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   Table of Contents - Current issue
Coverpage
July-August 2015
Volume 47 | Issue 4
Page Nos. 347-463

Online since Tuesday, July 21, 2015

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EDITORIAL  

Antimicrobial resistance and inappropriate use of antimicrobials: Can we rise to the challenge? p. 347
Sujith J Chandy
DOI:10.4103/0253-7613.161245  
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REVIEW ARTICLE Top

Paperless clinical trials: Myth or reality? p. 349
Sandeep K Gupta
DOI:10.4103/0253-7613.161247  
There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.
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EDUCATIONAL FORUM Top

Imiquimod - Its role in the treatment of cutaneous malignancies p. 354
Aditya Kumar Bubna
DOI:10.4103/0253-7613.161249  
Imiquimod is a synthetic imidazoquinolone amine, which has potent immune response modifier activity, when topically used. This characteristic property of imiquimod has led to its use in a number of applications in dermatology, particularly in cutaneous malignancies, where it has been found to be effective and safe. Currently, additional mechanisms for its activity in actinic keratosis, basal cell carcinoma, and invasive squamous cell carcinoma have been elucidated. Its usage for cutaneous metastasis in breast cancer has been a further addition to its therapeutic armamentarium recently.
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RESEARCH ARTICLES Top

Estimation of the plasma effect site equilibration rate constant of sufentanil in children using the time to peak effect of heart rate and blood pressure p. 360
In-Kyung Song, Ji-Hyun Lee, SungAe Jung, Jin-Tae Kim, Hee-Soo Kim
DOI:10.4103/0253-7613.161251  
Objectives: Although targeting the effect site concentration may offer advantages over the traditional forms of administering intravenous anesthetics, it is not applicable for sufentanil in children because its plasma effect site equilibration rate constant (k e0 ) is not known yet. We estimated k e0 of sufentanil in children using the time to peak effect (tpeak ) method. Materials and Methods: Under general anesthesia, sufentanil tpeak was measured after administration of a submaximal bolus dose by means of the decrease in heart rate, blood pressure and calculated approximate entropy (ApEn) of electroencephalogram in 105 children (age range: 3-11 years). k e0 was estimated using tpeak and known sufentanil pharmacokinetic parameters in normal children. Results: The mean tpeaks were measured as 44 ± 22 s and 227 ± 91 s by heart rate and by mean blood pressure respectively. The estimated k e0 were 5.16/min and 0.49/min by heart rate and blood pressure respectively. tpeak could not be measured using the ApEn, thus k e0 could not be calculated by ApEn in children. Conclusions: Shorter measured sufentanil tpeak by heart rate compared to blood pressure indicate that the heart rate decrease faster than decreasing of blood pressure. Moreover, the calculated sufentanil k e0 in children depends on the pharmacodynamics parameters.
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Comparative evaluation of 2 g single dose versus conventional dose azithromycin in uncomplicated skin and skin structure infections p. 365
Sudipta Kumar Dey, Amal Kanti Das, Sumit Sen, Avijit Hazra
DOI:10.4103/0253-7613.161254  
Objectives: Uncomplicated skin and skin structure infections (uSSSIs) are a common clinical problem. Majority are caused by staphylococci and streptococci. Different oral antibiotics are used for uSSSI, with comparable efficacy but varying treatment duration, cost, and adverse event profile. Azithromycin is used in uSSSI in adults conventionally in a dose of 500 mg once for 5 days. The extensive tissue distribution of the drug and its long elimination half-life prompted us to explore whether a single 2 g dose of the drug would produce a response in uSSSI comparable to conventional dosing. Materials and Methods: We conducted a parallel group, open-label, randomized, controlled trial (CTRI/2015/07/005969) with subjects of either sex, ≥12 years of age, presenting with uSSSI to the dermatology outpatient department. One group (n = 146) received 2 g single supervised dose while the other (n = 146) received conventional dose of 500 mg once daily for 5 days. Subjects were followed up on day 4 and day 8. Complete clinical cure implied complete healing of lesions, without residual signs or symptoms, within 7 days. Results: High cure rate was observed in both arms (97.97% and 98.63%, respectively) along with noticeable improvement in symptom profile from baseline but without statistically significant difference between groups. However, excellent adherence (defined as no tablets missed) was better in single dosing arm (98.65% vs. 86.30%). Tolerability was also comparable between groups with the majority of adverse events encountered being gastrointestinal in nature and mild. Conclusions: Single 2 g azithromycin dose achieved the same result as conventional azithromycin dosing in uSSSI with comparable tolerability but with the advantage of assured adherence. This dose can, therefore, be recommended as an alternative and administration supervised if feasible.
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Study of acute transfusion reactions in a teaching hospital of Sikkim: A hemovigilance initiative p. 370
Dhruva Kumar Sharma, Supratim Datta, Amlan Gupta
DOI:10.4103/0253-7613.161257  
Objective: Blood transfusions are inherently associated with risks ranging in severity from minor to life-threatening. Continuous monitoring of transfusion related complications can promote understanding of factors contributing to transfusion reactions and help to formulate necessary remedial measures. This study was designed to analyze the frequency and nature of transfusion reactions reported to the blood bank of a remote North East Indian teaching hospital. Materials and Methods: All acute transfusion reactions (ATRs) reported to the blood bank over a period of 20 months (May 2013 to January 2015) were reviewed and analyzed. The risk of transfusion reactions associated with each individual component was assessed. Results: A total of 3455 units of whole blood and component transfusions were carried out of which a total of 32 (0.92%) ATRs were encountered. Packed red blood cells (PRBCs) (n = 15, P = 0.06) and whole blood (WB) (n = 13, P = 0.83) were most commonly implicated. Allergic reaction was the most frequent transfusion reaction encountered (65.6%), seen most commonly with PRBC (risk of 0.76%, P = 0.42), and WB (risk of 0.68%, P = 0.63) transfusions. This was followed by febrile reactions (28.1%), which were seen more commonly with PRBCs (risk of 0.57%, P = 0.016). No reactions were observed with platelet transfusions. Conclusion: The overall incidence of transfusion reactions in this hospital is slightly higher than those having more advanced transfusion facilities in India. The lack of leukoreduction facilities in our hospital could be a likely cause for the same. The use of leukoreduced WB and PRBCs could possibly reduce the overall incidence of ATRs in general and febrile nonhemolytic transfusion reactions in particular.
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Antimicrobial drug prescribing patterns for community-acquired pneumonia in hospitalized patients: A retrospective pilot study from New Delhi, India p. 375
Anita Kotwani, Santosh Kumar, Prafulla Kumar Swain, JC Suri, SN Gaur
DOI:10.4103/0253-7613.161258  
Objective : The objective of this study was to determine patterns and frequency of antimicrobial drug use among hospitalized patients with community-acquired pneumonia (CAP). Methodology : A retrospective 5 years (April 2007-March 2012) detailed medical record review of patients diagnosed with CAP and discharged to home from Non-Intensive Care Unit respiratory medicine wards of two public hospitals in Delhi. Results : A total of 261 medical records were analyzed. Over the 5 years, 82.0% (2007-08), 78.6% (2008-09), 59.5% (2009-10), 64.7% (2010-11), and 67.8% (2011-12) patients were prescribed two antimicrobials. In the last two study years, the proportion of patients receiving three antimicrobials increased (from 2.0% to 26.5% and 28.8%), while the proportion receiving monotherapy decreased (from 16.0% to 8.8% and 3.4%). In accordance with guidelines, beta-lactams and macrolides were the two most frequently prescribed antimicrobials (34.1%). However, newer generation beta-lactams were prescribed. A total of 37 patients were prescribed beta-lactam-tazobactam combination preparations. Overall, beta-lactams constituted more than 40% of prescriptions while macrolides were the second most prescribed class. Cephalosporin prescriptions significantly increased (P < 0.01) and penicillin prescriptions significantly decreased over study periods. The prescription of fluoroquinolones also decreased (21.5-6.0%, P < 0.01) and aminoglycoside prescription ranged from 9.7% to 16.4%, over 5 years. Reasons for prescribing three antimicrobials, use of aminoglycosides, or higher-end/reserve antibiotics were not mentioned in the medical records. There were no hospital-specific guidelines for doctors to follow in the treatment of CAP. Conclusions : These findings suggest the need for implementing antimicrobial treatment guidelines. Adequate documentation and monitoring of antibiotic use for feedback are also lacking. An antimicrobial stewardship program may offer the most comprehensive solution for appropriate use of antimicrobials.
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Evaluation of acute effects of melatonin on ethanol drinking in ethanol naïve rats p. 383
Zahoor Ahmad Rather, Mukta N Chowta, Ganaraja Bolumbu, KB Rakesh
DOI:10.4103/0253-7613.161259  
Objective: The objective was to evaluate the acute effect of melatonin on ethanol drinking in ethanol naïve rats and to determine the specificity of the effect of melatonin on ethanol intake as compared to an intake of plain tap water or sugar water. Materials and Methods: A total of three experiments (2 weeks duration each) using different drinking solutions (ethanol, plain tap water, sugar water) was conducted in individually housed male wistar rats of 5 weeks age. Each animal had access to bottles containing drinking solutions for 2 h a day. In each experiment, on day 1, day 2, day 4, day 5, day 8, day 9, day 11, day 12 rats received drinking solutions. Each individual rat received single doses of saline, melatonin (50 mg and 100 mg/kg), and naltrexone on day 2, 5, 9, and 12, 1-h before receiving drinking solution. The order of drug administration is permuted such a way that each animal received the drugs in a different order in different experiments. Results: Melatonin has significantly decreased ethanol consumption by the rats and effect is dose-dependent. Naltrexone also has caused a significant reduction in the ethanol consumption. The maximum reduction in ethanol consumption was seen with melatonin 100 mg/kg dose compared to melatonin 50 mg/kg and naltrexone. There was no statistically significant effect of melatonin on plain water and sugar solution intake. Conclusions : Melatonin decreases ethanol consumption in ethanol naïve rats. The effect of melatonin is similar to naltrexone affecting selectively ethanol consumption, but not plain water and sugar water consumption.
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Modulation of muscarinic system with serotonin-norepinephrine reuptake inhibitor antidepressant attenuates depression in mice p. 388
Paramdeep Singh, Thakur Gurjeet Singh
DOI:10.4103/0253-7613.161260  
Objective: Several studies suggest that muscarinic receptor antagonist scopolamine is a rapidly acting antidepressant for the treatment-resistant depression. Therefore, this study was carried out to investigate the possibility of synergistic potential of scopolamine with antidepressants for the treatment of depression without memory impairment in mice. Materials and Methods: Antidepressants such as citalopram, duloxetine, fluvoxamine, and venlafaxine at their median effective dose that is 12.5, 42.8, 17.5, 15.7 mg/kg p.o., respectively, were evaluated in combination with scopolamine 0.2 mg/kg intraperitoneally for the synergistic potential for ameliorating depression in Swiss albino mice. A battery of tests including forced swim test (FST) and tail suspension test (TST) were performed in all the groups comprising vehicle control, scopolamine, antidepressants per se, and the combinations of antidepressants with scopolamine. This was followed by the locomotor activity and memory tests. Results: Behavioral studies indicated that only antidepressant venlafaxine with scopolamine resulted in 95.5% and 93.6% reduction in immobility time compared to the vehicle control in FST and TST, respectively. This is significant (P < 0.0001) synergistic hyper-additive antidepressive-like effect compared to scopolamine per se and venlafaxine per se treatment effects in antidepressant paradigms. All the data were evaluated using the one-way analysis of variance followed by individual comparisons using Tukey's post-hoc test. Control open field studies demonstrated no significant increase in general locomotion after co-administration of the compounds. Step down avoidance paradigm confirmed that scopolamine at the selected dose has no cognition deficit in any mice. Conclusions: The dose of scopolamine selected for synergistic potential has no detrimental effect on memory. The present results suggest the concoction of scopolamine with venlafaxine for enhanced synergistic antidepressive effects with the reduction of dose.
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Immunoprophylactic potential of wheat grass extract on benzene-induced leukemia: An in vivo study on murine model p. 394
Neelofar Khan, Aditya Ganeshpurkar, Nazneen Dubey, Divya Bansal
DOI:10.4103/0253-7613.161261  
Objectives: Wheat grass (Triticum aestivum) is a gift of nature given to mankind. A number of scientific research on wheatgrass establishes its anticancer and antioxidant potential. Current work was focused to determine antileukemic effect of wheat grass. Materials and Methods: The commercial wheatgrass powder was extracted with 95% of methanol. Methanol extract of wheat grass was studied for acute oral toxicity as per revised Organization for Economic Cooperation and Development Guidelines number 423. Leukemia was successfully induced in Wister rats by intravenous injection of benzene. The blood was collected and analyzed for hematological parameters. Phagocytotic activity of the extract was determined. Results : Phytochemical screening revealed the presence of flavonoids, phenolics, carbohydrates, and amino acids. From acute toxicity studies, it was found that the methanol extract of wheatgrass was safe up to a dose level of 2000 mg/kg of body weight. Outcomes of hematological parameters in various experimental groups of murine model demonstrated antileukemic effect of extract. Methanol extract of wheatgrass aroused the process of phagocytosis of killed Candida albicans and also demonstrated a significant chemotactic activity at all tested concentrations. Conclusion: In the current work, methanol extract of wheat grass demonstrated antileukemic potential that might be due to the presence of flavonoids and polyphenolics in it. Further isolation, structural characterization of active constituents is necessary to extrapolate the mechanism of action.
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Anti-hyperbilirubinemic and wound healing activity of aqueous extract of Calotropis procera leaves in Wistar rats p. 398
Rupali Arun Patil, Aakash B Makwana
DOI:10.4103/0253-7613.161262  
Aims: The aim of this study was to evaluate the bilirubin lowering and wound healing property of aqueous extract of Calotropis procera (AECP) leaves in Wistar rats. Materials and Methods: Albino Wistar rats of either sex were used for the study. Bilirubin lowering property of C. procera leaves was evaluated using phenylhydrazine and paracetamol as inducing agents followed by measuring the concentration of serum total bilirubin in hyperbilirubinemic rats. Wound healing property was evaluated using incision and excision models by measuring tensile breaking strength, percentage wound contractions, and epithelization days, respectively. Statistical Analysis: Statistical comparison between groups in each experiment was done with one-way analysis of variance followed by Dunnett's test. Results: AECP showed a significant (P < 0.05) decrease in concentrations of serum total bilirubin in hyperbilirubinemic rats as well as significant (P < 0.05) increase in breaking strength and percentage wound contractions with decreased epithelization period when compared to control groups. Conclusions: AECP showed significant bilirubin lowering and wound healing property in Wistar rats.
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Neuroprotective potential of Beta vulgaris L. in Parkinson's disease p. 403
Vandana S Nade, Laxman A Kawale, Shankar S Zambre, Amit B Kapure
DOI:10.4103/0253-7613.161263  
Objective: The objective was to investigate the neuroprotective role of Beta vulgaris in Parkinson's disease (PD). Materials and Methods: PD was induced by administration of reserpine (5 mg/kg/day, i.p for 5 consecutive days), haloperidol (1 mg/kg, i.p.), and tacrine (2.5 mg/kg, i.p.) in experimental animals. The symptoms of PD such as tremors, akinesia, rigidity, catalepsy, and vacuous chewing movements (VCMs) were evaluated. Foot shock-induced aggression (FSIA) model was used to confirm anti-parkinsonian activity. The methanolic extract of Beta vulgaris (MEBV) was administered at doses of 100, 200, and 300 mg/kg, p.o. The combination of L-dopa and carbidopa was used as a standard drug. Behavioral studies such as locomotor activity and grip strength were determined, and oxidative stress was evaluated in FSIA model in rat brain. Results: Pretreatment with MEBV (200 and 300 mg/kg) significantly reduced the intensity of muscular rigidity, duration of catalepsy, akinesia, the number of tremors, VCMs, and increase fighting behavior. The locomotor activity and grip strength were significantly increased by MEBV. In FSIA, the biochemical analysis of brain revealed the increased level of lipid peroxidation (LPO) and decreased levels of superoxide dismutase (SOD) and catalase (CAT). MEBV significantly reduced LPO level and restored the defensive antioxidant enzymes SOD and CAT in rat brain. Conclusions: The results indicated the protective role of B. vulgaris against PD. The mechanism of protection may be due to augmentation of cellular antioxidants.
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Evaluation of skeletal muscle relaxant activity of aqueous extract of Nerium oleander flowers in Albino rats p. 409
Jayasree Tirumalasetti, Maulik Patel, Ubedulla Shaikh, K Harini, J Shankar
DOI:10.4103/0253-7613.161265  
Objectives: Nerium oleander is traditionally used in various diseases because of its medicinal properties. One of its uses is in musculoskeletal disorder. The aim of the study was to evaluate the skeletal muscle relaxant activity of the aqueous extract of Nerium oleander flowers (AENOF) in albino rats in comparison with diazepam. Materials and Methods: A total of 20 Swiss albino rats aged 6-7 weeks, of either sex, weighing about 100-150 g, were taken, and after acute toxicity studies two different doses were selected. The animals were divided into four different groups. The first group was kept as the control (normal saline), second as the standard (diazepam) and the remaining two groups as Test I and Test II, and given different doses of the AENOF. Skeletal muscle relaxant activity (motor coordination) on Rotarod and locomotor activity on photoactometer was performed. Statistical analysis was carried out by using analysis of variance, followed by Dunnett's multiple comparison tests. Results: The result from the Actophotometer test and Rotarod test showed that the extract of AENOF significantly reduced (P < 0.05) the motor coordination of the tested animals. Conclusions: Our data indicates that AENOF possesses skeletal muscle relaxant activities.
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Antioxidant, mutagenic, and antimutagenic activities of Tragopogon longirostis var. longirostis, an edible wild plant in Turkey p. 414
Nurdan Sarac
DOI:10.4103/0253-7613.161267  
Objectives: The ethanolic extract of Tragopogon longirostis var. longirostis, a wild edible plant in Anatolia was isolated, and its antioxidant, mutagenic, and antimutagenic properties were investigated. Materials and Methods: The antioxidant activity (AA) was determined by the inhibition of 2,2-diphenyl-1-picrylhydrazyl (DPPH) radical, total AA, and phenolic compounds. The mutagenic and antimutagenic activities were investigated by Ames Salmonella/microsome mutagenicity test. Results: The IC 50 value for DPPH radicals was 7.84 ± 0.603 mg/mL. The total AA increased with an increase in the concentration of the extracts (1, 5, 10, 20, and 30 mg/mL), containing linoleic acid emulsion. The total phenolic content was 284.71 ± 5.6 mg gallic acid equivalent/g extract. The results showed that the ethanolic extract can be considered safe, because it does not have any mutagenic effect at the tested concentrations. As a result, the ethanolic extract of the leaves exhibited antimutagenic effects at 2.5, 0.25, and 0.025 mg/plate concentrations. Conclusions: To our knowledge, this is the first study of the antioxidant, mutagenic, and antimutagenic activities of T. longirostis var. longirostis. These activities are an important topic in the food industry, as well as in the medical field.
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Calotropis procera : A potential cognition enhancer in scopolamine and electroconvulsive shock-induced amnesia in rats p. 419
Rohit Malabade, Ashok D Taranalli
DOI:10.4103/0253-7613.161269  
Objectives: Present study evaluates the effect of Calotropis procera (Apocynaceae) dry latex on cognitive function in rats using scopolamine and electroconvulsive shock (ECS) induced amnesia model. Materials and Methods: Male Wistar rats were pretreated with 200, 400 and 800 mg/kg of C. procera dry latex in scopolamine-induced amnesia model. Dose showing maximum effect in cognitive performance was selected and further evaluated using scopolamine and ECS-induced amnesia model for its effect on neurochemical enzymes and cognitive performance. Acetylcholinesterase (AChE) activity, β amyloid 1-42 , and dopamine level were analyzed, while the cognitive performance was assessed by elevated plus maze, step-through passive avoidance test, and Morris water maze. Simultaneously, C. procera dry latex (25, 50, 100, 250, 500, and 1000 μg/mL) was screened for in vitro AChE inhibition assay. Results: Pretreatment with (200, 400 and 800 mg/kg) C. procera dry latex shows dose dependent increase in cognitive performance in scopolamine-induced amnesia. Further, pretreatment with the selected dose (800 mg/kg) showed significant improvement in transfer latency (P < 0.001, P < 0.01), escape latency (P < 0.05), time spent in target quadrant (P < 0.001) also significant decrease in AChE activity (P < 0.05), β amyloid 1-42 level (P < 0.001), and increase in dopamine level (P < 0.01) in rat brain homogenate when compared with scopolamine and ECS disease control groups. IC 50 for C. procera dry latex was found to be <1000 μg/mL. Conclusions: Pretreatment with C. procera dry latex (800 mg/kg) produced significant cognition enhancement by improving cognitive performance and decreasing the marker neurochemical enzyme activity in scopolamine and ECS-induced amnesia model.
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In-vitro α-amylase and α-glucosidase inhibitory activity of Adiantum caudatum Linn. and Celosia argentea Linn. extracts and fractions p. 425
Madhusudhan Telagari, Kirankumar Hullatti
DOI:10.4103/0253-7613.161270  
Objective: The objective of the present study was to provide an in-vitro evidence for the potential inhibitory activity of extracts and fractions of Adiantum caudatum Linn. and Celosia argentea Linn. on α-amylase and α-glucosidase enzymes . Materials and Methods: The plant extracts were prepared, first with cold maceration (70% v/v ethanol) and then by Soxhlation techniques (95% v/v ethanol). Subsequently, the combined extracts were subjected for fractionation. Different concentrations (0.1, 0.2, 0.3, 0.4, and 0.5 mg/ml) of extract and fractions were subjected to α-amylase and α-glucosidase inhibitory assay. The absorbance was measured at 540 and 405 nm using multiplate reader and the percentage of α- amylase and α- glucosidase inhibitory activity and IC 50 values of extract and fractions were calculated. Results: Fraction 2 of A. caudatum and fraction 4 of C. argentea has shown highest α-amylase and α-glucosidase inhibitory potential with IC 50 values of 0.241, 0.211 and 0.294, 0.249 mg/ml, respectively, which was comparable with acarbose (0.125 and 0.93 mg/ml). Whereas, extracts and remaining fractions of both the plants have shown lesser activity. Conclusion: The results of the present study indicate that, fraction 2 of A. caudatum, rich in triterpenoids and phenolics and fraction 4 of C. argentea, rich in flavonoids, are effective α- amylase and α- glucosidase inhibitors, which may be helpful to reduce the postprandial glucose levels. Hence, further studies may throw light on the antidiabetic potential of A. caudatum and C. argentea, especially in the management of type 2 diabetes.
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Efficacy of Spirulina platensis in improvement of the reproductive performance and easing teratogenicity in hyperglycemic albino mice p. 430
Pranay Punj Pankaj
DOI:10.4103/0253-7613.161271  
Objectives: The present study evaluates the therapeutic efficacy of cell suspension of Spirulina platensis (SP) on estrous cycle, fetal development and embryopathy in alloxan (AXN) induced hyperglycemic mice. Materials and Methods: Diabetes was induced by intra-peritoneal administration of AXN. Mice with blood glucose level above 200 mg/dl were divided into Group I (control), Group II (diabetic control), Group III (diabetic control mice fed with SP), and Group IV (control mice fed with SP). Litter counts, estrous cycles, percent survival of litter, and gestation length were recorded. Results: In hyperglycemic mice, a significant (P < 0.05) increase in duration of diestrus (14.48%), estrus (84.21%), and metestrus (164.15%) with concomitant decrease in proestrus phase by 26.13% was recorded when compared with control. Reduction in litter count and survival of litter was 68.67% and 88.38%, respectively, whereas gestation length increased to 14.51% day in diabetic mice, but recovery in these parameters was observed (P < 0.05) when subjected to SP treatment. SP resulted in increased fertility rate from 77.5% to 82.5% and dropped off resorption of the fetus to 33.73% while the survival rate of offspring of diabetic mice went up to 88.89% from 83.61%. Conclusions: These findings suggest that SP is effective in improving the reproductive performance and easing teratogenic effects in diabetic mice and hence warrants further detailed dose-dependent studies to understand its mechanism of action.
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SHORT COMMUNICATIONS Top

Short and long-term impact of pharmacovigilance training on the pharmacovigilance knowledge of medical students p. 436
M Aylin Arici, Ayse Gelal, Yucel Demiral, Yesim Tuncok
DOI:10.4103/0253-7613.161272  
Objectives: The aim of this study was to evaluate the short and long-term impact of pharmacovigilance (PV) training on the 5 th year medical students' knowledge about definitions and on the awareness of the regulatory aspects in PV. Materials and Methods: In academic year 2010/11, the students completed structured, questionnaire before and just after training. They also completed the same questionnaire 1-year after the training. Results: The students' knowledge about PV significantly increased after training in the short term (P < 0.001). However, the improvement decreased significantly in the long-term (P < 0.001). Although long-term scores were higher than the baseline score, the difference was not statistically significant. Total scores were 17.5 ± 2.0, 20.8 ± 2.0 and 18.0 ± 2.5; before, at short and long-term after the training. Conclusion: PV training increased the students' knowledge significantly. However, in the long-term, the impact of the training is limited. Repeated training of PV should be planned.
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Nicotine quantity and packaging disclosure in smoked and smokeless tobacco products in India p. 440
Priyamvada Sharma, Pratima Murthy, Parul Shivhare
DOI:10.4103/0253-7613.161273  
Objectives: A variety of smoked and smokeless tobacco products with varying nicotine content are accessible in India. Nicotine quantity in tobacco products has direct bearing on tobacco dependence. Our objective was to estimate nicotine content in various types of smoked and smokeless products. Disclosure for essential health warning was also checked. Materials and Methods: Liquid-liquid extraction was used for nicotine extraction and high-performance thin layer chromatography technique was applied for quantification of nicotine in seventy-one smoked and smokeless tobacco products. Results: Significant variation in nicotine content was observed across products. In smoked tobacco, nicotine content varied from 1.01 to 13.0 mg/rod, while in smokeless tobacco products it ranged from 0.8 mg/g to 50.0 mg/g. Moisture content varied from 9% to 21%. Conclusion: This work lists a range of smoked and smokeless tobacco products available in this region. We report a wide variability in nicotine quantity across smoked and smokeless tobacco products. Such variation in nicotine content may have important implications for tobacco cessation interventions and policies.
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Dual inhibition of acetylcholinesterase and butyrylcholinesterase enzymes by allicin p. 444
Suresh Kumar
DOI:10.4103/0253-7613.161274  
Objectives: The brain of mammals contains two major form of cholinesterase enzymes, acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE). The dual inhibition of these enzymes is considered as a promising strategy for the treatment of neurological disorder such as Alzheimer's disease (AD), senile dementia, ataxia, and myasthenia gravis. The present study was undertaken to explore the anticholinesterase inhibition property of allicin. Materials and Methods: An assessment of cholinesterase inhibition was carried out by Ellman's assay. Results: The present study demonstrates allicin, a major ingredient of crushed garlic (Allium sativum L.) inhibited both AChE and BuChE enzymes in a concentration-dependent manner. For allicin, the IC 50 concentration was 0.01 mg/mL (61.62 μM) for AChE and 0.05 ± 0.018 mg/mL (308.12 μM) for BuChE enzymes. Conclusions: Allicin shows a potential to ameliorate the decline of cognitive function and memory loss associated with AD by inhibiting cholinesterase enzymes and upregulate the levels of acetylcholine (ACh) in the brain. It can be used as a new lead to target AChE and BuChE to upregulate the level of ACh which will be useful in alleviating the symptoms associated with AD.
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Anti-inflammatory activity of Nerium indicum by inhibition of prostaglandin E2 in murine splenic lymphocytes p. 447
Priyankar Dey, Tapas Kumar Chaudhuri
DOI:10.4103/0253-7613.161275  
Objective: Nerium indicum Mill (syn. N. oleander L. and N. odorum Aiton; family: Apocynaceae) is a medicinal plant, used in the treatment of diverse ailments including various chronic inflammatory diseases in traditional medicine. We have previously demonstrated the immunomodulatory activity of a bioactive fraction of Nerium indicum leaf (NILE) by studying up-regulation of interleukin-2 (IL-2), IL-10, interferon-gamma and down regulation of IL-4, tumor necrosis factor-alpha (TNF-α), nitric oxide, cyclooxygenase-1 (COX-1) and COX-2 activities. Therefore, this study aimed to confirm the anti-inflammatory activity of NILE by inhibition of prostaglandin E 2 (PGE 2 ) activity in murine splenic lymphocytes in vitro. Materials and Methods: Murine lymphocytes were isolated from spleen and stimulated with 5 ΅g/mL concanavalin A in RPMI-1640, supplemented with 50 U/mL penicillin, 50 U/mL streptomycin, 50 U/mL nystatin and 10% fetal bovine serum. Different concentrations (0-80 μg/mL) of NILE were added and the cells were cultured for 48 h. The culture supernatants were thereafter collected by centrifugation and assayed for expression of PGE 2 level. The data were analyzed statistically. Results: The results demonstrated a 2.26-fold inhibition of PGE 2 level at 80 μg/mL of NILE. Half maximum inhibitory concentration (IC 50 ) was calculated to be 44.95 ± 0.45 ΅g/mL. Linear correlation analysis of the dose-dependent PGE 2 inhibition with other pro- and anti-inflammatory mediators demonstrated high inter-correlation between the parameters. Conclusions: Thus, the present study remains in accordance with our previous report and confirms the anti-inflammatory claim of N. indicum, mentioned in the traditional medicine.
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DRUG WATCH Top

Pentazocine-induced contractures: Dilemma in management p. 451
Dileep Kumar, Anil Gupta, VP Sharma, Ganesh Yadav, Arpita Singh, Ajay Kumar Verma
DOI:10.4103/0253-7613.161276  
Pentazocine is a commonly used synthetic opioid analgesic for moderate to severe pain secondary to various conditions. Complications of parenteral opioid abuse including localized ulcerations, abscess, indurations, and sclerosis are well-documented. We present a rare case of drug abuse due to pentazocine (Fortwin) in a 32-year-old female, who had severe myogenic contractures of her knee joints.
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Ketamine-induced affective switch in a patient with treatment-resistant depression Highly accessed article p. 454
Girish Banwari, Prutha Desai, Prahlad Patidar
DOI:10.4103/0253-7613.161277  
There is growing evidence to support the rapid, albeit short-lived antidepressant effect of subanesthetic dose of ketamine, a noncompetitive glutamate N-methyl-D-aspartate receptor antagonist in treatment-resistant unipolar and bipolar depression. Ketamine is known to cause transient mood elevation or euphoria, psychotomimetic effects, and dissociative symptoms, but its use in unipolar or bipolar depression has not been reported to induce an affective switch amounting to persistent or prolonged hypomania/mania or manic-like syndrome. We report the case of a 52-year-old male with first episode, continuous, nonpsychotic, treatment-resistant, unipolar major depression of 10 years duration, who manifested a switch from depression to mania while being treated with subanesthetic dose of ketamine, given intramuscularly. This case suggests that polarity switch should be considered as a potential side effect while using ketamine for treatment-resistant depression.
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Medication error report: Intrathecal administration of labetalol during obstetric anesthesia p. 456
Baisakhi Laha, Avijit Hazra
DOI:10.4103/0253-7613.161278  
Labetalol, a combined alfa and beta-adrenergic receptor antagonist, is used as an antihypertensive drug. We report a case of an acute rise in blood pressure and lower limb pain due to the inadvertent intrathecal administration of labetalol, mistaking it for bupivacaine, during obstetric anesthesia. The situation was rescued by converting to general anesthesia. The cesarean delivery was uneventful, and mother as well as newborn child showed no ill-effect. This particular medication error was attributable to a failure on the part of the doctors administering the injection to read and cross-check medication labels and the practice of keeping multiple injections together. In the absence of an organized medication error reporting system and action on that basis, such events may recur in future.
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Oxcarbazepine induced toxic epidermal necrolysis - a rare case report p. 459
Vivek S Guleria, Chetan Sharda, Tanuja Rana, AK Sood
DOI:10.4103/0253-7613.161279  
Carbamazepine, is well known to cause Stevens-Johnson syndrome and toxic epidermal necrolysis(TEN). Oxcarbazepine, a 10-keto analog of carbamazepine, is an anticholinergic, anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy. Its efficacy is similar to carbamazepine but allergic reactions and enzyme induction is low. We describe a case of oxcarbazepine induced TEN, who presented with erythematous ulcerative maculopapular rash.
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LETTER TO THE EDITOR Top

Nebivolol: A unique drug in acute and chronic renal disorders p. 462
Fateme Shamekhi Amiri
DOI:10.4103/0253-7613.161281  
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