重组人干扰素α1b联合阿昔洛韦治疗单核细胞增多症患儿的临床研究OA北大核心CSTPCD
Clinical trial of recombinant human interferon α1b combined with aciclovir in the treatment of mononucleosis in children
目的 观察重组人干扰素α1b(rhIFN-α1b)雾化吸入联合阿昔洛韦治疗儿童单核细胞增多症(IM)的临床疗效及安全性.方法 将IM患儿按队列法分为对照组和试验组.对照组接受10 mg·kg-1阿昔洛韦,静脉滴注,q8h;试验组在对照组治疗的基础上,接受rhIFN-α1b雾化吸入治疗,每次2 μg·kg-1,q12 h.2组患儿均治疗10 d.比较2组患儿的临床疗效,临床症状改善时间,心肌酶指标[肌酸激酶(CK)、肌酸激酶同工酶(CK-MB)、谷草转氨酶(GOT)]水平,外周血T淋巴细胞亚群(CD3+、CD4+、CD8+、CD4+/CD8+)水平和Toll样受体(TLR7、TLR9)及控叉状头/翅膀状螺旋转录因子3(Foxp3)相关mRNA的表达水平;统计治疗期间药物不良反应的发生情况.结果 本研究对照组共入组47例,试验组共入组43例.治疗后,试验组和对照组的总有效率分别为90.70％和72.34％,在统计学上差异有统计学意义(P＜0.05).治疗后,试验组和对照组的退热时间分别为(4.43±1.27)和(5.28±1.82)d,外周血异型淋巴细胞百分比＜10％时间分别为(4.14±1.74)和(5.04±1.97)d,CK水平分别为(98.76±12.53)和(118.19±15.42)U·L-1,CK-MB 水平分别 为(18.41±2.15)和(23.67±3.79)U·L-1,CD4+/CD8+水平分别为 0.83±0.17和0.70±0.15,TLR7 mRNA 相对表达水平分别为 1.12±0.35 和 1.33±0.40,TLR9 mRNA相对表达水平分别为1.09±0.27和1.46±0.36,Foxp3 mRNA相对表达水平分别为3.77±0.82和3.37±0.91,在统计学上差异均有统计学意义(均P＜0.05).试验组和对照组的总药物不良反应发生率分别为9.30％和6.38％,在统计学上差异无统计学意义(P＞0.05).结论 rhIFN-α1b雾化吸入联合阿昔洛韦治疗儿童IM的临床疗效良好,可缩短患儿临床症状缓解时间,减轻心肌损伤,改善患儿免疫功能,临床用药安全性较高.
Objective To observe the clinical efficacy and safety of recombinant human interferon α1b(rhIFN-α1b)aerosol inhalation combined with aciclovir in the treatment of monocytosis(IM)in children.Methods The children with IM were divided into control group and treatment group according to cohort method.The children were divided into control group and treatment group according to cohort method.The control group was treated with intravenous infusion of 10 mg·kg-1 aciclovir,q8 h.On this basis,the treatment group was treated with 2 μg·kg-1 rhIFN-α1b aerosol inhalation,q12 h.The course of treatment was 10 d.Clinical efficacy,clinical symptom improvement time,the levels of myocardial enzymes[creatine kinase(CK),creatine kinase isoenzyme(CK-MB)and glutamic oxalacetic transaminase(GOT)]and peripheral blood T lymphocyte subsets(CD3+,CD4+,CD8+and CD4+/CD8+),and the expression of Toll-like receptors(TLR7 and TLR9)and forkhead/wing spiral transcription factor 3(Foxp3)related mRNAs were compared between the two groups.Adverse drug reactions that occurred during treatment was statistically analyzed.Results A total of 47 cases were enrolled in the control group and 43 cases in the treatmet group.After 10 d of treatment,the clinical effective rates in the treatment group and the control group were 90.70％and 72.34％,with statistically significant difference between the groups(P＜0.05).The fever regression time in the treatment group and the control group were(4.43±1.27)and(5.28±1.82)d;the duration of atypical lymphocytes＜10％were(4.14±1.74)and(5.04±1.97)d;CK levels were(98.76±12.53)and(118.19±15.42)U·L-1;CK-MB levels were(18.41±2.15)and(23.67±3.79)U·L-1;CD4+/CD8+were 0.83±0.17 and 0.70±0.15;the relative expression levels of TLR7 mRNA were 1.12±0.35 and 1.33±0.40;the relative expression levels of TLR9 mRNA were 1.09±0.27 and 1.46±0.36;the relative expression levels of Foxp3 mRNA were 3.77±0.82 and 3.37±0.91.The differences were statistically significant(all P＜0.05).There was no significant difference in the incidence of adverse reactions between treatment group with control group(9.30％vs 6.38％,P＞0.05).Conclusion RhIFN-α1b aerosol inhalation combined with aciclovir is effective in the treatment of children with IM.The combined treatment can shorten clinical symptom relief time,alleviate myocardial injury and improve immune function,with high drug safety.
陈谷
马鞍山十七冶医院儿科,安徽马鞍山 243000
药学
重组人干扰素α1b注射剂阿昔洛韦注射剂单核细胞增多症免疫功能疗效评价安全性评价
monocytosis injectionaciclovir injectionrecombinant human interferon α1bimmune functionefficacy evaluationsafety evaluation
《中国临床药理学杂志》 2024 (007)
944-948 / 5
评论