静注人免疫球蛋白联合注射用甲基泼尼龙琥珀酸钠治疗小儿重症手足口病的效果及安全性分析

Efficacy and safety analysis of intravenous human immunoglobulin combined with methylprednisolone sodium succinate for injection in the treatment of severe hand-foot-mouth disease in children

目的观察静注人免疫球蛋白联合注射用甲基泼尼龙琥珀酸钠治疗小儿重症手足口病(HFMD)的效果及安全性分析。方法选取2015年1月—2018年12月毕节市第一人民医院收治的重症HFMD患儿120例,按随机数字表法分为联合组和对照组,每组60例。在规范化诊治和对症治疗基础上,对照组给予注射用甲基泼尼龙琥珀酸钠治疗,联合组在对照组基础上联合静注人免疫球蛋白治疗。比较2组临床疗效,治疗前后实验室相关指标、临床症状消失时间及实验室指标异常持续时间,并统计药物不良反应发生率。结果联合组患儿治愈率高于对照组,进展至危重型HFMD发生率低于对照组(P均<0.05),但2组好转率比较差异无统计学意义(P>0.05);治疗5 d后,2组肿瘤坏死因子-α(TNF-α)、C反应蛋白(CRP)、白介素-6(IL-6)水平均较治疗前下降,且联合组低于对照组(P<0.05或P<0.01);联合组退热时间、神经系统受累时间、肺炎表现消失时间短于对照组,白细胞增高、血糖增高持续时间短于对照组(P均<0.01),但2组退疹时间和心肌酶谱增高及PaO_(2)下降持续时间比较差异无统计学意义(P>0.05);2组治疗期间均未见上消化道出血、过敏性休克等严重不良反应事件,联合组不良反应发生率为3.33%,对照组中未见任意不良反应症状。结论静注人免疫球蛋白联合注射用甲基泼尼龙琥珀酸钠治疗对小儿重症HFMD可更迅速缓解临床症状并改善实验室相关指标,不仅疗效更佳,安全性亦有保障。

Objective To analyze the curative effect and safety of intravenous human immunoglobulin combined with methylprednisolone sodium succinate for injection in the treatment of severe hand-foot-mouth disease(HFDM)in children.Methods 120 children with severe HFMD admitted to the First People's Hospital of Bijie City from January 2015 to December 2018 were randomly divided into the combined group(n=60)and the control group(n=60).On the basis of standardized diagnosis and treatment and symptomatic treatment,the control group was treated with methylprednisolone sodium succinate for injection,and the combined group was treated with intravenous human immunoglobulin on the basis of the control group.The clinical curative effect,laboratory related indicators,disappearance time of clinical symptoms and duration of abnormal laboratory indicators were compared between the two groups.The incidence of adverse drug reactions was statistically analyzed.Results The cure rate of children in the combined group was higher than that in the control group,and the incidence of progression to critical HFMD was lower than that in the control group(all P<0.05),but there was no significant difference in the improvement rate between the two groups(P>0.05).After 5 days of treatment,the levels of tumor necrosis factor-α(TNF-α),C-reactive protein(CRP),and interleukin-6(IL-6)in the two groups were decreased compared with those before treatment,and the combined group was lower than the control group(P<0.05 or P<0.01).The antipyretic time,nervous system involvement time,and the disappearance time of pneumonia symptoms in the combined group were shorter than those in the control group,and the duration of increased white blood cells and blood sugar were shorter than those in the control group(all P<0.01).There was no significant difference in the time of rash withdrawal,the increase in myocardial enzyme spectrum and the duration of decrease in PaO_(2) between the two groups(P>0.05).There were no serious adverse reactions such as upper gastrointestinal bleeding and anaphylactic shock in both groups during the treatment period.The incidence of adverse reactions in the combined group was 3.33%,and no adverse reactions were found in the control group.Conclusion Intravenous human immunoglobulin combined with methylprednisolone sodium succinate for injection can quickly relieve clinical symptoms and improve laboratory related indicators in children with severe HFMD.The curative effect of the combined treatment is good,with safety.