A multicentre, double-blind, placebo-controlled randomized trial of Mycobacterium w in critically ill patients with COVID-19 (ARMY-2).

BACKGROUND: Mycobacterium w (Mw), an immunomodulator, resulted in better clinical status in severe coronavirus infectious disease 19 (COVID-19) but no survival benefit in a previous study. Herein, we investigate whether Mw could improve clinical outcomes and survival in COVID-19. MATERIALS AND METHODS: In a multicentric, randomized, double-blind, parallel-group, placebo-controlled trial, we randomized hospitalized subjects with severe COVID-19 to receive either 0.3 mL/day of Mw intradermally or a matching placebo for three consecutive days. The primary outcome was 28-day mortality. The co-primary outcome was the distribution of clinical status assessed on a seven-point ordinal scale ranging from discharged (category 1) to death (category 7) on study days 14, 21, and 28. The key secondary outcomes were the change in sequential organ failure assessment (SOFA) score on days 7 and 14 compared to the baseline, treatment-emergent adverse events, and others. RESULTS: We included 273 subjects (136 Mw, 137 placebo). The use of Mw did not improve 28-day survival (Mw vs. placebo, 18 [13.2%] vs. 12 [8.8%], P = 0.259) or the clinical status on days 14 (odds ratio [OR], 1.33; 95% confidence intervals [CI], 0.79-2.3), 21 (OR, 1.49; 95% CI, 0.83-2.7) or 28 (OR, 1.49; 95% CI, 0.79-2.8) between the two study arms. There was no difference in the delta SOFA score or other secondary outcomes between the two groups. We observed higher injection site reactions with Mw. CONCLUSION: Mw did not reduce 28-day mortality or improve clinical status on days 14, 21 and 28 compared to placebo in patients with severe COVID-19. [Trial identifier: CTRI/2020/04/024846].

Analysis of Drugs Prescribed to Elderly Patients in a Tertiary Health Care Center in Raipur, Central India: An Observational Study.

Background Most elderly patients suffer from multiple diseases and are on multiple drugs for treatment. Polypharmacy in the elderly, physiological changes with old age, changes in the pharmacokinetics and pharmacodynamic effects of many drugs, and newer drug prescription trends for diseases like diabetes and cardiovascular disease make drug prescribing in the elderly more difficult. There are many chances of drug-drug interactions with easily available over-the-counter (OTC) medications. To prevent the irrational use of drugs in the elderly, there is a need for prescription analysis studies. Prescription analysis studies will help in finding errors in prescriptions and also change trends in the use of medication among the elderly. Methodology This cross-sectional observation study was conducted on 234 elderly patients to investigate medicine use patterns among the geriatric patients attending the Medicine Outpatient Department in a tertiary care teaching hospital. Drug data were collected from the study participants after obtaining written informed consent and analysed, including demographic details, personal history, disease history, and details of the drug, including the generic name of the drug, dose and duration of therapy, and prescription pattern. The proportions of drugs prescribed for different diseases were analysed. Also, the drugs were analysed as per their pharmacological profiles. Results and interpretation A total of 1298 drug prescriptions were analysed in this study. Of the total participants, 60.26% were male, 35% were unemployed, 53% were retired, and 27% were taking OTC herbal medications. Most of the patients included in this study were suffering from diabetes, hypertension, and other comorbidities. Telmisartan and telmisartan in combination with other drugs were the most commonly encountered prescription drugs, i.e., 24% among the cardiovascular drugs. Aspirin and statins alone or in combination were the most commonly encountered prescriptions, i.e., 27.88% of the drugs used for prophylaxis of cardiovascular diseases. Conclusion This study showed a prescription pattern for the elderly and highlighted precautions to be taken with some of the prescribed drugs. As polypharmacy is observed with elderly prescriptions, possible drug interactions must be taken into account. Regular prescription analysis of drugs prescribed to the elderly will help in the appropriate and rational use of drugs.

Cardiac Autonomic Neuropathy in Newly Diagnosed Patients With Type 2 Diabetes Mellitus.

INTRODUCTION: Cardiac autonomic neuropathy (CAN) is a debilitating complication in diabetes mellitus, leading to life-threatening arrhythmias and various impairments. Its prevalence varies widely, and early detection and management are crucial. This study investigates the prevalence of CAN in newly diagnosed type 2 diabetes mellitus patients in Central India, comparing them to a control group. METHODOLOGY: This case-control study included 35 newly diagnosed type 2 diabetes mellitus patients and 35 age-matched healthy controls from the general population. Cardiac autonomic function testing (AFT) was done by heart rate variability (HRV), the deep breathing test (DBT), the cold pressor test (CPT), and the lying-to-standing test (LST). Parameters were recorded and analyzed using statistical tests. RESULTS: Patients with type 2 diabetes mellitus had significantly higher weight, BMI, fasting blood sugar, post-prandial blood sugar, urine albumin-creatinine ratios, and systolic and diastolic blood pressure than controls. Abnormalities in HRV and E: I ratio during the DBT and CPT were more prevalent in these patients. Parasympathetic dysfunction (delta HR) and a lower E: I ratio were also significantly high in this group. Also, LST results suggested a greater likelihood of orthostatic symptoms in the patients' group. CONCLUSION: This study highlights the importance of AFT in diagnosing early CAN in newly diagnosed patients. Early diagnosis and management of diabetic CAN are essential to prevent complications.

Association of Serum IL-17 and IL-23 Cytokines With Disease Activity and Various Parameters of Rheumatoid Arthritis in Indian Patients.

Introduction Interleukin-23/T helper 17 (IL-23/Th17) axis cytokine has been thought to be a critical pathway for rheumatoid arthritis (RA) disease development and its association with disease severity, joint erosion, and functional outcome. There is a paucity of data on the role of IL-23/Th17 axis cytokines in an Indian RA subset of patients. We aimed to determine the association between serum cytokines (interleukin-17 [IL-17] and [IL-23]) and disease activity as well as with clinical and biochemical parameters of RA patients. Methods In this observational cross-sectional study, 84 consecutive RA cases were recruited after obtaining consent. Serum IL-17 and IL-23 levels were measured by the enzyme-linked immunosorbent assay (ELISA) method. Clinical and laboratory parameters, disease activity score 28-erythocyte sedimentation rate (DAS28-ESR), and Health Assessment Questionnaire-II (HAQ-II) were recorded. Correlation of cytokines with various clinical and biochemical parameters was elicited. Results Only C-reactive protein (CRP) correlated positively with IL-23 (rs = 0.26, p = 0.014) but not the ESR. Both IL-17 and IL-23 levels showed an insignificant, weak positive correlation with the disease activity DAS28 (rs = 0.18, p = 0.097; rs = 0.12, p = 0.259, respectively). Neither IL-17 nor IL-23 levels differed among the disease severity group (p = 0.13, p = 0.215). Only the IL-23 level positively correlated with functional status (HAQ-II) (rs = 0.28, p = 0.009). IL-17 level was higher in advanced RA as compared to early RA (p = 0.028). Both IL-17 and IL-23 levels did not vary within the different subgroups (age, obesity, disease-modifying drugs/steroid/biologics use, and serology status). Conclusion Females had higher IL-23 levels than males. Advanced RA had higher IL-17 levels than early RA. The cytokine levels were not influenced by factors like age, duration of disease, serology status, or drugs. Neither of the cytokines correlated significantly with disease severity. Higher IL-17 levels may have a role in the progression of early non-erosive to chronic erosive arthritis. Higher IL-23 levels may signal a bad functional outcome.

Cardiac Autonomic Neuropathy (Can) in Newly Diagnosed Type 2 Diabetes Mellitus Patients.

Autonomic dysfunction associated with Type 2 Diabetes Mellitus is a well known entity, of which cardiac autonomic neuropathy deserves a special mention due to its propensity to cause major cardiac events in a seemingly asymptomatic individual. The incidence of Cardiac autonomic neuropathy among newly diagnosed Diabetes patients is less studied, with most of the current studies done in Western populace who have a different metabolic milieu compared to Indians. This study aims to find the prevalence of cardiac autonomic neuropathy in the Central Indian population, presenting to our center who are diagnosed to be having Diabetes Mellitus within one year. MATERIAL: 35 patients, of the age group (18-45 years), who were diagnosed to have Type 2 Diabetes Mellitus within the last one year were taken, after excluding any other chronic illness, like CKD, CLD, CVA, etc. and after getting consent. 35 healthy age and sex-matched controls were included in the study. Cardiac Autonomic Testing was done for all of them, using the measurement of Heart Rate Variability (HRV), Deep Breathing Test (DBT), Cold Pressor Test (CPT), and Lying to Standing Test (LST). The experimental data was analyzed using Labchart Software for autonomic dysfunction. OBSERVATION: On preliminary analysis, around 40% of the patients enrolled in the study had cardiac autonomic dysfunction, predominantly parasympathetic dysfunction, compared to the controls. There was no significant age-wise difference in cardiac autonomic dysfunction. There was also no statistically significant correlation with the HbA1c of the patient at presentation and their cardiac autonomic dysfunction. CONCLUSION: There is significant cardiac autonomic dysfunction among newly diagnosed Diabetes patients. This reaffirms the fact that early screening and diagnosis of this disease is paramount to prevent significant morbidity and mortality associated with the complications of the disease.

Information technology-based joint preoperative assessment, risk stratification and its impact on patient management, perioperative outcome, and cost.

BACKGROUND:  Despite negative recommendations, routine preoperative testing practice is nearly universal. Our aim is to bring the healthcare providers on one platform by using information-technology based preanaesthetic assessment and evaluate the routine preoperative testing's impact on patient outcome and cost. METHODS: A prospective, non-randomised study was conducted in a teaching hospital during January 2019-August 2020. A locally developed software and cloud-computing were used as a tool to modify preanaesthesia evaluation. The number of investigations ordered, time taken, cost incurred, were compared with the routine practice. Further data were matched as per surgical invasiveness and the patient's physical status. Appropriate tests compared intergroup differences and p-value <0.05 was considered significant.  Results: Data from 114 patients (58 in routine and 56 in patient and surgery specific) were analysed. Patient and surgery specific investigation led to a reduction in the investigations by 80-90%, hospital visit by 50%, and the total cost by 80%, without increasing the day of surgery cancellation or complications. CONCLUSION: Information technology-based joint preoperative assessment and risk stratification are feasible through locally developed software with minimal cost. It helps in applying patient and surgery specific investigation, reducing the number of tests, hospital visit, and cost, without adversely affecting the perioperative outcome. The application of the modified method will help in cost-effective, yet quality and safe perioperative healthcare delivery. It will also benefit the public from both service and economic perspective.

Comparison of patterns of infarction in TB and cryptococcal meningitis.

BACKGROUND: To compare the frequency and patterns of stroke, the specificity of tubercular zone (TBZ) infarction and its effect on outcomes in TB (TBM) and cryptococcal meningitis (CM). METHODS: This retrospective study was conducted at two tertiary centres in India from May 2018 to July 2020. Sixty-one patients with TBM and 22 with CM were included. The primary outcome was the proportions of TBM and CM patients with infarction. Secondary outcomes included the anatomical locations of infarction and in-hospital mortality. RESULTS: Infarction was noted in 52.5% of patients with TBM and in 54.5% of those with CM (p=0.87), with caudate head infarcts in 9.4% vs 41.7% (p=0.01), cerebellar in 9.4% vs 33.3% (p=0.05), thalamic in 25% vs 0% and lobar in 28.1% vs 0%, respectively. In TBM, the infarcts were located in the TBZ in 3 (9.4%), in the ischaemic zone in 23 (71.9%), while 6 (18.8%) patients showed infarcts in both, while in CM, the infarcts were in 0 (0%), 6 (50%) and 6 (50%) patients, respectively. Infarcts were not associated with in-hospital mortality, either in TBM or CM. CONCLUSION: Caudate head and cerebellar infarction was more common in CM, while thalamic and lobar infarcts were more frequent in TBM. TBZ infarcts were not specific to TBM.