Open label trial of adjuvant immunotherapy with Dzherelo, Svitanok and Lizorm, in MDR-TB, XDR-TB and TB/HIV co-infected patients receiving anti-tuberculosis therapy under DOT

Abstract


Nathalia D. Prihoda , Olga V. Arjanova , Lyudmila V. Yurchenko , Nina I. Sokolenko , Lyudmila A. Vihrova , Volodymyr S. Pylypchuk , Galyna A. Kutsyna*

Open label trial of anti-tuberculosis therapy (ATT) combined with oral immunomodulators derived from medicinal plants, Dzherelo, Svitanok, and Lizorm, was conducted in a representative group of 14 Ukrainian patients, half of whom (7) were dually infected with HIV. Among them 9 individuals had multidrug-resistant form of TB (MDR-TB) including 2 (22%) patients who presented with extensively drug-resistant TB (XDR -TB). Patients hospitalized in our TB dispensary were treated under directly observed therapy (DOT) until they became culture negative and their radiological and clinical symptoms improved. All patients, except one, gained weight, ranging between 3-17 kg with median gain of 9 kg (P=0.0002) . The liver function tests revealed that the level of total bilirubin had decreased from 15.5 to 12 mol/L – an improvement that was statistically significant (P=0.03). Alanine transaminase (ALT), another marker of hepatic damage, declined from abnormally high 55.4 IU/L to a normal 38.2 IU/L level (P=0.03) . The median time to bacterial clearance was 32 days. The mean duration of therapy was 3.9 months - shorter than average 12 months time needed to treat drug- resistant TB. These findings indicate that the combination of Ekomed’s phytopreparations with ATT enhances the efficacy of TB therapy and is safe and beneficial even to patients with poor prognosis due to drug resistance and/or co-infection with HIV.

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