Report of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide.

A collaborative study was conducted to establish the first Indian Pharmacopoeia Reference Standard (IPRS) for teriparatide to be used in quality control testing of marketed products in compliance with the Indian Pharmacopoeia (IP) monograph. The study objective was to evaluate the candidate standard in terms of the WHO International Standard (IS) to assign its content in mg per vial terms. This study involved four laboratories from India and the candidate standard was calibrated against the WHO IS by each participant laboratory using high-performance liquid chromatography (HPLC) assay method per IP monograph. Direct calibration of the candidate standard resulted in an assigned content of 1.02 mg per vial. Based on the study results the candidate standard was judged suitable to serve as the first IPRS for teriparatide for identification and assay by HPLC.

Comparison of patch test positivity after 24 and 48 hours of occlusion time in patients of allergic contact dermatitis: A prospective study.

BACKGROUND: Patch test is the gold standard for diagnosing allergic contact dermatitis. Conventionally, the patches are applied for 48 h, which in tropical weather conditions causes excessive sweating, leading to irritation, and sometimes the patches come off, making the test inconclusive. OBJECTIVE: To compare the patch test positivity after 24 and 48 h of occlusion time in patients of allergic contact dermatitis, using standard allergen concentration. MATERIALS AND METHODS: Clinically suspected patients of allergic contact dermatitis were enrolled and patch tested using the Indian Standard Series, parthenium acetone extracts (1:50, 1:100 and 1:200 dilutions) and patient material. Patches were applied in duplicate on either side of the back, using a random number table. One set of patches was removed after 24-h of occlusion, while the other set after 48-h. Readings were performed at 48- and 96-h by two independent dermatologists, blinded to the duration of occlusion. RESULTS: The study had 97 adult patients (58 males and 39 females; mean age: 48.12 ± 13.07 years). A total of 133 and 142 positive reactions were observed after 48 h occlusion at 48 and 96 h reading, respectively. Of these 117 (87.9%) and 132 (92.9%) patches were positive and concordant and noted at 24 h occlusion time. The Cohen's kappa coefficient were 0.94 for 48 h and 0.97 for 96 h reading, hence showing an almost complete agreement (ⱪ > 0.81) between patches occluded for 24 and 48 h. CONCLUSION: Though there is no significant difference in patch test positivity among ISS allergens after either occlusion time, 48 h occlusion performs significantly better compared with 24 h, when reactions of all allergens (ISS, patient material and parthenium acetone extract) are analysed together.

Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report.

Humane Society International India (HSI India) organized and facilitated a workshop on the 'Future of Target Animal Batch Safety Test (TABST) and Laboratory Animal Batch Safety Test (LABST) in the Indian Pharmacopoeia (IP) Monographs'. The workshop hosted key Indian regulators from the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO), industry representatives from the Indian Federation of Animal Health Companies (INFAH), Asian Animal Health Association (AAHA), and international experts representing the European Directorate for the Quality of Medicines (EDQM), the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and multinational veterinary products manufacturers. The workshop was organized to encourage a bidirectional flow of information and to discuss the deletion of TABST and LABST from the veterinary vaccine monographs in the IP. This workshop was built from the symposium held by Humane Society International on the 'Global Harmonization of Vaccine Testing Requirements' held in 2019. This report details the outcomes of the workshop with proposed activities to be taken up as part of the next steps for the elimination or waiving of these tests.

3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report.

Regulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace in vivo testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled "3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-art and future opportunities" was jointly organized by the Animal-Free Safety Assessment Collaboration, HealthforAnimals, and the International Alliance of Biological Standardization. Two webinars and a workshop aimed to outline the state-of-the-art non-animal approaches for veterinary batch-release testing. The events included information on the state of the deletion of obsolete safety testing and the current initiatives implemented by European, North American, and Asian-Pacific stakeholders on 3Rs implementation and regulatory acceptance. The events contributed to a better understanding of the barriers to 3Rs implementation. Participants highlighted the need for open communication, continued collaboration between stakeholders, and international harmonization of regulatory requirements to help accelerate acceptance. Despite the challenges, the countries represented at this three-part event have shared their commitments to advancing the acceptance of alternative methods.

Nutrition morbidity interactions in pre-school children.

Background & objectives: Research studies in the 1970s reported that in pre-school children, undernutrition increased the risk of infections and infections aggravated undernutrition. Over decades, there has been a reduction in prevalence of undernutrition and improvement in access to healthcare for treatment of infections. A mixed longitudinal study was undertaken to assess whether over time there were any changes from the earlier reported effect of undernutrition prior to infection on the risk of morbidity and effect of morbidity on nutritional status in pre-school children. Methods: Pre-school (0-59 months of age) children from urban low- and middle-income families whose parents were willing to allow their participation in the study were enrolled. Information on sociodemographic profile of the families was collected at enrolment. Weight of all children and length in infants were recorded every month; length/height in children 12-59 months of age was recorded once in three months. Morbidity information was collected through fortnightly visits. Results: 3888 pre-school children were followed up in 74636 home visits. Among these children, underweight and wasting were associated with a small increase in risk of infections. The odds ratio for risk of infection for underweight children was 1.09 (95% CI: 1.02 to 1.16) and for wasting was 1.18 (95% CI: 1.08 to 1.29). The deterioration in Z scores for weight-for-age and body mass index-for-age in children during illness and convalescence was small but significant (P<0.001). Interpretation & conclusions: The increased risk of infections in undernourished children living in overcrowded tenements in areas with poor environmental hygiene was not significant, perhaps because the risk of infection in normally nourished children was also high. The deterioration in nutritional status following infection was small because of the ready access to and utilization of health and nutrition care.

Comprehensive chemo-profiling of coumarins enriched extract derived from Aegle marmelos (L.) Correa fruit pulp, as an anti-diabetic and anti-inflammatory agent.

Aegle marmelos (L.) Correa is an Indian medicinal plant known for its vast therapeutic activities. In Ayurveda, the plant is known to balance "vata," "pitta," and "kapha" dosh. Recent studies suggest anti-inflammatory, anti-microbial, and anti-diabetic potential but lack in defining the dosage over the therapeutic activities. This study aims to determine the chemical profile of Aegle marmelos fruit extract; identification, enrichment, and characterization of the principal active component(s) having anti-inflammatory and anti-diabetic potential. Targeted enrichment of total coumarins, focusing on marmelosin, marmesin, aegeline, psoralen, scopoletin, and umbelliferone, was done from Aegle marmelos fruit pulp, and characterized using advanced high-throughput techniques. In vitro and in silico anti-diabetic and anti-inflammatory activities were assessed to confirm their efficacy and affinity as anti-diabetic and anti-inflammatory agents. The target compounds were also analysed for toxicity by in silico ADMET study and in vitro MTT assay on THP-1 and A549 cell lines. The coumarins enrichment process designed, was found specific for coumarins isolation as it resulted into 48.61% of total coumarins enrichment, which includes 31.2% marmelosin, 8.9% marmesin, 4% psoralen, 2% scopoletin, 1.7% umbelliferone, and 0.72% aegeline. The quantification with HPTLC and qNMR was found to be correlated with the HPLC assay results. The present study validates the potential use of Aegle marmelos as an anti-inflammatory and anti-diabetic agent. Coumarins enriched from the plant fruit have good therapeutic activity and can be used for Phytopharmaceutical ingredient development. The study is novel, in which coumarins were enriched and characterized by a simple and sophisticated methodology.

Evaluation of plasma and urine neutrophil gelatinase-associated lipocalin (NGAL) as an early diagnostic marker of acute kidney injury (AKI) in critically ill trauma patients.

Background and Aims: Acute kidney injury (AKI) is a frequent complication of severe trauma associated with high mortality. The aim of this study was to evaluate the diagnostic ability of plasma and urine neutrophil gelatinase-associated lipocalin (NGAL) as an early marker of AKI assessed by RIFLE criteria as reference in trauma patients in intensive care unit (ICU). Material and Methods: This was a prospective observational study. Four hundred and eighteen patients admitted in the trauma ICU with age ≥18 years without known renal diseases were followed-up (serum creatinine, urine output, and estimated glomerular filtration rate) for 5 consecutive days. As per RIFLE criteria, 70 patients were broadly classified as AKI and rest of the patients (n = 348) as non-AKI. Plasma and urine samples of AKI (n = 70) and non-AKI (n = 70) patients were further assessed for 3 consecutive days following admission. Results: Mean plasma NGAL (pNGAL) was significantly elevated in AKI patients as compared with non-AKI patients; on admission: 204.08 versus 93.74 ng/mL (P = 0.01); at 24 h: 216.73 versus 94.63 ng/mL (P = 0.01); and 48 h: 212.77 versus 86.32 ng/mL (P = 0.01). Mean urine NGAL (uNGAL) at 48 h was also significantly elevated: 15.45 ng/mL in AKI patients as compared with 13.48 ng/mL in non-AKI patients (P = 0.01). Plasma and urine NGAL levels were significantly associated with increased mortality. Conclusion: pNGAL had good predictive value on admission (area under the receiver operative characteristic [AUROC] 0.84), at 24 h (AUROC 0.88) and 48 h (AUROC 0.87), while uNGAL had moderate performance at 24 h (AUROC 0.61) and 48 h (AUROC 0.71). pNGAL can be used as an early and potent diagnostic and predictive marker of AKI and mortality in critically ill trauma patients.

Frontal lobe metabolic alterations characterizing Parkinson's disease cognitive impairment.

BACKGROUND AND PURPOSE: Diagnosis of Parkinson's disease (PD) cognitive impairment at early stages is challenging compared to the stage of PD dementia where functional impairment is apparent and easily diagnosed. Hence, to evaluate potential early stage cognitive biomarkers, we assessed frontal lobe metabolic alterations using in vivo multi-voxel proton magnetic resonance spectroscopic imaging (1H-MRSI). METHOD: Frontal metabolism was studied in patients with PD with normal cognition (PD-CN) (n = 26), with cognitive impairment (PD-CI) (n = 27), and healthy controls (HC) (n = 30) using a single slice (two-dimensional) 1H-MRSI at 3 T. The acquired spectra were post-processed distinctly for voxels corresponding to the bilateral middle/superior frontal gray matter (GM) and frontal white matter (WM) regions (delineated employing neuromorphometrics atlas) using the LC-Model software. RESULT: Significant (post hoc p < 0.016) reduction in the concentration of N-acetyl aspartate (NAA) in the middle and superior frontal GMs and total choline (tCho) and total creatine (tCr) in the frontal WM was observed in PD-CI compared to PD-CN and HC, while that in HC and PD-CN groups were comparable. The NAA and tCr/tCho metabolite concentrations showed significant (p < 0.05) positive correlations with cognitive test scores in the frontal GM and WM, respectively. The receiver operating curve (ROC) analysis revealed significant (p < 0.05) "area under curve" for NAA/tNAA in the frontal GM and tCho in the frontal WM. CONCLUSION: The frontal metabolic profile is altered in cognitively impaired PD compared with cognitively normal PD. Neuronal function loss (NAA), altered energy metabolism (Cr), and cholinergic (Cho) neural transmission are implicated in PD cognitive pathology. Frontal neuro-metabolism may promisingly serve as PD cognitive biomarker.

Outcomes of surgical interventions for the treatment of limbal stem cell deficiency.

Background & objectives: In the current scenario, with availability of different surgical procedures for limbal stem cell deficiency (LSCD), there exists no common consensus as to the standardization of the management protocol for the same. In addition, there also exists diversity in the views about the clinical diagnosis, ancillary investigations and clinical parameters. The objective of the present study was to evaluate the reported outcomes of surgical interventions for the management of LSCD. Methods: A systematic review of published literature on limbal stem cell transplantation (LSCT) was performed using Ovid Medline, Embase and PubMed for a duration of 2009 to 2019. Original studies including prospective, retrospective case series and randomized controlled trials, articles in English language, articles with access to full text and studies with more than or at least 10 patients were included in this review. Data related to clinical and visual outcomes were evaluated, and pool estimates of different surgeries were calculated using random-effects model and individually using Pearson's Chi-square test. Results: A total of 1133 abstracts were evaluated. Finally, 17 studies were included for the analysis. Among these 17 studies, direct limbal lenticule transplantation was performed in five studies, of which autologous tissue from the fellow eye [conjunctival limbal autograft (CLAU)], allograft from a cadaver/live donor [keratolimbal allograft (KLAL)/conjunctival limbal allograft (CLAL)] and combination of CLAU plus KLAL were done in one, three and one studies, respectively. The ex vivo expanded cultivated limbal epithelial transplantation (CLET) was reported in six studies and simple limbal epithelial transplantation (SLET) in four studies. Two were comparative studies comparing CLET and CLAL (living-related CLAL) with cadaveric KLAL, respectively. Outcome analysis of the included studies showed significant heterogeneity. Calculated pool rate for various types of surgeries was calculated. The pool estimate for CLAL was 67.56 per cent [95% confidence interval (CI), 41.75-93.36; I2=83.5%, P=0.002]. For KLAL, this value was 63.65 per cent (95% CI, 31.38-95.91; I2=92.4%, P=0.000). Pool estimate for CLET was 78.90 per cent (95% CI, 70.51-87.28; I2=73.6%, P=0.001). Corresponding values for SLET were 79.08 per cent (95% CI, 74.10-84.07; I2=0.0%, P=0.619). CLAU and combination of CLAU plus KLAL were done in one study each; hence, statistical analysis could not be done. The functional outcome in terms of gain in visual acuity post-operatively was better in KLAL (P<0.005) and SLET group as compared to CLET group. Interpretation & conclusions: The present analysis suggests that though the anatomical success rates were almost identical between SLET, CLET, CLAL, and KLAL procedures, the functional success rates were better following KLAL and SLET procedures as compared to CLET. Decision for LSCT for cases of ocular burns based on either clinical judgement of the surgeon or individual diagnosis remains a suitable option.

Association between concentration of active MMP-9 in pulpal blood and pulpotomy outcome in permanent mature teeth with irreversible pulpitis - a preliminary study.

AIM: To investigate the correlation between the concentration of active-matrix metalloproteinases-9 (aMMP-9) in pulpal blood and the outcome of pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis (SIP). METHODOLOGY: Forty permanent molar teeth with a clinical diagnosis of SIP and normal apical tissues with periapical index (PAI) score ≤ 2 and ten permanent teeth (8 molars and two premolars) with a diagnosis of normal pulp that required root canal treatment for prosthetic reasons from patients between the ages of 15-35 years were recruited. All clinical procedures were performed under local anaesthesia and rubber dam isolation. After access opening, the coronal pulp tissue was amputated up to the canal orifice. A 100 µL volume of the pulpal blood was collected using a micropipette and transported to the laboratory. Sodium hypochlorite (2.5 %) was used as a haemostatic agent, and mineral trioxide aggregate (MTA) was used as the pulp capping material. The tooth was restored with composite at the same visit. Teeth with normal pulps were treated with single-visit root canal treatment. Patients with pulpotomy were recalled at 6 and 12 months. Outcome assessment of teeth with pulpotomy was carried out at 12 months and was categorized as success (asymptomatic patients with PAI score ≤ 2) or failure (symptomatic patients or PAI score ≥ 3). Quantification of aMMP-9 in pulpal blood was achieved using a fluorometric assay. The following statistical analyses were performed to assess the data: t-test, Fisher's exact test, kappa coefficient, non-parametric test, Wilcoxon rank-sum test, Spearman rank correlation test and receiver operating characteristic curve (ROC). RESULT: The success rate of pulpotomy was 88 % at 12-months. There was a significant difference between the median concentrations of aMMP-9 in pulpal blood of teeth with normal pulps (52 (12-96) ng mL-1 :) and SIP (193.3 (25.8-607.7) ng mL-1 :) (P = 0.0003) and successful (132.3 (25.8-548.3) ng mL-1 :) and failed cases (512.4 (334.8-607.7 ng mL-1 :) (P = 0.0015) of MTA pulpotomy. A significant association was established between aMMP-9 concentration and outcome of pulpotomy. The area under the receiver operating characteristics curve (0.9484, 95%CI) suggested excellent discriminatory power of aMMP-9 concentration in pulpal blood to predict the pulpotomy outcome. CONCLUSION: The pulpal blood concentration of aMMP-9 was significantly associated with the outcome of pulpotomy in teeth with symptomatic irreversible pulpitis, where it may be used as a potential prognostic biomarker.

Cortical thickness and gyrification index measuring cognition in Parkinson's disease.

OBJECTIVE: Cortical dynamics is driven by cortico-cortical connectivity and it characterizes cortical morphological features. These brain surface features complement volumetric changes and may offer improved understanding of disease pathophysiology. Hence, present study aims to investigate surface features; cortical thickness (CT) and gyrification index (GI) in Parkinson's disease (PD) patients of normal cognition (PD-CN), cognitively impaired patients with PD (PD-CI) in comparison with cognitively normal healthy controls (HC) to better elucidate cognition linked features in PD. METHOD: Anatomical MRI (3DT1) was carried out in 30 HC (56.53 ± 8.42 years), 30 PD-CN (58.8 ± 6.07 years), and 30 PD-CI (60.3 ± 6.43 years) subjects. Whole brain ROI based parcellation using Desikan-Killiany (DK-40) atlas followed by regional CT and GI differentiation [with 'age' and 'total intracranial volume' (TIV) correction], multiple linear regression (with 'age', 'TIV', and 'education' correction) with clinical variables, ROC analysis, and CT-GI correlation across the groups was used for data analysis. RESULTS: Widespread cortical thinning with regional GI reduction was evident in PD-CI with respect to other two groups (HC and PD-CN), and with absence of such alterations in PD-CN compared to HC. Frontal, parietal, and temporal CT/GI significantly correlated with cognition and presented classification abilities for cognitive state in PD. Mean regional CT and GI were found negatively correlated across groups with heterogeneous regions. CONCLUSION: Fronto-parietal and temporal regions suffer cognition associated cortical thinning and GI reduction. CT may serve better discriminator properties and may be more consistent than GI in studying cognition in PD. Heterogeneous surface dynamics across the groups may signify neuro-developmental alterations in PD.

High burden of cardiometabolic risk factors in spouses of Indian women with hyperglycaemia in pregnancy.

AIM: To evaluate the burden and association of cardiometabolic risk factors in the spouses of women with and without hyperglycaemia in pregnancy. METHODS: Women with (n = 204) and without (n = 197) hyperglycaemia in pregnancy, along with their spouses, participated in this cross-sectional study. The hyperglycaemia in pregnancy group included women with gestational diabetes and diabetes in pregnancy. A detailed questionnaire was completed for all participants (men and women), documenting relevant personal and medical history, along with biochemical investigations (men). RESULTS: A total of 401 couples were evaluated at the time point during the pregnancy of 24.7 ± 5.2 gestational weeks (mean ± sd). Dysglycaemia (prediabetes or diabetes), overweight/obesity (BMI ≥25 kg/m2 ) and metabolic syndrome were detected in 120 (58.9%), 123 (60.3%) and 98 spouses (48.3%) of women with hyperglycaemia in pregnancy, respectively. In the fully adjusted model, an increased risk of dysglycaemia [odds ratio 1.43 (95% CI 0.95-2.17); P = 0.088], overweight/obesity [odds ratio 1.49 (95% CI 0.98-2.27); P = 0.064] and metabolic syndrome [odds ratio 2.00 (95% CI 1.30-3.07); P = 0.001] was seen in the spouses of women with hyperglycaemia in pregnancy. The prevalence of these metabolic conditions was higher in spouses of women with diabetes in pregnancy compared to spouses of women with gestational diabetes mellitus. CONCLUSIONS: A high burden of cardiometabolic risk factors was observed in the spouses of women with hyperglycaemia in pregnancy. The opportunity provided by pregnancy could be used by the healthcare system not only to improve the health of the woman and her offspring, but also her spouse.

Effect of cardiac resynchronization therapy on septal perfusion and septal thickening: Association with left ventricular function, reverse remodelling and dyssynchrony.

BACKGROUND: We evaluated the effect of cardiac resynchronization therapy (CRT) on septal perfusion and thickening at 6 months post implantation assessed on Tc99m-MIBI Gated myocardial perfusion SPECT (GMPS).We also studied the association of change in septal perfusion and thickening with primary outcome defined as at least one [improvement in ≥1NYHA class, left ventricular ejection fraction (LVEF) by ≥ 5%, reduction of end-systolic volume (ESV) by ≥ 15%, and improvement ≥ 5 points in Minnesota living with heart failure questionnaire (MLHFQ)]. METHOD: One hundred and five patients underwent clinical and GMPS evaluation before and at 6 months post CRT. RESULT: Post CRT there was significant improvement in mean normalized septal perfusion uptake and in septal thickening (P value = 0.001, both). There was no significant relation between improvement in septal perfusion and primary outcome. However, improvement in septal thickening was statistically significant with favorable primary outcome (P = 0.001).There was no significant correlation between improvement of septal perfusion and improvement in LVEF, reduction in End diastolic volume (EDV), ESV, and Left ventricular Dyssynchrony (LVD). But, there was significant correlation between improvement of septal thickening and these parameters. CONCLUSION: Improvement in septal thickening was associated with reverse remodeling, improvement in LVEF, and reduction of LVD.

Increase in concentration of patch test allergen reduces patch test occlusion time to 12 hours without affecting patch test reactivity in patients with parthenium dermatitis.

BACKGROUND: Patch testing is the standard method to diagnose contact allergy. Patches are applied for 48 hours, which is inconvenient to patients in tropical weather. Therefore, we evaluated different patch test occlusion times with increased concentrations of an allergen to determine if occlusion time can be reduced without compromising patch test reactivity. METHODS: Patch test positive patients with parthenium dermatitis were enrolled and patch tested using five different concentrations (10%, 4%, 2%, 1%, and 0.5%) of parthenium extract. The patches were applied in triplicate. The first set was removed after 12 hours, whereas the second and third sets were removed after 24 and 48 hours, respectively. Readings were performed at 24, 48, and 96 hours. RESULTS: Fifty patients with parthenium dermatitis were included. The positive patch test reaction rates were comparable in all three sets at 24- and 48-hour readings irrespective of the occlusion time. All were positive, with 10%, 4%, and 2% concentrations at 96-hour reading with an occlusion time of 12 hours. CONCLUSION: An occlusion time of 12 hours seems adequate to elicit positive patch test reaction at a 96-hour reading if the concentration of patch test allergen can be increased, that is, from 1% to 2% in these patients.

Evaluation of 75 g glucose load in non-fasting state [Diabetes in Pregnancy Study group of India (DIPSI) criteria] as a diagnostic test for gestational diabetes mellitus.

BACKGROUND & OBJECTIVES: There is no consensus regarding optimal standard for diagnosis of gestational diabetes mellitus (GDM). In this study, use of 75 g glucose load in non-fasting state [Diabetes in Pregnancy Study Group of India (DIPSI) criteria] as a diagnostic test for GDM in pregnant women was compared with different oral glucose tolerance tests (OGTTs). METHODS: This prospective study included 936 pregnant women, who underwent plasma glucose evaluation two hours after the challenge of 75 g glucose load irrespective of the timing of last meal (DIPSI criteria for GDM). After three days, standard 75 g OGTT was done in all women irrespective of previous plasma glucose value. Accuracy of the first result was compared to OGTT using cut-offs as per the World Health Organization (WHO) and International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria for the diagnosis of GDM. RESULTS: Of the total 936 pregnant women, 73 (7.8%) patients had plasma glucose value ≥140 mg/dl when measured two hours after glucose load. When comparing with the WHO and IADPSG criteria, the sensitivity values were 65.1 and 74.1 per cent, respectively, and the corresponding specificity values were 96.3 and 96.9 per cent, respectively. On comparing with the WHO OGTT, only 41 of the 73 (56.2%) were true positives, whereas when IADPSG criteria were used, true positives were 46 (63%). False negative cases were also present when classified by the WHO and IADPSG criteria though in lesser numbers than false positives. The positive predictive values (PPVs) for the WHO and IADPSG criteria were 56.1 and 63 per cent, respectively, and their corresponding negative predictive values were 97.7 and 97.9 per cent, respectively. INTERPRETATION & CONCLUSIONS: Our findings showed that when 75 g glucose load in non-fasting state was used as a diagnostic test for GDM, almost one quarter of patients with GDM escaped diagnosis as sensitivity values were low. On the other hand, some GDM cases were falsely labelled as normal as this test did not account for cases of fasting hyperglycaemia. In addition, comparison with other OGTTs showed low PPVs. Hence, use of DIPSI criteria for diagnosing GDM must be reconsidered till further validation.

Assessment of home hazards for childhood injuries in an urban population in New Delhi.

BACKGROUND: Childhood injuries, especially the unintentional category of injuries, occur most commonly in the environment inside a child's home. The primary objective of the present study was to assess the presence of home hazards for childhood injuries in households in an urban resettlement colony in New Delhi. METHODS: A community-based cross-sectional study was carried out in an urban resettlement colony in Delhi. A hazards assessment tool was used to check the presence of hazards in the houses. RESULTS: A total of 225 households were included. It was seen that121 (53.7%) had a cooking stove within the reach of the child, and 190 (84.3%) had the gas pipe within reach. Fire hazard was seen in 84% of houses. About 78% of households did not have locked storage for chemicals. CONCLUSION: The study revealed a significant burden of hazards for childhood injuries within their own homes, thus emphasizing the need for injury prevention interventions to reduce the number of hazards.

Cytotoxic and pro-apoptotic activities of leaf extract of Croton bonplandianus Baill. against lung cancer cell line A549.

The acetone extract (AcE) of the Croton bonplandianus Baill., an exotic weed of the Euphorbiaceae family was studied for cytotoxicity, apoptosis, cell cycle arrest in A549 cell line and antioxidant capacities using MTT assay, acridine orange/ethidium bromide (AO/EB staining), cell cycle analysis and DPPH radical scavenging assay respectively. Based on the cytotoxic activity, the extract was tested for the apoptotic effect using AO/EB and Hoechst 33258 staining. The apoptosis was characterized by chromatin condensation and DNA fragmentation. Further, to determine the stage of cell death, cell cycle analysis was performed by flow cytometry and AcE was found to arrest G2/M phase in a dose dependent manner. The number of cells in G2/M phase increases with concurrent accumulation of cells in sub G0/G1phase indicates the induction of apoptosis at G2M phase. The free radical scavenging activity of the AcE against DPPH was considerably significant. The cytotoxic, apoptotic and antioxidant effect of the AcE could be well correlated with the presence of potent free radical scavenging secondary metabolites such as phenols (43 ± 0.05 µg/mL), flavonoids (3.5 ± 0.07 µg/mL) and tannin (0.36 ± 0.1 µg/mL). Our study has shown that A549 cells were more sensitive to AcE with an IC50 of 15.68 ± 0.006 µg/mL compared to the standard drug 2.20 ± 0.008 µg/mL (cisplatin). The results suggest that Croton bonplandianus could serve as a potential source of alternative therapeutic agent for treating cancer. Further research is required to isolate the active principle compound and determination of its anticancer property.

Tumour morphology after neoadjuvant chemotherapy as a predictor of survival in serous ovarian cancer: an experience from a tertiary care centre in India.

Serous ovarian cancer is the most common malignant ovarian tumour. Traditional management consists of surgical resection with postoperative chemotherapy. Currently neoadjuvant chemotherapy is offered to patients with advanced stage disease. The present study aims to analyse the histomorphological alterations in serous ovarian cancer following neoadjuvant chemotherapy. Correlation of these morphological alterations with survival is also presented here. Serous ovarian cancers from 100 advanced stage cases were included; 50 were treated with pre-surgery chemotherapy. Semi-quantitative scoring was used to grade the alterations in tumour morphology. Survival data was correlated with the final morphological score. Tumour morphology was significantly different in cases treated with neoadjuvant chemotherapy (CT group) as compared to cases with upfront surgery. The CT group cases showed more fibrosis, calcification, and infiltration by lymphocytes, plasma cells, foamy and hemosiderin-laden macrophages. The residual tumour cells had degenerative cytoplasmic changes with nuclear atypia. Patients with significant morphological response had a longer median survival, although it did not attain statistical significance in the current study. With the increasing use of neoadjuvant chemotherapy in management, the pathologist needs to be aware of the altered morphological appearance of tumour. Further studies are required to establish a grading system to assess the tissue response which can be helpful in predicting the overall therapeutic outcome and the prognosis of patients.

Protective effect of Monascus fermented rice against STZ-induced diabetic oxidative stress in kidney of rats.

In the present study, anti-diabetic activity and nephroprotective effect of MMFR was evaluated by using STZ-induced diabetic rats. Administration of MMFR at 100 and 200 mg/kg bw showed significant (P < 0.01) anti-hyperglycemic activity by lowering blood glucose level, HbA1C and increasing body weight. Altered lipid profiles in diabetic rats were restored to normal level on treatment with MMFR and showed significant (P < 0.01) decrease in the elevated levels of biochemical parameters. MMFR produced significant (P < 0.01) improvement in antioxidant levels in kidney. Food safety of MFR produced by using mutant Monascus purpureus 254 (MMFR) was evaluated for genotoxicity and oral acute toxicity. In Ames mutagenicity assay MMFR doesn't showed any toxicity to the test strain S. typhimurium till 5 mg/plate. Acute toxicity study also recorded no toxicity till the dose of 5,000 mg/kg bw. The study concluded that MMFR, not only possess anti-diabetic activity but also prevents nephropathy and hypercholesterolemia due to diabetes.

Designer foods and their benefits: A review.

Designer foods are normal foods fortified with health promoting ingredients. These foods are similar in appearance to normal foods and are consumed regularly as a part of diet. In this article we have reviewed the global regulatory status and benefits of available designer foods such as designer egg, designer milk, designer grains, probiotics, designer foods enriched with micro and macronutrients and designer proteins. Designer foods are produced by the process of fortification or nutrification. With the advances in the biotechnology, biofortification of foods using technologies such as recombinant DNA technology and fermentation procedures are gaining advantage in the industry. The ultimate acceptability and extensive use of designer foods depend on proper regulation in the market by the regulatory authorities of the country and by creating consumer awareness about their health benefits through various nationwide programs.