Evaluation of the Efficacy and Safety of Intravenous Immunoglobulin (IVIG) in Moderate-to-Severe Hospitalized COVID-19 Patients: A Randomized, Open-Label Parallel-Group Study.

Purpose: Since February 2020, the world has been overwhelmed by the SARS-CoV-2 outbreak, and several patients suffered interstitial pneumonia and respiratory failure requiring mechanical ventilation, threatening the capability of healthcare systems to handle this amount of critical cases. Intravenous immunoglobulins (IVIG) possess potential immunomodulatory properties beneficial for COVID-19 patients, yet evidence supporting IVIG as adjunctive therapy remains sparse. This study evaluated the outcomes of adjunctive IVIG with the standard of care (SoC) in moderate-to-severe COVID-19 patients. Methods: This randomized study included 59 moderate-to-severe COVID-19 patients with known comorbidities. One arm (n = 33) received high-dose IVIG (400 mg/kg/day) within 48 hours for five days alongside SoC, while the other arm (n = 26) received SoC, comprising steroids, enoxaparin, and remdesivir. The primary endpoint was clinical improvement, as measured by the National Early Warning Score 2 (NEWS2) and discharged/death proportions. Secondary outcomes included IVIG safety, hospitalization duration, changes in oxygen saturation, inflammatory markers, IgG titer, CTSS (CT severity score), and radiological findings. Results: There was an improvement in the NEWS2 at the end of treatment in the IVIG arm (5.67 vs. 5.96). A significant absolute effect improvement (Day 1 vs. Day 9) was seen in serum LDH, D-dimer, hs-CRP, IL-6, CTSS, procalcitonin, respiratory rate, and chest radiographic findings. SARS-CoV-2 IgG titer increased significantly in the IVIG arm. There was a statistically significant reduction in mortality in the IVIG group (5 vs. 10). Conclusion: IVIG was a safe and effective adjunctive therapy to SoC treatment in moderate-to-severe COVID-19 patients needing ventilatory support. Furthermore, studies are required to validate our findings. This trial is registered with CTRI/2021/05/033622.

Effect of Supplementation of Vitamin C and Thiamine on the Outcome in Sepsis: South East Asian Region.

INTRODUCTION: The global burden of sepsis is overwhelming and novel therapeutic agents is the need of the hour. The present study was designed to understand the role of Malondialdehyde as a marker of the oxidative stress in sepsis, as well as the effect of supplementation of Vitamin C and Thiamine in patients of sepsis. METHODS: 80 patients of sepsis were randomly divided into 4 groups of 20 each. Twenty age-sex matched healthy volunteers were chosen as controls. The first group received Vitamin C, the second group received Thiamine, the third group received both and the fourth group received neither. Vitamin C (2g 8 hourly) and Thiamine (200 mg 12 hourly) were given intravenously for five days. The outcome was recorded in terms of mortality in the various groups as well as by the improvement in SOFA scores (ΔSOFA). The serum levels of Vitamin C, Thiamine and Malondialdehyde were estimated. RESULTS: Among the 80 patients, 17 (21%) were in septic shock. The mortality rate was 10% overall, and 47% among patients of septic shock. No additional mortality benefit was observed in the groups supplemented with Vitamin C and Thiamine. However, the ΔSOFA score in patients who received both Vitamin C and Thiamine was significantly higher as compared to the other groups. The mean malondialdehyde level was higher in patients of sepsis (1.81±1.18 µmol/l) as compared with healthy controls (0.78 ± 0.36 µmol/l). The Vitamin C level and Thiamine level (estimated indirectly by TPP effect), at presentation were 5.14±4.19 ng/ml and 52.99±28.45 % in patients of sepsis, which was significantly lower than that in healthy controls, in whom the levels were 14.64±5.51 ng/ml and 27.55±13.67% respectively. CONCLUSION: Vitamin C and Thiamine supplementation is a cost-effective approach with a good safety profile. Additional studies including a larger population is required to study the mortality benefits and reaffirm our findings.

Lactate enhanced-quick Sequential Organ Failure Assessment 2 (LqSOFA2): A new score for bedside prognostication of patients with sepsis.

Background & objectives: Early diagnosis and prompt treatment remain a challenge in sepsis. To study the role of quick Sequential Organ Failure Assessment (qSOFA), blood lactate levels and a new score Lactate - Enhanced-qSOFA 2 (LqSOFA2) in predicting outcome in patients with sepsis and their association with established severity scores. Methods: This was a prospective, observational study in patients admitted to ICU of a tertiary care hospital in north India. qSOFA, Acute Physiology and Chronic Health Evaluation II (APACHE II), SOFA score and LqSOFA2 were calculated in 150 patients with sepsis. Measurements of lactate and SOFA score was done on days one, three and seven. Results: The mean arterial pressure (MAP) was significantly higher in survivors (70.14±19.54 vs. 48.53±26.86). The mean qSOFA significantly predicted mortality (1.81 vs. 2.63; P<0.0001). The mean lactate on days one, three and seven in survivors were 2.27±0.91, 1.72±0.77 and 1.14±0.48, respectively, while it was 4.32±2.35, 3.57±2.28 and 2.13±1.22, respectively, in the non-survivor group (P<0.001). The new score LqSOFA2 also significantly predicted mortality between non survivors and survivors (3.52±0.71 vs. 2.37±0.91). There was a significant correlation of qSOFA with SOFA and APACHE II on day one. Lactate levels and SOFA correlated on all three days. Interpretation & conclusions: qSOFA, a novel score and lactate can independently predict mortality in patients with sepsis. They correlate with APACHE II and SOFA but fail to equilibrate with either. The combination score LqSOFA2 showed marginal (statistically insignificant) increase in predictive accuracy and specificity when compared to lactate or qSOFA alone. Early diagnosis by LqSOFA2 makes it a good standalone bedside prognostic marker.

Adrenomedullin and Its Possible Role in Improved Survival in Female Patients with Sepsis: A Study in the South East Asian Region.

AIMS AND OBJECTIVES: Serum adrenomedullin (ADM) as a prognostic biomarker to study the gender-related differences in mortality pattern and its correlation with the sequential organ failure assessment (SOFA) and acute physiologic assessment and chronic health evaluation II (APACHE II) scores in patients of sepsis. MEASUREMENTS AND MAIN RESULTS: Eighty patients of sepsis of which 36 were males and 44 were females, were taken in the study as per sepsis III guidelines. They were followed up for a period of 28 days. Serum ADM was measured on day 1 and day 5. The endpoint was mortality or survival at day 28 after admission. The death rate among males was higher, with 23 of the total 36 (63.89%) patients having died when compared with females in which 25 patients out of 44 (56.82%) had died. The observed mortality rates correlated well with average APACHE II scores. The average APACHE II score was slightly higher in males (29 ± 8.97) when compared with females (27.02 ± 8.69). Similarly, day 1 SOFA and mean SOFA values were higher in males (10.22 ± 5.36) and (10.73 ± 6.01) when compared with females (8.27 ± 4.79) and (8.89 ± 5.6), respectively. Males despite having higher mortality rates, higher APACHE II, SOFA, and mean SOFA values were still having less mean levels of serum ADM (454.40 ± 81.13 pg/mL) when compared with females (479.62 ± 126.97 pg/mL). CONCLUSION: Adrenomedullin is a protective neurohormone with antibacterial and anti-inflammatory properties. It is elevated in all patients with sepsis but the rise is more so in the female when compared with males. Higher ADM levels in females may suggest the protective effect of ADM as a part of the general protective neurohormonal stress response, which may explain the low death rate in females in sepsis. HOW TO CITE THIS ARTICLE: Daga MK, Kumar L, Mawari G, Kumar N, Singh S, Mishra TK. Adrenomedullin and Its Possible Role in Improved Survival in Female Patients with Sepsis: A Study in the South East Asian Region. Indian J Crit Care Med 2020;24(12):1180-1184.

Mercury air, urine monitoring and health effects on occupationally exposed dental healthcare workers in Delhi, India.

BACKGROUND: Mercury (Hg) is a toxic heavy metal with multiple uses in various medical devices. Hg is used in dentistry as a restorative material. Such use creates significant exposure to dental practitioners. Hence, it is important to assess the risk created by Hg use in healthcare. OBJECTIVE: To quantify airborne Hg vapour exposure and Hg levels in dental healthcare workers, and determine the association of various symptoms and diseases to Hg exposure. METHODS: Air monitoring of Hg vapours were conducted in dental clinics and amalgam rooms. Urine samples were collected from occupationally exposed dental healthcare workers and urine Hg levels were measured. A cross-sectional health survey was conducted in 23 healthcare units of Delhi to determine an association between Hg exposure and various health effects. RESULTS: Hg vapour concentration ranged from 0.96µg/m3 to 15µg/m3, the highest concentration was recorded in the amalgam room (15µg/m3). Urine Hg levels in healthcare workers (0.51±0.17µg/L) were higher than the control (0.29±0.05µg/L). A cross-sectional health survey revealed a significant prevalence of confusion, forgetfulness, muscle spasm, and tremors by the respondents. CONCLUSION: Hg concentration in dental clinics may hover above the prescribed safe levels posing a definitive health risk to healthcare workers. Urinary Hg measurements did not reveal an excess of body burden except in one case. Since Hg bio accumulates, it is probable as these workers grow older, they may end up with a higher body burden of Hg that may lead to a variety of adverse health outcomes.

Systemic inflammatory response syndrome criteria (SIRS) and sepsis 3 criteria for assessing outcomes in sepsis: A prospective observational study.

Background: Sepsis is a major cause of death in hospitalised patients worldwide. Most studies for assessing outcomes in sepsis are from the western literature. Sparse data from Indian settings are available comparing the systemic inflammatory response syndrome (SIRS), Sequential Organ Failure Assessment (SOFA) and quick SOFA (qSOFA) (sepsis 3 criteria) for assessing outcomes in sepsis. In this study, we aimed to compare the SIRS criteria and sepsis 3 criteria to assess disease outcome at day 28 (recovery/mortality) in a North Indian tertiary care teaching hospital. Methods: A prospective observational study was performed in the Department of Medicine from 2019 to early 2020. Patients admitted to the medical emergency with clinical suspicion of sepsis were included. Systemic inflammatory response syndrome, qSOFA and SOFA scores were calculated at the time of presentation to the hospital. Patients were followed through the course of their hospital stay. Results: Out of 149 patients, 139 were included in the analysis. Patients who died had significantly higher mean SOFA, qSOFA scores and mean change in SOFA score than patients who survived (P value <0.01). There was no statistical difference between recovery and deaths at similar SIRS scores. A 40.30% fatality rate was recorded. Systemic inflammatory response syndrome had low Area Under Curve (AUC) (0.47) with low sensitivity (76.8) and specificity (21.7). SOFA had the maximum AUC (0.68) compared to qSOFA (0.63) and SIRS (0.47). SOFA also had the maximum sensitivity (98.1) while the qSOFA score had the maximum specificity (84.3). Conclusion: SOFA and qSOFA scores had superior predictive ability as compared to the SIRS score in assessing mortality in sepsis patients.

Clinical profile of hospitalised moderate category COVID-19 patients: Short study from a Tertiary Care Centre in Delhi.

Background: The clinical profile of hospitalized moderate-category COVID-19 patients has been understudied globally and in India. Aim: The present study was conducted to study the clinical profile and assess the proportions of patients who progressed to severe disease and its predictors among moderate COVID-19 patients. Materials and Methods: In this single-center observational study, 100 moderate-category COVID-19 patients as per Ministry of Health and Family Welfare (MoHFW) criteria of age ≥18 years of either sex, excluding pregnant females from February to November 2021, were studied by analyzing their clinical profiles and assessing Quick Sequential Organ Failure Assessment (qSOFA), National Early Warning Score 2 (NEWS-2), and chest computed-tomography severity score (CTSS) to predict progression to severe disease. Severe disease was defined as per MoHFW criteria. Results: Out of 100 moderate-category COVID-19 patients, progression to severe disease was seen in 11 patients (11%), among which eight patients had expired, three patients were discharged, and the rest of the 89 patients (89%) who did not progress to severe disease were discharged. A higher age (62.2± 19.5 vs 54.8 ± 14.6 years), along with multivariate analysis revealing male sex (1.25 times), chronic kidney disease (2.86 times), leukocytosis (6.10 times), thrombocytopenia (1.04 times), anemia (9.3 times), a higher qSOFA score (3.6 times), and a higher NEWS-2 score on admission (1.56 times) had higher odds of progression to severe disease. A significant correlation (P < .05) of qSOFA score with serum LDH, ferritin, and hs-CRP levels; CT severity score with the serum ferritin, IL-6, and LDH levels; and NEWS-2 with serum LDH, hs-CRP, and ferritin levels were found. Moreover, the NEWS-2 score was found slightly better than qSOFA on receiver operating characteristic (ROC) curve analysis, with an area under the curve of 85.8% and 83.2%, respectively, predicting progression to severe disease. Conclusion: Our study revealed male gender, chronic kidney disease, leukocytosis, anemia, thrombocytopenia, a higher qSOFA and NEWS-2 score on admission, and further, NEWS-2 score better than qSOFA on ROC curve analysis, with an area under the curve of 85.8% and 83.2%, respectively, in predicting severe disease among hospitalized moderate COVID-19 patients.

A case report on uneventful anticoagulation and persistence of Type 1 Respiratory Failure post severe COVID-19 infection in a patient of Osler-Weber-Rendu syndrome.

The SARS-CoV-2 pandemic has led researchers worldwide to study the patterns of association of SARS-CoV-2 with different diseases, which have been a prime focus of medical literature. Osler-Weber-Rendu syndrome, also known as hereditary hemorrhagic telangiectasia (HHT), is a rare genetic disorder in which patients present with recurrent epistaxis, nostril manipulations, and multiple arteriovenous malformations (AVMs) along with telangiectasias involving internal organs and mucocutaneous areas. In addition, these AVMs are prone to bleeding or act as a nidus for thrombus formation, apart from other serious complications, such as chronic hypoxemia, anemia, pulmonary artery hypertension, heart failure, and cerebrovascular accidents. Here, we present a case report of a patient who presented with acute onset respiratory complaints, had multiple episodes of epistaxis in the past, and was later diagnosed with HHT as per Curaçao criteria in our hospital. Doppler ultrasound over the left calf region showed an AVM. Contrast-enhanced computed tomography (CECT) angiography of the chest and abdomen revealed multiple pulmonary and hepatic AVMs along with splenic and uterine telangiectasias and malformations, who on acquiring severe COVID-19 infection developed complications such as anemia, pulmonary artery hypertension, sepsis, acute kidney injury, and post-COVID-19 persistence of Type 1 respiratory failure. Furthermore, the risk-benefit ratio of anticoagulation therapy in such patients with COVID-19 infection is tricky and challenging. However, our patient was prophylactically anti-coagulated with enoxaparin for 12 days with an uneventful outcome.

Sewer gas poisoning causing transient and focal ST-segment elevation in the ECG: Case report.

In India, a large number of sanitary care workers are involved in manual scavenging. This exposes them to sewer gas mainly consisting of hydrogen sulphide. Sewer gas toxicity primarily causes neurological injury, followed by cardiac and respiratory involvement. A few cases of diffuse ST-segment elevation in the electrocardiogram (ECG) following hydrogen sulphide poisoning are known in the literature. Here, we report a case of acute sewer gas poisoning in a 45-year-old man with transient and focal ST-segment elevation in the anteroseptal leads of the ECG mimicking acute anterior wall myocardial infarction.

Heavy Metal Accumulation in Fruits and Vegetables and Human Health Risk Assessment: Findings From Maharashtra, India.

background: Vegetables are consumed enormously by humans all over the world. Consumption of contaminated fruits and vegetables is the most likely route of heavy metal exposure. Hence, it is important to quantify heavy metal concentration in frequently consumed fruits and vegetables. materials and methods: The main aim of our study is to investigate heavy metal (Pb, Cd, As, and Hg) contamination in 24 different kinds of vegetables and fruits grown in the industrialized city of Solapur, Maharashtra, India. Potential health risks due to the consumption of fruits and vegetables were assessed. Heavy metal concentration and quality of native soil were also determined. Vegetable and fruit samples were analyzed using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) Agilent 7500. results: The mean concentrations of selected heavy metals in fruits and vegetables analyzed were: Lead (0.17 ± 0.38 mg/kg) > Mercury (0.06 ± 0.09 mg/kg) > Cadmium (0.02 ± 0.007 mg/kg) > Arsenic (0.002 ± 0.003 mg/kg). Among them, garlic showed the highest heavy metal accumulation followed by potato. conclusion: Overall, vegetables showed higher metal accumulations than fruits. Some vegetables showed alarming levels of human health risk indices such as the Metal Pollution Index (MPI), Health Risk Index (HRI) and Hazard Index (HI), suggesting that reducing the intake amount of these vegetables may lower the adverse health effects.

Human Health Risk Assessment due to Heavy Metals in Ground and Surface Water and Association of Diseases With Drinking Water Sources: A Study From Maharashtra, India.

Background: Contamination of freshwater sources can be caused by both anthropogenic and natural processes. According to Central Pollution Control Board, Maharashtra along with 2 other states, contribute 80% of hazardous waste generated in India, including heavy metal pollution. Hence, it is important to quantify heavy metal concentrations in drinking water sources in such areas. Materials and methods: Water samples were analyzed for toxic elements (F, As, Cd, Hg, Pb, Ni, Cu, Zn, Mn, and Cr) using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) Agilent 7500. Health risks due to ingestion and dermal contact was assessed. A total of 557 people were randomly selected, with consumers from all 4 types of water sources that is surface water, hand pump, wells, and municipal water. Spot urine samples were collected from 47 people after considering inclusion and exclusion criteria. Urine was collected for estimating mercury and arsenic levels in the study participants. Results: Arsenic contributes the most health risk from ingestion from water. Among surface water users, 14 people (32%) reported frequent loose stool (P-value < .05) (OR 2.5), and 11 people (23%) reported frequent abdominal pain (OR 1.9). Hand pump and well water users reported frequent abdominal pain (27%) (OR 1.4) and gastric discomfort (31%) (P-value < .05) (OR 3) respectively. The mean value of urinary Hg and As were 4.91 ± 0.280 and 42.04 ± 2.635 µg/L respectively. Conclusion: Frequent loose stool, gastric discomfort, and frequent abdominal pain were associated with the various sources of drinking water. Urine Hg levels were found higher than the NHANES (USA) Survey. It is recommended that frequent monitoring of drinking water should be enforced around the industrial hub, so that appropriate actions can be taken if present in excess.

Massive hemoptysis causing mortality in a post COVID-19 infected Asian male patient: Presenting as pulmonary mucormycosis, pulmonary tuberculosis and later sino-nasal mucormycosis.

While the developed nations are discussing giving a third dose of the COVID-19 vaccine to immunocompromised individuals, there are still challenges that are of global concern, especially in developing countries. The Delta variant which is predominantly responsible for the disease burden has now been reported in over 148 countries. The catastrophe caused in the Indian subcontinent has highlighted some associations, most notable being the unprecedented rise in the cases of mucormycosis in COVID-19 patients referred to as CAM (COVID-19 associated mucormycosis). This life-threatening opportunistic fungal infection which was historically associated with immunosuppression has reached a new peak as its incidence has increased many folds with the advent of COVID-19. Here we present one of the very first Case reports on how to post COVID immunosuppression state, uncontrolled blood sugar levels in the background of diabetic ketoacidosis led to the development of pulmonary mucormycosis with superimposed pulmonary tuberculosis and later Sino-nasal mucormycosis eventually leading to life-threatening massive hemoptysis, causing mortality of a post-COVID-19 infected middle-aged diabetic Asian male patient who presented twenty days after COVID-19 infection. However, our patient did not have risk factors such as severe COVID-19 infection requiring hospitalization, use of steroids or other immunomodulatory drugs like remdesivir or tocilizumab. Our case report aims to bring forth this post COVID pulmonary mucormycosis with pulmonary tuberculosis association as well as highlight the fact that tuberculosis is still a major public health burden that should not be forgotten in the fight to combat the pandemic.

Correlation of chronic obstructive pulmonary disease assessment test and clinical chronic obstructive pulmonary disease questionnaire score with BODE index in patients of stable chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) has a major impact on health status in accordance with disease severity. It is usually assessed by the various quality of life questionnaires. OBJECTIVES: The aim of this study is to assess the disease severity and health status in stable patients of COPD using COPD assessment test (CAT) and clinical COPD questionnaire (CCQ) scores and to correlate with BODE index and its components. METHODS: One hundred patients of stable COPD were subjected to CAT, CCQ irrespective of the stage of COPD during their visit. BODE index was also calculated. RESULTS: COPD severity status assessed using forced expiratory volume 1% (FeV1%) predicted values correlated significantly with individual scores (CAT and FeV1%; r = -0.67; P < 0.001 and CCQ and FeV1%; r = 0.61; P < 0.001). CAT and CCQ score also correlated significantly (r = 0.84, P < 0.001) and both with the BODE index (r = 0.80; CAT and r = 0.66; CCQ, P < 0.01). Individual components of BODE index significantly correlated with CAT and CCQ scores. CONCLUSIONS: The CAT and CCQ have similar psychometric as well physical properties to assess the health status of COPD patients and can be used as a reliable scientific research tool and can be used in clinical practise to study the disease state and plan an appropriate treatment plan. The BODE index which is more objective, correlated well.

The Effect of Folic Acid Supplementation on Hyperhomocysteinemia and Pulmonary Function Parameters in Chronic Obstructive Pulmonary Disease: A Pilot Study.

INTRODUCTION: Preliminary studies have established the elevated plasma total Homocysteine (tHcy) levels as a risk factor for Chronic Obstructive Pulmonary Disease (COPD). However, studies describing plasma tHcy levels and their relationship to folic acid supplementation and Forced Expiratory Volume in 1 Second (FEV1) status in COPD patients are still lacking. AIM: We investigated the role of hyperhomocysteinemia in COPD and then prospectively examined the relationship between plasma tHcy concentration and effect of folic acid supplementation on FEV1 status in COPD patients. MATERIALS AND METHODS: This was a prospective case-control study with 50 clinically stable patients of COPD attending the chest clinic of the hospital and 30 healthy controls. The study was done at Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India, from August 2011 to February 2013. Plasma levels of Hcy were measured by Enzyme Linked Immuno-Sorbent Assay (ELISA) method. All the subjects were given folic acid therapy (5mg daily) for six weeks duration and were followed up. Repeat plasma Hcy and FEV1 were measured after six weeks. RESULTS: COPD patients had higher baseline plasma tHcy concentration than controls (Mean: 27.42±23.89µmol/L, versus 15.21±15.71µmol/L, p<0.001) and COPD was associated with higher tHcy concentrations also after adjusting for smoking, and age. The mean BMI of the patients was 21.36±4.26kg/m2. The mean Hcy values decreased from 27.42±23.89µmol/L to 15.2±15.71µmol/L (p-value=0.001) after six weeks of folic acid supplementation. However, no significant change was observed in FEV1 upon folic acid supplementation (FEV1=1.14±0.60 and 1.08±0.56 respectively; p-value=0.654). A significant correlation was observed between BMI and Hcy and also between plasma Hcy levels at the baseline and after six weeks of folic acid supplementation (r=0.283, p=0.04 and r=0.340, p=0.02, respectively) and (r=0.840, p=0.001). CONCLUSION: COPD patients seem to have a poor folic acid status and as a consequence high tHcy. Also, folic acid supplementation has shown decreased plasma tHcy concentrations, but not necessarily significant change in FEV1.

Evaluation of BODE index and its relationship with systemic inflammation mediated by proinflammatory biomarkers in patients with COPD.

INTRODUCTION: BODE index, a multidimensional grading system which is based on Body mass index, airway Obstruction, Dyspnea scale, and Exercise capacity, has been increasingly used for the evaluation of chronic obstructive pulmonary disease (COPD). Many of the systemic manifestations of COPD are shown to be mediated by elevated levels of proinflammatory biomarkers. OBJECTIVE: We aimed to investigate the relationship between the BODE index, its components, disease severity, and proinflammatory biomarkers like C-reactive protein (CRP), tumor necrosis factor (TNF)-α, and interleukin (IL)-6. MATERIALS AND METHODS: A cross-sectional study which included 290 clinically stable COPD patients and 80 smoker controls was conducted. Medical history, body mass index, pulmonary function tests, 6-minute walking test, and modified scale of Medical Research Council dyspnea scale were evaluated. BODE scores were determined. Systemic inflammation was evaluated with the measurement of CRP, TNF-α, and IL-6 in the serum samples of all studied subjects. The correlation between inflammatory biomarkers and BODE index was assessed in COPD patients. RESULTS: We found a significant relationship between COPD stages and BODE index. Our analysis showed significant association between systemic biomarkers and components of the BODE index. Both TNF-α and CRP levels exhibited weak but significant correlation with BODE index. Serum IL-6 concentrations exhibited significant correlation with 6-minute walking test, modified scale of Medical Research Council, and BODE index (r=0.201, P=0.004; r=0.068, P=0.001; and r=0.530, P=0.001, respectively). Also, an inverse and significant correlation was observed between BODE index and FEV1 (r=0.567, P=0.001). IL-6 exhibited a highly significant and inverse correlation with FEV1 (r=-0.580, P=0.001). CONCLUSION: BODE index should be considered for evaluating patients with COPD. Also, IL-6 seems to be a potential biomarker that may enable determination of the severity and prediction of the course of the disease.

Study of body composition, lung function, and quality of life following use of anabolic steroids in patients with chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airflow limitation and is associated with weight loss and decreased muscle strength and exercise capacity. METHODS: A double-blinded randomized controlled trial of 32 male COPD patients (age, 54.94 ± 11.27 years) was carried out to assess effects of anabolic steroid in terms of a daily high-protein, high-calorie diet alone or one combined with anabolic steroids on body composition, lung function, and health-related quality of life (HRQL). Outcomes were assessed by anthropometric and spirometric measurements, peak expiratory flow rate, partial pressure of oxygen in arterial blood, 6-minute walk test (6MWT), hand grip test, and HRQL index scores. Measurements were made at baseline and end of treatment (6 weeks). RESULTS: All patients showed significant difference (P < .001) in pulmonary function parameters and anthropometric measurements after 6 weeks of intervention (within-group changes); however, no significant improvement occurred in the pulmonary function parameters between the groups. The difference in exercise capacity (6MWT) and HRQL scores in the treatment group were statistically significant (P < .001) compared with control group after 6 weeks of intervention. In the treatment group, the average 6MWT distance increased from 213.5 m to 268.5 m at 6-week follow-up, and HRQL scores increased from 101.25 to 118.45. Also, HRQL and 6MWT parameters were positively correlated in response to steroid supplementation at the end of the study. CONCLUSION: Weekly administration of anabolic steroids during 6 weeks increased exercise capacity and quality of life in patients with COPD.