Study of Characteristics of COVID-19 Patients with Fatal Outcome during Wave-2 from a Tertiary Care Center in Western India.

BACKGROUND: A large surge of intensive care unit (ICU) admissions leading to mortal outcome was observed in wave-2 of coronavirus disease 2019 (COVID-19) due to the higher virulence of the Delta variant of the COVID-19 virus, which led to the scarcity of resources in hospitals. This study was done to observe the clinical characteristics of COVID-19 patients with fatal outcomeMaterials and methods: We conducted a retrospective cross-sectional study in adults with COVID-19 pneumonia having fatal outcome during wave-2 of COVID-19, and their clinical characteristics were studiedResults: Out of 136 patients included in the study, the most common risk factors leading to adverse outcome were in the male gender, age (middle and elderly), with hypertension and diabetes mellitus (DM) as predominant comorbidities, early onset dyspnea, high C-reactive protein (CRP), high neutrophil to lymphocyte ratio (NLR), high D-dimer, bilateral lower zone involvement of lungs in chest X-ray (CXR), and development of acute kidney injury (AKI)Conclusion: The characteristics of the severely ill COVID-19 patients highlighted in the study could help clinicians in the early identification and management of high-risk patients. This study would help with resource planning and preparation for further COVID-19 waves and future pandemics.

An evaluation of trigger tool method for adverse drug reaction monitoring at a tertiary care teaching hospital.

OBJECTIVES: The objective of this study is to evaluate the trigger tool method (TTM) in detection, monitoring, and reporting of adverse drug reactions (ADRs) at Civil Hospital Ahmedabad, India. MATERIALS AND METHODS: A prospective, single-center, observational cum intervention study was conducted in two phases in the Department of Medicine over 15 months. In phase I, preliminary trigger tool list (PTTL) comprising 55 triggers was evaluated by pharmacologist in terms of detection of ADR in 400 patients and then, modified trigger tool list (MTTL) was prepared. In Phase II, the TTM using MTTL was compared with the spontaneous method of ADR monitoring after educational interventions in resident doctors of the two units of medicine department. RESULTS: Of the 55 triggers in PTTL, 34 triggers were observed in 327 patients, of which 19 triggers lead to the detection of 66 ADRs. The rate of ADEs was 16.5%/100 patients. Positive predictive value (PPV) of each trigger ranged from 0% to 100%. PPV for drug trigger, laboratory trigger, and PT was 14.4%, 4.5%, and 23.3%, respectively. Overall, PPV of PTTL was 19.27%. Sensitivity and specificity were 100% and 21.66%, respectively. MTTL consists of these 19 triggers. In Phase II, resident doctors reported 16 ADRs, using spontaneous method and 23 ADRs using MTTL. The rate of ADEs per 100 patients was 1.63 and 2.13, respectively, with these methods. A total of 105 ADRs were reported during both phases. CONCLUSION: TTM is an effective method of ADR reporting if it is utilized by a trained person. This method could be used as add-on method to spontaneous method to improve ADR reporting.

Changing incidence of nevirapine-induced cutaneous drug reactions: After revised guideline Nov 2011.

AIMS AND OBJECTIVES: To study the change in the incidence and pattern of nevirapine (NVP)-induced adverse cutaneous reactions (ADR) after commencement of revised National AIDS Control Organisation (NACO) guidelines for initiation of antiretroviral therapy (ART) since Nov 2011. MATERIALS AND METHODS: The study was conducted on patients who developed cutaneous reactions after starting NVP based regimen. According to the revised NACO ART initiation guidelines Nov 2011, ART should be started if CD4 count is < 350 cells/mm(3) in stages 1, and 2 and irrespective of CD4 count in stages 3, and 4. Patients were divided in groups A and B. Group A consisted of patients enrolled on NVP-based regimen during Jan 2011 to Oct 2011, whereas, in Group B patients from Nov 2011 to Aug 2012 were included. Grading of rash, appropriate investigations and management was done. OBSERVATIONS: In Group A, out of 645 patients 30 (4.66%) patients developed cutaneous reactions, where as in Group B out of 720, 65 (9.03%) patients presented with drug reaction. In Group A (n = 30) developed reaction as Grade 1 in 1.55% (n = 10), Grade 2 in 1.86% (n = 12), grades 3 and 4 in 0.76% (n = 5) and 0.47% (n = 3), respectively. In Group B (n = 65) developed reaction, out of which Grade 1 reaction was seen in 1.39% (n = 10), Grade 2 was seen in 2.78% (n = 20), grades 3 and 4 was seen in 3.33% (n = 24) and, 1.53% (n = 11), respectively. CONCLUSION: There is a striking increase in the incidence of NVP-induced cutaneous reactions of all forms and considerable increase in frequency of severe kind of reactions with the revised guidelines.

Efficacy and safety of anti-tuberculosis drugs in HIV-positive patients: a prospective study.

OBJECTIVES: To assess the efficacy and safety of anti-tuberculosis drugs in HIV-positive patients at a tertiary care teaching hospital. MATERIALS AND METHODS: As a part of an ongoing study of opportunistic infections (OIs) in HIV-positive patients, drug treatment in patients suffering from tuberculosis was assessed to determine its efficacy and safety. Based on prevalence data for last three years, a purposive sampling of study population was carried out in this observational, prospective, single centre study. Tuberculosis (TB) was the most common OI observed. The selected patients were followed up for a period of one year to evaluate the clinical course and outcome of OIs, and the efficacy and safety of drugs used was checked. RESULTS: Tuberculosis was observed in 89 out of 134 enrolled patients. These included 79 adults and 10 children. Males (66.2%) were commonly affected. Extra pulmonary TB (73%) was the most common manifestation with abdominal TB observed in 55 (61.7%) patients. All patients were treated in accordance with the Revised National Tuberculosis Control Programme (RNTCP) guidelines as recommended by National AIDS Control Organization (NACO), India. Outcome of TB was assessable in 70 patients. Majority (82.8%) of the patients were cured, while 12 patients (17.1%) died during the course of treatment. A total of 149 ADRs were observed in 67 (75.2%) patients. Majority of ADRs (n = 147) were non-serious and did not warrant a change in therapy. Discoloration of urine was the most common ADR observed. CONCLUSION: TB is the most common opportunistic infection in HIV-positive patients with abdominal TB being the most common manifestation. RNTCP and NACO guidelines are adhered to in these patients. Anti-tuberculosis drugs are well tolerated and effective in majority of the patients.

Pregnancy outcome and glycemic control in women with type 1 diabetes: a retrospective comparison between CSII and MDI treatment.

AIM: Present study was aimed to evaluate glycemic control and maternal-fetal outcome in pregnant type 1 diabetic patient treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections of insulin (MDI). PATIENTS AND METHODS: A retrospective observational study included thirty-four pregnant type 1 diabetic patients. Patients were divided into two group, CSII treated group (n=14) and MDI treated group (n=20). The HbA1c level and maternal-fetal outcome were evaluated in both the treatment group. Outcome parameters such as glycemic control (HbA1c), hypoglycemic events, time and mode of delivery and labor results (abortion, premature labor, perinatal mortality, neonatal weight, Apgar score, neonatal hypoglycaemia, presence of congenital abnormalities) were analyzed. RESULTS: Pregnancy outcome and glycemic control in pregnant type 1 diabetic patients treated with CSII and MDI were evaluated and compared. Two groups were compared for their epidemiological parameters, although patients on CSII treatment had longer duration of diabetes compared to MDI treated group. Reduction in HbA1c level was higher in CSII treated patients at first (CSII: 0.9% vs MDI: 0.46%), second (CSII: 1.58% vs MDI: 0.78%) and third trimester (CSII: 1.74% vs MDI: 1.09%) of pregnancy compared to MDI treated patients. Duration of pregnancy and new born baby weight were founded similar in both group. Moreover, the rate of abortion, preterm labor, cesarean section and hypoglycemia in new born were founded less in CSII treated group compared to MDI treated group and Apgar score was significantly (p<0.05) higher in CSII treated group compared to MDI treated group. CONCLUSION: Results of present study revealed that the CSII gives better glycemic control and pregnancy outcome in pregnant type 1 diabetic patients compared to MDI treatment. CSII also decreases the daily insulin requirement compared MDI.

Tenofovir induced Fanconi syndrome: a possible pharmacokinetic interaction.

Tenofovir was introduced as a second line drug for the treatment of human immunodeficiency virus (HIV) infection in India in December 2009. Although rare, renal toxicity is a recognized adverse drug reaction (ADR) of this drug, especially when administered with boosted lopinavir-ritonavir. In this case, an HIV positive patient receiving tenofovir based antiretroviral therapy (ART) for last 1 year developed albuminuria, glycosuria and hypophosphatemia. Renal function tests and random blood sugar were within normal limits. He was diagnosed as a case of tenofovir induced Fanconi syndrome. Tenofovir was discontinued and patient was prescribed an alternate regimen. Five months later clinical symptoms and renal functions returned to normal. A pharmacokinetic interaction between tenofovir and ritonavir may have resulted in the toxicity. A periodic monitoring of renal functions is desirable in patients on tenofovir based ART.

Study of clinical and aetiological profile of 100 patients of pancytopenia at a tertiary care centre in India.

Pancytopenia is not a disease but an important clinico-haematological entity encountered in our day-to-day clinical practice with findings that may result from a number of disease processes. A total of 100 patients of pancytopenia admitted in medicine wards of Civil Hospital, Ahmedabad, Gujuarat, India, were studied. The most common cause of pancytopenia was megaloblastic anaemia (45%) followed by infections (20%) and hypersplenism (15%). As compared with other causes, megaloblastic anaemia was statistically significant cause (P < 0.01) of pancytopenia, in our study. The most common clinical presentation of patients with megaloblastic anaemia was lethargy (100%) and pallor (100%). In patients with megaloblastic anaemia, mean haemoglobin (Hb) was 5.6 ± 1.7 g/dl, mean white blood corpuscle (WBC) count was 2735 ± 4152 and mean platelet count was 52,250 ± 24,213. Mean corpuscular volume (MCV) was 101.2 ± 11 in patients of megaloblastic anaemia. Morphology of RBC was marocytic in 95% of patients with megaloblastic anaemia, whereas hypersegmented neutrophils and macrovalocytes were seen in 60-65% patients of megaloblastic anaemia.

Epidemiology and clinical outcome of H1N1 in Gujarat from July 2009 to March 2010.

OBJECTIVE: Epidemiology and clinical outcome of H1N1 in Gujarat from July 2009 to March 2010. METHODS AND MATERIALS: This retrospective descriptive study analyses the month wise distribution of suspected as well as confirmed cases of H1N1 with their outcomes in the state of Gujarat from the month of July 2009 to March 4th 2010. The study included only those who were falling in Category C according to the national guidelines. Besides the government hospitals, the data also have been sought from all the private hospitals suspecting and treating swine flu cases. The patients are classified according to age, gender, location, approach to either government or private hospital, duration of symptoms on admission, associated co morbid conditions, the final outcome, duration of death after symptoms and the district wise distribution of sale of Oseltamivir. The incidence ratio for cases and deaths per 10 lakh population is calculated and compared with other states. RESULTS: 28760 patients attended the swine flu ward and the OPD. Out of 5532 suspected severe (Category C) cases, 1486 cases were confirmed positive with positivity ratio of 26.8%. 28% of all suspected and 37.9% of all positive were seen during the month of January. 64.9% cases were seen amongst the young age group of 13 to 45 years. 55.6% cases were seen in men and maximum cases (336) and deaths (54) were seen in Ahmedabad district. Oseltamivir was started after 5 days in 52% of cases. 297 had expired with an overall Case Fatality Rate of 19.9%. Maximum deaths were seen in young age group (13-45 years) with case fatality rate of 19.6%. 41% patients succumbing to disease were referred from Private to government hospitals and overall 35% cases had expired between 1 and 24 hour of admission. 69% patients did not have history of comorbid illness/condition. Gujarat ranked 5th in Case Incidence Rate per 10 lakh population while ranked second in Death Rate per 10 lakh population. CONCLUSION: The incidence and mortality from H1N1 in the state was significantly higher in young, more during the winter months. The case fatality rate in Gujarat is higher than rest of the world, the reason being a selection bias created by the categorization of the patients into category A, B and C as only category C patients were admitted and observed. The sale of Oseltamivir after liberalization of sale of the drug has greatly increased.