Clinical analysis of recombinant human interferon α-2b in treatment of immune thrombocytopenia children who failed to first-line therapy

Abstract

Objective To investigate the efficacy and safety of recombinant human interferon (rh-IFN) α-2b in treatment of pediatric immune thrombocytopenia (ITP) as a second-line therapy regimen. Methods From October 2015 to September 2017, a total of 95 ITP children who were not respond to first-line therapy regimen or glucocorticosteroid-dependent, and receiving rh-IFNα-2b treatment, were selected as study subjects after admitted to Department of Hematology and Oncology, Kunming Children′s Hospital. The average age of the children was 5.3 years. And 53 cases were male and 42 were female, and the gender composition ratio of male and female was 1.3∶1. Clinical characteristics of the children were collected retrospectively, and the curative effect and treatment-related adverse reactions were analyzed. The chi-square test was used to compare the total effective rate of children of different genders, age, and disease duration; the Bonferroni correction was used in pairwise comparisons of total effective rates of children with different disease dunration. The procedure of this study is accordance with the requirement of the revised World Medical Association Declaration of Helsinki in 2013. Informed consents were obtained from all participants′ guardians. Results ① Total effective rate of 95 ITP children treated by rh-IFNα-2b was 53.7% (51/95). And among 95 ITP children, 33 cases (34.7%) were continuously effective during the period of follow-up. And 18 cases (19.0%) were relapsed after rh-IFNα-2b treatment of short-term effective condition and responded to first-line treatment, and 2 cases (2.1%) were relapsed after rh-IFNα-2b treatment of short-term effective condition and did not respond to first-line treatment and rh-IFNα-2b. 34 cases (35.8%) were ineffective after treatment of rh-IFNα-2b. Two cases (2.1%) were discontinued after the first use of the drug due to high fever, 2 cases (2.1%) were discontinued by themselves and 4 cases (4.2%) were lost during the follow-up. ② There was no significant difference in the total effective rate among ITP children with different gender and age (P>0.05). The total effective rates of children with duration of disease less than or equal to 3 months, 3-12 months, and more than 12 months, were 45.4% (30/66), 75.0% (15/20) and 66.7% (6/9), respectively. And there was significant difference among them (χ2=6.282, P=0.043). However, there was no significant difference in pairwise comparison of the total effective rates of ITP children with different disease duration (P>0.017). ③ Among 95 cases of ITP children, 20 cases (21.1%) developed flu-like symptoms after the first dose, mainly including fever, headache, fatigue, and muscle pain. Among them, 4 patients (4.2%) had high fever (maximum temperature of 39 ℃), and 2 cases of them were withdrawn. 16 cases (16.8%) had mild fever (maximum temperature of 38 ℃). Except for 2 children who discontinued rh-IFNα-2b due to intolerable severe flu-like symptoms, symptoms of the other 18 children were alleviated or disappeared the next day after medication, and no significant decrease in white blood cell count and severe liver and kidney function damage were observed during follow-up, indicating good tolerance. Conclusions Efficacy and safety of rh-IFNα-2b in the treatment of pediatric ITP children who are not respond to first-line treatment regimen or glucocorticosteroid-dependent is good. rh-IFNα-2b can be used as the second-line treatment regimen for pediatric ITP. Key words: Interferon type Ⅰ, recombinant; Thrombocytopenia; Drug therapy; Treatment outcome; Child; Interferon alfa-2b