title: Treatment of cavitary and infiltrating pulmonary tuberculosis with and without the immunomodulator Dzherelo.
abstract: An open-label, 60-day trial was conducted in 75 newly diagnosed tuberculosis (TB) patients to assess the adjunctive effect of the oral immunomodulator Dzherelo with standard anti-TB chemotherapy (ATT) consisting of izoniazid, rifampicin, pyrazinamide and streptomycin (HRZS) administered as directly observed therapy (DOT). Group 1 (n = 28) with cavitary TB and group 2 (n = 17) with infiltrating pulmonary TB received 50 drops of Dzherelo twice daily in addition to HRZS. Group 3 (n = 30), which served as a control, received ATT only. Liver damage indicators, bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) decreased to normal levels in groups 1 and 2, but increased significantly in group 3. Kidney failure markers, urea and creatinine, normalized in Dzherelo recipients, but were unchanged or worsened in the ATT-only group. The changes in serum lactate dehydrogenase, catalase, malondialdehyde and diene conjugates suggested that Dzherelo downregulates TB-associated inflammation. The anti-inflammatory property of Dzherelo was further supported by a favourable haematology profile, reduced erythrocyte sedimentation rate and faster defervescence. Radiological recovery was significant in both Dzherelo groups, but not in the control group (p = 0.0085, p = 0.025 and p = 0.23, respectively). These findings correlated positively with sputum smear conversion and clinical findings (r = 0.94; p < 0.05). Mycobacterial clearance at day 30 was observed in 77%, 72% and 40% of patients in groups 1, 2 and 3, respectively. After 2 months sputum conversion rates in groups 1, 2 and 3 were 93%, 89% and 70%, respectively. Sixty-day treatment outcomes in groups 1, 2 and 3 as assessed by improvement in clinical features and respiratory function attained respective p-values of 0.008, 0.25 and 0.72, and 0.013, 0.48 and 0.0015. Dzherelo is thus useful as an immunotherapeutic adjunct in the management of TB.
authors.affiliation: Department of Phtysiatry and Pulmonology, Kharkov National Medical University, Kharkov, Ukraine. zaitzeva@list.ru
authors.forename: S I
authors.initials: SI
authors.lastname: Zaitzeva
authors.forename: S L
authors.initials: SL
authors.lastname: Matveeva
authors.forename: T G
authors.initials: TG
authors.lastname: Gerasimova
authors.forename: Y N
authors.initials: YN
authors.lastname: Pashkov
authors.forename: D A
authors.initials: DA
authors.lastname: Butov
authors.forename: V S
authors.initials: VS
authors.lastname: Pylypchuk
authors.forename: V M
authors.initials: VM
authors.lastname: Frolov
authors.forename: G A
authors.initials: GA
authors.lastname: Kutsyna
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000627:therapeutic use; D023801:Directly Observed Therapy; D004359:Drug Therapy, Combination; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use; D056747:Immunomodulation; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D028321:Plant Preparations / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use; D010946:Plants, Medicinal; D016896:Treatment Outcome; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy* / Q000382:microbiology; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D007155:Immunologic Factors; D028321:Plant Preparations; C534980:dzherelo