Enhancement of efficacy of tuberculosis drugs with Immunoxel (Dzherelo) in HIV-infected patients with active pulmonary tuberculosis.
ABSTRACT Immunoxel (Dzherelo) is an oral, herbal immunomodulator used in Ukraine for adjunct therapy of infectious and autoimmune diseases. Antiretroviral drug-naive, tuberculosis (TB)/HIV coinfected patients with active pulmonary TB were divided into two arms, A (n = 20) and B (n = 20), to receive first-line anti-TB therapy (ATT) or ATT + Dzherelo, respectively. As a result, three (16%) versus 12 (67%; p = 0.003) patients had Mycobacterium tuberculosis culture conversion, with time to negative culture of 6 and 4 months in arms A and B, respectively. In the ATT-alone arm, the healing of pulmonary cavitations was observed in 25% of patients at weeks 24-28, while 60% of individuals in arm B healed at 16-18 weeks (p = 0.025). The TB lesions, on chest x-ray, had cleared in 46 and 84%, with time-to-clearance of 24-28 and 16-18 weeks in arms A and B, respectively. In the ATT-alone arm, the bodyweight at baseline was 64 +/- 6.3 kg, with 13 cachexic patients who had an average weight deficit of -5.2 +/- 1.7 kg. At the end of 6 months of follow-up, they have lost an additional 0.6 kg (-5.8 +/- 2.4). The study entry-level weight in arm B was 52 +/- 5.7 kg, with 12 individuals who had a body mass deficit of -8.5 +/- 2.7 kg. The immunotherapeutic intervention increased bodyweight by an average of 5.8 +/- 2.6 kg above baseline (p < 0.0001). The inclusion of Dzherelo into the ATT regimen decreased the incidence of new opportunistic infections (OI) with three episodes of OI versus 12 in arm A (p = 0.003). These findings indicate that Dzherelo contributes positively to the clinical efficacy of TB drugs.
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ABSTRACT: For centuries the treatment of TB has presented an enormous challenge to global health. In the 20th century, the treatment of TB patients with long-term multidrug therapy gave hope that TB could be controlled and cured; however, contrary to these expectations and coinciding with the emergence of AIDS, the world has witnessed a rampant increase in hard-to-treat cases of TB, along with the emergence of highly virulent and multidrug-resistant Mycobacterium tuberculosis strains. Unfortunately, these bacteria are now circulating around the world, and there are few effective drugs to treat them. As a result, the prospects for improved treatment and control of TB in the 21st century have worsened and we urgently need to identify new therapies that deal with this problem. The potential use of immunotherapy for TB is now of greater consideration than ever before, as immunotherapy could potentially overcome the problem of drug resistance. TB immunotherapy targets the already existing host anti-TB immune response and aims to enhance killing of the bacilli. For this purpose, several approaches have been used: the use of anti-Mycobacteria antibodies; enhancing the Th1 protective responses by using mycobacterial antigens or increasing Th1 cytokines; interfering with the inflammatory process and targeting of immunosuppressive pathways and targeting the cell activation/proliferation pathways. This article reviews our current understanding of TB immunity and targets for immunotherapy that could be used in combination with current TB chemotherapy.Immunotherapy 02/2012; 4(2):187-99. · 2.39 Impact Factor
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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.Immunotherapy 03/2012; 4(3):273-82. · 2.39 Impact Factor
Article: Immunotherapy for TB.[Show abstract] [Hide abstract]
ABSTRACT: Mycobacterium tuberculosis was one of the first human pathogens to be identified as the cause of a specific disease--TB. TB was also one of the first specific diseases for which immunotherapy was attempted. In more than a century since, multiple different immunotherapies have been attempted, alongside vaccination and antibiotic treatment, with varying degrees of success. Despite this, TB remains a major worldwide health problem that causes nearly 2 million deaths annually and has infected an estimated 2 billion people. A major reason for this is that M. tuberculosis is an ancient human pathogen that has evolved complex strategies for persistence in the human host. It has thus been long understood that, to effectively control TB, we will need to address the ability of the pathogen to establish a persistent, latent infection in most infected individuals. This review discusses what is presently known about the interaction of M. tuberculosis with the immune system, and how this knowledge has been used to design immunotherapeutic strategies.Immunotherapy 06/2012; 4(6):629-47. · 2.39 Impact Factor