Development and Validation of Signature Sequence-Based PCR for Improved Molecular Diagnosis of Tuberculosis.

Reliable, fast, and affordable diagnosis for tuberculosis (TB) remains a challenge to reduce disease incidence in resource-poor countries. Tests based on nucleotide sequences that are signature to Mycobacterium tuberculosis have the potential to make a positive impact on case detection rates, which can eventually help control TB. Using extensive comparative bioinformatics approach, we mined the genome for M. tuberculosis-specific genes and identified four genes so-called signature sequence (SS). With <25% homology with other known genes/proteins of mycobacterial/nonmycobacterial origin in various databases, these SS genes are ideal targets for species-specific identification. Sputum from suspected patients was liquefied using novel complete liquefying reagent, and DNA was isolated. Samples from patients (n = 417), reporting to TB clinics at two different hospitals, which met our inclusion criteria, were collected for this study. A small number (n = 143) was used for initial standardization, and the remaining patient samples (n = 274) were evaluated by SS and compared with smear microscopy, GeneXpert, culture, and clinical outcome. An overwhelming sensitivity of 97.0%, significantly higher than GeneXpert (95.0%), was seen. SS could pick all smear-negative, but culture-positive samples, along with other culture-negative samples; some of the latter were declared clinically positive. Our results yielded superior sensitivity and specificity through conventional PCR.

Elevated urinary IL-36α and IL-18 levels are associated with diabetic nephropathy in patients with type 2 diabetes mellitus.

BACKGROUND: Inflammatory cytokines have been reported to be pathogenic factors for the development and progression of diabetic nephropathy (DN). Interleukin (IL)-36α is a newly discovered member of the IL-1 cytokine family that has been implicated in animal models of renal impairment. However, little is known about the role of IL-36α in DN in humans. The purpose of the present study was to assess the levels of IL-36α and IL-18 in type 2 diabetic patients (T2DM) patients with and without DN. METHODS: Subjects were divided into 3 groups: Control (N.=20), T2DM without DN (N.=30), and T2DM with DN (N.=30). Urinary IL-36α and IL-18 levels were assessed using ELISA. Correlation analysis was performed to determine the association of the IL levels with clinical markers of T2DM and DN. RESULTS: IL-36α and IL-18 levels were significantly elevated in T2DM patients with DN, when compared to T2DM patients without DN (P<0.0001, P=0.0025, respectively) and controls (P<0.0001, for both). IL-36α levels showed a positive correlation with urinary albumin excretion (r=0.754, P<0.0001), HbA1c (r=0.433, P=0.0168), fasting plasma glucose (r=0.433, P=0.0168) and negative correlation with glomerular filtration rate (r=-0.852 P<0.0001). CONCLUSIONS: The results highlighted the association of IL-36α with DN. However, further extensive studies are suggested for evaluating the association.

Evaluation of Stress and Associated Biochemical Changes in Patients with Type 2 Diabetes Mellitus and Obesity.

PURPOSE: Type 2 diabetes mellitus (T2DM), a metabolic disorder, remains associated with a physiological impairment affecting large populations worldwide. Onset of T2DM is multifactorial where obesity and abnormal basal metabolic rate are considered most critical. Of people diagnosed with T2DM, about 80% are also obese. It is also reported that obese individuals have an increased odds of developing depression, whereas T2DM is estimated to increase the incidence by two-fold. The preponderance of research data demonstrates that T2DM alters the serum level of cortisol and adiponectin which are known to be associated with neuronal physiology. The study explored, how a metabolic disorder like T2DM is linked with the altered plasma level of cortisol and adiponectin, the risk factors for stress and depression. PATIENTS AND METHODS: A cross-sectional population study was conducted in T2DM patients using a bimodal approach. First approach used questionnaires, (1) Patient Health Questionnaire (PHQ-9) and (2) Stress Coping Inventory Questionnaire (SCQ) to assess signs and symptoms of depression and stress, respectively, in T2DM patients. In the second approach, robust biochemical analysis was conducted for serum adiponectin and cortisol levels. RESULTS: An association of T2DM in stress and depression was evaluated in 158 subjects (105 T2DM obese patients and 53 healthy controls). A lower PHQ-9 score and adiponectin levels were seen in T2DM obese patients compared to healthy controls (p<0.05). Further, results also depicted a lower adiponectin levels in T2DM obese patients with depression compared to T2DM obese patients without depression (p<0.05). The study did not find a significant difference in cortisol serum levels among the T2DM and control groups. However, a higher level of serum cortisol was reported in T2DM obese patients with depression over those T2DM obese patients who lacked depression (p<0.05). CONCLUSION: The findings suggest that T2DM obese patients might have a higher risk of developing stress and depression. Further, biochemical parameters, adiponectin and cortisol, might be the potential biomarkers for T2DM and may help in early diagnosis of these comorbid conditions.

Impact of metformin therapy on health-related quality of life outcomes in tuberculosis patients with diabetes mellitus in India: A prospective study.

OBJECTIVE: To assess the impact of metformin use on health-related quality of life (HRQoL) in tuberculosis (TB) patients who are presented with type 2 diabetes mellitus (T2DM). METHODOLOGY: In this community-based prospective study, TB patients attending Hakeem Abdul Hameed Centenary Hospital, New Delhi (India) and had comorbidity of T2DM between April 2018 and July 2019 were enrolled. Patients were divided into metformin users and metformin non-users on the basis of the presence of metformin in their routine as antidiabetic drug(s). HRQoL was determined using a validated TB-specific tool (Dhingra and Rajpal-12 scale ie, DR-12) consists of symptom and socio-psychological and exercise adaptation domains. The HRQoL scores were compared at pretreatment (1st visit), end of intensive phase (2nd visit) and end of treatment (3rd visit) between the two groups. RESULTS: A total of 120 patients were enrolled, of which 24 were excluded as they did not respond at follow-up visits. Among the metformin users (n = 48) the mean age of patients was 47.56 years and 62.50% was males. Among the metformin non-users (n = 48), the mean age of patients was 49.02 years and 54.10% was males. The baseline characteristics were similar in both groups except for the substance used history (P = .025), literacy level (P = .048) and BMI (P = .028). Metformin users demonstrated significant improvement in symptom scores (2nd visit: P < .001; 3rd visit: P = .001) and socio-psychological and exercise adaptation scores (2nd visit: P < .0001; 3rd visit: P < .0001) as compared with metformin non-users at 2nd visit and 3rd visit. Overall, scores were also found to be significantly improved in metformin users (2nd visit: P < .001; 3rd visit: P = .001). CONCLUSION: Metformin therapy exerted favourable effects on HRQoL in patients with TB and T2DM and can be recommended as an adjuvant antitubercular drug in TB patients with co-morbidity of T2DM, unless contraindicated.

Trends of Antimicrobial Resistance of Sepsis Pathogens at a University Hospital in New Delhi, India.

Knowledge of the aetiological agents and its susceptibility to antimicrobial agents enables the clinician to initiate appropriate empirical antimicrobial therapy and guides diagnostic procedures. The aims of the study were to identify prevalence of bacterial pathogens causing sepsis and observe their antimicrobial resistance trends in hospitalized patients. A prospective cohort study was conducted on patients of sepsis admitted at a university hospital over a period of six months. Pathogens were identified by morphological, biochemical and serological tests as per the American Society for Microbiology. Antibacterial sensitivity of bacterial strains isolated from clinically diagnosed sepsis was carried out by Kirby-Bauer disk diffusion method and interpreted according Clinical and Laboratory Standards Institute guidelines. The data were analyzed by using Statistical Package for Social Sciences, version 16.0 (SPSS 16.0, Chicago, IL, USA). Coagulase negative Staphylococcus (63.5%) and Staphylococcus aureus (23.1%) were the most frequently isolated Gram positive bacteria. Acinetobacter species (31%) and Salmonella typhi (24.1%) were the most frequently isolated Gram negative bacteria. Coagulase negative Staphylococcus showed significant resistance to ciprofloxacin and tetracycline. Acinetobacter species showed significant resistance to ampicillin, amoxicillin and amoxiclav. Salmonella typhi showed significant resistance to ampicillin, amoxicillin, cefotaxime, netilmicin and, tetracycline. Escherichia coli showed significant resistance to ampicillin and netilmicin. All the stains of Staphylococcus aureus were resistant to amoxicillin. Coagulase negative Staphylococcus and Acinetobacter species were predominant Gram positive and Gram negative bacteria, respectively, causing sepsis. Increasing rates of bacterial resistance to commonly use antimicrobial agents were observed.

Health-related quality of life and sleep quality among North Indian type 2 diabetes mellitus patients: evidence from a cross-sectional study.

OBJECTIVE: The objective of this study is to measure the relationship between sleep quality and health-related quality of life (HRQOL), in Indian population with type 2 diabetes mellitus (T2DM). METHODS: A cross-sectional study, included a total of 300 patients with T2DM. All participants were responding to the Pittsburgh Sleep Quality Index (PSQI) and European Quality of Life-5 Dimensions Questionnaire (EQ-5D). A PSQI global score ≥5 was defined as poor sleep quality. EQ-5D visual analogue scale (VAS), determining the overall health status. Logistic regression analysis was used to examine the association between PSQI and EQ-5D. All the study data were analysed using the SPSS software version 20.0. Values of p < 0.05 were considered statistically significant. RESULTS: The mean age of included participants were 55.29. Majority of the participants (55.3%) were identified as "poor sleepers" and female (31.3%) contributing higher proportion. Poor sleepers had significantly lower the HRQoL (p < 0.001). After adjustment, poor sleep quality was significantly associated with a lower HRQoL; EQ-5D index (OR = 1.080, 95%, CI: 1.015-1.148, p < 0.05), and EQ-5D VAS (OR = 1.092, 95%, CI: 1.021-1.176, p < 0.01). Overall, the EQ-5D index and EQ-5D VAS were found to be an independent predictors of sleep quality. CONCLUSIONS: Poor sleep quality is prevalent in Indian T2DM population, and it imparts negative impact on several dimensions of EQ-5D that characterising the daily activities performance. Therefore, further real-world studies are needed to determine the causal relationship between T2DM patients and measure of objective sleep and their impact on health.

Systematic evidence of health economic evaluation of drugs for postmenopausal osteoporosis: A quality appraisal.

This paper systematically and critically reviewed all published economic evaluations of drugs for the treatment of postmenopausal osteoporosis. A systematic search was conducted using relevant databases for economic evaluations to include all relevant English articles published between January 2008 to January 2020. After extracting the key study characteristics, methods and outcomes, we evaluated each article using the Quality of Health Economic Studies (QHES) and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) instruments. A total of 49 studies met the inclusion criteria. Majority of studies were funded by the industry and reported favorable cost-effectiveness. Based on the QHES total scores, studies (n = 35) were found to be industry-funded with higher QHES mean 82.44 ± 8.69 as compared with nonindustry funding studies (n = 11) with mean 72.22 ± 17.67. The overall mean QHES scores were found to be higher 79.06 ± 11.84, representing high quality (75-100) compared to CHEERS scores (%) 75.03 ± 11.21. The statistical pairwise comparison between CHEERS mean (75.03 ± 11.21) and QHES mean (79.06 ± 11.84) were not statistically significant (P = 0.10) whereas, QHES score showed higher means as compared to CHEERS. This study suggests the overall quality of the published literatures was relatively few high-quality health economic evaluation demonstrating the cost-effectiveness of drugs for postmenopausal osteoporosis, and the majority of the literature highlights that methodological shortcoming.

Potential role of adjuvant drugs on efficacy of first line oral antitubercular therapy: Drug repurposing.

Despite the availability of potent antitubercular drugs, tuberculosis (TB) still remains one of the world's leading causes of death. The current antitubercular therapy (ATT) suffers from a drawback of longer duration that imposes a major challenge of patient non compliance and resistance development. The current scenario necessitates alternative strategies with potential to shorten treatment duration that could pave the way for improved clinical outcomes. In recent years, host directed adjunctive therapies have raised considerable attention and emerged as a promising intervention which targets clinically relevant biological pathways in hosts to modulate pathological immune responses. Few of the approved drugs namely statins, metformin, ibuprofen, aspirin, valproic acid, adalimumab, bevacizumab, zileuton and vitamin D3 have shown promising results in clinical outcomes during their preliminary screening in TB patients and can be potentially repurposed as antitubercular drugs. This review highlights clinical and non clinical evidences of some already existing drug and their targets in hosts that could help in shortening treatment duration and reducing bacterial burden at minimal doses.

Factors Influencing Participation Of Healthy Volunteers In Clinical Trials: Findings From A Cross-Sectional Study In Delhi, North India.

PURPOSE: To identify the specific motivations that drive healthy volunteers to consent for their participation in clinical studies. Additionally, the study aimed to document the socio-demographic determinants of participation in the trial related solely to the intention of securing financial gains. PATIENTS AND METHODS: This cross-sectional study was conducted among subjects who participated as healthy volunteers in clinical trials conducted by Contract Research Organizations (CROs) of Delhi. Pre-tested, validated semi-structured questionnaires were used to collect baseline socio-demographic data, information about factors motivating participation in clinical trials, and pattern of utilisation of money received against participation in the trial. Logistic regression analysis was done to determine the factors that influenced participation in the trial related purely to the motive of securing financial gains. RESULTS: A total of 400 participants were selected. The majority of the volunteers (77.5%) reported that their sole reason for participating in clinical trials was for monetary gain. Around a tenth of the volunteers participated with the intent to advance scientific knowledge and another 4.5% participated due to benefits of free medical check-ups. Participants in the age group of 29-38 years, those that were married, those residing in an urban slum, male participants, those with a high number of dependent family members (ie, 5 to 8), and those earning less than 5000 INR (71 USD) a month had higher odds of participating in a clinical trial purely for the financial benefits. Those educated till intermediate and above had lower odds of participation in the trial due to monetary benefits. CONCLUSION: Our study shows that healthy volunteers in Delhi consider participation in clinical trials mainly because of the prospect of financial reward. More research is needed to inform judgments around the ethics of providing financial rewards and enrollment of healthy research volunteers.

SeeTB: A novel alternative to sputum smear microscopy to diagnose tuberculosis in high burden countries.

Microscopy-based tuberculosis (TB) diagnosis i.e. Ziehl-Neelsen screening still remains the primary diagnostic method in resource poor and high TB burden countries, however this method has poor sensitivity (~60%). Bringing three million TB patients who are left undiagnosed under the treatment has been a major focus as part of END-TB strategy across the world. We have developed a portable set-up called 'SeeTB' that converts a bright-field microscope into fluorescence microscope (FM) with minimal interventions. SeeTB, a total internal reflection-based fluorescence excitation system allows visualization of auramine-O stained bacilli efficiently with high signal-to-noise ratio. Along with the device, we have developed a sputum-processing reagent called 'CLR' that homogenizes and digests the viscous polymer matrix of sputum. We have compared the performance of SeeTB system in 237 clinical sputum samples along with FM, GeneXpert and liquid culture. In comparison with culture as gold standard, FM has sensitivity of 63.77% and SeeTB has improved sensitivity to 76.06%. In comparison with GeneXpert, FM has sensitivity of 73.91% while SeeTB has improved sensitivity to 85.51%. However, there is no significant change in the specificity between FM and SeeTB system. In short, SeeTB system offers the most realistic option for improved TB case identification in resource-limited settings.

Atherosclerosis risk assessment in patients with chronic obstructive pulmonary disease: a case-control study.

PURPOSE: Chronic Obstructive Pulmonary Disease (COPD) is considered as a risk factor for atherosclerosis and a leading cause of mortality due to cardiovascular disease (CVD). The study assessed the association of COPD with atherosclerotic risk factors and compared the predictor role of various cardiovascular (CV) risk score calculators in Indian subjects with COPD. PATIENTS AND METHODS: Forty subjects with stable COPD and forty age, gender and body mass index (BMI)-matched healthy controls were included in the case-control study conducted in a tertiary care hospital. Atherogenic indices were calculated by using the values of lipid parameters. CV risk calculators were utilized to assess the 10-year CV risk for the COPD group. RESULTS: The study subjects had a mean age of 60.83±12.40 years in COPD group and 57.73±9.49 years in control group (p=0.213). Gender distribution was similar in both the groups. The mean High sensitivity C-reactive protein (hs-CRP) levels were 3.70±2.37 mg/L in COPD group and 2.39±2.23 mg/L in control group. The hs-CRP levels were significantly higher in COPD than in control subjects (p=0.012). Using bivariate correlations, we found significant positive correlations between hs-CRP and atherogenesis indices-atherogenic index of plasma, cardiogenic risk ratio, atherogenic coefficient in COPD patients [(r=0.4265, p<0.006); (r=0.7034, p<0.001) and (r=0.7034, p<0.001), respectively]. Framingham risk score-cardiovascular disease (FRS-CVD) has identified maximum number of COPD subjects (45%) to be in high CVD risk category. CONCLUSION: The study concluded that hs-CRP levels in COPD subjects were significantly higher than in control subjects. FRS-CVD was most useful for identifying high CV risk subjects in COPD subjects.

Periostin as a novel biomarker of cardiovascular disease: A systematic evidence landscape of preclinical and clinical studies.

BACKGROUND: Periostin is a matricellular protein, expressed in various normal adult and fetal tissues. Recently, elevated periostin levels have been reported in heart failure, coronary artery disease, and stroke. However, there is lack of clinical studies to clarify the prognostic significance of systemic periostin levels in cardiovascular diseases (CVDs). The aim of the study was to perform a systematic review of published evidence on periostin and CVDs, and to clarify the diagnostic and prognostic significance of systemic periostin levels in CVDs. METHODS: A systematic search on PubMed was performed to identify relevant articles from inception to December 2018. The eligible studies evaluating the periostin expression and periostin levels in animal and human studies. RESULTS: A total of 24 relevant studies, including both animal and human data, were included. Periostin is significantly observed in myocardium tissue of failing hearts compared with control, and is also expressed in atherosclerotic plaques. Systemic periostin levels were significantly correlated with cardiac function and severity of CVD in several studies. A clinical study also observed positive correlation between periostin and N-terminal pro b-type natriuretic peptide (NT-proBNP), highly sensitive troponin (hsTnT), and ST2 cardiac biomarker. Studies reported limited adjustment for potential confounders. CONCLUSIONS: The evidence of current review support potential role of periostin in the pathophysiology of CVD. However, scarcity of data regarding the clinical use of periostin levels in the current management of CVDs further creates room for the future investigation. Therefore, further studies warrant to clarify its potential role, if any, as a novel cardiac biomarker.

Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation.

Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi. Validated questionnaires were used to assess their knowledge, attitude, and practice of informed consent process. Most of the volunteers, 226 (56.5%), had participated in 1 to 3 clinical trials. Majority (54%) were unaware about any informed consent document. None of them were aware of their right of profession competence, privacy and integrity, transparency, nonexploitation, and nonusage of their biological samples. Effective implementation of principles of informed consenting is largely lacking among contract research organizations in Delhi, India. This could potentially cause risk to the participants.

Attenuated serum 25-hydroxyvitamin D and vitamin D binding protein associated with cognitive impairment in patients with type 2 diabetes.

PURPOSE: Clinical studies suggest that 25-hydroxyvitamin D (25[OH]D) deficiency plays a pivotal role in both type 2 diabetes mellitus (T2DM) and cognitive impairment. However, it is unclear if 25(OH)D deficiency could be a possible cause of cognitive impairment in T2DM. Vitamin-D binding protein (VDBP) acts as a major 25(OH)D transporter. Preclinical study has demonstrated improvement in cognitive function by VDBP via inhibiting synaptic degeneration. The aim of the study was to assess the association between serum 25(OH)D, VDBP and cognitive impairment in T2DM patients. PATIENTS AND METHODS: In this case-control study, cognitive function was assessed using the Mini-Mental State Examination (MMSE) and serum 25(OH)D and VDBP levels were estimated using ELISA kits. RESULTS: A total of 88 subjects were included in the study. T2DM patients had lower serum 25(OH)D (p=0.02), VDBP levels (p=0.04) and MMSE scores (p<0.0001) than controls. T2DM patients had higher prevalence of 25(OH)D deficiency and insufficiency, aOR 0.322 (0.128-0.809), p=0.016 and cognitive impairment, aOR 4.405 (1.617-12.002); p=0.004. Cognitive impairment was associated with serum 25(OH)D, aOR 0.131 (0.027-0.638); p=0.014 and VDBP, aOR 1.008 (1.001-1.015), p=0.029. A general linear model showed a significant association of MMSE with serum 25(OH)D (p=0.022). CONCLUSION: Serum 25(OH)D deficiency and cognitive impairment was higher in T2DM patients. Routine assessment of cognitive function is suggested to prevent further behavioral complications. The association of VDBP and cognitive impairment in T2DM needs further exploration.

Adverse drug reaction monitoring during antimicrobial therapy for septicemia patients at a university hospital in New Delhi.

BACKGROUND/AIMS: Adverse drug reaction (ADR) is an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product. The present study was conducted in order to monitor the frequency and severity of ADR during antimicrobial therapy of septicemia. METHODS: A prospective, observational, and noncomparative study was conducted over a period of 6 months on patients of septicemia admitted at a university hospital. Naranjo algorithm scale was used for causality assessment. Severity assessment was done by Hartwig severity scale. RESULTS: ADRs in selected hospitalized patients of septicemia was found to be in 26.5% of the study population. During the study period, 12 ADRs were confirmed occurring in 9, out of 34 admitted patients. Pediatric patients experienced maximum ADRs, 44.4%. Females experienced a significantly higher incidence of ADRs, 66.7%. According to Naranjo's probability scale, 8.3% of ADRs were found to be definite, 58.3% as probable, and 33.3% as possible. A higher proportion of these ADRs, 66.7% were preventable in nature. Severity assessment showed that more than half of ADRs were moderate. Teicoplanin was found to be the commonest antimicrobial agent associated with ADRs, followed by gemifloxacin and ofloxacin. CONCLUSION: The incidence and severity of ADRs observed in the present study was substantially high indicating the need of extra vigilant during the antimicrobial therapy of septicemia.

Effect of orlistat on periostin, adiponectin, inflammatory markers and ultrasound grades of fatty liver in obese NAFLD patients.

Orlistat is recommended in the treatment of obesity, which is an independent risk factor for nonalcoholic fatty liver disease (NAFLD). The reported findings of orlistat in NAFLD are divisive. Recently, periostin is identified as an important regulatory molecule in the pathogenesis of obesity-induced fatty liver. Therefore, this study aimed to evaluate the potential effects of orlistat in the treatment of NAFLD. A 16-week prospective observational study was conducted, with obese NAFLD patient (n=77) receiving orlistat (120 mg capsules, three times a day) with hypocaloric diet or hypocaloric diet only. Grades of fatty liver were determined using ultrasound (US) echogenicity of liver; serum levels of periostin, adiponectin, tumor necrosis factor (TNF)-α and interleukin-6 were determined using ELISA kits at 0 and 16 weeks. Correlations of US grades of fatty liver with these biomarkers were also determined. Orlistat significantly reversed the US grades of fatty liver (P=0.016), decreased serum levels of periostin (P=0.030) and TNF-α (P=0.040), and increased serum adiponectin levels (P<0.001) when compared with hypocaloric diet only. Serum interleukin-6 levels were not found to be significantly different in both groups after the treatment. In the orlistat group, the degree of reduction in grades of fatty liver was found to be positively correlated with the changes in serum levels of periostin (rs=0.306, P=0.041) and adiponectin (rs=0.314, P=0.036), whereas the associations were insignificant with the change in serum levels of TNF-α (rs=0.053, P=0.729). Mild gastrointestinal side effects (20%) were reported in the orlistat group. In conclusion, orlistat is effective in the treatment of NAFLD patients without fibrosis. This study demonstrated a positive association between the reduction of fatty infiltration in the liver and the changes in serum levels of periostin and adiponectin in obese NAFLD patients.

Antimicrobial sensitivity pattern of bacterial pathogens in urinary tract infections in South Delhi, India.

Seventy-four bacterial proven cases of urinary tract infections were studied, and identified by Mac Conkey agar and blood agar medium separately; all the isolates were subjected to antimicrobial sensitivity testing by Stokes technique. Ninty-six percent of total isolated organisms were found to be gram negative while remaining 4% were gram positive. Among gram negatives, E. coli and gram positive S. aureus were the most prevalent organisms. The percentage of gram negative isolates were as follows, E. coli (79.7%) followed by Klebsiella (9.5%), Pseudomonas, Acinetobacter were (2.7% each), Proteus constituted (1.4%). and among gram positive S. aureus (4%). The antibiotic resistance of identified organisms was carried out by disc-diffusion method with commercially available disc of thirteen antibiotics having different mode of actions such as inhibition of cell wall synthesis, membrane permeability alternatives, inhibition of protein synthesis and DNA synthesis inhibitors. Gram negatives showed more resistance to these antibiotics as compared to gram positive organisms. The most effective antibiotic for gram negative UTI isolates is amikacin showing 63% efficacy followed by Cefotaxime 55% efficacy, Amoxicillin and Ciprofloxacin with (49% each) efficacy. Among gram positives, Chloramphenicol, Co-trimoxazole, Gentamicin, Amikacin, Ciprofloxacin and Cefotaxime are most effective with (66.6% each) efficacy, then Ampicillin, Amoxicillin, Tetracycline and norfloxacin with (33.3% each) efficacy.

Monitoring of adverse drug reactions associated with antihypertensive medicines at a university teaching hospital in New Delhi.

AIM: To monitor the adverse drug reactions (ADRs) caused by antihypertensive medicines prescribed in a university teaching hospital. METHODS: The present work was an open, non-comparative, observational study conducted on hypertensive patients attending the Medicine OPD of Majeedia Hospital, Jamia Hamdard, New Delhi, India by conducting patient interviews and recording the data on ADR monitoring form as recommended by Central Drugs Standard Control Organization (CDSCO), Government of India. RESULTS: A total of 21 adverse drug reactions were observed in 192 hypertensive patients. Incidence of adverse drug reactions was found to be higher in patients more than 40 years in age, and females experienced more ADRs (n = 14, 7.29%) than males, 7 (3.64%). Combination therapy was associated with more number of adverse drug reactions (66.7%) as against monotherapy (33.3%). Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions (n = 7), followed by diuretics (n = 5), and ß-blockers (n = 4). Among individual drugs, amlodipine was found to be the commonest drug associated with adverse drug reactions (n = 7), followed by torasemide (n = 3). Adverse drug reactions associated with central nervous system were found to be the most frequent (42.8%) followed by musculo-skeletal complaints (23.8%) and gastro-intestinal disorders (14.3%). CONCLUSIONS: The present pharmacovigilance study represents the adverse drug reaction profile of the antihypertensive medicines prescribed in our university teaching hospital. The above findings would be useful for physicians in rational prescribing. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions.

Resistant patterns of bacteria isolated from bloodstream infections at a university hospital in Delhi.

BACKGROUND: The choice of antimicrobial therapy for bloodstream infections is often empirical and based on the knowledge of local antimicrobial activity profiles of the most common bacteria causing such infections. AIMS: The present study was aimed to investigate frequency of bacterial pathogens causing septicemia and their antimicrobial resistant pattern in hospital admitted patients. SETTINGS AND DESIGN: It was a prospective study, conducted at Majeedia Hospital, Hamdard University, New Delhi, India. MATERIAL AND METHODS: We examined prospectively, 168 bacterial strains isolated from 186 clinically diagnosed septicemia cases admitted at a University Hospital in New Delhi, over a period of six months from July 2009 to December 2009. Antimicrobial susceptibility was performed according to Clinical and Laboratory Standards Institute (CLSI, USA) guidelines. RESULTS: The most frequently identified Gram-positive bacteria were coagulase-negative staphylococci 63.5%, Staphylococcus aureus 23.1%, enterococci 5.8% and alpha-haemolytic streptococci 5.8%. The most frequently Gram-negative bacteria identified were Acinetobacter species 31%, Salmonella typhi 24.1%, Escherichia coli 23.3% and Pseudomonas aeruginosa 13.8%. Coagulase-negative staphylococci showed maximum resistance to cefaclor 57.1% and ampicillin 46.9%. Staphylococcus aureus showed maximum resistance to amoxicillin 100% and ampicillin 91.7%. Acinetobacter species showed maximum resistance to amoxicillin 89.7%, amoxiclav 87.1% and ampicillin 85.7%. Salmonella typhi, Escherichia coli, Pseudomonas aeruginosa and Klebsiella pneumoniae showed maximum resistance to ampicillin, 46.4%, 92%, 93.8% and 100%, respectively. CONCLUSIONS: Gram-negative pathogens predominated in bloodstream infections. Resistance to most of the antimicrobial agents for a number of pathogens implicated in bloodstream infections, especially in Gram-negative bacteria, has reached worrisome levels and continues to increase.

A pharmacovigilance study in the department of medicine of a university teaching hospital

The aim of the present study was to monitor adverse drug reactions (ADRs) in the Medicine outpatient department (OPD) of a University Teaching Hospital. Method: A prospective evaluation of the ADRs reported in the Department of Medicine of our University Teaching Hospital over a period of 4-months was conducted. Results: During the study period, a total of 600 patients visited the Medicine OPD and 122 ADRs were reported. Out of 122 reports that were identified, a higher percentage of ADRs in males (52.4%) was observed as compared to females (47.5%). Of the 122 ADRs, 50 were found to be mild (41.0%), 49 moderate (40.2%), and 23 severe (18.2%). A total of 71 (58.0%) ADRs were observed in patients receiving 4 or more medications concurrently. Conversely 46 (37.7%) ADRs were detected in patients using 3 or less medicines. The largest number of reports were associated with antihypertensive therapy (39.3%), followed by antimicrobials (31.1%) and antidiabetics (10.7%). Amongst the organ systems affected, gastrointestinal ADRs constituted a major component (24.7%) followed by skin reactions (22.2%). On causality assessment, nearly 29.5% ADRs were considered as probable, 33.6% possible and 6.6% could not be categorised and were placed under unassessable. Conclusion: The present work is the maiden pharmacovigilance study conducted at our university teaching hospital. The data presented here will be useful in future, long term and more extensive ADR monitoring in the hospital and in promotion of rational prescribing and drug use in the hospital (AU)

El objetivo del presente estudio fue monitorizar las reacciones adversas medicamentosas (RAM) en el departamento de consultas externas (DCE) de un Hospital Universitario. Método: Se realizó una evaluación prospectiva del as RAM comunicada sen el Departamento de Medicinad e nuestro Hospital Universitario durante un periodo de 4 meses. Resultados: Durante el periodo de estudio, 600 pacientes visitaron el DCE y en 122 se comunicaron RAM. De las 122 comunicaciones, se observó un mayor porcentaje de hombres (52,4%) que de mujeres (47,5%). De las 122 RAM, 50 fueron leves (41,0%), 49 moderadas (40,2%) y 23 graves (18,2%). 71 RAM (58,0%) se observaron en pacientes con 4 o más medicamentos simultáneos. Mientras que 46 (37,7%) RAM se observaron en pacientes con 3 o menos medicamentos. El mayor número de comunicaciones estaba asociado a tratamientos antihipertensivos (39,3%), seguidos de antimicrobianos (31,1%) y antidiabeticos (10,7%). Entre los órganos y sistemas afectados, el gastrointestinal constituía el mayor (24,7%) seguido del as reacciones cutáneas (22,2%). Ene n análisis de causalidad, casi el 29,5% de las RAM se consideraron como probables, el 33,6% como posibles y el 6,6% no pudieron clasificarse por ser invalorables. Conclusión: El presente trabajo es el principal estudio de farmacovigilancia realizado en nuestro hospital universitario. Los datos aquí presentados serán útiles para la monitorización futura y más intensa de RAM en el hospital y para promover la prescripción y el uso racionales en el hospital (AU)