C-peptide Level in Patients With Uncontrolled Type 2 Diabetes Mellitus on Oral Anti-diabetic Drugs.

BACKGROUND: In the development and progression of type 2 diabetes mellitus, ß-cell dysfunction occurs after insulin resistance. Despite poor glycaemic control, there is a practice of increasing the dose of oral anti-diabetics or adding more drugs to the regimen due to the common perception that low endogenous insulin secretion is related to type 1 diabetes mellitus only and patient's poor compliance to injectables. Keeping this perspective in mind, this study was conducted to assess the prevalence of beta cell dysfunction by low serum C-peptide levels and its correlation with poor glycaemic control. MATERIALS AND METHODS: A total of 134 patients with type 2 diabetes mellitus for more than 10 years on oral anti-diabetic drugs fulfilling our eligibility criteria were enrolled in our study. Blood samples for fasting blood sugar and fasting C-peptide level were taken before breakfast and uptake of anti-diabetic drugs. Correlation analysis was performed to evaluate the relationship between fasting C-peptide and glycaemic control with respect to glycated haemoglobin (HbA1c). RESULTS: Of the patients, 19.40% had insufficient beta cell reserve serum levels (C-peptide < 0.5 ng/ml), of which most of the patients (14/26 = 53.85%) had poor glycaemic control (HbA1c < 8.0%). Overall, there was a significant correlation between poor glycaemic control with respect to HbA1c and low serum C-peptide levels (p < 0.05). We found a significant association of beta cell dysfunction (low fasting C-peptide level) with the use of insulin secretagogue. The proportion of patients with C-peptide levels less than 0.5 ng/ml was lower in patients using sodium-glucose cotransporter-2 (SGLT-2) inhibitors as compared to insulin secretagogue. CONCLUSION: SGLT-2 inhibitors should be preferred over other anti-diabetic drugs as an add-on to existing metformin therapy. Insulin requirement must be assessed in patients who have long-term type 2 diabetes mellitus.

A Study of Drug Utilization Pattern and Pharmacoeconomic Analysis of Immunosuppressant Drugs in Patients With Skin Disorders in a Tertiary Care Hospital in Bihar.

Aims The cost-effective therapy of immunosuppressant drugs in dermatological conditions will not only lead to adherence to rational prescribing but will also increase patient compliance with fewer dropouts due to cost factor. Thus, this study was done to determine and compare the drug utilization pattern, prescribed daily dose/defined daily dose (PDD/DDD) defined by WHO, and the cost-effectiveness ratio of different immunosuppressants.  Methods and material Prescriptions for patients with skin disorders prescribed with any one systematic or topical immunosuppressant were collected. The utilization of drugs in different skin disorders was expressed as frequency and percentage. PDD was compared with DDD as per the WHOCC-Anatomical Therapeutic Chemical (ATC)/DDD index. The pharmacoeconomic analysis was done using a cost-effectiveness ratio. Statistical analysis Descriptive statistics were used to calculate percentages, frequency, and 95% CI. The cost-effectiveness ratio in terms of SFDs (symptom-free days) was defined as the total cost of the initial antibiotic during the study period divided by the number of SFDs (cost/ SFD) and was expressed as mean±standard deviation, and the Kruskal-Wallis test was used to determine statistical significance of difference. Results Immunosuppressants were prescribed in 117 (19.12%) prescriptions out of a total of 612 prescriptions. Deflazacort was the most utilized systemic immunosuppressant prescribed in 27.18% of cases and was commonly prescribed for irritant contact dermatitis (ICD) and allergic contact dermatitis (ACD) followed by prednisolone and betamethasone. Tacrolimus was the most utilized topical immunosuppressant prescribed in 15.90% of patients and was commonly used for ICD and vitiligo followed by clobetasol and mometasone. Betamethasone, prednisolone, clobetasol, and mometasone had better cost-effectiveness. PDD/DDD of all immunosuppressants was less than one except prednisolone, which had a PDD/DDD ratio of 3.52. Conclusions The cost-effectiveness of steroids has the advantage of providing better patients' adherence to pharmacotherapy, but over-prescribing could also lead to long-term adverse effects of steroids. Pharmacovigilance research should also incorporate pharmacoeconomic analysis to determine the relation between these two aspects.

Role of Sensitization and Awareness Program on Knowledge, Attitude, Views, and Practice of Self-Medication Among MBBS Students in a Medical College of Bihar.

Aims Self-medication is an essential component of self-care; however, its use has significantly increased. Its practice has many risks such as wrong diagnosis, adverse drug reactions, antimicrobial resistance, etc. Being future doctors, self-medication has a special impact on MBBS students. Henceforth, the present study was undertaken to sensitize MBBS students in a medical college in Bihar and to analyze its role in different aspects of self-medication. Methods and material This was a cross-sectional, questionnaire-based study. The questionnaire was circulated to MBBS students of all the phases. After collecting the responses, scoring and grading was done and then a sensitization and awareness program was conducted through different modes and medium. After three months the same questionnaire was distributed, and their response was again collected. Statistical analysis used With an expected 40% prevalence, the minimum sample size needed to attain a power of 95% and an alpha value of 0.05 was calculated to be 201. Statistical Package for Social Sciences version 16 was used for data analysis. The chi-square test was used to see the association in responses obtained, before and after sensitization. A P-value with ≤0.05 was considered statistically significant. Results The questionnaires were circulated among 439 students. On comparing the grades, we found that phase III students comparatively had better knowledge regarding different aspects of self-medication. On analyzing different aspects of self-medication, we found that there was a significant improvement in many aspects post-sensitization. Conclusions MBBS students are future doctors, hence they should be more educated about the pros and cons of self-medication. This study showed that the perception of participants improved after our educational activities. We hope that after becoming aware, these young budding doctors will spread awareness, which, in turn, will benefit society. Additionally, we hope that this study will have an impact on students from different medical colleges and even healthcare providers, promoting responsible self-medication practices when necessary.

Stability and numerical analysis of the generalised time-fractional Cattaneo model for heat conduction in porous media.

This work investigates the generalised time-fractional Cattaneo model. The homotopy perturbation transform technique is used to get the numerical solution of this model. The stability is analysed using the Lyapunov function, also the error analysis is discussed. Finally, the effectiveness of the proposed technique is illustrated by calculating the L 2 and L ∞ error and comparing it with the existing techniques.

Identifying oral microbiome alterations in adult betel quid chewing population of Delhi, India.

The study targets to establish a factorial association of oral microbiome alterations (oral dysbiosis) with betel quid chewing habits through a comparison of the oral microbiome of Betel quid chewers and non-chewing individuals. Oral microbiome analysis of 22 adult individuals in the Delhi region of India through the 16S sequencing approach was carried out to observe the differences in taxonomic abundance and diversity. A significant difference in diversity and richness among Betel Quid Chewers (BQC) and Betel Quid Non-Chewers (BQNC) groups was observed. There were significant differences in alpha diversity among the BQC in comparison to BQNC. However, in the age group of 21-30 years old young BQC and BQNC there was no significant difference in alpha diversity. Similar result was obtained while comparing BQC and Smoker-alcoholic BQC. BQ smoker-chewers expressed significant variance in comparison to BQC, based on cluster pattern analysis. The OTU-based Venn Diagram Analysis revealed an altered microbiota, for BQ chewing group with 0-10 years exposure in comparison to those with 10 years and above. The change in the microbial niche in early chewers may be due to abrupt chemical component exposure affecting the oral cavity, and thereafter establishing a unique microenvironment in the long-term BQC. Linear discriminant analysis revealed, 55 significant features among BQC and Alcoholic-Smoker BQC; and 20 significant features among BQC and Smoker BQC respectively. The study shows the abundance of novel bacterial genera in the BQC oral cavity in addition to the commonly found ones. Since the oral microbiome plays a significant role in maintaining local homeostasis, investigating the link between its imbalance in such conditions that are known to have an association with oral diseases including cancers may lead to the identification of specific microbiome-based signatures for its early diagnosis.

Feasibility and efficacy of delayed pharmacoinvasive therapy for ST-elevation myocardial infarction.

BACKGROUND: ST-elevation myocardial infarction (STEMI) refers to a clinical syndrome that features symptoms of myocardial ischemia with consequent ST-elevation on electrocardiography and an associated rise in cardiac biomarkers. Rapid restoration of brisk flow in the coronary vasculature is critical in reducing mortality and morbidity. In patients with STEMI who could not receive primary percutaneous coronary intervention (PCI) on time, pharmacoinvasive strategy (thrombolysis followed by timely PCI within 3-24 h of its initiation) is an effective option. AIM: To analyze the role of delayed pharmacoinvasive strategy in the window period of 24-72 h after thrombolysis. METHODS: This was a physician-initiated, single-center prospective registry between January 2017 and July 2017 which enrolled 337 acute STEMI patients with partially occluded coronary arteries. Patients received routine pharmacoinvasive therapy (PCI within 3-24 h of thrombolysis) in one group and delayed pharmacoinvasive therapy (PCI within 24-72 h of thrombolysis) in another group. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) within 30 d of the procedure. The secondary endpoints included major bleeding as defined by Bleeding Academic Research Consortium classification, angina, and dyspnea within 30 d. RESULTS: The mean age in the two groups was comparable (55.1 ± 10.1 years vs 54.2 ± 10.5 years, P = 0.426). Diabetes was present among 20.2% and 22.1% of patients in the routine and delayed groups, respectively. Smoking rate was 54.6% and 55.8% in the routine and delayed groups, respectively. Thrombolysis was initiated within 6 h of onset of symptoms in both groups (P = 0.125). The mean time from thrombolysis to PCI in the routine and delayed groups was 16.9 ± 5.3 h and 44.1 ± 14.7 h, respectively. No significant difference was found for the occurrence of measured clinical outcomes in the two groups within 30 d (8.7% vs 12.9%, P = 0.152). Univariate analysis of demographic characteristics and risk factors for patients who reported MACCE in the two groups did not demonstrate any significant correlation. Secondary endpoints such as angina, dyspnea, and major bleeding were non-significantly different between the two groups. CONCLUSION: Delayed PCI pharmacoinvasive strategy in a critical diseased but not completely occluded artery beyond 24 h in patients who have been timely thrombolyzed seems a reasonable strategy.

Nano-inspired smart medicines targeting brain cancer: diagnosis and treatment.

Cancer, despite being the bull's eye for the research community, accounts for a large number of morbidity and mortality. Cancer of the brain is considered the most intractable, with the least diagnosis rates, hence treatment and survival. Despite the extensive development of therapeutic molecules, their targeting to the diseased site is a challenge. Specially tailored nanoparticles can efficiently deliver drugs and genes to the brain to treat tumours and diseases. These nanotechnology-based strategies target the blood-brain barrier, the local space, or a specific cell type. These nanoparticles are preferred over other forms of targeted drug delivery due to the chances for controlled delivery of therapeutic cargo to the intended receptor. Targeted cancer therapy involves using specific receptor-blocking compounds that block the spreading or growth of cancerous cells. This review presents an account of the recent applications of nano-based cancer theragnostic, which deal in conjunct functionalities of nanoparticles for effective diagnosis and treatment of cancer. It commences with an introduction to tumours of the brain and their grades, followed by hurdles in its conventional diagnosis and treatment. The characteristic mechanism of nanoparticles for efficiently tracing brain tumour grade and delivery of therapeutic genes or drugs has been summarised. Nanocarriers like liposomes have been widely used and commercialized for human brain cancer treatment. However, nano-inspired structures await their translational recognition. The green synthesis of nanomaterials and their advantages have been discussed. The article highlights the challenges in the nano-modulation of brain cancer and its future outlook.

Chlorella minutissima-assisted silver nanoparticles synthesis and evaluation of its antibacterial activity.

The conventional methods of nanoparticles synthesis led to the production of highly toxic by-products and the use of toxic chemicals that are highly expensive in nature. Thus, the recent past has witnessed a surge in green synthesis of nanoparticles as a sustainable alternative. The present study outlines the biogenic silver nanoparticles (Ag-NPs) synthesis from an aqueous extract of Chlorella minutissima. The effect of certain parameters such as the reaction mixture's pH and precursor metal solution to algal extract ratios were explored and optimized. The UV spectrophotometric analysis of Ag-NPs gave surface plasmon response maximally at 426 nm. The developed Ag-NPs were characterized using zeta potential, indicating their high stability (-21.2 mV) with a mean diameter of 73.13 nm. Results from field emission-scanning electron microscopy (FE-SEM) showed that the particles were spherical in shape. Ag-NPs synthesized using Chlorella minutissima extract could significantly inhibit the growth of both Gram-positive and Gram-negative bacterial species. The study highlights that using C. minutissima extract for Ag-NPs synthesis is a convenient and fast process for controlling the growth of Gram-positive as well as Gram-negative bacteria.

Alternate Approach in Storing and Shipment of SARS-CoV-2 RNA Samples with the Use of FTA Cards.

Shipment of COVID-19 specimens within the country or overseas at long distances requires cold chain facility using dry ice and triple packing to prevent the risk of COVID-19 infection to the personnel involved in sample transport. The present study aimed to utilize FTA card technology as an alternate means of sample transport and storage across the country. Twenty-one SARS-CoV-2 lab confirmed samples with different Ct value (High, medium & low) were used to detect viral load in samples loaded on FTA card and further compared with VTM samples. The SARS-CoV-2 RNA was detected by rRT-PCR after storing for 14 days at 4 °C and 37 °C. The present study evaluated the utility of FTA cards for preserving the SARS CoV-2 RNA for 14-day period. A significant difference (P < 0.05) was observed in the cycle threshold (ΔCt 4-5) values obtained from FTA and VTM viral samples but it did not affect the positivity. The SARS-CoV-2 RNA could be recovered efficiently from FTA sample stored at 4 °C and 37 °C for 14 days. Thus, FTA cards could be an alternate option for transporting the samples at ambient temperature for a long time.

Disease Prevention and Treatment Using ß-Carotene: the Ultimate Provitamin A.

Humans being unable to synthesize beta-carotene, the provitamin A, depend on external sources as its supplement. Health benefits and dietary requirements of beta-carotene are interrelated. This orange-red coloured pigment has been enormously examined for its capacity to alleviate several chronic diseases including various types of cancer, cystic fibrosis, as well as COVID-19. However, this class of phytoconstituents has witnessed a broad research gap due to several twin conclusions that have been reported. Natural sources for these compounds along with their extraction methods have been mentioned. The current communication aims at contributing to the global scientific literature on beta-carotene's application in prevention and treatment of lifestyle diseases.

Clinical Presentation, Investigation and Control of an Outbreak of Adenoviral Conjunctivitis in a Neonatal Unit at a Tertiary Hospital.

BACKGROUND: Nosocomial spread of adenovirus infection has been reported in neonatal, pediatric and adult medical units. This nonenveloped and hardy virus is resistant to numerous disinfectants thus posing a challenge for control and prevention of adenovirus infections in health care settings. METHODS: An epidemiologic outbreak investigation revealed an adenoviral outbreak in the neonatal nursery as well as in the neonatal screening outpatient department for Retinopathy of Prematurity (ROP). All suspected cases (94 neonates) underwent adenoviral conventional polymerase chain reaction (PCR) and representative samples underwent sequencing by Sanger's method. The clinical features and disease course were studied. Infected babies were started on tobramycin eye drops. Topical steroid eye drops were added for those who developed pseudomembranes. RESULTS: We found 58 cases of laboratory-confirmed neonatal adenovirus conjunctivitis (between July 10 and October 24, 2019). Redness (96%) was the most common presentation followed by discharge (68.9%) and lid edema (51.7%). Pseudomembrane were seen in 77.5% of the infected neonates. Prior ROP examination was carried out in 38 (65.5%) neonates. Respiratory symptoms were present in 7 (12.06%) neonates. Sequencing revealed serotype 8 as the cause of the outbreak. Control measures were strictly implemented. Standard Operating Procedures (SOPs) for ROP screening were revisited, revised and reinforced to prevent future outbreaks. CONCLUSIONS: We observed ROP screening as a risk factor for the development of adenoviral conjunctivitis in neonatal care units. Neonates present with different clinical manifestations as compared with adults. Prompt control measures were implemented to control the adenoviral outbreak.

Rapid antigen detection kit for the diagnosis of SARS-CoV-2 - are we missing asymptomatic patients?

PURPOSE: To determine the utility, diagnostic accuracy, sensitivity, specificity, and negative predictive value of the laboratory based Covid-19 antigen detection test (Coris Bio- Concept, Gembloux, Belgium) for the diagnosis of SARS-CoV-2 in a tertiary care hospital among symptomatic and asymptomatic patients. METHODS: The nasopharyngeal swab samples were collected from the symptomatic patients and their contacts. The diagnostic accuracy of this antigen kit was determined in comparison to SARS-CoV-2 real-time reverse transcriptase (RT-PCR). RESULTS: A total of 825 patients fulfilling the inclusion criteria were included in the study; RT-PCR and antigen detection was performed simultaneously for 484 samples to determine the sensitivity and specificity of the test. The overall specificity and sensitivity was 99.32% and 71.96% respectively. Also, 3.7% of the asymptomatic patients who were negative by RAT were detected positive by RT-PCR. CONCLUSION: This rapid antigen test (RAT) was sensitive in the symptomatic patients presenting during the initial phase of the illness. Since, majority of the SARS-CoV-2 patients are asymptomatic and considering the huge population, the testing strategy formulated by Indian Council of Medical Research (ICMR) at the national level was cost effective. Thus, Ag-RDTs could play a pivotal role in early diagnosis, policy making and surveillance of the SARS-CoV-2.

Correction: Particle removal from air by face masks made from Sterilization Wraps: Effectiveness and Reusability.

[This corrects the article DOI: 10.1371/journal.pone.0240398.].

Impact of individual demographic and social factors on human-wildlife interactions: a comparative study of three macaque species.

Despite increasing conflict at human-wildlife interfaces, there exists little research on how the attributes and behavior of individual wild animals may influence human-wildlife interactions. Adopting a comparative approach, we examined the impact of animals' life-history and social attributes on interactions between humans and (peri)urban macaques in Asia. For 10 groups of rhesus, long-tailed, and bonnet macaques, we collected social behavior, spatial data, and human-interaction data for 11-20 months on pre-identified individuals. Mixed-model analysis revealed that, across all species, males and spatially peripheral individuals interacted with humans the most, and that high-ranking individuals initiated more interactions with humans than low-rankers. Among bonnet macaques, but not rhesus or long-tailed macaques, individuals who were more well-connected in their grooming network interacted more frequently with humans than less well-connected individuals. From an evolutionary perspective, our results suggest that individuals incurring lower costs related to their life-history (males) and resource-access (high rank; strong social connections within a socially tolerant macaque species), but also higher costs on account of compromising the advantages of being in the core of their group (spatial periphery), are the most likely to take risks by interacting with humans in anthropogenic environments. From a conservation perspective, evaluating individual behavior will better inform efforts to minimize conflict-related costs and zoonotic-risk.

Particle removal from air by face masks made from Sterilization Wraps: Effectiveness and Reusability.

Wearing face masks is highly recommended to prevent SARS-CoV-2 transmission in health care workers and for the general public. The demand for high quality face masks has seen an upsurge in the recent times, leading to exploration of alternative economic and easily available options, without compromising on the quality. Particle removal from air in terms of capture efficiency of the filter media or the face mask is a crucial parameter for testing and quality assurance. Short-term reusability of the face masks is also an important aspect as the demand for masks will potentially outstrip the supply in future. Sterilization Wraps, which are used to wrap sterile surgical instruments, have shown a promising performance in terms of removal of particles from air. In this study, we evaluate the particle filtration characteristics of face masks made of 2 different metric weights [45 and 60 gram per square metre (GSM)] respectively, using locally available Sterilization Wraps. The aerosol filtration characteristics were also studied after sterilisation by different techniques such as heat with 50% humidity (thermal treatment), ethylene oxide (ETO), steam and radiation dose of 30kGy. We found that 60 GSM face mask had particle capture efficiency of 94% for total particles greater than 0.3 microns and this capture efficiency was maintained even after sterilisation with ETO and thermal treatment. The cost of producing these masks was 30 US cents/mask at our institute. Our study suggests that sterilization wrap material made of non-woven polypropylene spunbond-meltblown-spunbond (SMS) fibres could be an appropriate readily available inexpensive material for making face masks or N95 respirators.

Comparative study of medial opening wedge high tibial osteotomy using fixator-cum-distractor device or locking plate in medial unicompartmental osteoarthritis of knee.

OBJECTIVE: The aim of our study was to evaluate the role of medial opening wedge high tibial osteotomy (MOWHTO) in medial unicompartmental osteoarthritis of the knee and compare two different fixation devices for stability, duration, outcome, and complications. METHODS: Fifty-seven patients (60 knees) of age < 60 yrs and either sex with medial unicompartmental osteoarthritis of the knee were divided into 2 groups. Twenty-four patients (25 knees) in Group I underwent MOWHTO using fixator-cum-distractor and 33 patients (35 knees) in Group II underwent MOWHTO using locking plate osteosynthesis. The results were assessed by VAS, KOOS and WOMAC score. RESULTS: Mean age of the patients in Group I was 53.13 ±â€¯5.20 years and 51.32 ±â€¯6.91 years in Group II. Mean preoperative varus deviation was 11.97 ±â€¯3.34° in Group I and 11.78 ±â€¯3.05° in Group II which was corrected to 3.27 ±â€¯1.75° and 3.56 ±â€¯1.47° valgus respectively. All the patients achieved full weight bearing by 35th day postoperatively in Group I with the mean of 30.27 ±â€¯2.71 days and 38th day in Group II with the mean of 30.32 ±â€¯3.08. The VAS, KOOS, and WOMAC score improved significantly postoperatively in both the groups. CONCLUSION: The difference between the two methods of fixation was statistically insignificant. Fixator-cum-distractor is minimally invasive giving good control over the final limb alignment; however, it is cumbersome with less patient compliance and has complications like pin tract infection. Locking plate provides better fixation stability than fixator-cum-distractor even without bone grafting; however, it is an invasive procedure requiring more soft tissue exposure and precise amount of wedge removal.

Individuals in urban dwelling primate species face unequal benefits associated with living in an anthropogenic environment.

In primates, living in an anthropogenic environment can significantly improve an individual's fitness, which is likely attributed to access to anthropogenic food resources. However, in non-professionally provisioned groups, few studies have examined whether individual attributes, such as dominance rank and sex, affect primates' ability to access anthropogenic food. Here, we investigated whether rank and sex explain individual differences in the proportion of anthropogenic food consumed by macaques. We observed 319 individuals living in nine urban groups across three macaque species. We used proportion of anthropogenic food in the diet as a proxy of access to those food resources. Males and high-ranking individuals in both sexes had significantly higher proportions of anthropogenic food in their diets than other individuals. We speculate that unequal access to anthropogenic food resources further increases within-group competition, and may limit fitness benefits in an anthropogenic environment to certain individuals.

Rates of human-macaque interactions affect grooming behavior among urban-dwelling rhesus macaques (Macaca mulatta).

OBJECTIVES: The impact of anthropogenic environmental changes may impose strong pressures on the behavioral flexibility of free-ranging animals. Here, we examine whether rates of interactions with humans had both a direct and indirect influence on the duration and distribution of social grooming in commensal rhesus macaques (Macaca mulatta). MATERIALS AND METHODS: Data were collected in two locations in the city of Shimla in northern India: an urban setting and a temple area. We divided these two locations in a series of similar-sized physical blocks (N = 48) with varying rates of human-macaque interactions. We conducted focal observations on three free-ranging rhesus macaque groups, one in the urban area and two in the temple area. RESULTS: Our analysis shows that macaques engaged in shorter grooming bouts and were more vigilant while grooming in focal sessions during which they interacted with people more frequently, suggesting that humans directly affected grooming effort and vigilance behavior. Furthermore, we found that in blocks characterized by higher rates of human-macaque interactions grooming bouts were shorter, more frequently interrupted by vigilance behavior, and were less frequently reciprocated. DISCUSSION: Our work shows that the rates of human-macaque interaction had both a direct and indirect impact on grooming behavior and that macaques flexibly modified their grooming interactions in relation to the rates of human-macaque interaction to which they were exposed. Because grooming has important social and hygienic functions in nonhuman primates, our work suggests that human presence can have important implications for animal health, social relationships and, ultimately, fitness. Our results point to the need of areas away from people even for highly adaptable species where they can engage in social interactions without human disruption.

A Retrospective Analysis of Reporting of Adverse Drug Reactions in a Tertiary Care Teaching Hospital: One Year Survey.

INTRODUCTION: Pharmacovigilance (PV) is related to detection, assessment, understanding and prevention of Adverse Drug Reactions (ADRs) which are incurred when drug is made available in the market and used in different physiological conditions. In many countries, ADRs ranks among the top ten leading cause of morbidity and mortality. There is a lack of formal culture for monitoring and reporting of ADRs in India, with ADR reporting rate being only 1% as compared to 5% in world. This type of academic detailing activity helps to create awareness of ADR reporting in the institutions. AIM: This study was planned to evaluate and analyse the incidence and patterns of ADRs in various inpatient and outpatient departments of hospital. MATERIALS AND METHODS: This was an observational, retrospective and record based study conducted by analysing the spontaneous ADR forms, collected over a period of 12 months (September 2014 to August 2015) at Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India. RESULTS: During the period of one year, 292 ADR forms were collected from 4,34,965 patients attending OPD and inpatients of the hospital. Incidence of ADR was 0.67 per thousand patients and average of around 24 ADR collected per month. Male:Female ratio was 1.30. Adolescent (16-30 yr) was the most common age group affected. Department of Skin and VD reported the maximum number of ADRs (33.22%), followed by the Departments of Oncology (18.84%). Antibiotics were the most common drug implicated followed by anticancer drugs. CONCLUSION: ADR reporting is an ongoing and continuous process. Studies from the institute helps to identify and rectify the problems related to ADR reporting. Pitfalls can be addressed by creating awareness among physicians and the patients to achieve finally the goal of Pharmacovigilant India.

Radiological Downstaging with Neoadjuvant Therapy in Unresectable Gall Bladder Cancer Cases.

BACKGROUND: Gall bladder cancer (GBC) usually presents as unresectable or metastatic disease. We conducted a feasibility study to evaluate the effect of neoadjuvant therapy (NAT) on radiologic downstaging and resectability in unresectable GBC cases. MATERIALS AND METHODS: Patients with locally advanced disease were treated with chemoradiotherapy [CTRT] ( external radiotherapy (45Gy) along with weekly concurrent cisplatin 35mg/ m2 and 5-FU 500 mg) and those with positive paraaortic nodes were treated with neoadjuvant chemotherapy [NACT (cisplatin 25mg/m2 and gemcitabine 1gm/m2 day 1 and 8, 3 weekly for 3 cycles). Radiological assessment was according to RECIST criteria by evaluating downstaging of liver involvement and lymphadenopathy into complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). RESULTS: A total of 40 patients were evaluated from January 2012 to December 2014 (CTRT=25, NACT=15). Pretreatment CT scans revealed involvement of hilum (19), liver infiltration (38), duodenum involvement (n=22), colon involvement (n=11), N1 involvement (n=11), N2 disease (n=8), paraaortic LN (n=15), and no lymphadenopathy (n=6). After neoadjuvant therapy, liver involvement showed CR in 11(30%), PR in 4 (10.5%), SD in 15 (39.4%) and lymph node involvement showed CR in 17 (50%), PR in 6 (17.6%), SD in 4 (11.7 %). Six patients (CTRT=2, NACT=4) with 66.6 % and 83% downstaging of liver and lymphnodes respectively underwent extended cholecystectomy. There was 16.6 % and 83.3% rates of histopathological CR of liver and lymph nodes. All resections were R0. CONCLUSIONS: Neoadjuvant therapy in unresectable gall bladder cancer results in a 15% resectability rate. This approach has a strong potential in achieving R0 and node negative disease. Radiologic downstaging (CR+PR) of liver involvement is 40.5% and lymphadenopathy is 67.5%. Nodal regression could serve as a predictor of response to neoadjuvant therapy.