Uterine artery Doppler analysis at 11-14 weeks as a predictor of intra-uterine growth restriction

Background: Successful pregnancy results from reciprocity between placental and maternal cardiovascular system. Intra-uterine growth restriction (IUGR) is a condition which arises from insufficiency of placenta and can be seen as variations in waveforms in uterine artery (UtA). In our study, we studied, whether predictive accuracy of various UtA Doppler indices for IUGR in first trimester early enough to provide an intervention for prevention of IUGR, as it was a leading cause of neonatal morbidity and mortality.Methods: The study design was a prospective observational study. UtA Doppler was done at 11-14 weeks in 120 pregnancies attending the outpatient and inpatient department of obstetrics and gynaecology, PCMS, Bhopal. The left and right UtA velocity waveforms were studied. Mean pulsatility index (PI), mean resistive index (RI) and diastolic notch were noted. Results obtained were analyzed and tabulated.Results: Amongst these, 25.86% developed IUGR. First trimester UtA mean RI and PI were remarkably elevated in patients who developed IUGR on follow up. No relationship was noted between diastolic notch and IUGR. Mean RI and PI were found to be good predictors of IUGR. Using receiver operating characteristics (ROC) curve, the best cut-off of mean RI and mean PI to detect IUGR was 0.68 and 1.56 respectively.Conclusions: UtA Doppler at 11-14 weeks of gestation recognizes a huge proportion of women who will develop IUGR.

Antimicrobials associated adverse drug reaction profiling: a four years retrospective study (Pharmacovigilance study)

Background: All drugs profoundly modify our biological processes and may manifest as adverse drug reactions (ADRs), which are unpredictable and inevitable consequences. Antibiotics are a common cause of ADR, necessitating stopping or change of antibiotics. The incidence of ADRs increases with the number of drugs prescribed in a prescription, and antibiotics are rarely prescribed as monotherapy.Aim: The study aimed to assess frequency, class of antibiotics, symptoms, causality, the severity of antimicrobial-associated ADRs, and see the demographic distribution.Methods: ADRs were collected and filled in suspected ADR forms and sent via vigiflow to the National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI). These ADR reports, termed individual case safety reports (ICSRs), were analyzed from Jan 2016 to Dec 2019.Results: A total of 414 (54.33%) ICSRs of 762 were identified as antimicrobial-associated. Adults in the age group 19–65 years accounted for 345 (83.09%) of ADRs. A total of 192 (46.38%) were males, and 222 (53.14%) were females. Skin and subcutaneous tissue System organ class was involved in 54% of cases. In the causality assessment, 268 (64.49%) were “probable,” 123 (29.71%) were “possible,” and 23 (5.56%) were “certain.” On severity assessment, 256 ADRs (61.83%) were mild, 133 (32.12%) were moderate, and 25 (6.03%) were severe. A total of 54 antimicrobial agents, excluding anti-tubercular drugs, were identified, and antibacterial accounted for 268 (64.73%) ADRs, followed by antiviral 90 (21.73%), antiprotozoal agents 33 (7.97%) antimalarials anti-scabicidal, antifungal accounting for the remaining.Conclusion: Antimicrobials play a crucial role in treating infections, and utmost vigilance during antimicrobials prescription reduces the frequency and severity of the ADRs, thereby reducing the morbidity and mortality and the pharmacoeconomic burden to the health care system. Pharmacovigilance must be boosted to ensure the safe and effective use of antibiotics and reduce the occurrence of ADRs

A study to identify clinical and laboratory parameters in cases of excessive vomiting in early pregnancy

Background: Around half of all pregnant women experience vomiting, and more than 80% of women experience nausea in the first 12 weeks. Women with severe nausea and vomiting during pregnancy may have hyperemesis gravidarum (HG), an entity distinct from nausea and vomiting of pregnancy (NVP), which if left untreated may lead to significant maternal and foetal morbidity. In our study, we studied, clinical and laboratory parameters in patients presenting with excessive vomiting. The study may help in evaluating what is the major clinical problem encountered during treatment and how many days of care are needed in such cases.Methods: The study design was a prospective observational study. Patients attending the ANC clinic and emergency indoor cases at Peoples college of medical sciences, Bhopal were considered as study population. 100 patients who satisfied inclusion and exclusion criteria were included in the study. Patient’s sociodemographic variables, detailed obstetric history, clinical and laboratory parameters were recorded. Results obtained were analysed and tabulated.Results: Persistence of vomiting in the first trimester leading to dehydration and hospitalization was documented in 12% of patients. The 5% of then had metabolic acidosis and 1% required correction of starvation ketoacidosis, but there was not significant weight loss observed in any of the case. Liver function test were normal in almost in all cases except 9% had raised serum alkaline phosphatase levels.Conclusions: All cases with vomiting in early pregnancy should receive attention and exclusion of all emergency clinical conditions. Patient should be screened for urine tract infection and diabetes in all cases.

Status of package insert guidelines for drugs accessible as over the counter drugs

Background: As per Indian pharmacopoeia, package inserts are part of a label that provides information on the article. It may be the sole source of information for drugs, which are available in the pharmacies without the prescription and it may include both prescription and over the counter (OTC) drugs. So, to aid in safety and efficacy of these drugs, package inserts must follow the standard guidelines (The Drugs and Cosmetics rule, 1945). The objective of this study was to observe the status of the standard guidelines for package insert in drugs accessible as OTC drugs.Methods: Based on the inquiries made with pharmacies, list of drugs commonly bought without prescription was made. 256 drugs were evaluated. Their package inserts were observed for the extent to which the guidelines given by The Drugs and Cosmetics rule 1945, section 6.2 and 6.3 are being followed. Secondary objectives were made to assess if package inserts are physician friendly or patients friendly.Results: Package inserts were missing in 180 (70%) of the drugs.  Therapeutic indications were present in 71% of the available package inserts (76). Pharmaceutical information was given in 57% of the package inserts. English was the preferred language and medicinal terms were used. Only one package insert was patient friendly.Conclusions: Package inserts should be made available in every drug. There should be a separate patient oriented package insert guideline, as per US food and drug administration (FDA), in India as well. This will aid in their safe and effective use

Protein Kinase C Epsilon Overexpression in Prostate Adenocarcinoma is Associated with Oncogenesis

Background: PKCε, an isozyme of serine-threonine kinase, has been implicated in epithelial cancer metastasis and progression. This study investigates the impact of the oncogenic PKCε, overexpressed abnormally in human Prostate tumor samples and cell lines, to understand its efficacy. Methods: The microarray dataset, GSE86257, was processed for normalization. The identification of upregulated and downregulated genes was based on FDR >1 and p <0.05 values. Cytoscape analysis and functional enrichment of significant genes were done. The identified genes were validated on the TCGA dataset and survival analysis was performed by Kaplan-Meier analysis. Results: A total of 1524 DEGs were identified with 728 upregulated genes and 818 downregulated genes. The two significant modules with MCODE score:9.0 and Venn analysis provided cyclin-dependent kinase inhibitor protein (CDK1), Cyclin B1 (CCNB1), Phospholipase C Gamma 1 (PLCG1), Cyclin Dependent Kinase 9 (CDK9), Phosphoinositide-3-Kinase Regulatory Subunit 3 (PIK3R3), H4 Clustered Histone 6 (H4C6), Phospholipase C Gamma 2 (PLCG2) as most interacting genes. TCGA data analysis and Prognostic analysis revealed CCNBI, CDK9, and PLCG1 associated with poor prognosis. Conclusion: PKCε regulates genes that are responsible for cancer progression. Therefore, targeting PKCε in Prostate cancer may serve as an important regulatory effect and may improve the prognosis of the disease.&nbsp

Study of drug use in outdoor pediatric patients of upper respiratory tract infections in a tertiary care hospital

Background: Upper respiratory tract infections (URTI) are the most common and frequent occurring infections in the pediatric population. URTI is mostly viral in origin and requires mostly symptomatic treatment. The present study was undertaken to analyze the pattern of drug use in the management of URTI in the pediatric age group.Methods: It is a retrospective study to assess the pattern of drug use in URTI in pediatric outpatient department during the 5 months period from January 2015 to May 2015.Results: A total of 2256 prescriptions were analyzed. Most of the pediatric patients belonged to 1-5 years age group and 58.33% were males, and 41.66% were females. A total of 6332 drugs were prescribed out of which the antibiotics used was 1341. The average number of drugs per prescription used was 2.81. The percentage of prescriptions containing antibiotics was found to be 59.44%. Amoxicillin (70.91%) was the most frequent prescribed antibiotic followed by cotrimoxazole (10.21%). Antihistaminic and expectorant combinations were found to be the most common prescribed class of drugs (29.34%) followed by analgesic and antipyretics (26.45%) and antibiotics (21.17%).Conclusions: The study revealed that the majority of children were below 5 years of age. The most common class of drugs prescribed was antihistaminics and expectorant combinations followed by analgesics and antipyretics. Although the majority of the patients received antibiotics, 40.55% of patients received symptomatic treatment. This is a welcome step as inappropriate use of the antibiotics can potentiate to the increasing trend of antimicrobial resistance

Knowledge, attitude and practice toward adverse drug reaction reporting among practicing clinicians at a tertiary care hospital

Background: Pharmacovigilance has evolved as an important tool for dealing with Adverse Drug Reactions (ADRs) both in pre-marketing and post-marketing scenario. Underreporting of ADRs at our Adverse drug reaction Monitoring Centre (AMC) led us to conduct this study to assess Knowledge, Attitude and Practice (KAP) of the practicing clinicians at our tertiary care Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur, Chhattisgarh, India, towards ADRs reporting.Methods: This was a cross-sectional study using pretested questionnaires consisting of 29 questions related to KAP of the practicing clinicians at Pt. J.N.M. Medical College associated Dr. B.R.A.M.  Hospital, Raipur towards ADRs reporting. The percentage of responders for each question was calculated. All statistical analysis was performed in Microsoft Office Excel 2007.Results: Out of 135 questionnaires distributed only 100 were considered for analysis, so the overall response rate was 74.07%. We calculated the result from the 100 responders. Overall 77% responders were aware of existence of ADR monitoring system in India, while only 40% were aware of its existence at their hospital. Only 8% responders had reported ADRs to the National Pharmacovigilance Centre and 10% to the Adverse drug reaction Monitoring Centre (AMC) at their hospital. Lack of knowledge about where, how and whom to report ADRs, lack of time, inability to decide what to report (known or unknown ADRs) and unavailability of ADR reporting form were the important factors discouraging them reporting ADRs.Conclusions: Creating awareness regarding ADR reporting through CMEs among practicing clinicians and early sensitization at medical undergraduate level for medical students may improve the current ADR reporting rate. 

Quantum Dissension: Generalizing Quantum Discord for Three-Qubit States

We introduce the notion of quantum dissension for a three-qubit system as a measure of quantum correlations. We use three equivalent expressions of three-variable mutual information. Their differences can be zero classically but not so in quantum domain. It generalizes the notion of quantum discord to a multipartite system. There can be multiple definitions of the dissension depending on the nature of projective measurements done on the subsystems. As an illustration, we explore the consequences of these multiple definitions and compare them for three-qubit pure and mixed GHZ and W states. We find that unlike discord, dissension can be negative. This is because measurement on a subsystem may enhance the correlations in the rest of the system. This approach can pave a way to generalize the notion of quantum correlations in the multiparticle setting.Comment: 9 pages 6 figures typo fixed and some arguments adde

Knowledge, Attitude and Practice on Biologicals and Biosimilars among Clinicians in Radiotherapy Department

Background: The decoding of human genome helped to design pharmacological agents like Biologicals and Biosimilars which can target the affected etiological aberrations. Biological agents are large complex molecules produced by recombinant techniques in a living system for therapeutic or diagnostic uses and have revolutionized treatment of many diseases. Patent expiry of Biologicals has led to the development of Biosimilars which are similar in efficacy & safety and have no clinically meaningful differences, but are not identical to Biologicals and undergo fewer clinical trials than their reference biologicals. Clinicians’ in- depth knowledge of these agents is important to optimize the use of cost-effective & easily accessible options. Methods: This is a cross sectional observational study conducted between Feb-March 2020 in Radiotherapy/Chemotherapy Oncology Department of Dr B.R.A.M. Hospital & Pt. J. N. M. Medical College, Raipur, Chhattisgarh, using a self-administered, structured questionnaire consisting of 15-question among 30 clinicians prescribing Biologicals and Biosimilars. Results: 83.3% of clinicians were familiar with the term ‘Biologicals’ & ‘Biosimilars’. 60% believed that Biosimilars are same as Generic Medicines and have the same potency as Biologicals. 53% assumed that Biologicals & Biosimilars can be switched. 50% were able to explain the difference or similarity between Biologicals and Biosimilars. Conclusion: The findings reveal that the clinicians had good knowledge about Biologicals and Biosimilars but lacked application of this knowledge in clinical practice. This highlights a need for regular educational initiative to reduce the knowledge deficit & its application in clinical practice. Further, there must be a National Treatment Guidelines on use of Biologicals  and Biosimilars

Insights from establishing a high throughput viral diagnostic laboratory for SARS-CoV-2 RT-PCR testing facility: challenges and experiences

Background: The World Health Organization declared the coronavirus disease 2019 (COVID-19) a global pandemic on 11 March 2020. Identifying the infected people and isolating them was the only measure that was available to control the viral spread, as there were no standardized treatment interventions available. Various public health measures, including vaccination, have been implemented to control the spread of the virus worldwide. India, being a densely populated country, required laboratories in different zones of the country with the capacity to test a large number of samples and report test results at the earliest. The Indian Council of Medical Research (ICMR) took the lead role in developing policies, generating advisories, formulating guidelines, and establishing and approving testing centers for COVID-19 testing. With advisories of ICMR, the National Institute of Cancer Prevention and Research (NICPR) established a high-throughput viral diagnostic laboratory (HTVDL) for RT-PCR-based diagnosis of SARS-CoV-2 in April 2020. HTVDL was established during the first lockdown to serve the nation in developing and adopting rapid testing procedures and to expand the testing capacity using “Real-Time PCR.” The HTVDL provided its testing support to the national capital territory of Delhi and western Uttar Pradesh, with a testing capacity of 6000 tests per day. The experience of establishing a high-throughput laboratory with all standard operating procedures against varied challenges in a developing country such as India is explained in the current manuscript which will be useful globally to enhance the knowledge on establishing an HTVDL in pandemic or non-pandemic times