摘要目的:探讨大剂量丙种球蛋白辅助治疗小儿急性重症病毒性心肌炎(ASVMC)的效果和安全性。方法:随机对照研究。抽取2017年1月至2021年12月郑州大学第一附属医院收治的ASVMC患儿70例，按照随机数字表法分为对照组与治疗组，每组35例。对照组给予常规治疗，治疗组采用大剂量丙种球蛋白辅助常规治疗。比较两组临床疗效及不良反应发生率。比较两组治疗前后体液免疫指标[免疫球蛋白G(IgG)、免疫球蛋白A(IgA)、免疫球蛋白M(IgM)]、细胞免疫指标(CD3 ＋、CD4 ＋、CD8 ＋)、心肌酶谱指标[肌酸激酶(CK)、肌酸激酶同工酶(CK-MB)、乳酸脱氢酶(LDH]水平。 结果:治疗组临床治疗总有效率(94.29%，33/35)高于对照组(77.14%，27/35)， P<0.05。治疗2周后，两组血清IgG、IgA、IgM、CD3 ＋、CD4 ＋、CD8 ＋水平均升高，且治疗组上述指标水平高于对照组( P<0.05)。治疗2周后，两组血清CK、CK-MB、LDH水平均降低，且治疗组低于对照组( P<0.05)。治疗组不良反应总发生率(8.57%，3/35)与对照组(5.71%，2/35)比较差异未见统计学意义( P>0.05)。 结论:大剂量丙种球蛋白辅助治疗可以改善相关免疫指标及心肌酶谱水平，有效减轻心肌损伤，提高患者的治疗效果，且安全性高。

abstractsObjective:To investigate the efficacy and safety of high-dose gamma-globulins in the adjuvant treatment of acute severe viral myocarditis (ASVMC) in children.Methods:A total of 70 children diagnosed with ASVMC admitted to the First Affiliated Hospital of Zhengzhou University from January 2017 to December 2021 were selected for the randomized controlled study. And they were divided into a control group and a treatment group by random number table method, with 35 cases in each group. The control group was treated with conventional treatment, and the treatment group was treated with high-dose gamma-globulins combined with conventional treatment. The clinical efficacy and incidence of adverse reactions were compared between the two groups. The humoral immunity indexes, including immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM), cellular immunity indexes, including cluster of differentiation 3 + (CD3 + ), cluster of differentiation 4 + (CD4 + ) and cluster of differentiation 8 + (CD8 + ), myocardial enzyme profile indexes, including creatine kinase (CK), creatine kinase myocardial isoenzyme (CK-MB) and lactate dehydrogenase (LDH), were compared between the two groups before and after treatment. Results:The total effective rate in the treatment group (94.29%, 33/35) was higher than that in the control group (77.14%, 27/35), P<0.05. After 2 weeks of treatment, levels of serum IgG, IgA and IgM and T lymphocyte subsets, such as CD3 +, CD4 + and CD8 +, in the two groups significantly increased, and the above indexes in the treatment group were higher than those in the control group ( P<0.05). After 2 weeks of treatment, the levels of serum CK, CK-MB and LDH in the two groups decreased, and the levels of the above indexes in the treatment group were lower than those in the control group ( P<0.05). There was no significant difference in the total incidence of adverse reactions between the treatment group (8.57%, 3/35) and the control group (5.71%, 2/35), P>0.05. Conclusions:Hight-dose gamma-globulins, as the adjuvant treatment for children with ASVMC, can improve levels of relevant immunization indicators and myocardial enzyme profile, effectively decrease myocardial damage, and improve therapeutic effect, with high safety.