Częstość zakażeń układu oddechowego u dzieci z dysplazją oskrzelowo-płucną otrzymujących profilaktycznie paliwizumab

Abstract

IntroductionRespiratory syncytial virus (RSV) is responsible for annually recurring epidemics of lower respiratory tract infections – including bronchiolitis – and remains the leading cause of hospitalizations in children younger than 1 year of age. The first Polish national program of immunoprophylaxis (OPZRSV) using palivizumab was instituted in view since causal treatment for RSV infections is as yet unavailable and efforts aimed at developing a vaccine are still underway. Patients and methodsa multicenter, retrospective, non-interventional study to evaluate the incidence of respiratory infections in children with bronchopulmonary dysplasia (BPD) receiving palivizumab prophylaxis. In total, the study included 557 children (4–102-weeks-old; 22–34 weeks gestational age) representing 25 centres actively participating in the prophylactic program, and having received at least one dose of the palivizumab. Patient data was entered into dedicated forms. All episodes of respiratory infection and hospitalization were identified, no later than 35 days following last palivizumab administration. Adverse events and tolerance were determined, as were the number and specific cause of reported deaths. Results2001 doses of the palivizumab were administered. In total, 436 episodes of respiratory infection were registered. The percentage of patients experiencing at least one episode of respiratory tract infection declined from 22.9% (128/557) after the first dose to 7.5% (7/93) following the fifth dose of palivizumab, but the reduction did not reach statistical significance (p=0.0524). Decline in the percentage of patients experiencing at least one episode of respiratory infection was due to a statistically significant decrease in the number of infection episodes affecting lower airway (total of lower respiratory tract infections and mixed infections) from 11.1% (62/557) after the first dose to 0% (0/93) following the fifth dose of palivizumab (p<0.0001). During the period of palivizumab administration, 183 episodes of hospitalization were reported, including 91 (49.7%) caused by respiratory infections. The percentage of respiratory-related hospitalizations after the first dose was 5.2% (29/557). After the fifth dose there were no respiratory-related hospitalizations registered. The repeated measures binary data analysis applied to respiratory-related hospitalizations proved statistically significant correlation between number of injections and number of respiratoryrelated hospitalizations (p<0.0001). Adverse reactions occurred in 3.6% of children, with nervousness being the most frequently reported effect. 5 of 557 (0.9%) children died. In none of the cases was RSV infection identified as the cause of death. Conclusions1. After subsequent doses of palivizumab, statistically significant reduction is reported in the following areas: number of episodes of lower respiratory tract infections, and number of respiratory-related hospitalizations comparing the first vs fifth dose, and incidence of corticosteroid or bronchodilators administration. 2. Mortality in the analyzed population was few and none of the reported deaths were caused by RS V infection. 3. The incidence of adverse reactions was low. 4. Prophylactic administration of palivizumab was offered to children through sites located throughout the country. It was conducted in line with relevant guidelines and supports that such an intervention is effective and should take the form of a mandatory program based on an assumption that RS V infection was prevented.