Undernutrition among rural school-age children: a major public health challenge for an aspirational district in Karnataka, India.

Background: For school-age children, a healthy transition from childhood to adolescence and adulthood depends on proper nutrition. Globally, most nutritional surveys focus on preschool and adolescents, neglecting school-age children. Recent studies have shown the prevalence of thinness among adolescents to be 26.5% in Karnataka. Similarly, among children aged < 5 years in the Raichur district, the prevalence of stunting, wasting, and being underweight was 39.8, 23.2, and 40.7%, respectively. The present study aimed to bridge the data gap between < 5 years of children and adolescents through a nutritional survey of school-going children in Raichur, one of the aspirational districts of India. Materials and methods: A cross-sectional survey was conducted from January to March 2020 among rural school-age children (n = 2700) in 30 villages of the Raichur district of Karnataka, India. The school children were selected through a multi-stage cluster sampling technique. The WHO Anthro-plus software was used for calculating the age and sex-specific Z-scores for weight-for-age (WAZ), height-for-age (HAZ), and BMI-for-age (BAZ). Results: Of the 2,700 school-age children surveyed, the mean weight and height were 22.2 kg (+5.8) and 124.9 cm (+11.6), respectively. The prevalence of children having weight-for-age Z-scores < -2 SD (Underweight) was 45.3% (95% CI: 42.7%-47.8%). The magnitude of stunting and severe stunting was 19.5% (95% CI: 18.0%-21.0%) and 7.6% (95% CI: 6.6%-8.6%), respectively. The proportion of children with BMI for age Z-scores < -2SD (thinness) was 43% (95% CI: 41.1%-44.9%), with sub-district Sindhanur having a dual burden of malnutrition. Conclusion: Despite many flagship programs, the prevalence of undernutrition in school-age children remains a considerable public health problem in the aspirational district of Raichur, India. Furthermore, exploratory studies are recommended to identify the factors associated with undernutrition among school-age children and strategize evidence-based intervention.

Suspected cutaneous adverse drug reactions reported with traditional medicines: analysis of data for United Nations Asia region from WHO VigiBase.

Background: Data on traditional medicine-induced cutaneous adverse drug reactions (ADRs) is very scarce. The current secondary analysis based on the WHO database (VigiBase) of individual case safety reports (ICSRs) focuses on the suspected cutaneous ADRs linked to traditional medicines (TMs). Methods: All the ICSRs reported between 1st January 2016 and 30th June 2021 from the UN Asia region in VigiBase where at least one TM was suspected to cause cutaneous ADRs were included in the study. Data regarding demographic details, suspected drug, adverse reaction as per MedDRA term, the seriousness of the reaction, de-challenge, re-challenge, and clinical outcome for suspected cutaneous ADRs associated with TM were obtained from VigiBase and analyzed for frequency of reported events and suspected medicines. Findings: Total 3,523 ICSRs with 5,761 ADRs related to "skin and subcutaneous tissue disorders" were included in the analysis. Amongst these, 6.8% of ICSRs were reported as serious. Pruritus (29.6%), rash (20.3%), urticaria (18.9%), and hyperhidrosis (3.3%) were commonly reported ADRs. Artemisia argyi H.Lév. and Vaniot. (14.9%), Ginkgo biloba L. (5.1%), Vitis vinifera L. (4%), Vitex agnus-castus L. (3.8%), Silybum marianum (L.), Gaertn (3.5%), and Viscus album L. (2.7%) were some commonly suspected TMs for cutaneous ADRs. There were 46 cases of Stevens-Johnson syndrome and toxic epidermal necrolysis reported with TMs during the study period. Death was reported in 5 ICSRs. Interpretation: TMs are linked with various cutaneous ADRS ranging from pruritus to toxic epidermal necrolysis which may have serious consequences. TMs listed as suspected offending agents in this analysis, should be kept in mind while dealing with suspected cutaneous ADRs. Clinicians should be more vigilant in detecting and reporting events associated with TMs.

A community-based study of dental fluorosis in rural children (6-12 years) from an aspirational district in Karnataka, India.

Objectives: The present study was planned to estimate the prevalence of dental fluorosis in 6-12 years of children and its association with various drinking water sources, water, and urine fluoride levels among the subset of children under the umbrella of a larger study to address iodine deficiency disorders and iron deficiency anemia in 17 villages of Manvi and Devadurga talukas of Raichur district of Karnataka. Methods: Analysis of subset of data and urine samples of children under the umbrella of a larger cross-sectional community-based study was conducted in 17 villages of Manvi and Devadurga taluks of Raichur district. House to house survey was carried out to collect data using a semi-structured questionnaire in ODK software. Demographic details, source of drinking water, clinical assessment of dental fluorosis, and height and weight measurements were performed by trained staff. Urine and water samples were collected for fluoride level estimation. The overall prevalence of dental fluorosis and its severity-wise prevalence were estimated. Association between dental fluorosis and age, gender, type of diet, source of drinking water, height for age, BMI for age, water fluoride level, and urine fluoride level were carried out using logistic regression analysis. Results: The prevalence of dental fluorosis was 46.0%. Mild, moderate, and severe dental fluorosis was found in 37.9, 7.8, and 0.3% of children. With the increasing age of participants, the odds of dental fluorosis were found to increase by 2-4 folds. The odds of having dental fluorosis were significantly increased with increasing water fluoride levels of 3 to 5 ppm [AOR = 3.147 (1.585-6.248); P = 0.001] in comparison with water fluoride levels of < 1 ppm. The similar trend was found with urine fluoride level > 4 ppm [AOR = 3.607 (1.861-6.990); P < 0.001]. As compared to river water, other sources of drinking water were significantly associated with higher odds of dental fluorosis. Conclusions: Prevalence of dental fluorosis was high in 6 to 12 years due to overexposure of fluoride from drinking water. High water and urine fluoride levels in children indicate the chronic exposure to fluoride and suggest that the population is at high risk of developing chronic fluorosis.

Evaluation of efficacy of Aloe vera (L.) Burm. f. gel solution in methylcellulose-induced ocular hypertension in New Zealand white rabbits.

Objectives The present study aimed to evaluate the efficacy of Aloe vera in the methylcellulose-induced ocular hypertension model. Methods Fifty-six rabbits were randomly divided into seven groups. Intraocular pressure (IOP) was raised by anterior chamber injection of 2% methylcellulose in all the groups except the normal control group. Disease control animals were treated with sterile water and active control with topical 0.5% timolol 12 hourly; 6 and 12% A. vera gel topical solutions 8 hourly were given in group IV and V, respectively; 6 and 12% A. vera gel solutions along with timolol were given in group VI and VII animals, respectively. Mean IOP values and percentage of reduction in IOP were compared at 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, 12 h, 24 h, 36 h, and 48 h. Results A. vera gel solutions (6 and 12%) showed a significant reduction in mean IOP from 4 to 2 h time points, respectively, whereas, A. vera gel solutions (6 and 12%) + timolol showed significant less mean IOP from a 30 min time point as compared with disease control. A. vera gel solutions (6 and 12%) showed 8.6 and 10.4% more reduction in IOP, respectively (66.8 ± 4.9% and 68.6 ± 5.4% vs. 58.2 ± 2.3%; p > 0.05), whereas 6 and 12% A. vera gel solutions along with timolol showed 14.5 and 16.2% more reduction in IOP, respectively (72.7 ± 4.7% and 74.4 ± 4.1% vs. 58.2 ± 2.3%; p < 0.05), than disease control group at 48 h. Conclusions Six and twelve percent A. vera gel solutions reduced the IOP effectively. Concurrent treatment with 12% A. vera gel and timolol produced the maximum reduction in IOP.

Cephalosporins Associated Pseudomembraneous Colitis in an Elderly Male Patient - A Case Report.

INTRODUCTION: Incidence of antibiotic- associated diarrhoea is a common (10-30%) but pseudomembranous colitis (PMC) is less frequent (1-5%). Fluoroquinolones, clindamycin, penicillins, cephalosporins (mostly third generation) are commonly associated with PMC. The association between cephalosporins and PMC is now well established. CASE PRESENTATION: A 78 year old male patient developed pseudomembraneous colitis after administration of Ceftriaxone and Cefazoline for the treatment of pleural effusion. The reaction was confirmed by ultrasonography and CT scan. Causative agents were stopped and patient was managed by systemic therapy. Patient was expired due to respiratory complications as there was complexity in management of disease due to development of pseudomembraneous colitis. CONCLUSION: Increase awareness of prescribers for high-risk drugs, close monitoring, with immediate withdrawal of the culprit drug can reduce the complexity of management that occur due to development of such adverse drug reaction.

A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital.

INTRODUCTION: Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). AIM: To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. MATERIALS AND METHODS: The application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents. RESULTS: Total 100 application forms were analysed. Among them, 98 were academic and 2 were industrial studies. Majority of academic studies were of basic science type. In 63.26% studies, type of study was not mentioned in title. Age group of subjects was not mentioned in 8.16% application forms. In 34.6% informed consent, benefits of the study were not mentioned. Signature of investigators/co-investigators/Head of the Department was missing in 3.06% cases. CONCLUSION: Our study recommends that the efficiency and speed of review will increase if investigator will increase vigilance regarding filling of application forms. Regular meetings will be helpful to solve the problems related to content of application forms. The uniformity in functioning of EC can be achieved if common application form for all ECs is there.

Isoniazid induced convulsions at therapeutic dose in an alcoholic and smoker patient.

We report a case of isoniazid induced convulsions in 35 years old male alcoholic and smoker patient receiving intensive phase therapy for pulmonary tuberculosis. A case was confirmed by accidental positive de-challenge and rechallenge as well as ruled out other conditions. Use of isoniazid in alcoholic and smoker patient required a caution for prevention of neurological adverse reactions. Pyridoxine should always be prescribed to such patients for the prevention of such adverse reaction.

Evaluation of cardioprotective effect of aqueous extract of Garcinia indica Linn. fruit rinds on isoprenaline-induced myocardial injury in Wistar albino rats.

In the present study, cardioprotective effect of aqueous extract of Garcinia indica Linn. fruit rinds in isoprenaline-induced myocardial infarction in Wistar albino rats was evaluated. In vitro total phenolic, total flavonoid content and 2, 2'-diphenyl-1-picrylhydrazyl hydrate radical scavenging activity was measured. In vivo effect of aqueous extract of G. indica was evaluated in Wistar albino rats by isoprenaline-induced myocardial injury model. Thirty six rats were randomly divided in 6 groups. Rats were treated with G. indica 250 mg/kg and 500 mg/kg doses for 21 days and myocardial injury was produced by subcutaneous injection of isoprenaline 85 mg/kg on day 20 and 21. Carvedilol 1 mg/kg for 21 days served as active control. Electrocardiogram parameters, cardiac injury markers (serum troponin-I, uric acid, lactate dehydrogenase, creatinine kinase-MB, aspartate aminotransferase and alanine aminotransferase), oxidative stress markers (superoxide dismutase, catalase and malondialdehyde level) and histopathological changes were evaluated in each group and compared using appropriate statistical tests. In vitro evaluation of aqueous extract showed significant antioxidant property. Isoprenaline produced significant myocardial ischemia as compared to normal control group (P<0.05). Administration of G. indica in both the doses did not significantly recover the altered electrocardiogram, cardiac injury markers, oxidative stress markers and histopathological myocardial damage as compared to disease control group (P>0.05). The aqueous extract of G. indica was not found to be cardioprotective against myocardial injury. Further study with more sample size and higher dose range may be required to evaluate its cardioprotective effect.

Drug-induced anaphylactic reactions in Indian population: A systematic review.

BACKGROUND: Epidemiological data on drug-induced anaphylactic reactions are limited in India and are largely depending on studies from developed countries. AIM: The aim was to analyze the published studies of drug-induced anaphylaxis reported from India in relation with causative drugs and other clinical characteristics. MATERIALS AND METHODS: The electronic databases were searched for Indian publications from 1998 to 2013 describing anaphylactic reactions. The information was collected for demographics, set up in which anaphylaxis occurred, causative drugs, incubation period, clinical features, associated allergic conditions, past reactions, co-morbid conditions, skin testing, IgE assays, therapeutic intervention and mortality. Reactions were analyzed for severity, causality, and preventability. Data were extracted and summarized by absolute numbers, mean (95% confidence interval [CI]), percentages and odds ratio (OR) (95% CI). RESULTS: From 3839 retrieved references, 52 references describing 54 reactions were included. The mean age was 35.31 (95% CI: 30.52-40.10) years. Total female patients were 61.11%. Majority reactions were developed in perioperative conditions (53.70%), ward (20.37%) and home (11.11%). The major incriminated groups were antimicrobials (18.52%), nonsteroidal antiinflammatory drugs-(NSAIDs) (12.96%) and neuromuscular blockers (12.96%). Common causative drugs were diclofenac (11.11%), atracurium (7.41%) and ß-lactams (5.96%). Cardiovascular (98.15%) and respiratory (81.48%) symptoms dominated the presentation. Skin tests and IgE assays were performed in 37.03% and 18.52% cases, respectively. The fatal cases were associated with complications (OR =5.04; 95% CI: 1.41-17.92), cerebral hypoxic damage (OR =6.80; 95% CI: 2.14-21.58) and preventable reactions (OR =14.33; 95% CI: 2.33-87.97). CONCLUSION: Antimicrobials, NSAIDs, and neuromuscular blockers are common causative groups. The most fatal cases can be prevented by avoiding allergen drugs.

Utilization of potentially inappropriate medications in elderly patients in a tertiary care teaching hospital in India.

AIM: To evaluate the use of potentially inappropriate medicines in elderly inpatients in a tertiary care teaching hospital. MATERIALS AND METHODS: Retrospective analysis was performed for cases of elderly patients admitted between January 2010 and December 2010. Data on age, gender, diagnosis, duration of hospital stay, treatment, and outcome were collected. Prescriptions were assessed for the use of potentially inappropriate medications in geriatric patients by using American Geriatric Society Beer's criteria (2012) and PRISCUS list (2010). RESULTS: A total of 676 geriatric patients (52.12% females) were admitted in the medicine ward. The average age of geriatric patients was 72.69 years. According to Beer's criteria, at least one inappropriate medicine was prescribed in 590 (87.3%) patients. Metoclopramide (54.3%), alprazolam (9%), diazepam (8%), digoxin > 0.125 mg/day (5%), and diclofenac (3.7%) were the commonly used inappropriate medications. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) in heart and renal failure patients was the commonly identified drug-disease interaction. According to PRISCUS list, at least one inappropriate medication was prescribed in 210 (31.06%) patients. CONCLUSION: Use of inappropriate medicines is highly prevalent in elderly patients.

Drug utilization pattern and pharmacoeconomic analysis in geriatric medical in-patients of a tertiary care hospital of India.

OBJECTIVE: To evaluate drug utilization pattern in terms of defined daily dose along with pharmacoeconomic analysis in geriatric patients admitted in medical ward of a tertiary care hospital. MATERIALS AND METHODS: Retrospective medical record analysis was performed for indoor cases of the geriatric patients (age ≥65 years) admitted in medicine ward from January 2010 to December 2010 were analyzed for demographics, indications for admission, various systems involved, duration of hospital stay, various drugs prescribed, and adverse drug reaction. The drugs were categorized by anatomical therapeutic classification and defined daily dose was calculated. The World Health Organization prescribing indicators were assessed. Cost of the drugs was calculated to assess the economic burden. RESULTS: Cardiovascular diseases were the common cause for admission. Antiplatelet drugs-B01AC (93%), H2 blockers-A02BA (77.22%), antiemetics-A03FA (67.6%), vasodilators-C01D (55%), and hypolipidemic drugs-C10AA (52%) were commonly utilized groups. Average number of drugs per patient was 9.37 (95% CI: 9.09-9.64). Average number of antimicrobials prescribed per patient was 0.91 (95% CI: 0.82-0.99). Cefotaxime was the commonly prescribed antimicrobial drug. Average cost of treatment was ₹540.5 (95% CI: ₹458.0-623.0). Patients shared 45% of the economic burden for prescribed medicines. The average economic burden for drugs was significantly higher in expired than survived patients (₹749.49 vs. 457.59). CONCLUSION: Polypharmacy and irrational use of medicines are common problems in geriatric prescription. Prescription guidelines should be formatted for them.

Interaction between rosuvastatin and rocuronium in rat sciatic-gastrocnemius nerve-muscle preparation.

PURPOSE: Long-term use of rosuvastatin may be associated with myotoxicity. Statins are one of the groups commonly found to be associated with neuromuscular weakness. The present study was designed to investigate the interaction between rosuvastatin and rocuronium in vivo by using a sciatic-gastrocnemius nerve-muscle preparation of rat. METHODS: In our study groups, animals received rosuvastatin 2 mg/kg for 14 and 28 days. Train of four (TOF) stimulation was applied to the sciatic nerve, and gastrocnemius muscle contractions were recorded in Wistar albino rats. Intravenous infusion of rocuronium was given until the twitch responses were abolished. We ultimately compared the effective dose required for a desired effect in 95% of the population (ED95), duration 25%, deep block, recovery index, and time for returning of TOF ratio to 0.9 between the active control and study groups. RESULTS: Chronic administration of rosuvastatin at a dose of 2 mg/kg for 28 days significantly reduced the ED95 of rocuronium as compared to the active control group. Deep block and duration 25% were increased by 3.5 and 2.5 times, respectively, compared to the active control group. The spontaneous recovery of neuromuscular block was delayed, as evidenced by the prolonged recovery index and increase in time required for a return of the TOF ratio to 0.9. CONCLUSION: The neuromuscular blocking potency of rocuronium is increased and recovery is delayed in rats that pre-treated with rosuvastatin.

Evaluation of anti-inflammatory, analgesic, and antipyretic effects of ethanolic extract of Pedalium murex Linn. fruits.

This study investigated the possible anti-inflammatory, analgesic, and antipyretic effects of ethanolic extract of Pedalium murex Linn. fruits in selected experimental animal models. Anti-inflammatory activity of Pedalium murex Linn., with doses of 200 mg/kg and 400 mg/kg, p.o., was evaluated by Lambda-carrageenan induced paw oedema in Wistar albino rats; analgesic activity with doses of 280 mg/kg and 560 mg/kg, p.o., was evaluated by hot plate method and acetic acid induced writhing method in Swiss albino mice; and antipyretic activity with doses of 110 mg/kg and 220 mg/kg, p.o., was evaluated in New Zealand white rabbits by injecting gram -ve lipopolysaccharide obtained from E. coli. Results were analysed by one way ANOVA followed by Dunnet's multiple comparison test. Pedalium murex Linn. showed significant anti-inflammatory activity from 15 min to 180 min as compared to vehicle treated animals. It was comparable to diclofenac sodium at 180 min. The extract did not prolong the reaction time on hot plate method but significantly reduced the number of writhing after acetic acid administration. Also the extract did not show any antipyretic activity on lipopolysaccharide induced pyrexia. It is therefore concluded that the ethanolic extract of Pedalium murex Linn. fruits has an anti-inflammatory and peripheral analgesic effects.

A systematic review of the drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in Indian population.

BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare severe cutaneous drug reactions. No large scale epidemiological data are available for this disorder in India. AIMS: To carry out a systematic review of the published evidence of the drug-induced SJS and TEN in Indian population. METHODS: Publications from 1995 to 2011 describing SJS and TEN in Indian population were searched in PubMed, MEDLINE, EMBASE and UK PUBMED Central electronic databases. Data were collected for the causative drugs and other clinical characteristics of SJS and TEN from the selected studies. RESULTS: From 225 references, 10 references were included as per selection criteria. The major causative drugs were antimicrobials (37.27%), anti-epileptics (35.73%) and non-steroidal anti-inflammatory drugs (15.93%). Carbamazepine (18.25%), phenytoin (13.37%), fluoroquinolones (8.48%) and paracetamol (6.17%) were most commonly implicated drugs. Regional differences were observed for fluoroquinolones, sulfa drugs and carbamazepine. Total 62.96% of patients showed systemic complications. Most common complications were ocular (40.29%) and septicemia (17.65%). Higher mortality was observed for TEN as compared to SJS (odd ratio-7.19; 95% confidence interval (CI) 1.62-31.92; p = 0.0023). Observed mortality is higher than expected as per SCORTEN score 3. Duration of hospital stay was significantly higher in TEN (20.6 days; 95% CI 14.4-26.8) as compared to SJS (9.7 days; 95% CI 5.8-13.6; p = 0.020). Cost of management was significantly higher in TEN (Rs. 7910; 95% CI 5672-10147; p < 0.0001) as compared to SJS (Rs 2460; 95% CI 1762-3158). No statistical data were described for steroid use in the studies included. CONCLUSION: Carbamazepine, phenytoin, fluoroquinolones and paracetamol were the major causative drugs. TEN is showing higher mortality, morbidity and economic burden than SJS.

Drug utilization pattern in critical care unit in a tertiary care teaching hospital in India.

AIMS: The aim of this study is to evaluate the drug utilization pattern and pharmacoeconomic analysis in critical care unit (CCU). MATERIALS AND METHODS: Indoor case papers of patients admitted in CCU between January 2008 and December 2010 were analyzed for demographic variables; indications; duration of CCU stay; proportion of common drugs used. Use of antimicrobials was evaluated based on the culture report and empirical regimen used. Defined daily dose (DDD)/100 bed-days were calculated. Various World Health Organization prescribing indicators were evaluated. Cost of drugs was calculated from Indian Drug Review (2010). RESULTS: A total of 397 cases were evaluated with a mean age of 44.62 years (95% confidence interval [CI]: 42.56-46.69). Average duration of CCU stay was 4.15 days (95% CI: 3.79-4.51). The average number of drugs prescribed per patient was 13.54 (95% CI: 13.05-14.04). Total drug utilization in terms of DDD/100 bed-days was 226.27. Metronidazole, cefotaxime, atropine, adrenaline, dopamine, dobutamine, deriphyllin, ranitidine, metoclopramide and furosemide were prescribed in more than 30% cases. Number of antimicrobials prescribed per patient was 2.50 (95% CI: 2.37-2.66). Cefotaxime + metronidazole (26.70%) were the most common empirical regimen used. Average cost of treatment per patient was Rs 3225.70 (95% CI: 2749.8-3701.6). Higher economic burden was noted among expired patients and admitted due to medical + surgical indication (P < 0.05). CONCLUSION: Poly-pharmacy and use of antimicrobials without culture report is a common problem in CCU.

Stavudine induced acute necrotizing pancreatitis with tetany in a pediatric patient.

A nine year old female patient presented with complaints of severe colicky abdominal pain, vomiting, and tingling with numbness for 3 days. Acute necrotizing pancreatitis associated with tetany due to anti-retroviral therapy was diagnosed. Stavudine was the probable causal agent. Unfortunately, the patient died due to severity of the reaction. High index of suspicion and early withdrawal of the offending drug may prevent further harm in such cases.

Toxic epidermal necrolysis due to lamotrigine in a pediatric patient.

A 12-year-male child developed toxic epidermal necrolysis (TEN) probably due to lamotrigine. The patient was on antiepileptic therapy (sodium valproate and clonazepam) since 6-7 months, and lamotrigine was added in the regimen 1-2 months back. A serious cutaneous reaction is more likely to occur during the first 2 months of starting lamotrigine. The use of lamotrigine as an add-on to valproate may have precipitated the reaction. Other drugs were ruled out based on the incubation period of TEN. Drug interactions should be kept in mind with multiple antiepileptic therapies. The patient died because of the severity of reactions and delay in starting the treatment with steroids. One must be vigilant in early detection of the reaction.