Effect of rifampin with bio-enhancer in the treatment of newly diagnosed sputum positive pulmonary tuberculosis patients: A double-center study.

OBJECTIVE: To compare a fixed-dose combination (FDC) of Rifampicin 450 mg, Isoniazid 300 mg, Pyrazinamide 1500 mg and Ethambutol 800 mg (usual care group) and regimen of Rifampicin 200 mg, Isoniazid 300 mg and piperine 10 mg along with Pyrazinamide 1500 mg and Ethambutol 800 mg (intervention care group). METHODS: A randomized, prospective, parallel group study was conducted on newly diagnosed tuberculosis patients. The drugs were given during intensive and continuous phase of treatment to newly diagnosed sputum positive pulmonary tuberculosis. All the patients were subjected to sputum examination, biochemical investigations followed by adverse drug event (ADE) monitoring. RESULTS: A total of 63 patients completed the study. No significant difference was observed in baseline characteristics of patients between the study groups. At the end of the continuous phase, both the groups showed zero bacteria detection. However, in the intervention group, the rate of sputum conversion was much faster than the usual care group. The rate of increase in SGOT and SGPT was much higher in the usual care group (p < 0.0001) than the interventional group (p < 0.05). Urea and creatinine has also increased from pre-treatment to end visit. The number of patients reported ADEs was less in the intervention care group (22.22%) when compared to the usual care group (36.84%). CONCLUSION: Rifampicin 200 mg with piperine 10 mg FDC is compatible with the usual CAT-1 regimen.

Periostin - A Novel Systemic Biomarker for Eosinophilic Airway Inflammation: A Case Control Study.

INTRODUCTION: Chronic airway inflammation and remodelling are fundamental features of asthma. The molecular phenotypes in asthma are Th2 high and Th2 low. Serum periostin is a biomarker which aid in understanding Th2 high eosinophilic asthma. AIM: The present study aimed to identify whether or not serum periostin is a systemic biomarker for eosinophilic airway inflammation in asthmatics. MATERIALS AND METHODS: The study was designed as a prospective, case control study. Patients who presented with consistent symptoms of asthma and confirmed by spirometry with reversibility were the cases. The controls were healthy subjects who had no history of lung disease with normal lung function. The sputum and blood samples were collected from both the groups. Sputum eosinophils, Absolute Eosinophil Counts (AEC) and serum periostin levels were compared between the groups. RESULTS: The study comprised of 101 participants in which 30 were controls and 71 were cases. In the study group, mean post FEV1 was 64.45. There was a positive correlation of sputum eosinophils with severity of obstruction. The ROC curve analysis showed the cut-off value of 24.556 for serum periostin with the p-value of <0.001. As the severity of obstruction increased, the serum periostin levels were also found to be increased. Serum periostin had a sensitivity and specificity of 97.18% and 86.67% with a diagnostic accuracy of 94.06%. CONCLUSION: Serum periostin appears to be a more sensitive tool for detection of airflow limitation in asthmatic patients with a Th2 high eosinophilic phenotype when compared to AEC and sputum eosinophils.

Effect of vitamin D3 on mild to moderate persistent asthmatic patients: A randomized controlled pilot study.

BACKGROUND: Asthma is a common chronic inflammatory disease of the bronchial airways. Well defined treatment options for asthma are very few. The role of vitamin D3 on asthma is still baffling. AIM: We have examined the effect of vitamin D3 supplementation in mild to moderate persistent asthma patients. MATERIALS AND METHODS: We conducted an open labeled, randomized comparative trial in 48 asthma patients. The study duration was about 90 days. The study had a run-in-period of 2 weeks. At the end of run-in-period, patients were divided into two groups: Usual care group (n = 31) patients received budesonide and formoterol and intervention care group (n = 32) patients received vitamin D3 supplementation along with their regular medicine. RESULTS: The primary outcome of the study was to measure the improvement in forced expiratory volume in 1 second (FEV1). Patients in both groups had a significant improvement in FEV1 at the end of the study. The mean difference in percentage predicted FEV1 in usual care and intervention care group was 4.95 and 7.07 respectively. CONCLUSION: The study concluded that adjunctive therapy of vitamin D3 is effective in asthma patients. The present study will be an evidence based report; however, future studies are warranted in longer duration of time to substantiate the present findings.

Association of interleukin-10 cytokine expression status with HLA non-DRB1*02 and Mycobacterium bovis BCG scar-negative status in south Indian pulmonary tuberculosis patients.

HLA DRB1*02 and its subtypes predispose individuals for a far-advanced sputum-positive pulmonary tuberculosis transcending ethnic boundaries. Mycobacterium bovis BCG does not afford the desired protection against adult pulmonary tuberculosis, and a spectrum of immune reactivity exists in controls and hospital contacts. All of these findings have been identified and demonstrated in areas of endemicity. Skewing of immunity from protective to pathogenic may involve a shift in the Th1-Th2 paradigm. To elaborate these ideas, we studied gamma interferon (IFN-gamma), interleukin-4 (IL-4), and IL-10 cytokine expression in 71 adult pulmonary tuberculosis patients and 74 controls from areas of endemicity in south India by 48-h microculture and reverse transcription-PCR. Most of the patients and controls expressed IFN-gamma de novo, and in the presence of purified protein derivative (PPD), all of them expressed significantly higher levels of IFN-gamma, suggesting a PPD-specific recall memory. HLA DRB1* allele-dependent IFN-gamma expression was identified only in controls, suggesting a skewing of the immune response in patients. In contrast to the case for IFN-gamma, only some patients and controls expressed IL-4 or IL-10 (Th2 profile); thus, the Th1 profile was identifiable only by a nonexpression of IL-4 or IL-10 in this area of endemicity. The Th2 profile was associated with HLA non-DRB1*02 and BCG scar-negative status in patients, attributing a significant risk (odds ratio = 2.074; 95% confidence interval = 0.612 to 7.07). It is possible that Mycobacterium tuberculosis (PPD)-specific IL-10 is expressed preemptively in unvaccinated (BCG scar-negative) individuals with a non-DR2 genetic background by chronic exposure in this area of endemicity and leads to pulmonary tuberculosis of adults.