A prospective multicenter randomized controlled study on the efficacy and safety of pharyngeal spraying recombinant human interferon alpha 2b in the treatment of children with herpangina

Abstract

Objective To evaluate the efficacy and safety of pharyngeal spraying recombinant human interfe-ron alpha 2b (rhIFNα2b) in the treatment of herpangina in children. Method s A prospective, multicenter, rando-mized, opened and controlled study was carried out in 11 hospitals in Anhui province from August 2018 to March 2019.According to the time of admission, 180 patients diagnosed as herpangina were prospectively and randomly divided into rhIFNα2b treatment group and Ribavirin control group.On the basis of giving both groups the heat-clearing, detoxifying and anti-infection treatment, the patients in treatment group received pharyngeal spraying rhIFNα2b 9 g/L saline solution[1 million IU/mL, 0.1 million IU/(0.1 mL·press)], and the patients in control group were treated by pharyngeal spraying Ribavirin (0.5 mg RBV/press, 150 press), 3 presses per time, 4 times per day, continuous administration for 5 days for both groups.Those who recovered in advance were no longer given medication.All patients were observed to fully recover.The clinical efficacy and the disappearing time of symptoms and signs between two groups were compared, and the safety of pharyngeal spraying rhIFNα2b for patients was evaluated. Result s All of the 180 patients completed the study, including 90 cases in the treatment group and 90 cases in the control group.There was no statistically significant difference in terms of gender, age, weight and course of illness before treatment between the two groups (all P>0.05), which had clinical comparability.The apparent efficiency of the treatment group [63.3% (57/90 cases)] was significantly higher than that in the control group [38.9% (35/90 cases)] and the difference was statistically significant(χ2=10.934, P=0.004); no significant difference in the total efficiency between the treatment group [96.7% (87/90 cases)]and the control group [92.2% (83/90 cases)]was observed (χ2=2.924, P=0.169). The duration of fever[(32.59±20.73) h vs.(45.72±26.96) h], hyperemia[(76.48±23.12) h vs.(92.44±24.31) h], herpes[(72.99±25.77) h vs.(85.09± 26.62) h], salivation[(45.44±24.96) h vs.(54.42±31.20) h] and anorexia[(62.70±23.99) h vs.(78.71±30.54) h] in the treatment group were significantly shorter than those in the control group, and the differences were statistically significant(all P 0.05). After treatment, the serum levels of TNF-α and IL-6 were(7.26±1.99) ng/L and (2.42±0.73) ng/L in the treatment group, which were significantly lower than those in the control group [(12.09±6.39) ng/L and (7.32±11.51) ng/L](all P 0.05). The comparison on positive rate of virus in pharyngeal swab between the treatment group [65.3% (32/49 cases) and 40.6% (13/32 cases) respectively] and the control group[66.7%(36/54 cases) and 41.0% (16/39 cases), respectively]before and after therapy showed no significant difference (all P>0.05). During the treatment, no serious adverse reactions were observed in the two groups.The incidence of adverse reactions was 1.1% (1/90 cases) in the treatment group and 5.6% (5/90 cases) in the control group.In addition, the serum hemoglobin level of children in the control group after treatment was significantly lower than that before treatment and that in the treatment group (all P<0.05). Conclusions Compared with pharyngeal spraying ribavirin, pharyngeal spraying rhIFNα2b can greatly improve the clinical efficiency, accelerate the disappearance of clinical symptoms and signs, and shorten the total course of disease, and is more safe and worthy of clinical application. Key words: Herpangina; Recombinant human interferon alpha 2b; Ribavirin; Pharyngeal spraying