RESUMO
OBJECTIVE: The objective of the study was to evaluate the effect of administration of the immunoregulating preparation Immodin (Sevapharma, CZ) to influence immunoparalysis in intensive care unit patients. METHOD: A double blind, randomised clinical study was designed for the above purpose. The patients in whom immunoparalysis was detected during monitoring (CD14+ HLA-DR+ < or = 40 %) were randomised for the administration of Immodin (IM) or placebo (PL); the treatment lasted for 5 days. 45 (25% of all monitored) patients - the men/women ratio being 29/16, 60 (54; 65) years of age - were enrolled in the study (of which 25 IM and 20 PL). RESULTS: The patients did not show differences in ICU mortality - 23 IM patients survived, 2 IM patients died; 15 PL patients survived and 5 PL patients died (p = 0.214). The time of ICU hospitalisation did not differ, either - 11.6 days for IM patients (8.2; 14.9), 12.6 days for PL patients (9.1; 16.1) (P = 0.659) - nor did the number of nosocomial infections - 4 out of 25 IM patients and 4 out of 20 PL patients (p = 0.776). No difference was observed between the patient groups during a 5 day intervention period in terms of SOFA score development (p = 0.954), SIRS days (p = 0.614), sepsis or severe sepsis (respectively p = 0.451 and p = 0.250). No difference was recorded in the trends of basic immunologic parameters, either (CD14+ HLA-DR+ - p = 0.460, production of TNFalpha - p = 0.802, IL-6 - p = 0.335 , IL-10 - p = 0.226). The trend of inflammation parameters was also identical (CRP - p = 0.673, PCT - p = 0.711 ). CONCLUSION: The effect of 5 day administration of Immodin to ICU patients with symptoms of immunoparalysis does not differ from that of placebo.
