Результаты II/III фазы клинических испытаний иммуномодулятора полимурамил при гнойной хирургической инфекции

The paper presents the results of an open-label, placebo-controlled phase II/III clinical trial of an immunomodulatory drug Polymuramyl in patients with purulent surgical infections. An experimental group of 30 patients received the standard treatment together with Polymuramyl in a dose of 200 mcg IM once daily for 5 days. A control group of 30 patients received the standard treatment only. Polymuramyl significantly accelerated resolution of inflammation, reduced time to normalization of the body temperature, reduced pain, sleep disturbances and general discomfort. The overall effectiveness of treatment was judged as good in 83,3% patients in the Polymuramyl group and only in 56,7% in the control group (p<0,05 in the x-square test). Only one adverse event was registered in the Polymuramyl group, which was not caused by the drug being tested and did not require medical intervention. The laboratory examination revealed that Polymuramyl stimulated the components of the immune system that are involved in the elimination of extracellular purulent bacteria. In conclusion, Polymuramyl can be used as an auxilliary treatment of purulent surgical infection.