Clinical trial of recombinant human interferon α1b injection combined with vidarabine injection in the treatment of hand foot and mouth disease
10.13699/j.cnki.1001-6821.2018.19.013
- VernacularTitle: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
- Author:
Li-Yun CAI
1
;
Min YAO
;
Yong-Qing WANG
;
Xiao-Bin WEI
;
Qing ZHENG
;
Xian-Xian FU
;
Huan-Yu FENG
;
Su-Ling ZHANG
Author Information
1. 中南大学 湘雅医学院 附属海口医院检验科
- Keywords:
recombinant human interferon α1b injection;
vidarabine injection;
hand foot and mouth disease;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(19):2287-2290
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of re-combinant human interferon α1b injection combined with vidarabine injec-tion 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 re-combinant human interferon α1b injection 6-20 μg· d-1, qd, intramus-cular 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 ki-nase isoenzyme ( CK-MB), lactate dehydrogenase ( LDH) and lactate dehydrogenase 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 interferon α1b injection combined with vidarabine injection has a definitive clinical efficacy in the treatment of HFMD , without increasing the incidence of adverse drug reactions .
