Document Detail

Treatment of cavitary and infiltrating pulmonary tuberculosis with and without the immunomodulator Dzherelo.
MedLine Citation:
PMID:  19456829     Owner:  NLM     Status:  MEDLINE    
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.
S I Zaitzeva; S L Matveeva; T G Gerasimova; Y N Pashkov; D A Butov; V S Pylypchuk; V M Frolov; G A Kutsyna
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't     Date:  2009-05-16
Journal Detail:
Title:  Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases     Volume:  15     ISSN:  1469-0691     ISO Abbreviation:  Clin. Microbiol. Infect.     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-11-25     Completed Date:  2010-01-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9516420     Medline TA:  Clin Microbiol Infect     Country:  France    
Other Details:
Languages:  eng     Pagination:  1154-62     Citation Subset:  IM    
Department of Phtysiatry and Pulmonology, Kharkov National Medical University, Kharkov, Ukraine.
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MeSH Terms
Administration, Oral
Antitubercular Agents* / administration & dosage,  therapeutic use
Directly Observed Therapy
Drug Therapy, Combination
Immunologic Factors* / administration & dosage,  immunology,  therapeutic use
Middle Aged
Plant Preparations* / administration & dosage,  immunology,  therapeutic use
Plants, Medicinal
Treatment Outcome
Tuberculosis, Pulmonary / drug therapy*,  microbiology
Young Adult
Reg. No./Substance:
0/Antitubercular Agents; 0/Immunologic Factors; 0/Plant Preparations; 0/dzherelo

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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