96%和对照组总有效率65.22%比较,差异无统计学意义(P>0.05);治疗前,两组JADAS27各维度评分比较差异无统计学意义(P>0.05),治疗后,观察组各维度评分降低幅度均高于对照组,JADAS27总分(11.17±0.95)分低于对照组(15.87±1.03)分(P<0.05);治疗前,两组T淋巴细胞免疫及实验室各指标比较差异无统计学意义(P>0.05),治疗后,观察组CD4+、CD8+、CD4+/CD8+、Th2细胞比例高于对照组,IgA、IgG、IgM、Th1细胞比例、Th1/Th2比值及红细胞沉降率、TNF-α均低于对照组(P<0.05);两组治疗期间均无严重不良反应发生(P>0.05)。结论白芍总苷胶囊联合益赛普治疗JIA疗效肯定,可改善病儿临床症状及体征,调节机体免疫,改善Th1/Th2漂移,下调外周红细胞沉降率、TNF-α水平。

Objective To analyze the clinical curative effects of Total Glucosides of Paeony Capsules combined with injection of recombinant human type Ⅱ tumor necrosis factor-αreceptor antibody fusion protein(rhTNFR:Fc,etanercept)on children with juvenile idiopathic arthritis(JIA)and their influences on T lymphocyte immunity,Th1/Th2 drift and level of erythrocyte sedimentation rate(ESR).Methods Forty-six JIA children admitted to Zhenzhou Children’s Hospital from January 2015 to June 2018 were randomly assigned into control group and observation group,23 cases in each group.The control group was treated with etanercept alone. The observation group was additionally treated with Total Glucosides of Paeony Capsules. The curative effects of the two groups were compared.The juvenile arthritis disease activity scale(JADAS27)was used to evaluate the improvements of clinical symptoms and signs.The peripheral blood T lymphocyte immunity(CD4+,CD8+,CD4+/CD8+),immunoglobulin(IgA,IgG,IgM),the proportions of Th1 and Th2 cells,ratio of Th1 to Th2 and changes in blood ESR and tumor necrosis factor-α(TNF-α)levels before and after treatment were measured.Incidence of adverse reactions was statistically analyzed.Results The total response rate of the observation group was higher than that of the control group with no statistically significant difference(86.96% vs. 65.22%,P>0.05).Before treatment,there were no significant differences in the dimensions scores of JADAS27 between the two groups(P>0.05).The decreases in scores of all dimensions in observation group after treatment were higher than those in control group,and the total score of JADAS27 was lower than that in control group[(11.17±0.95)vs.(15.87±1.03)](P<0.05).Before treatment,there was no significant difference in the T lymphocyte immunity or laboratory indexes between the two groups(P>0.05).After treatment,CD4+,CD8+,CD4+/CD8+and proportion of Th2 cells in the observation group were higher than those in the control group,while IgA,IgG,IgM,proportion of Th1 cells,ratio of Th1 to Th2 and levels of ESR and TNF-α were lower than those in the control group(P<0.05).There were no serious adverse reactions during the treatment period in either group(P>0.05).Conclusion The curative effect of Total Glucosides of Paeony Capsules combined with etanercept is positive on JIA,which can improve the clinical symptoms and signs of children,regulate the body immunity,improve Th1/Th2 drift,and down-regulate the levels of ESR and TNF-α in peripheral blood.