Plant-based formulation in the management of chronic obstructive pulmonary disease: a randomized double-blind study.

BACKGROUND: A randomized double-blind placebo controlled clinical study was undertaken to investigate the safety and efficacy of a plant-based formulation (DCBT1234-Lung KR), which earlier through 2 trials was found to improve FEV1 and the quality of life of COPD patients. OBJECTIVE: The efficacy of DCBT1234-Lung KR was assessed using pulmonary function tests, arterial blood gas (ABG) analyses and the clinical symptoms of COPD in a 6-month study period against a matching placebo and a biomedical drug combination (salbutamol+theophylline+bromhexine). METHODS: One hundred and five subjects aged between 35 and 85 years with a smoking history of more than 20 pack years, showing little or no improvement in FEV1 upon a bronchial challenge of 200 microg of inhaled salbutamol and exhibiting ABG percentage of less than 85% of oxygen saturation were taken up for the study. The study had 3 arms viz., the plant-based formulation (DCBT1234-Lung KR), placebo and salbutamol (12 mg/day) plus theophylline (300 mg/day) plus bromhexine (24 mg/day). The end point of the study was determined as an improvement of FEV1 by 200 mL and/or increased ABG values (>90% PaO2) and clinical symptoms like dyspnoea, wheezing, cough, expectoration, disability, and sleep disturbances. RESULTS: DCBT1234-Lung KR patients showed statistically significant (95% level) improvement in FEV1 and PaO2 in comparison with salbutamol+theophylline+bromhexine and placebo patients. Twenty-three per cent of DCBT1234-Lung KR patients, 19% of salbutamol+theophylline+bromhexine group and 12% of placebo group patients showed the desired 200 mL improvement in FEV1 values in comparison with the other 2 arms. Improved PaO2 was observed in 15.4% of the DCBT1234-Lung KR patients while no improvement was seen with patients in any other arms. Symptoms like dyspnoea, wheezing, cough, expectoration, disability and sleep disturbances also significantly reduced in DCBT1234-Lung KR and the biomedical group patients, but not in the placebo arm. CONCLUSIONS: DCBT1234-Lung KR was equivalent, if not better than the present day treatment with salbutamol, theophylline and bromhexine combination in COPD patients and this was ascertained using FEV1 and ABG values.

Colonization of mycoplasma in the upper respiratory tract of AIDS patients with pulmonary symptoms in Chennai, India.

BACKGROUND & OBJECTIVE: Mycoplasmas have been implicated in causing minor to severe respiratory infections in man. Mycoplasmas are considered to act as cofactors in patients with AIDS. A preliminary study was conducted to isolate mycoplasmas from sputum specimens of AIDS patients and non-HIV patients with underlying pulmonary symptoms and signs. METHODS: A total of 130 sputum samples (100 from AIDS patients and 30 from non-HIV) were cultured on standard pleuropneumonia-like organisms (PPLO) glucose agar up to 3 wk. The plates were examined for the presence of fried-egg colonies characteristic of Mycoplasma. Subsequently the plates were stained using Diene's stain. Sputum specimens from the AIDS patients were also screened for other bacterial pathogens. RESULTS: Mycoplasmas were detected from 36 (36%) of the AIDS patients and only 5 (16.6%) of the non HIV control individuals with underlying pulmonary symptoms. Data on the detection rates of other microorganisms from the AIDS cases were also analysed. INTERPRETATION & CONCLUSION: This preliminary study provided supportive evidence that mycoplasma colonized in upper respiratory tract of individuals with AIDS to a larger extent than that of the non HIV subjects with pulmonary symptoms. Further studies need to be done to characterize mycoplasma isolates to species level.

Decreased bioavailability of rifampin and other antituberculosis drugs in patients with advanced human immunodeficiency virus disease.

We evaluated the effects of human immunodeficiency virus (HIV) disease on pharmacokinetics of antituberculosis medications by measuring concentrations of isoniazid and rifampin in blood and of pyrazinamide and ethambutol in urine. Peak concentration and exposure were reduced for rifampin, and rapid acetylators of isoniazid had lower drug levels. HIV and HIV-tuberculosis patients who have diarrhea and cryptosporidial infection exhibit decreased bioavailability of antituberculosis drugs.

Malabsorption of rifampin and isoniazid in HIV-infected patients with and without tuberculosis.

The absorption of rifampin, isoniazid, and D-xylose in patients with human immunodeficiency virus (HIV) infection and diarrhea, in patients with HIV infection and tuberculosis (TB), in patients with pulmonary TB alone, and in healthy subjects was studied. Percentage of dose of the drugs, their metabolites, and D-xylose excreted in urine were calculated. A significant reduction in the absorption of drugs and D-xylose in both the HIV infection/diarrhea and HIV infection/TB groups was observed (P<.05), and the correlation between them was significant. Our results indicate that patients with HIV infection and diarrhea and those with HIV infection and TB have malabsorption of rifampin and isoniazid.