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Effect of Solid Formulation of Immunoxel (Dzherelo) as an Adjuvant Immunotherapy in Treatment of TB and TB/HIV Co-infected Patients.

Olga V. Arjanoval, Nathalia D. Phhoda2, Larisa V. Yurchenko3, Nina I.Sokolenko4, LyudmilaA. Vihrova5, VolodymyrS. Pylypchuk6, ValeryM. Frolov7, GalynaA. Kutsyna8 Lisichansk Tuberculosis Dispensary, Lisichansk, Ukrainel; Lisichansk Regional Hospital, Lisichansk, Ukraine!; Ekomed LLC, Kiev, Ukraine3; Luhansk Regional AIDS Center and Luhansk State Medical University, Luhansk, Ukraine kutsynagalyna@yahoo. com

Background: In previous studies Immunoxel - an oral immunomodulator used as an adjunct to TB therapy - was formulated as alcohol-water extract of medicinal herbs. In this study a solid, sublingual, sugar-based formulation of Immunoxel was tested to determine whether it will be as effective as liquid formula.
Methods: TB and TB/HIV co-infected patients received either first-line anti-TB therapy (ATT consisting of HRZES; Arm A; N=20) or ATT+ once daily dose of Immunoxel (Arm B; N=19).
Results: At the end of one-month of follow-up, 2 (10.5%) vs 17 (89.5%) patients had cleared M. tuberculosis in sputum samples and 7 (35%) vs 13 (65%) had culture conversion (P=0.0006) in arms A and B respectively. In ATT arm the body weight at baseline was 62.6±8.3 kg, after one month the average gain was 1.1 kg (P=0.03). The mean starting weight in Immunoxel arm was 54.1±7.5 kg, the immunotherapeutic intervention helped them to gain 2.8 kg (P=0.0000004). The hemoglobin (Hb) had increased by 2.95 g/L from 116.1 to 119 (P=0.03) in arm A, whereas those who received Immunoxel had Hb risen by 10.4 g/L from 117.3 to 127.7 (P=0.00007). Erythrocyte sedimentation rate in arms A and B decreased from 19.1 to 13.1 (P=0.00001) and 20.5 to 10.5 (P=0.0003) respectively. The leukocyte count decreased from 10.8 to 9 x109 (P=0.0007) and 9.5 to 5.8 x109 (P=0.00005). Clinical improvement was seen in 7 out 20 and 18 oat 19 patients in arms A and B. In each arm one patient died at the end of follow-up. The arms A and B had 7 and 2 patients co­ntacted with HIV who seemed to respond to therapy at the same rate as TB patients. Other solid formulations of Immunoxel are now being tested and results will be available in near future.
Conclusion: The preliminary findings indicate that solid formulation of Dzherelo is equally or perhaps even more effective than liquid formulation and improves significantly the clinical efficacy of anti-TB drugs and shortens treatment duration.

Read also:

Treatment of cavitary and infiltrating pulmonary tuberculosis with and without the immunomodulator DzhereloClinical validation of sublingual formulations of Immunoxel (Dzherelo) as an adjuvant immunotherapy in treatment of TB patientsImmune approaches in tuberculosis therapy: a brief overviewAdjuvant Immunotherapy of Extensively Drug-Resistant Tuberculosis (XDR-TB) in Ukraine
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