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1.
J Assoc Physicians India ; 71(3): 11-12, 2023 Mar.
Article in English | MEDLINE | ID: mdl-37354503

ABSTRACT

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.


Subject(s)
COVID-19 , Adult , Humans , Male , Aged , SARS-CoV-2 , Tertiary Care Centers , Retrospective Studies , Cross-Sectional Studies
2.
Article in English | MEDLINE | ID: mdl-36483421

ABSTRACT

Objective: Short-term improvements in hospital room cleaning can readily be achieved but are difficult to maintain. This is particularly true for high-risk, "high-touch" surfaces. Therefore, we embarked on a process to sustain improvements in surface cleaning and disinfection to reduce hospital-acquired infection (HAI) rates. Interventions: Our environmental services (EVS) and infection prevention departments incorporated a formal education, monitoring, and feedback process for focused cleaning and disinfection of high-touch surfaces into their routine policies and procedures in 2011. Cleaning validation was performed by infection prevention liaison nurses using a fluorescent targeting method to evaluate the thoroughness of cleaning. Results: Surface cleaning performance on medical-surgical units in 2011 was 74.7%, but this rate incrementally increased in response to the interventions and has been sustained at >90% for the past 6 years. Similar patterns of improvement were observed in the operating room, labor and delivery, endoscopy suite and cardiac catheterization laboratory. Conversely, HAI rates, particularly C. difficile rates, decreased by 75% and surgical site infection rates decreased by 55%. Conclusions: EVS training, monitoring, and feedback interventions, instituted 10 years ago have enhanced our environmental cleaning and disinfection efforts in multiple areas of the hospital and have been sustained to the present. Although other concurrent initiatives to reduce infection rates also existed, the improvements in environmental cleaning were associated with dramatic reductions in HAI rates over the 10-year period.

3.
Perspect Clin Res ; 12(1): 40-47, 2021.
Article in English | MEDLINE | ID: mdl-33816208

ABSTRACT

OBJECTIVE: The objective of the study was to compare the maternal and fetal outcomes of currently preferred tenofovir-based regimen with previous zidovudine-based regimen and also to determine whether the time of starting antiretroviral therapy (ART), whether it can affect the pregnancy and fetal outcome. MATERIALS AND METHODS: Pregnant patients prescribed any of the above regimens were followed up every month till delivery and newborns for initial 6 months. Maternal endpoints were body weight, hemoglobin, and CD4 count, whereas fetal endpoints were birth weight, Apgar score, body weight, and HIV status at 6 months. Data were analyzed using ANOVA and unpaired t-test. P <0.05 was considered statistically significant. RESULTS: A significant increase in CD4 count was observed in patients treated with both the regimens at 12 months as compared to baseline (P < 0.001 and 0.05). Moreover, a significant increase in CD4 count was observed at 12 months as compared to baseline, whether treatment was started before or after the diagnosis of pregnancy (P < 0.05 and 0.001). A significant difference in mean body weight at the end of 9 months was observed in patients wherein ART was started before or after the diagnosis of pregnancy (P < 0.005). Majority of patients had a favorable maternal outcome, while fetal birth weight, Apgar score, body weight, and HIV status were comparable at 6 months irrespective of treatment and time of starting ART. CONCLUSION: All ART regimens are equally effective in terms of increase in CD4 count, gestational gain in body weight, and pregnancy and fetal outcome. Furthermore, there is no significant difference in efficacy, pregnancy, and fetal outcome in women who were already on ART when diagnosed pregnancy or who were started ART later in antenatal period.

4.
Perspect Clin Res ; 12(1): 33-39, 2021.
Article in English | MEDLINE | ID: mdl-33816207

ABSTRACT

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.

5.
Article in English | MEDLINE | ID: mdl-38983971

ABSTRACT

Idiopathic intracranial hypertension (IIH) is a chronic condition characterized by raised intracranial pressure of undetectable origin, that causes morbidity due to debilitating headaches and vision loss. Continuity of outpatient care is important to monitor for permanent vision loss, manage symptoms and limit emergency care. The purpose of this retrospective study was to identify factors associated with neuro-ophthalmology follow-up appointment completion among patients with IIH at a US academic medical center in order to establish evidence-based interventions to improve adherence patterns. Included are 111 completed or no-show neuro-ophthalmology return outpatient appointments by 23 subjects with IIH. Generalized estimating equation models were used to assess association between appointment completion status and factors previously shown to be associated with appointment adherence. Appointments were more likely to be completed during the summer (p=0.08) and by subjects with headache symptoms (p=0.06), however none of the patient factors reached statistical significance. Completed and no-show appointments did not differ by subject demographic or insurance factors. Further studies are needed to identify risk factors for lack of appointment adherence by patients with IIH, particularly those amenable to intervention, in order to improve continuity of care for IIH.

6.
Open Forum Infect Dis ; 7(11): ofaa511, 2020 Nov.
Article in English | MEDLINE | ID: mdl-33269297

ABSTRACT

In the midst of the coronavirus disease 2019 (COVID-19) pandemic, we were surprised to find that all other respiratory viral infections fell precipitously. The difference in respiratory viral infections during the 16-week period of our peak COVID-19 activity in 2020 (Centers for Disease Control and Prevention weeks 14-29) was significantly lower than during the same period in the previous 4 years (a total of 4 infections vs an average of 138 infections; P < .0001). We attribute this to widespread use of public health interventions including wearing face masks, social distancing, hand hygiene, and stay-at-home orders. As these interventions are usually ignored by the community during most influenza seasons, we anticipate that their continued use during the upcoming winter season could substantially blunt the case load of influenza and other respiratory viral infections.

7.
Virulence ; 11(1): 730-738, 2020 01 01.
Article in English | MEDLINE | ID: mdl-32490754

ABSTRACT

The mounting evidence supporting the capacity of Plasmodium vivax to cause severe disease has prompted the need for a better characterization of the resulting clinical complications. India is making progress with reducing malaria, but epidemics of severe vivax malaria in Gujarat, one of the main contributors to the vivax malaria burden in the country, have been reported recently and may be the result of a decrease in transmission and immune development. Over a period of one year, we enrolled severe malaria patients admitted at the Civil Hospital in Ahmedabad, the largest city in Gujarat, to investigate the morbidity of severe vivax malaria compared to severe falciparum malaria. Patients were submitted to standard thorough clinical and laboratory investigations and only PCR-confirmed infections were selected for the present study. Severevivax malaria (30 patients) was more frequent than severe falciparum malaria (8 patients) in our setting, and it predominantly affected adults (median age 32 years, interquartile range 22.5 years). This suggests a potential age shift in anti-malarial immunity, likely to result from the recent decrease in transmission across India. The clinical presentation of severe vivax patients was in line with previous reports, with jaundice as the most common complication. Our findings further support the need for epidemiological studies combining clinical characterization of severe vivax malaria and serological evaluation of exposure markers to monitor the impact of elimination programmes.


Subject(s)
Malaria, Vivax/epidemiology , Severity of Illness Index , Adolescent , Adult , Antimalarials/therapeutic use , Child , Child, Preschool , Female , Humans , India/epidemiology , Malaria, Vivax/drug therapy , Male , Middle Aged , Plasmodium vivax/pathogenicity , Prospective Studies , Young Adult
8.
Perspect Clin Res ; 9(2): 70-75, 2018.
Article in English | MEDLINE | ID: mdl-29862199

ABSTRACT

OBJECTIVES: To analyze clinical spectrum, seriousness, outcome, causality, severity and preventability of ADRs in geriatrics and pediatric patients. MATERIALS AND METHODS: All ADRs reported in geriatrics (≥ 65 years) and pediatrics (≤ 12 years) indoor as well outdoor patients from January, 2010 to April, 2016 at ADR monitoring centre, Department of Pharmacology, B. J. Medical College and Civil Hospital were identified. A retrospective analysis was carried out for clinical presentation, causality (as per WHO-UMC scale and Naranjo's algorithm), severity (Hatwig and Seigel scale) and preventability (Schaumock and Thornton criteria). RESULTS: Out of 3690 ADRs, 160 were in geriatric patients (4.33%) while 231 in pediatric patients (6.26%). The most commonly affected body system was gastrointestinal (53, 33.13%) followed by neurological disorders (26, 16.25%) in geriatric patients. While in pediatric patients, the most commonly affected body system was skin and appendages (73, 31.60 %) followed by gastrointestinal disorders (58, 25.11%). The most common causal drugs in geriatric patients was cardiovascular (38, 23.75%) followed by antimicrobials (28, 13.25%). While in pediatric patients, the most common causal drug group was antimicrobials (85, 33.46%) followed by blood products (36, 14.12%). Total 17 ADRs reported following vaccination, 7 (41.17%) were injection site abscess and 11 (64.70%) were due to pentavalent vaccine. Polypharmacy was common in geriatrics (31, 19.37%). Causality assessment for majority of ADRs in geriatrics (83, 52.5%) and pediatrics (171, 67.32%) were probable. CONCLUSION: ADRs are common in geriatric and pediatric patients usually within four weeks of oral therapy. Active surveillance of drug safety monitoring in these vulnerable population is recommended.

9.
Perspect Clin Res ; 9(1): 15-22, 2018.
Article in English | MEDLINE | ID: mdl-29430413

ABSTRACT

AIMS: This study aims to measure the quality of life (QOL), treatment satisfaction, and tolerability of antidiabetic drugs in patients suffering from type 2 diabetes mellitus (DM). METHODS: The prospective, observational study was conducted in consenting patients of type 2 DM attending the outpatient department of a tertiary care hospital in Western India. The QOL instrument for Indian diabetes (QOLID) patients questionnaire and the Diabetes Treatment Satisfaction Questionnaire were administered to all patients at baseline, 3 months, and 6 months of treatment. Tukey-Kramer comparison test was used to analyze the difference in QOLID scores in various domains at baseline, 3 months, and 6 months. WHO-UMC scale, Naranjo's probability scale, Hartwig and Siegel, and Schumock and Thornton modified criteria were used to analyze the adverse drug reactions. RESULTS: A male preponderance was observed in 200 patients enrolled in the study. The mean duration of diabetes was 10.96 ± 5.99 years. The patients received metformin alone (40), metformin and glipizide (47), metformin, glipizide and other oral hypoglycemic agents (OHAs) (78), and OHAs and insulin (35). A significant improvement in fasting and postprandial blood sugar was observed at 6 months as compared to the baseline (P < 0.05). A total of 39 (19.5%) patients suffered from adverse effects to metformin and insulin. Physical health and physical endurance improved in patients receiving metformin alone or in combination with glipizide as compared to patients receiving other OHAs and/or insulin. Treatment satisfaction, highest in patients receiving metformin and least in those receiving insulin, was unaltered during the study period. CONCLUSIONS: While polypharmacy is evident, using lesser medicines offers better treatment satisfaction and QOL in DM. Periodic assessment of QOL and treatment satisfaction are recommended in DM.

10.
Indian J Sex Transm Dis AIDS ; 39(2): 84-90, 2018.
Article in English | MEDLINE | ID: mdl-30623177

ABSTRACT

BACKGROUND: Long-term toxicity of antiretroviral agents is rarely addressed in initial clinical trials. Effective pharmacovigilance is essential for long-term safety of antiretroviral therapy (ART). MATERIALS AND METHODS: All adverse drug reactions (ADRs) reported due to ART between January 2014 and September 2016 were analyzed as per different drug regimens used. ADRs were also analyzed for system organ classification, seriousness, time relationship of ADRs with drug therapy, causality (as per the World Health Organization-Uppsala Monitoring Centre scale and Naranjo algorithm), and severity (Hartwig and Siegel scale). Comparison was done between (tenofovir + lamivudine + efavirenz [TLE]) and (zidovudine + lamivudine + nevirapine [ZLN]) regimens. RESULTS: During a study period, 2983 patients were on ART. The most common drug regimen prescribed was TLE (1805) followed by ZLN (326). A total of 325 (10.89%) ADRs were reported in which 150 ADRs were reported in TLE regimens (46%) and 130 in ZLN regimens (40%). The mean age of patients with ADRs was 40 ± 12.56 years and men (58.1%) were more affected than women (41.8%). The most common system organ involved in ZLN regimen was blood (50, 39%) and skin (35, 27%), while it was neurological (63, 42%) and renal disorder (27, 18%) in TLE regimen. Most of ADRs were observed after 1 month of therapy (79.5%) and showed possible causal relation with drug therapy (78.15%). Majority of ADRs were mild in nature (86.7%). The serious ADRs were reported more in ZLN (18%) regimen as compared to TLE (9%) (P < 0.05). CONCLUSION: Both ART regimens are associated with ADRs affecting all body system; however, the frequency and severity of ADR are high with ZLN regimen.

12.
Curr Med Res Opin ; 30(7): 1257-66, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24669876

ABSTRACT

OBJECTIVE: To compare efficacy and safety of hydroxychloroquine with pioglitazone in type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: This double-blind study randomized 267 uncontrolled type 2 diabetes patients (HbA1c ≥7.5% and ≤11.5%), post 3 months' treatment with glimepiride/gliclazide and metformin, to additionally receive hydroxychloroquine 400 mg/day (n = 135) or pioglitazone 15 mg/day (n = 132) for 24 weeks. Efficacy was assessed by changes in HbA1c, fasting (FBG) and post-prandial (PPG) blood glucose at Week 12 and Week 24. RESULTS: At Week 12 and Week 24, HbA1c, FBG and PPG significantly reduced from baseline in both groups. Mean reduction in glycemic parameters at Week 12 (HbA1c: -0.56% vs -0.72%, p = 0.394; FBG: -0.99 mmol/L vs -1.05 mmol/L, p = 0.878; PPG: -1.93 mmol/L vs -1.52 mmol/L, p = 0.423) and Week 24 (HbA1c: -0.87% vs -0.90%, p = 0.909; FBG: -0.79 mmol/L vs -1.02 mmol/L, p = 0.648; PPG: -1.77 mmol/L vs -1.36 mmol/L, p = 0.415) was not significantly different between the hydroxychloroquine and pioglitazone groups. Change in total cholesterol (TC) and LDL-C was significant in favor of hydroxychloroquine (TC: -0.37 mmol/L vs 0.03 mmol/L, p = 0.002; LDL-C: -0.23 mmol/L vs 0.09 mmol/L, p = 0.003). Triglycerides significantly reduced in both groups at Week 24. Mean HDL-C remained unchanged. Study treatments were well tolerated. CONCLUSION: With favorable effects on glycemic parameters and lipids, hydroxychloroquine may emerge as well tolerated therapeutic option for T2DM. LIMITATIONS: The sample size for this study was small. However, based on the encouraging results of this proof-of-concept study, longer duration studies in larger population can be conducted to further confirm these findings. TRIAL REGISTRATION DETAILS: Clinical Trial Registry-India URL: http://ctri.nic.in, Registration Number: CTRI/2009/091/001036.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hydroxychloroquine/therapeutic use , Hypoglycemic Agents/therapeutic use , Thiazolidinediones/therapeutic use , Adolescent , Adult , Aged , Biomarkers/blood , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/blood , Double-Blind Method , Drug Therapy, Combination , Female , Gliclazide/therapeutic use , Glycated Hemoglobin/metabolism , Humans , Male , Metformin/therapeutic use , Middle Aged , Pioglitazone , Sulfonylurea Compounds/therapeutic use , Treatment Outcome , Young Adult
13.
Indian J Sex Transm Dis AIDS ; 34(2): 113-8, 2013 Jul.
Article in English | MEDLINE | ID: mdl-24339462

ABSTRACT

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.

15.
Indian J Pharmacol ; 45(5): 447-52, 2013.
Article in English | MEDLINE | ID: mdl-24130377

ABSTRACT

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.


Subject(s)
AIDS-Related Opportunistic Infections/drug therapy , Antitubercular Agents/therapeutic use , Tuberculosis/drug therapy , Adult , Child , Female , Humans , Male , Prospective Studies
16.
Diabetes Metab Syndr ; 7(2): 68-71, 2013.
Article in English | MEDLINE | ID: mdl-23680243

ABSTRACT

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.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/epidemiology , Glycemic Index/physiology , Insulin/administration & dosage , Pregnancy in Diabetics/drug therapy , Pregnancy in Diabetics/epidemiology , Adult , Blood Glucose/metabolism , Diabetes Mellitus, Type 1/blood , Drug Administration Schedule , Female , Humans , Infant, Newborn , Infusions, Subcutaneous , Injections, Subcutaneous , Pregnancy , Pregnancy Outcome/epidemiology , Pregnancy in Diabetics/blood , Retrospective Studies , Treatment Outcome
17.
Indian J Pharmacol ; 45(2): 191-2, 2013.
Article in English | MEDLINE | ID: mdl-23716900

ABSTRACT

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.


Subject(s)
Adenine/analogs & derivatives , Anti-HIV Agents/adverse effects , Fanconi Syndrome/chemically induced , HIV Protease Inhibitors/therapeutic use , Organophosphonates/adverse effects , Ritonavir/therapeutic use , Adenine/adverse effects , Adenine/pharmacokinetics , Albuminuria/chemically induced , Albuminuria/diagnosis , Anti-HIV Agents/pharmacokinetics , Drug Interactions , Drug Therapy, Combination , Fanconi Syndrome/diagnosis , Glycosuria/chemically induced , Glycosuria/diagnosis , HIV Infections/drug therapy , HIV Protease Inhibitors/pharmacokinetics , Humans , Hypophosphatemia/chemically induced , Hypophosphatemia/diagnosis , India , Male , Middle Aged , Organophosphonates/pharmacokinetics , Ritonavir/pharmacokinetics , Tenofovir , Time Factors
18.
J Assoc Physicians India ; 61(8): 535-8, 2013 Aug.
Article in English | MEDLINE | ID: mdl-24818336

ABSTRACT

BACKGROUND: Ulinastatin is reported to inhibit pro-inflammatory markers and also inhibits coagulation and fibrinolysis. The drug is available in East Asia for the treatment of acute pancreatitis. AIM: To study the effect of addition of ulinastatin to standard care on mortality and morbidity in Indian subjects with acute pancreatitis. DESIGN: Randomized, double-blind, placebo-controlled, multi-centre trial across 15 centres in India. METHODS: Subjects, aged 18 to 70 years, with acute pancreatitis and elevated serum C-reactive protein (CRP) levels, were eligible for enrolment. Acute pancreatitis was diagnosed if the patient had at least two of the following criteria: suggestive abdominal pain, serum amylase and/or lipase > 3 times upper limit of normal, and imaging findings of acute pancreatitis. Subjects were classified as having mild or severe acute pancreatitis on the basis of the APACHE II score (< 8 mild, > or = 8 severe). Standard care was given to all subjects as per the treating physician's protocol. Eligible subjects were randomized to receive intravenous infusion of 200,000 IU ulinastatin or placebo in 100 mL of 0.9% saline given over one hour every 12 hours for 5 days. RESULTS: Of 135 randomized subjects, 129 completed the study (mild 62, severe 67). Pancreatitis was due to alcohol intake in a majority (81%) of subjects. Baseline characteristics were similar between the ulinastatin and placebo groups. Efficacy was evaluated in subjects who had received at least 3 days (6 doses) of ulinastatin/placebo. One subject with severe pancreatitis in the ulinastatin group versus six in the placebo group died (p = 0.048). New organ dysfunction developed in 5 ulinastatin vs 4 placebo group subjects (p = 0.744) with mild pancreatitis and 12 ulinastatin vs 29 placebo group subjects (p = 0.0026) with severe pancreatitis. Adverse events were significantly lower in subjects with severe pancreatitis in the ulinastatin group as compared to the placebo group (p = 0.00001). Reduction in serum CRP was not different between the groups. Median hospitalization was shorter by one day in the ulinastatin group; the difference was not significant. There was no infusion-related adverse event. CONCLUSIONS: Ulinastatin prevents new organ dysfunction and reduces mortality in subjects with severe pancreatitis.


Subject(s)
Glycoproteins/therapeutic use , Pancreatitis/drug therapy , Trypsin Inhibitors/therapeutic use , APACHE , Adolescent , Adult , Aged , Double-Blind Method , Female , Glycoproteins/adverse effects , Humans , Male , Middle Aged , Trypsin Inhibitors/adverse effects , Young Adult
19.
Hematology ; 17(2): 100-5, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22664048

ABSTRACT

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.


Subject(s)
Anemia, Megaloblastic/pathology , Communicable Diseases/pathology , Hypersplenism/pathology , Pancytopenia/pathology , Adult , Aged , Anemia, Megaloblastic/complications , Blood Cell Count , Communicable Diseases/complications , Community Health Centers , Erythrocyte Indices , Humans , Hypersplenism/complications , India , Lethargy/physiopathology , Middle Aged , Pallor/physiopathology , Pancytopenia/etiology
20.
J Assoc Physicians India ; 60: 95-7, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22715554

ABSTRACT

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.


Subject(s)
Antiviral Agents/therapeutic use , Disease Outbreaks , Influenza A Virus, H1N1 Subtype/isolation & purification , Influenza, Human/mortality , Oseltamivir/therapeutic use , Adolescent , Adult , Age Distribution , Aged , Aged, 80 and over , Female , Hospitalization/statistics & numerical data , Hospitals, Private , Hospitals, Public , Humans , Incidence , India/epidemiology , Influenza A Virus, H1N1 Subtype/drug effects , Influenza, Human/diagnosis , Male , Middle Aged , Retrospective Studies , Severity of Illness Index , Sex Distribution , Treatment Outcome , Young Adult
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