Staphylococcus hemolyticus: The Most Common and Resistant Coagulase-Negative Staphylococcus Species Causing Bacteremia in North India.

INTRODUCTION: Coagulase-negative Staphylococcus (CoNS) species are normal skin commensals but may also cause bacteremia. Therefore, isolating a CoNS species on blood culture often leads to a diagnostic dilemma about whether to consider the isolate as a true pathogen or not. This study was done to understand the distribution of various CoNS species in bloodstream infections, determine their antibiotic resistance patterns, and identify possible risk factors and patient outcomes in hospital settings. MATERIALS AND METHODS: Inpatients with confirmed bacteremia defined as isolation of the same CoNS species with similar antibiograms from paired blood culture bottles, which were obtained from patients with at least clinical evidence of infection, were included. The isolates obtained were studied for CoNS species distribution and antibiotic resistance patterns, and the corresponding patients were assessed for possible risk factors and outcomes. RESULTS: A total of 170 CoNS isolates obtained from 85 patients were analyzed. Staphylococcus haemolyticus (S. haemolyticus)(90, 52.9%) was the most common species isolated, and it was also the most resistant of all, followed by S. hominis (50, 29.4%), S. epidermidis (26, 15.3%), S. lentus (2,1.2%), and S. succinus (2,1.2%). S. haemolyticus and S. hominis were significantly more isolated from patients aged 18-60 years and >60 years, respectively. Methicillin-resistant (MR)-CoNS (68.8%) were significantly more resistant than methicillin-sensitive (MS)-CoNS (31.2%) to certain antibiotics, and none were resistant to vancomycin, linezolid, or teicoplanin. Mortality occurred in 17.6% of patients, which was most commonly associated with S. haemolyticus infection. CONCLUSION: Age-specific predisposition of CoNS species, high rates of methicillin resistance, and mortality in CoNS bacteremia are highlights of this study. To our knowledge, we are the first to study the age-related association of CoNS species.

The Indian registry on current patient profiles & treatment trends in hypertension (RECORD): One year interim analysis.

Background & objectives: In India, hypertension constitutes a significant health burden. This observational, non-interventional, prospective study was conducted in five centres across India to evaluate the current clinical practices for the management of hypertension. Methods: Participants were enrolled if they were newly diagnosed with essential hypertension or had pre-existing hypertension and were on the same therapeutic plan for the previous three months. At baseline, three months, six months, and one year, information on the patient and their treatment regimen was documented, and their quality of life (QoL) was evaluated. Results: A total of 2000 individuals were enrolled in this study, with a mean age of 54.45 yr. Of these, 55.7 per cent (n=1114) were males, and 957 (47.85%) were newly diagnosed with hypertension, while 1043 (52.15%) had pre-existing hypertension. Stage 2 hypertension (systolic blood pressure (BP) >140 or diastolic BP ≥90 mmHg) accounted for more than 70 per cent of the participants (70.76% of pre-existing and 76.29% of newly diagnosed); the average duration of pre-existing hypertension was 68.72 months. Diabetes (31.6%) and dyslipidaemia (15.8%) were the most common comorbidities. In 43.3 per cent of the participants, monotherapy was used, and in 56.7 per cent (70.55% fixed-dose combination), combination therapy was used. Telmisartan (31.6%), amlodipine (35.2%), and a combination of the two (27.1%) were the most commonly prescribed treatment regimens. At three months, six months, and one year, treatment modifications were observed in 1.4, 1.05, and 0.23 per cent of the participants receiving monotherapy and 2.74, 4.78 and 0.35 per cent receiving combination therapy, respectively. In both groups, the proportion of individuals with controlled hypertension (≤140/90 mmHg) increased by more than 30 per cent after a year. At one year, physical and emotional role functioning, social functioning, and health improved considerably. Interpretation & conclusions: Combination therapy for hypertension is increasingly preferred at the time of initial diagnosis. The efficacy, safety, and tolerance of the recommended medications were reflected by improvements in the QoL and the minimal changes in the therapeutic strategy required.

Serum Ammonia Levels as a Non-invasive Predictor of the Presence and Severity of Esophageal Varices in Chronic Liver Disease Patients.

Background Portal hypertension leads to the formation of portosystemic collateral veins, of which esophageal varices (EV) are the most severe complications and have the greatest clinical impact. The possibility of identifying cirrhotic patients with varices by non-invasive tests is appealing, as they can lead to reduced healthcare costs and can be done in resource-limited settings. In this study, we investigated ammonia as a potential non-invasive predictor of EV. Methods This was a single-center cross-sectional observational study that was done at a tertiary health care hospital in north India. It included 97 chronic liver disease patients irrespective of etiology after excluding patients with portal vein thrombosis and hepatocellular carcinoma to participate in endoscopic screening for the presence of EV and correlate it with various non-invasive markers like serum ammonia levels, thrombocytopenia and aspartate aminotransferase to platelet ratio index (APRI ). On the basis of endoscopy, enrolled patients were divided into two groups, i.e., group A consisting of large varices (grade III and grade IV) and group B consisting of patients with low-grade varices and no varices (grade II, grade I, and no varices). Results This study included 97 patients, out of which 81 patients have varices on endoscopy, and mean serum ammonia levels were found to be significantly higher in cases with varices (135 ±69.70 ) vs. those without varices (94±43) (p value=0.026). Further, on comparing serum ammonia values between patients with large varices (Grade III/IV) (Group A) with a mean value of 176 ± 83 vs. Grade I/II/No varices (Group B) with a mean value of 107±47, which were significantly higher in Group A patients (<0.001). In our study, we also found a correlation between blood urea level as a non-invasive predictor of varices, but no statistically significant relation was found between thrombocytopenia and APRI. Conclusion This study found that serum ammonia can be used as a useful marker for the prediction of EV and can also be used to determine the severity of varices. Apart from ammonia, serum urea levels can also prove to be a good non-invasive marker for the prediction of varices although further multicentric studies are warranted to reach this conclusion.

Early and Effective Diagnosis of Sepsis Using Flow Cytometry.

Objective Sepsis is a major global health issue due to its high death and morbidity rates. To avoid the negative effects of sepsis and decrease mortality, it is vital to diagnose and treat it as soon as possible. Blood cultures can take up to 2 days to give result, and they are not always reliable. According to recent studies, neutrophil CD64 expression might be a sensitive and specific option for assessing sepsis. This study aimed to evaluate the diagnostic performance of a flow cytometry analysis for the expression of neutrophil CD64 in sepsis and its comparison with other standard tests in a tertiary care center. Materials and Methods Prospective analysis on 40 blood samples from suspected sepsis patients admitted to intensive care units with criteria for the systemic inflammatory response syndrome on presentation was performed for expression of neutrophil CD64, C-reactive protein, procalcitonin, and complete blood count. Ten healthy volunteers were also enrolled in this prospective study. The laboratory results were compared in different groups. Results The neutrophil CD64 had the highest diagnostic value to differentiate between patients of sepsis and nonsepsis groups with a sensitivity of 100% (95% confidence interval [CI]: 77.19-100%) and 100% (95% CI: 55.32-86.83%); specificity of 90.00% (95% CI: 59.58-99.49%) and 87.24% (95% CI: 66.69-99.61%); and likelihood ratio of 10.00 and 7.84, respectively. Conclusion The neutrophil CD64 expression provides a more sensitive, specific, and novel marker for the early detection of sepsis in critically ill patients.

Co-administration of AYUSH 64 as an adjunct to standard of care in mild and moderate COVID-19: A randomized, controlled, multicentric clinical trial.

OBJECTIVE: Evaluate the efficacy of AYUSH 64, a standard polyherbal Ayurvedic drug in COVID-19. METHODS: During the first pandemic wave, 140 consenting and eligible hospitalized adult participants with mild-moderate symptomatic disease (specific standard RT-PCR assay positive) were selected as per a convenience sample, and randomized (1:1 ratio) to an open-label (assessor blind) two-arm multicentric drug trial; standard of care (SOC as per Indian guidelines) versus AYUSH 64 combined with SOC (AYUSH plus). Participants were assessed daily and discharged once clinical recovery (CR, primary efficacy) was achieved which was based on a predetermined set of criteria (resolution of symptoms, normal peripheral oximetry, and negative specific RT-PCR assay). Each participant was followed using an indigenous software program(mobile phone) and completed a 12-week study period. The dose of AYUSH 64 was 2 tablets oral, 500 mg each, bid for 12 weeks (AYUSH plus only). Significant P was <0.05 (two-sided). On randomization, the groups were found well matched. RESULTS: The mean interval time from randomization to CR was significantly superior in the AYUSH plus group [mean 6.45 days versus 8.26 days, 95% Confidence Interval of the difference -3.02 to -0.59 (P = 0.003, Student's 't test] as per-protocol analysis (134 participants); significant (P = 0.002) on an intention to treat analysis. 70% of the participants in AYUSH plus recovered during the first week (P = 0.046, Chi-square) and showed a significantly better change in physical health, fatigue, and quality of life measures. 48 adverse events, mostly mild and gut related, were reported by each group. There were 20 patient withdrawals (8 in AYUSH plus) but none due to an AE. There were no deaths. Daily assessment (hospitalization) and supervised drug intake ensured robust efficacy data. The open-label design was a concern (study outcome). CONCLUSIONS: AYUSH 64 in combination with SOC hastened recovery, reduced hospitalization, and improved health in COVID-19. It was considered safe and well-tolerated. Further clinical validation (Phase III) is required. TRIAL REGISTRATION: CTRI/2020/06/025557.

Type 2 Diabetes Mellitus in a Young Female Later Diagnosed as​​​​ Pancreatogenic Diabetes: The Dilemma in Classifying Diabetes Mellitus.

Diabetes mellitus type 3c (DM3c) is a diabetes caused by pancreatic pathology. It occurs due to the destruction of the endocrine islet cells. Diabetes diagnosed at the age of 20-30 years share a common dilemma in segregating between the type of diabetes the patient has, as its management varies depending on the type of diabetes the patient is harboring. However, insulin remains the treatment of choice in later decades as the pancreatic reserves of beta cells exhaust, although it takes decades to happen. We report a case of a woman who was diagnosed with diabetes mellitus at the age of 26, was on oral hypoglycemic agents (OHA), and was shifted to insulin therapy as she became non-responsive to OHA in a short span of six years, which was alarming. The patient presented to us with the chief complaints of recurrent abdominal pain that aggravated on taking meals and was associated with multiple episodes of vomiting for two months. Blood gas analysis on admission had no evidence of metabolic acidosis, urine ketones were negative, and a random blood sugar test (RBS:202) excluded the possibility of diabetic ketoacidosis. Serum amylase and serum lipase were within normal limits. Contrast-enhanced computed tomography (CECT) of the abdomen was suggestive of the atrophic pancreas with the non-dilated main pancreatic duct. Magnetic resonance cholangiopancreatography (MRCP) was done to rule out the congenital anomalies of the pancreas responsible for chronic pancreatitis, which showed no structural abnormalities. During our clinical workup, we postulated that the diabetes she was diagnosed with at the age of 26 was DM3c, i.e., pancreatogenic diabetes. The rapid shift of patients from OHA to subcutaneous insulin in a short span must be alarming to the physician managing diabetes and needs extensive workup to look upon the etiology of the same.

The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-world Observational Study.

Objectives: The Indian Registry on Current Patient Profiles and Treatment Trends in Hypertension (Record) evaluated the current trends and outcomes related to hypertension (HTN) management at 3, 6, 12, and 24 months in India. This study highlights and evaluates the outcomes and trends noted at 24 months. Materials and methods: The detailed study methodology is provided in the earlier publication (interim analysis at 12 months). Aspects such as changes in the quality of life (QOL), percentage of patients reaching target blood pressure (BP), treatment pattern among patients with comorbid conditions, and difference in treatment patterns between public and private healthcare settings, at 24 months, were evaluated in the current study. Results: The study population included 2,000 patients (55.7% males) with a mean age of 54.45 years. Telmisartan (43.7%) and amlodipine + telmisartan (16.4%) were the most prescribed monotherapy and combination therapy among patients with newly diagnosed HTN. A significant decrease in both systolic BP (SBP) and diastolic BP (DBP) was noted in the overall patient population at 24 months (p < 0.001). The mean change in SBP and DBP was slightly higher at 24 months compared to 12 months. This was more evident among patients on combination therapy. A significant improvement in QOL was noted at 24 months. Conclusion: Treatment strategies in HTN management are changing and are associated with effective HTN control and improvements in QOL. However, there is a further need for improved awareness regarding the optimal usage of combination therapy for better management of uncontrolled HTN. How to cite this article: Rajadhyaksha GC, Reddy H, Singh AK, et al. The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-World Observational Study. J Assoc Physicians India 2023;71(11):43-49.

Hematological Changes in the Second Wave of SARS-CoV-2 in North India.

Background COVID-19 is a rapidly spreading pandemic caused by SARS-CoV-2. India experienced a second wave peak in mid of April 2021, and it emerged as a medical crisis. This study was taken up to show if the hematological and peripheral blood changes can be used as a readily available tool to demarcate the patients needing ICU care so that the ICU can be utilized more prudently.  Material and method One hundred reverse transcription-polymerase chain reaction (RT-PCR) confirmed cases of COVID-19, 50 each from ICU and non-ICU wards, were included in this observational study. At the time of admission blood sample was collected for evaluation of hematological parameters. Results We noted that 74% of patients admitted in ICU were males and 28% were more than 60 years of age. In ICU patients, the absolute neutrophil count (ANC) was significantly raised when compared to non-ICU cases (p=0.023). The nadir absolute lymphocyte count (ALC) was 0.11x109/L in ICU patients and 0.95x109/L in non-ICU patients. There was a significant increase in neutrophil-lymphocyte ratio (NLR; p<0.001) in ICU patients with a proposed cut-off value of 7.73. Platelet-lymphocyte ratio (PLR) was also raised in ICU patients; however, this increase was not significant (p= 0.623). The proposed cut-off value of PLR is 126.73. A significant reduction in a lymphocyte-monocyte ratio (LMR) was observed in ICU patients when compared to non-ICU cases (p<0.001). Thrombocytopenia was more commonly seen in ICU patients; however, this was not statistically significant. Viral-induced cytopathic effects like plasmacytoid lymphocytes with cytoplasmic granules, the presence of toxic changes in neutrophils, and large-sized platelets were commonly observed in ICU patients. Conclusion Our results suggest that hematological parameters like ANC, absolute lymphocyte count (ALC), platelet count, NLR, PLR, and peripheral smear changes are simple assessment factors that can serve as indicators for the severity of COVID-19 and will demarcate the patients who need ICU-care. This will help in the judicious use of ICU facilities for patients who are actually in need.

Phase III, Randomized, Double-blind, Placebo controlled trial of Efficacy, Safety and Tolerability of Antiviral drug Umifenovir vs Standard care of therapy in non-severe COVID-19 patients.

OBJECTIVE: To test efficacy, safety and tolerability of Umifenovir in non-severe COVID-19 adult patients. METHODS: We carried out randomized, double-blind, placebo-controlled, multicenter, phase III trials involving adult (18-75 years), non-severe COVID19 patients, randomized 1:1 on placebo or Umifenovir (800 mg BID, maximum 14 days) respectively along with standard-of-care. The primary endpoint for Asymptotic-mild patients was time to nasopharyngeal swab RT-PCR test negativity. For Moderate patients, the average change in the ordinal scale from the baseline scores on the eight-point WHO ordinal scale was assessed. RESULTS: 132 patients were recruited between 3rd October to 28th April 2021, of which 9 discontinued due to various reasons. In Mild-asymptomatic patients (n=82), we found that 73% patients in the Umifenovir arm were RT-PCR negative, while 40% patients in the placebo arm were negative (P=0.004) on day 5. However, in the moderate group (n=41), the WHO scores for the Umifenovir arm was not statistically significant (P=0.125 on day 3), while it was statistically significant in the Mild-asymptomatic group (P=0.019 on day 5). CONCLUSION: Umifenovir meets the primary and secondary endpoint criteria and exhibits statistically significant efficacy for Mild-asymptomatic patients. It is efficacious, safe and well-tolerated at the tested dosage of 800mg BID, maximum 14 days.

Hematological and serum biochemistry parameters as a prognostic indicator of severally ill versus mild Covid-19 patients: A study from tertiary hospital in North India.

BACKGROUND/OBJECTIVES: In, India coronavirus disease (COVID-19) cases are on the rise in terms of the total number of cases. Findings on clinical and hematological parameters alone carry no significance apart from telling patients present status and hence are diminutive. This study aims to assess the hematological and serum biochemistry parameters and correlate them with the presenting symptoms and severity of disease which can help predict the need for intensive care unit (ICU) care, help in triage, assess the severity of the disease which will help clinicians decide their future course of action and further improve patients clinical outcome. METHODS: A total of 200 COVID-19 positive patients were included. Hematological and serum biochemistry parameters were recorded for the patients at the time of admission and categorized as mild, moderate, and severely ill based on clinical status and then admitted into various wards. RESULTS: Total leucocyte count (TLC) was significantly different and higher in severely ill patients (13,200 ± 6,999.2) compared to cases presented with mild and moderate symptoms (12,100 ± 6,488.41& 8,788.20 ± 4,954.32, p = 0.001). The mean difference of TLC, Neutrophil% (N%), Lymphocyte% (L%) and Monocyte (M%) was significantly different between mild and moderate symptoms cases (p = 0.030, p = 0.002, p = 0.004 & p = 0.003). Between groups comparison of moderate vs. severely ill cases showed a significant difference in TLC (p = 0.000), N% (p = 0.000), L% (0.000), and L/N ratio (p = 0.002). The serum ionic calcium (Ca), random blood sugar (RBS), C-reactive protein (CRP), fibrinogen, prothrombin (PT), International Normalized Ratio (INR), ferritin, and Lactate Dehydrogenase (LDH) level also differed significantly between mild, moderate and severely ill cases (p = 0.001, p=<0.001, p = 0.002, p=<00.1, p = 0006, p = 0.005, p=<0.001 and p=<0.001) respectively. Comparison of the mild vs. severely ill cases showed a significant difference in urea, fibrinogen, and procalcitonin (PCT) level (p = 0.005, p = 0.000 & p = 0.048) respectively. CONCLUSION: The preliminary findings of this study suggest hematological and serum biochemistry parameters could be used as a screening tool to identify patients requiring intensive care and thus allowing clinical stratification and triage at the time of presentation.

Prothrombotic state in HIV: A study on protein C, protein S, homocysteine and correlation with CD4 counts.

Introduction: Human immunodeficiency virus (HIV) may result in variable haematological manifestations. Thrombotic events are more common among HIV-infected persons than the general population, possibly due to the increased inflammatory/hypercoagulable state and presence of concurrent comorbidities. Aims and Objectives: (1) Screen for coagulation abnormalities in HIV-infected patients. (2) Detect certain prothrombotic factors such as deficiency of protein C and protein S and elevation of homocysteine as possible precursors of coagulation defects in HIV patients. (3) Correlation of coagulation abnormalities with CD4 counts. Methods: A pilot study of 1-year duration conducted in the Department of Pathology in collaboration with ART centre, KGMU Lucknow. All diagnosed HIV-seropositive patients (n = 30) who were not taking Vitamin K, antithrombotic and antiplatelet drugs including aspirin, oral contraceptives and not having known protein C/S deficiency were included in the present study as cases. Apart from this, 30 age- and sex-matched healthy individuals were also included in the present study. Assessment of the bleeding time, prothrombin time and activated partial thromboplastin time, complete blood count was done. Protein C and S were measured by calorimetric assay. Serum homocysteine was measured by the semi-automated method. CD4 count was done by flow cytometry. Results: The findings of the present study suggest a relationship between HIV, its complications and thrombosis. The HIV-seropositive patients have reduced levels of haemoglobin, CD4 counts, platelet counts, mean platelet volume, protein C and S activity as compared to the healthy individuals. Thrombophilic abnormality in the form of hyperhomocysteinaemia is more frequent in HIV-infected patients. All these parameters have a definite correlation with CD4 count.

Comparative Effect of Insulin Sensitizers and Statin on Metabolic Profile and Ultrasonographical Score in Non Alcoholic Fatty Liver Disease.

INTRODUCTION: Non Alcoholic Fatty Liver Disease (NAFLD) is a metabolic disorder involving fat accumulation in the liver. The initial management for patients with NAFLD includes lifestyle modification and weight loss in overweight or obese patients. AIM: The present study was conducted to compare the efficacy of insulin sensitizers and statin in the patients of NAFLD. MATERIALS AND METHODS: The study included 98 patients diagnosed with NAFLD on USG (Ultrasonography) abdomen, divided into three Groups randomly and administered Metformin (Group I), Rosuvastatin (Group II) or Pioglitazone (Group III) along with dietary intervention and lifestyle modification. Their Body Mass Index (BMI), liver function tests, fasting lipid profile, USG scores for fatty liver were done and followed up at 4 weeks, 12 weeks and 24 week for change in above parameters. RESULTS: Out of the three Groups, Group II showed a maximum improvements in usg scores for NAFLD (p<0.001) and fasting lipid profile. Group II also showed maximum derangement of liver enzymes at 24 weeks though none of the subjects had more than three times elevation of liver enzymes. CONCLUSION: Rosuvastatin may be an effective therapy as add on treatment to dietary and lifestyle intervention in patients of NAFLD. As an add-on treatment Rosuvastatin was superior to Pioglitazone or Metformin and acute decompensation is unlikely with this drug. Metformin was not effective as add on therapy for NAFLD, rather rapid weight loss in short period of time resulted in worsening of hepatic steatosis.

Effect of high-dose zinc supplementation with oral hypoglycemic agents on glycemic control and inflammation in type-2 diabetic nephropathy patients.

OBJECTIVE: The study aims to evaluate the effect of zinc sulfate on markers of glycemic control, lipid profile and inflammation in type-2 diabetes with microalbuminuria patients. MATERIALS AND METHODS: Type-2 diabetes with microalbuminuria patients on oral hypoglycemic agents (OHA) and angiotensin converting enzyme (ACE) inhibitors were selected and divided into 2 groups: One group (n = 27) continued with OHA alone, second group (n = 27) was on OHA and in addition 50 mg elemental zinc as zinc sulphate supplementation for 12 weeks. Fasting, post-prandial blood glucose, glycosylated hemoglobin, lipid profiles, inflammatory marker hs-CRP and urine microalbumin were measured. RESULTS: There were no significant differences in biochemical status among groups at baseline. After receiving zinc, the mean fasting blood glucose (FBS), post-prandial blood glucose (PPBS) and glycosylated hemoglobin (HbA1c) were decreased significantly (P = 0.0001). Significant decrease was observed in TG (P = 0.002) and VLDL-cholesterol (P = 0.002), whereas there was no significant decrease in TC and LDL-cholesterol. The high-density lipoprotein (HDL) cholesterol was significantly (P = 0.0001) increased from baseline. Zinc supplementation had significant effects in decreasing serum hs-CRP from 10.51 ± 1.68 mg/L to 7.75 ± 1.56 mg/L (P = 0.0001) and microalbumin level from 146.87 ± 30.83 mg/day to 80.70 ± 33.99 mg/day (P = 0.0001). There were no significant changes in the levels of all these parameters in OHA group. CONCLUSION: Our results conclude that supplementation of zinc improved the effectiveness of OHA and may be beneficial in decreasing blood glucose, TG, urinary albumin excretion and inflammation in diabetic nephropathy patients and thus reducing the risk of complications.

Acute hypokalaemic quadriparesis in dengue fever.

The authors report acute hypokalaemic quadriparesis in two young patients that occurred during dengue epidemic in 2010 in India. Both patients developed flexic type of pure motor weakness in all four limbs without bladder bowel involvement, following 2 to 3 days of fever and malaise. Higher mental functions were normal. Serum potassium level was very low; 2-2.5 m mol/l. Non-structural protein (NS(1))-antigen and immunoglobulin M-antibody for dengue were positive in both patients. Both patients improved with potassium supplementation. In follow-up, they are doing well.