A 5-drug daily regimen with moxifloxacin results in significantly higher sputum culture conversion in the first 2 months compared with a thrice-weekly, 4-drug regimen in patients with newly diagnosed sputum-positive pulmonary tuberculosis.
The benefit of daily over thrice-weekly antituberculosis therapy among HIV-positive patients with pulmonary tuberculosis (TB) who are receiving antiretroviral therapy remains unproven. OBJECTIVE To compare the efficacy and safety of daily, part-daily, and intermittent antituberculosis therapy regimens in the treatment of HIV-associated pulmonary TB. DESIGN, SETTING, AND PARTICIPANTS This open-label, randomized clinical trial was conducted by the National Institute for Research in Tuberculosis, south India. Adults infected with HIV with newly diagnosed, culture-positive, pulmonary TB were enrolled between September 14, 2009, and January 18, 2016. INTERVENTIONS Patients were randomized to daily, part-daily, and intermittent antituberculosis therapy regimens, stratified by baseline CD4 lymphocyte count and sputum smear grade. Antiretroviral therapy was initiated as per national guidelines. Clinical and sputum microbiological examinations of patients were performed monthly until 18 months after randomization. Adverse events were recorded using standard criteria. MAIN OUTCOMES AND MEASURES The primary outcome was favorable response, defined as treatment completion with all available sputum cultures negative for Mycobacterium tuberculosis during the last 2 months of treatment. Unfavorable responses included treatment failures, dropouts, deaths, and toxic effects among regimens. RESULTS Of 331 patients (251 [76%] male; mean [SD] age, 39 [9] years; mean [SD] HIV viral load, 4.9 [1.2] log 10 copies/mL; and median [interquartile range] CD4 lymphocyte count, 138 [69-248] cells/μL), favorable responses were experienced by 91% (89 of 98), 80% (77 of 96), and 77% (75 of 98) in the daily, part-daily, and intermittent regimens, respectively. With the difference in outcome between daily and intermittent regimens crossing the O'Brien-Fleming group sequential boundaries and acquired rifampicin resistance emergence (n = 4) confined to the intermittent group, the data safety monitoring committee halted the study. A total of 18 patients died and 18 patients dropped out during the treatment period in the 3 regimens. Six, 4, and 6 patients in the daily, part-daily, and intermittent regimens, respectively, had TB recurrence. CONCLUSIONS AND RELEVANCE Among HIV-positive patients with pulmonary TB receiving antiretroviral therapy, a daily anti-TB regimen proved superior to a thrice-weekly regimen in terms of efficacy and emergence of rifampicin resistance. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00933790
Introduction COVID19* is a new disease with significant mortality risk. Because of the scarcity of the study on factors associated with the mortality in Tamil Nadu present study was done to determine the factors associated with the outcome of the COVID19 patients admitted in a tertiary care hospital, Madurai. Method ology : 4530 lab confirmed COVID19 patients admitted from March to August 31st , 2020; excluding the non-responders or who gave incomplete information were included in the study. Data retrieved from Case Investigation Forms *filled through telephonic interview. Chi -square test, Univariate and multivariate logistic regression were used to find out the association between the factors and risk of death(outcome). Results Out of 4530 COVID19 positive patients 381(8.4%) died and 4149(91.6%) were discharged. Using multivariate logistic regression* following were the factors predicted to be associated with mortality:Age group <17yrs(PR = 4.12),30–44yrs(PR = 2.28),45–59(PR = 3.12),60–69(PR = 4.26) and ≥ 70(PR = 7.05); male gender(PR = 1.26); breathlessness at the time of admission(PR = 7.05); with 1symptom (PR = 2.58), 2symptoms(PR = 3.16) and ≥ 3 symptoms(PR = 2.45); chronic kidney disease(PR = 3.07), malignancy(PR = 2.39); other chronic diseases(PR = 1.89); having only diabetes(PR = 1.58); diabetes with hypertension (PR = 1.70); diabetes with heart disease(PR = 1.94); Hypertension with heart disease(PR = 2.30); diabetes with hypertension and heart disease(PR = 1.58). Survival probability* was more than 90% when patient gets admitted within a week after symptom onset,<80% for between 7 and 10 days and declines thereafter. Conclusion Early insights into factors associated with COVID-19 deaths have been generated in the context of a global health emergency *which may help the treating physician.
background Shortening tuberculosis (TB) treatment duration is a research priority. We tested the efficacy and safety of 3-and 4-month regimens containing moxifloxacin in a randomised clinical trial in pulmonary TB (PTB) patients in South India. methods New, sputum-positive, adult, HIV-negative, non-diabetic PTB patients were randomised to 3-or 4-month moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E)] or to a control regimen (2H 3 R 3 Z 3 E 3 /4R 3 H 3 ) [C]. The 4 test regimens were 3R 7 H 7 Z 7 E 7 M 7 [M3], 2R 7 H 7 Z 7 E 7 M 7 /2R 7 H 7 M 7 [M4], 2R 7 H 7 Z 7 E 7 M 7 /2R 3 H 3 M 3 [M4-I] or 2R 7 H 7 Z 7 E 7 M 7 /2R 3 H 3 E 3 M 3 [M4-IE]. Treatment was directly observed. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post-treatment. The primary end point was TB recurrence post-treatment.results Of 1371 patients, randomised, modified intention-to-treat (ITT) analysis was done in 1329 and per-protocol (PP) analysis in 1223 patients. Regimen M3 was terminated due to high TB recurrence rates. 'Favourable' response at end of treatment was 96-100% in the moxifloxacin regimens and 93% in the control regimen. Among these, the TB recurrence occurred in 4.1% in the M4 regimen and in 4.5% in the control regimen and demonstrated equivalence within a 5% margin (95% CI À3.68, 4.55). Similar findings were observed in modified ITT analysis. The TB recurrence rates in the M4-I and M4-IE regimens did not show equivalence with the control regimen. Sixteen (1.4%) of 1087 patients in the moxifloxacin regimens required treatment modification.conclusion The 4-month daily moxifloxacin regimen [M4] was found to be equivalent and as safe as the 6-month thrice-weekly control regimen.keywords tuberculosis, chemotherapy of tuberculosis, short course chemotherapy, moxifloxacin, fluoroquinolones Sustainable Development Goals (SDGs): SDG 3 (good health and well-being), SDG 17 (partnerships for the goals)
BACKGROUNDChronic obstructive pulmonary disease (COPD) is associated with reduction in daily physical activity that contribute to the patient's disability and poor health-related quality of life. Pulmonary rehabilitation plays an essential role in the management of symptomatic patients with COPD by breaking the vicious circle of dyspnoea-decreased activity-deconditioning-isolation. Several randomised studies and meta-analyses greatly established the benefits of pulmonary rehabilitation. Pulmonary rehabilitation is recommended in a number of influential guidelines. In this study, we have compared the symptomatic wellbeing of COPD patients attending Pulmonology OP at Govt. Rajaji Hospital, Madurai.In this study, we aim to evaluate the benefits of Pulmonary Rehabilitation in COPD patients who are on Pharmacological treatment (Standard of care management) for COPD. MATERIALS AND METHODSTotal of 80 COPD (FEV1/FVC less than 0.7 with no reversibility after bronchodilators in Pulmonary Function Test) patients were taken with various degrees of obstruction (24-Mild, 32-Moderate, 24-Severe). The degree of obstruction was determined by FEV1 as per GOLD guidelines, FEV1 > 80-Mild, FEV1-Moderate and FEV1-Severe Obstruction. They were divided into two groups with 40 patients in each group (12-Mild, 16-Moderate, 12-Severe). One set of patients had only pharmacological treatment, whereas the other set had a combined pulmonary rehabilitation with pharmacological treatment. The improvement in Borg scale, Visual analogue scale, MMRC grading of dyspnea and 6-minute walk distance were compared between the two groups. RESULTSThe group with combined pulmonary rehabilitation with pharmacological treatment had a significant improvement in dyspnea index and a significant improvement in the 6-minute walk distance. The values were statistically significant (P < 0.05). CONCLUSIONThe group with combined pulmonary rehabilitation with pharmacological treatment had a significant improvement in dyspnea index and a significant improvement in the 6-minute walk distance. The values were statistically significant (P < 0.05). The benefits of pulmonary rehabilitation were greater in patients with severe COPD. The more severe the obstruction, the greater the benefit. KEYWORDSPulmonary Rehabilitation, COPD, Breathlessness Index. HOW TO CITE THIS ARTICLE:Babu BK, Rathinam P, Elamparithi S, et al. Role of pulmonary rehabilitation in COPD patients.
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