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: TB is typically caused by Mycobacterium tuberculosis, a symbiotic bacterium present in one-third of the world's population. There any many factors triggering overt clinical disease in a small proportion of humans. In our view the major role in the process is played by the host's immune response, especially self-directed, destructive inflammation. Conventional chemotherapy produces bactericidal or bacteriostatic effects, but immunopathological changes can only be corrected by immunotherapy. Various attempts have been made to identify the optimal immune intervention. Some have shown promising effects, but many have failed. It is commonly believed that the field started in 1890: the year Robert Koch announced his tuberculin therapy. In the Pên Ts'ao Kang Mu, classical Chinese materia medica, published during Ming dynasty, Li Shi Chen (1518-1593) recommended, as a remedy for hemoptysis, to collect from the sputum "…blood lumps, roast them till they are black, and take then them as a powder". In retrospect, this is perhaps the earliest recorded reference relating to immunotherapy of TB with heat-killed mycobacteria. Modern science is obviously geared toward more palatable approach, but without hindsight from often disdained empirical evidence no progress can be made. The clinical experience from various trial and error processes is briefly discussed in this review.Expert Review of Anticancer Therapy 03/2012; 10(3):381-9. · 3.22 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