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  

Clinical trial of recombinant human interferon α1b combined with aciclovir in the treatment of mononucleosis in children

作　　者：陈谷 CHEN Gu(Department of Paediatrics,Maanshan 17 Metallurgical Hospital,Maanshan 243000,Anhui Province,China)

机构地区：[1]马鞍山十七冶医院儿科,安徽马鞍山243000

出　　处：《中国临床药理学杂志》2024年第7期944-948,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：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10mg·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2μg·kg^(-1),q12 h。2组患儿均治疗10d。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,TLR7mRNA相对表达水平分别为1.12±0.35和1.33±0.40,TLR9mRNA相对表达水平分别为1.09±0.27和1.46±0.36,Foxp3mRNA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 interferonα1b(rhIFN-αlb)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 2μg·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 significan

关 键 词：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 

分 类 号：R974[医药卫生—药品]