Результаты рандомизированного исследования по оценке терапевтической эффективности интерферона α-2b в комплексной терапии вирусных менингитов у детей

Abstract

Objective. To evaluate the therapeutic efficacy and safety of the drug Viferon®, rectal suppositories (RS) in the complex therapy of viral meningitis (VM) based on the dynamics of clinical and laboratory parameters in children. Patients and methods. A randomized, double-blind, placebo-controlled trial was conducted to evaluate the therapeutic efficacy and safety of the drug Viferon® (recombinant interferon α-2b) in the complex therapy of VM in children. The study included 140 children from 2 to 18 years old, who made up two groups: group 1 (n = 70) received CP Viferon® in age doses: up to 3 years – 500.000 IU; from 4 to 11 years – 1.000.000 IU; from 12 to 18 years – 3.000.000 IU each. Viferon® was prescribed 1 suppository 2 times a day for 7 days, then 1 time a day for 7 days. The 2nd group (n = 70) consisted of children with VM who received placebo, RS according to the scheme of the Viferon®.The children were randomized by gender, age, weight and severity of the VM. The effectiveness of therapy was evaluated based on the duration of clinical symptoms, the dynamics of pleocytosis and rehabilitation of cerebrospinal fluid (CSF) on day 15, the frequency of complete recovery on day 15, after 1, 3 and 6 months. The safety of using of the Viferon® was assessed according to the state of clinical and laboratory parameters, frequency and severity of adverse events. Results. The etiology of VM was determined in 64.3% of cases (n = 90) and included herpes viruses 1, 2, 3, 4, 5, 6 type, interoviruses, tick-borne encephalitis virus. It was found that children of group 1 had significantly shorter duration of meningeal, cerebral and intoxication syndromes, approximately 2 times less pleocytosis on day 15 and CSF sanitation from viruses in all cases, unlike patients of group 2 (p < 0.001). The differences with group 2 were also significant in age subgroups. Patients receiving the Viferon® were more likely to achieve complete clinical recovery on day 15 and did not have a residual deficiency in the outcome in 100% of cases after 3 months. The use of the Viferon® turned out to be safe, did not increase the incidence of the adverse events compared with the 2nd group of children receiving placebo. Conclusion. The use of the Viferon® in children with VM according to the scheme developed by the authors significantly reduces the regression of inflammatory changes and the timing of CSF rehabilitation, the duration of the main clinical symptoms compared with the placebo group, leads to recovery in 100% of cases. Key words: viral meningitis, therapy, interferon-alpha2b, children