title: Clinical validation of sublingual formulations of Immunoxel (Dzherelo) as an adjuvant immunotherapy in treatment of TB patients.
abstract: Immunoxel (Dzherelo) is a water-alcohol extract of medicinal plants used in Ukraine as an adjunct immunotherapy to TB and HIV therapy. Four types of solid sublingual formulations of Immunoxel were made: sugar dragées, sugar-coated pills, gelatin pastilles and dried-honey lozenges. They were administered once-daily along with TB drugs. After 1 month, 84.1% of TB patients became sputum-negative with rates in individual groups of 89.5, 70, 76.9 and 100%, respectively. The conversion rate was independent of bodyweight, age, gender, differences in chemotherapy regimens or whether subjects had newly diagnosed TB, re-treated TB, multidrug-resistant TB or TB with HIV coinfection. Patients experienced earlier clinical improvement, faster defervescence, weight gain, a higher hemoglobin content and reduced inflammation as evidenced by lower leukocyte counts and erythrocyte sedimentation rate. By contrast, in the placebo group, only 19% of patients had converted. These findings imply that mucosal delivery of solid Immunoxel is equivalent to the original liquid formula given per os twice-daily for 2-4 months.
authors.affiliation: Lisichansk Tuberculosis Dispensary, Lisichansk, Ukraine.
authors.forename: Yuri V
authors.initials: YV
authors.lastname: Efremenko
authors.forename: Olga V
authors.initials: OV
authors.lastname: Arjanova
authors.forename: Natalia D
authors.initials: ND
authors.lastname: Prihoda
authors.forename: Larisa V
authors.initials: LV
authors.lastname: Yurchenko
authors.forename: Nina I
authors.initials: NI
authors.lastname: Sokolenko
authors.forename: Igor V
authors.initials: IV
authors.lastname: Mospan
authors.forename: Volodymyr S
authors.initials: VS
authors.lastname: Pylypchuk
authors.forename: John
authors.initials: J
authors.lastname: Rowe
authors.forename: Vichai
authors.initials: V
authors.lastname: Jirathitikal
authors.forename: Aldar S
authors.initials: AS
authors.lastname: Bourinbaiar
authors.forename: Galyna A
authors.initials: GA
authors.lastname: Kutsyna
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D028321:Plant Preparations / Q000008:administration & dosage*; D013997:Time Factors; D018088:Tuberculosis, Multidrug-Resistant / Q000097:blood / Q000150:complications / Q000453:epidemiology / Q000628:therapy*; D014455:Ukraine
chemical_list: D028321:Plant Preparations; C534980:dzherelo