重组人干扰素α1b注射液联合阿糖腺苷注射剂治疗手足口病的临床研究  

Clinical trial of recombinant human interferon α1b injection combined with vidarabine injection in the treatment of hand foot and mouth disease

作　　者：蔡丽云 姚敏[1] 王永卿 魏小斌[1] 郑青[1] 符先先[1] 冯焕玉 张素领 CAI Li-yun;YAO Min;WANG Yong-qing;WEI Xiao-bin;ZHENG Qing;FU Xian-xian;ZHANG Su-ling(a.Department of Clinical Laboratory/b.Department of Pharmacy,Central South University Xiangya School of Medicine Affiliated of Haikou Hospital,Haikou 570208,China;Department of Pediatrics,Hainan Agriculture And Reclamation Hospital,Zhanzhou 571700,Hainan Province,China)

机构地区：[1]中南大学湘雅医学院附属海口医院检验科,海口570208 [2]中南大学湘雅医学院附属海口医院药学部,海口570208 [3]海南省农垦那大医院儿科,海南儋州571700

出　　处：《中国临床药理学杂志》2018年第19期2287-2290,共4页The Chinese Journal of Clinical Pharmacology

基　　金：海南省卫生计生行业科研基金资助项目(15A200054)

摘　　要：目的观察重组人干扰素α1b注射液联合阿糖腺苷注射剂治疗手足口病(HFMD)的临床疗效及安全性。方法将94例HFMD患儿随机分为对照组和试验组,每组47例。对照组予以重组人干扰素α1b注射液6～20μg·d^(-1),qd,肌内注射;试验组在对照组治疗的基础上,予以5～10 mg·kg^(-1)·d^(-1)阿糖腺苷,qd,静脉滴注。2组患儿均治疗5 d。比较2组患儿的临床疗效、血清免疫球蛋白M(IgM)、IgG、IgA、磷酸肌酸激酶(CK)、磷酸肌酸激酶同工酶(CK-MB)、乳酸脱氢酶(LDH)、乳酸脱氢同工酶(LDH-1)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为97.87%(46例/47例)和72.34%(34例/47例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的IgM分别为(1.44±0.19)和(1.27±0.16)g·L^(-1),IgG分别为(9.08±1.28)和(8.47±1.17)g·L^(-1),IgA分别为(1.09±0.14)和(0.91±0.10)g·L^(-1),CK分别为(72.27±10.06)和(97.25±12.63)U·L^(-1),CK-MB分别为(19.94±2.66)和(32.14±4.17)U·L^(-1),LDH分别为(207.48±28.13)和(313.26±42.27)U·L^(-1),LDH-1分别为(53.39±7.17)和(78.27±10.81)U·L^(-1),差异均有统计学意义(P<0.05,P<0.01)。试验组发生的药物不良反应主要有白细胞减少和输注单磷酸阿糖腺苷时出现皮肤瘙痒及皮疹,对照组发生的药物不良反应主要有白细胞减少。试验组和对照组的总药物不良反应发生率分别为4.25%和2.13%,差异无统计学意义(P>0.05)。结论重组人干扰素α1b注射液联合阿糖腺苷注射剂治疗HFMD的临床疗效确切,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of recombinant human interferon α1b injection combined with vidarabine injection in the treatment of hand foot and mouth disease（ HFMD）. Methods A total of 94 children with HFMD were randomly divided into control and treatment groups with 47 cases per group. Control group received recombinant human interferon α1b injection 6-20 μg·d^-1,qd,intramuscular injection. Treatment group was given vidarabine injection 5-10 mg·kg^-1·d^-1,qd,intravenous drip,on the basis of control group.Two groups were treated for 5 days. The clinical efficacy,levels of serum immunoglobulin M（ IgM）,IgG,IgA,creatine kinase（ CK）,creatine kinase isoenzyme（ CK-MB）,lactate dehydrogenase（ LDH） and lactatedehydrogenase isoenzyme（ LDH-1）,and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 97. 87%（ 46 cases/47 cases） and 72. 34%（ 34 cases/47 cases） with significant difference（ P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared： IgM were（ 1. 44 ± 0. 19） and（ 1. 27 ± 0. 16） g · L^-1,IgG were（ 9. 08 ± 1. 28） and（ 8. 47 ± 1. 17） g·L^-1,IgA were（ 1. 09 ± 0. 14） and（ 0. 91 ± 0. 10） g · L^-1,CK were（ 72. 27 ± 10. 06） and（ 97. 25 ± 12. 63） U · L^-1, CK-MB were（ 19. 94 ± 2. 66） and（ 32. 14 ± 4. 17） U · L^-1, LDH were（ 207. 48 ± 28. 13） and（ 313. 26 ± 42. 27） U·L^-1,LDH-1 were（ 53. 39 ± 7. 17） and（ 78. 27 ± 10. 81） U·L^-1,the differences were statistically significant（ P〈0. 05 or P〈0. 01）. The adverse drug reactions of treatment group were leukopenia,skin pruritus and rash during the infusion of adenosine monophosphate,while those in the control group were leucopenia. The total incidences of adverse drug reactions in treatment and control groups were 4. 25% and 2. 13% without significant difference（ P〉0. 05）. Conclusion Recombinant human i

关 键 词：重组人干扰素α1b注射液 阿糖腺苷注射剂 手足口病 安全性 

分 类 号：R978[医药卫生—药品]