Introduction:

The parapneumonic pleural efussion as a complication of pneumonias adquired in the community by the pediatric population represents a health problem in the world and in Cuba. The use of intrapleural fibrinolytics is a good therapeutic option.

Objective:

To evaluate the effectiveness and security of the use of recombinant streptokinase in the treatment of complex parapneumonic pleural efussion in children.

Methods:

Phase III confirmatory clinical trial, monocentric, open, randomized and controlled (RPCEC00000292) - named as DENIS study- carried out from September 2018 to October, 2019. There were included children (from 1 to 18 years old) that met the selection criteria including voluntariness. All of them received the established conventional treatment and were distributed in two groups: I- experimental (recombinant streptokinase, intrapleural daily dose of 200 000 UI, 3 - 5 days); II- control (conventional therapy). The main variables were need of surgery and hospital stay. There were also assessed the adverse events.

Results:

55 children with the above mentioned disease were assessed; 34 of them (61.8%) were included in the study. Any of the patients of the experimental group required surgery, opposite to the control group that required it in a 25%. The hospital stay was significantly reduced in the group that had treatment with recombinant streptokinase. There were not any severe adverse events related to the experimental treatment.

Conclusions:

When recombinant streptokinase was administered in the complex parapneumonic pleural efussion resulted in an efficient and safe method for the elimination of the septic focus, with a positive impact expressed in the reduction of complications, the need of surgical treatment and the hospital stay without presenting related adverse events while using it.

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