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   Table of Contents - Current issue
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July-August 2020
Volume 52 | Issue 4
Page Nos. 249-340

Online since Wednesday, October 14, 2020

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EDITORIAL  

Pattern of clinical research in the era of COVID-19 pandemic: A new learning experience for the present as well as future Highly accessed article p. 249
Vidya M Mahalmani, Ankita Semwal, Harpinder Kaur, Sukhmeet Kaur, Ajay Prakash, Bikash Medhi
DOI:10.4103/ijp.IJP_669_20  PMID:33078724
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RESEARCH ARTICLES Top

Comparison of medication acceptance of intranasal midazolam administered by parents versus doctors in children – A randomized trial p. 254
M V. S Satya Prakash, S Sivasankar, Lenin Babu Elakkumanan, VK Mohan, Rithu Krishna Kamaladevi
DOI:10.4103/ijp.IJP_418_19  PMID:33078725
BACKGROUND: The positive effects of midazolam as a premedication in pediatric patients are well documented. Although there are many studies regarding the route and dosage of administration, literature does not have any evidence on the outcome of medication acceptance based on the person administering the drug. AIM: The aim of this study was to compare the medication acceptance and preoperative anxiolysis of intranasal midazolam administered by parents and anesthesiologists. MATERIALS AND METHODS: This prospective randomized study was conducted in sixty children belonging to the American Society of Anesthesiologists Class 1 or 2 belonging to either sex, aged between 1 and 9 years, undergoing elective surgeries. Group P received intranasal midazolam administered by parents, whereas Group D received intranasal midazolam administered by doctors. Various scores were assessed. RESULTS: Children were more sedated in Group P. Clinically, medication acceptance was better in Group P when compared with Group D, but a statistically significant difference in medication acceptance was seen only in patients who are >4 years of age. Parental separation, Ramsay Sedation Score, and mask acceptance were better in Group P than in Group D. CONCLUSION: Intranasal midazolam when given by parents produces better preoperative anxiolysis and easier parental separation as compared with administration by a medical staff.
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Medication errors in neonatal intensive care unit of a tertiary care hospital in South India: A prospective observational study p. 260
B Prakadeesh Bharathi, Jeffrey Pradeep Raj, Kevin Saldanha, PN Suman Rao, D Padmini Devi
DOI:10.4103/ijp.IJP_611_19  PMID:33078726
INTRODUCTION: Medication errors (MEs) can prolong hospital stay and are a cause of morbidity and mortality. Studies evaluating MEs and its determinants in Indian neonatal intensive care units (NICUs) are limited. Therefore, this study was done to assess the prevalence, characteristics, determinants, and outcomes of MEs in an Indian NICU setting. METHODOLOGY: A prospective observational study was conducted over a 1-year period (January–December 2016) among neonates receiving medications in NICU. Systematic random sampling was done, and data were collected using a semi-structured questionnaire after obtaining informed consent from the mother. An ME self-reporting system was also established. Data were analyzed using Chi-squared test and Student's t-test. Binary logistic regression was used to analyze the determinants of MEs. RESULTS: Among 269 babies included in the study, 57% (n = 154) were male babies with mean (standard deviation [SD]) birth weight of 2.59 kg (0.701). About 79% (n = 213/269) of the neonates were appropriate for gestational age. The mean (SD) duration of stay in NICU was 7.58 (5.07) days, and 67% of the babies had polypharmacy (use of ≥5 medications). The prevalence of MEs was 22% (95% confidence interval [CI]: 16.96%, 26.84%, n = 108) of all babies, of which only 2% (n = 2) were life threatening. Seventy-seven percent (n = 83) of these errors occurred during administration/preparation and 18% (n = 19) while prescribing. The significant determinants of MEs (adjusted odds ratio [95% CI]) include polypharmacy (4.126 [1.917–8.880]), duration of stay >7 days (1.335 [1.198–1.488]), and babies referred from outside (2.592 [1.217–5.521]). CONCLUSIONS: MEs were common in NICU setting. The occurrence of life-threatening MEs was minimal. Longer duration of hospital stay, polypharmacy, and babies born outside were significantly associated with occurrence of MEs.
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A comparative study of the effect of 10-day esomeprazole containing levofloxacin versus clarithromycin sequential regimens on the treatment of Iranian patients with Helicobacter pylori infection p. 266
Marjan Mokhtare, Mehdi Nikkhah, Behdad Behnam, Shahram Agah, Mansour Bahardoust, Mohsen Masoodi, Amirhosein Faghihi
DOI:10.4103/ijp.IJP_719_19  PMID:33078727
OBJECTIVE: Helicobacter Pylori (H. pylori) treatment may be different depending on the host and microbial factors in each region. The study was planned to estimate the effect of two 10-day esomeprazole containing clarithromycin and levofloxacin sequential therapies on H. pylori treatment. MATERIALS AND METHODS: Totally, 186 H. pylori-infected patients with gastro-duodenal ulcer who had not yet received treatment for infection, were enrolled. We randomly designated patients to group A (N = 94) who treated with esomeprazole 40 mg and amoxicillin 1 g bid during the early half of treatment, and continued the same dose of esomeprazole with levofloxacin 500 mg and tinidazole 500 mg bid during the second half of treatment and Group B (N = 92) who treated with the identical treatment excepting clarithromycin 500 mg bid as a substitute of levofloxacin. To assess eradication, C14-urea breath test was implemented 8 weeks afterward treatment. RESULTS: Finally, 172 patients completed the trial. We calculated 85.1% (95% confidence interval [CI] = 77.9–92.3) and 83.7% (95% CI = 76.2–91.2) eradication intention-to-treat analysis (P = 0.302) and so, 93.0% (95% CI = 87.6–98.4) and 90.0% (95% CI = 83.6–96.3) eradication by per-protocol analysis (P = 0.420) for Group A and B, respectively. No significant difference was seen among regimens. Drug adverse reactions were not significantly different between regimens. Group A had a 97.8% adherence rate to treatment and Group B had 98.9%. CONCLUSIONS: Both esomeprazole containing sequential regimens including levofloxacin and clarithromycin showed good eradication rates in spite of significant differences in antimicrobial resistance patterns in vitro. The efficacy of esomeprazole in lowering gastric acidity beside its antimicrobial effect should be considered in H. pylori regimens.
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Clinical Trials Registry – India: A decadal perspective p. 272
Mendu Vishnu Vardhana Rao, Mohua Maulik, Atul Juneja, Tulsi Adhikari, Saurabh Sharma, Jyotsna Gupta, Yashmin Panchal, Neha Yadav
DOI:10.4103/ijp.IJP_24_20  PMID:33078728
OBJECTIVE: To present a descriptive analysis of the clinical studies registered in the Clinical Trials Registry – India (CTRI) and deduce its impact. METHODS: We searched the CTRI databease for all registered clinical studies from July 20, 2007 to May 31, 2018. Extracted data were analyzed in three time periods i.e., Periods 1, 2, and 3 based on the major activities and milestones of the CTRI. In addition, comparative registrations of the various Primary Registries of the WHO were compiled and registration policy of Indian journals with regard to trial registration assessed. RESULTS: A total of 20,160 clinical studies were submitted to the CTRI in the designated study period. Of the registered 14,341 clinical studies, 10,485 (76.3%) were interventional trials which were either regulatory (n = 2004), academic non-regulatory (n = 3855), or those conducted as part of PG thesis (n = 4626) trials. Regulatory trials registration numbers varied according to the Indian regulatory scenario. PG thesis trial registrations showed a steep rise, although unlike regulatory trials, these were mostly retrospective registrations. CTRI registration numbers were comparable to that in other Primary Registries. Instructions to authors of 48% indexed Indian journals made a mention of trial registration. CONCLUSIONS: The CTRI has a strong global presence and has enhanced the transparency of regulatory trials as well as academic research particularly thesis-based work. The latter is expected to help improve standard of research and prevent repetitive research. Additional support from Indian journal editors by strict implementation of prospective registration is crucial for increasing compliance by researchers.
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Prescription pattern of antiepileptic drugs in a tertiary care center of India p. 283
Rupa Joshi, Manjari Tripathi, Pooja Gupta, Sheffali Gulati, Yogendra Kumar Gupta
DOI:10.4103/ijp.IJP_507_17  PMID:33078729
OBJECTIVES: The present study aimed to determine the pattern of prescription of antiepileptic drugs (AEDs) in a cohort of patients with epilepsy (PWE) attending a tertiary care center of North India. MATERIALS AND METHODS: Demographic variables including age, gender, age at onset, type and frequency of seizures, and prescription of all AEDs (dose and duration) were noted. Descriptive analysis of the use of AEDs was done, and their different combinations were studied. RESULTS: A total of 1187 prescriptions were evaluated. Demography showed 65.7% of males; mean age of 21.9 years (range: 2–77 years), generalized seizures (53%), and focal seizures (47%). Only 21.8% of the patients were seizure free with no seizure in 1 year of treatment. The five most frequently prescribed AEDs out of 12 AEDs were sodium valproate (VPA) (49.6%), clobazam (CLB) (39.3%), levetiracetam (LEV) (28.4%), carbamazepine (CBZ) (27.3%), and phenytoin (PHT) (26.5%). Monotherapy was effective in 36.6% of the patients. Sodium VPA (39.4%), PHT (25.6%), and CBZ (20.1%) were commonly used as monotherapy. Polytherapy was required in 63.4% of the patients, and most commonly prescribed combinations were PHT + CLB (n = 53), sodium VPA + CLB (n = 62), CBZ + CLB (n = 45), PHT + sodium VPA + CLB (n = 28), and CBZ + sodium VPA + CLB (n = 31). CONCLUSIONS: Polytherapy is a very common practice in our tertiary care center. Sodium VPA, a highly prescribed AED, results in good control of generalized seizures, whereas focal seizures are well controlled by CBZ alone as well as in combination. The present study highlights the commonly prescribed combinations of AEDs resulting in control of different types of seizures.
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A prospective study to assess the medication adherence pattern among hypertensives and to evaluate the use of cellular phone text messaging as a tool to improve adherence to medications in a tertiary health-care center p. 290
Garima Shukla, A Tejus, R Vishnuprasad, Sapna Pradhan, MS Prakash
DOI:10.4103/ijp.IJP_498_19  PMID:33078730
AIM: The aim of the study was to assess improvement in adherence to medications using mobile phone text messaging (short message services [SMSs] and social media). OBJECTIVES: The objective was to assess the pattern of adherence to medication in hypertensives and to assess the improvement in adherence pattern to antihypertensive medications using mobile phone text messaging as a tool. METHODOLOGY: After obtaining informed consent, the study participants' blood pressure was recorded, and their adherence to medications was graded as high, medium, and low using the Medication Adherence Questionnaire. Then, messages in the form of either SMSs or WhatsApp were sent regularly (once every 3 days) reminding them of the importance of regular medicine intake. After 2 months of follow-up, again blood pressure was recorded and adherence graded. Data were tabulated and statistically analyzed. RESULTS: Majority of study participants in who were initially placed in medium to low grading of adherence (65.2%) moved toward high adherence (88.4%) at follow-up after receiving messages for 2 months. A statistically significant decrease was noted in systolic (8.3 mmHg,P < 0.001) and diastolic blood pressure (2.4 mmHg,P < 0.002) at the end of follow-up. CONCLUSION: Nonadherence to medication is a global phenomenon to be tackled at the earliest. Our study clearly brings out the importance of improving adherence by regular reminders as messages. Hence, there is a wide scope to avail means to improve the adherence pattern and maximize the health benefits.
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Mangiferin ameliorates intracerebroventricular-quinolinic acid-induced cognitive deficits, oxidative stress, and neuroinflammation in Wistar rats p. 296
Mandeep Kumar Arora, Anglina Kisku, Ashok Jangra
DOI:10.4103/ijp.IJP_699_19  PMID:33078731
INTRODUCTION: Mangiferin (MGF), a xanthonoid polyphenol, confers neuroprotection via combating oxidative stress and inflammation. The current investigation aimed to assess the neuroprotective potential of MGF on behavioral and neurochemical anomalies evoked by administration of quinolinic acid (QA) through intrastriatal injection in male Wistar rats and to reveal the associated mechanisms. MATERIALS AND METHODS: QA (300 nm/4 μl saline) was administered intracerebroventricular in the striatum (unilaterally) once. Thereafter, MGF 20 and 40 mg/kg (peroral) was administered to the animals for 21 days. RESULTS: QA administration caused marked alteration in motor activity (rotatod), footprint analysis, and cognitive function (Morris water maze test, and novel object recognition test). Furthermore, oxido-nitrosative stress (increased nitrite content, lipid peroxidation, with reduction of GSH), cholinergic dysfunction, and mitochondrial complex (I, II, and IV) dysfunction were observed in hippocampus and striatal region of QA-treated rats in comparison to normal control. Pro inflammatory mediators (tumor necrosis factor-alpha TNF-α and interleukin-1β) were noted to increase in the hippocampus and striatum of QA-treated rats. In addition, we observed BDNF depletion in both the hippocampus and striatum of QA-treated animals. MGF treatment significantly ameliorated memory and motor deficits in QA-administered rats. Moreover, MGF treatment (40 mg/kg) restored the GSH level and reduced the MDA, nitrite level, and pro-inflammatory cytokines in striatum and hippocampus. Furthermore, QA-induced cholinergic dysfunction (AChE), BDNF depletion and mitochondrial impairment were found to be ameliorated by MGF treatment. CONCLUSION: The results suggest that MGF offers the neuroprotective potential that may be a promising pharmacological approach to ameliorate cognitive deficits associated with neurodegeneration.
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Silk fibroin nanofibers enhance cell adhesion of blood-derived fibroblast-like cells: A potential application for wound healing p. 306
Vandana S Nikam, Dhanshree S Punde, Raviraj S Bhandari
DOI:10.4103/ijp.IJP_609_19  PMID:33078732
AIM: The aim of this study is to evaluate silk-fibroin electrospun nanofibers and blood-derived fibroblast-like cells for cytotoxicity and cell adhesion. BACKGROUND: Silk fibroin (SF) has emerged as a favorable and potential bio-material owing to its unique properties such as biocompatibility, biodegradability, the possibility of functional modifications, mechanical strength, and regenerative capability. Despite current advancements in tissue engineering technologies, delay wound healing and scar formation remain unresolved. Bioequivalent skin graft having human fibroblast and keratinocytes (Apligraft®) has proven to be beneficial, but the cost is a limiting factor. OBJECTIVE: The blood born fibroblast-like cells express several growth factors, extracellular matrix proteins, and these factors are crucial in the various steps of the wound-healing process. SF is an idea polymer by the virtue of its multifaceted characteristics such as mechanical strength, biodegradability, improved cell attachment, biocompatibility, good elasticity, having application in biomedical, tissue engineering, and medicine. The objective of the present study is to evaluate SF as a biomaterial for making nanofibers scaffold and culturing blood-derived fibroblast-like cells on it for the potential application to wound site. MATERIALS AND METHODS: Blood-derived fibroblast-like cells evaluated for cytotoxicity, collagen 1 expression, and cell adhesion on SF electrospun nanofibers. The silk nanofibers were fabricated by the electrospinning method using silk-derived fibroin solution and analyzed for protein composition, viscosity, and further characterized using the Fourier transformed infrared spectroscopy. RESULTS: The SF nanofibers were nontoxic to the blood-derived fibroblast-like cells. It improved cell adhesion with collagen 1 expression. CONCLUSION: The composite scaffold of SF nanofibers with blood-derived fibroblast-like cells would be a potential healing patch for many types of wounds.
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SYSTEMATIC REVIEW AND META-ANALYSIS (ORIGINAL ARTICLE) Top

Safety and efficacy of lopinavir/ritonavir combination in COVID-19: A systematic review, meta-analysis, and meta-regression analysis Highly accessed article p. 313
Anusuya Bhattacharyya, Subodh Kumar, Phulen Sarma, Hardeep Kaur, Manisha Prajapat, Nishant Shekhar, Seema Bansal, Pramod Avti, Mythili Hazarika, Saurabh Sharma, Dhruv Mahendru, Ajay Prakash, Bikash Medhi
DOI:10.4103/ijp.IJP_627_20  PMID:33078733
BACKGROUND: Being protease inhibitors and owing to their efficacy in SARS-CoV, lopinavir + ritonavir (L/R) combination is being used in the management of COVID-19. In this systematic review and meta-analysis, we have evaluated the comparative safety and efficacy of L/R combination. MATERIALS AND METHODS: Comparative, observational studies and controlled clinical trials comparing L/R combination to standard of care (SOC)/control or any other antiviral agent/combinations were included. A total of 10 databases were searched to identify 13 studies that fulfilled the predefined inclusion/exclusion criteria. RESULTS: No discernible beneficial effect was seen in the L/R group in comparison to SOC/control in terms of “progression to more severe state” (4 studies, odds ratio [OR]: 1.446 [0.722–2.895]), “mortality” (3 studies, OR: 1.208 [0.563–2.592]), and “virological cure on days 7–10” (3 studies, OR: 0.777 [0.371–1.630]), while the L/R combination arm performed better than the SOC/control arm in terms of “duration of hospital stay” (3 studies, mean difference (MD): −1.466 [−2.403 to − 0.529]) and “time to virological cure” (3 studies, MD: −3.272 [−6.090 to − 0.454]). No difference in efficacy was found between L/R versus hydroxychloroquine (HCQ) and L/R versus arbidol. However, in a single randomized controlled trail (open label), chloroquine (CQ) performed better than L/R. The combination L/R with arbidol may be beneficial (in terms of virological clearance and radiological improvement); however, we need more dedicated studies. Single studies report efficacy of L/R + interferon (IFN, either alpha or 1-beta) combination. We need more studies to delineate the proper effect size. Regarding adverse effects, except occurrence of diarrhea (higher in the L/R group), safety was comparable to SOC. CONCLUSION: In our study, no difference was seen between the L/R combination and the SOC arm in terms of “progression to more severe state,” “mortality,” and virological cure on days 7–10;” however, some benefits in terms of “duration of hospital stay” and “time to virological cure” were seen. No significant difference in efficacy was seen when L/R was compared to arbidol and HCQ monotherapy. Except for the occurrence of diarrhea, which was higher in the L/R group, safety profile of L/R is comparable to SOC. Compared to L/R combination, CQ, L/R + arbidol, L/R + IFN-α, and L/R + IFN-1β showed better efficacy, but the external validity of these findings is limited by limited number of studies (1 study each).
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SHORT COMMUNICATION Top

Change in jaw occlusive power by paralysis of masseter muscle with a neuromuscular blocker: Sion's masseter muscle paralysis p. 324
Sion Jo, Jae Baek Lee, Youngho Jin, Taeoh Jeong, Jae Chol Yoon, Boyoung Park
DOI:10.4103/ijp.IJP_569_18  PMID:33078734
STUDY OBJECTIVE: We aimed to determine whether jaw occlusive power decreases with the injection of neuromuscular blocking agents in masseter muscle – a method we named Sion's masseter muscle paralysis (SMP). METHODS: A randomized, placebo-controlled animal study was conducted in which researchers were blinded to group allocation. We used 12 male mongrel dogs aged 10–12 months and weighing 30–35 kg. Four groups were formed: a conventional dose (CD) group (0.004 mg/kg succinylcholine in 4 ml normal saline [NS]); a high dose (HD) group (0.04 mg/kg succinylcholine in 4 ml NS); a placebo group (4 ml NS); and no intervention group. To measure the jaw occlusive power, 1 kg weight was hung sequentially on a specifically designed device on the animal's lower jaw. At −4, −2, 0', +2, +4, +6, +8, +10, +20, and +30 min, we measured the jaw occlusive power, oxygen saturation (SpO2), and end-tidal carbon dioxide (ETCO2). RESULTS: After SMP, jaw occlusive power began to decline in CD and HD group. The arithmetical mean jaw occlusive power values at −4, −2, 0', +2, +4, +6, +8, and +10 min were 9.7, 9.7, 9.7, 8.7, 8.3, 7.3, 6.7, and 6.3 kgw in the CD group and 9.7, 9.3, 8.7, 8.0, 6.7, 5.0, 5.0, and 5.3 kgw in the HD group. No abnormalities in SpO2or ETCO2were detected. CONCLUSION: Jaw occlusive power was decreased after SMP with succinylcholine, without inducing respiratory complication.
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LETTERS TO THE EDITOR Top

Need for national strategies for snake envenomations in India p. 331
Yogendra Kumar Gupta, Sharda Shah Peshin
DOI:10.4103/ijp.IJP_582_17  PMID:33078735
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The narrow road to a COVID-19 vaccine p. 333
Shesh Prakash Maurya, Namrata Das, Hitender Gautam, Ravinder Singh, Bimal Kumar Das
DOI:10.4103/ijp.IJP_709_20  PMID:33078736
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Human immunodeficiency virus, neuroinflammation, CD16+ pathobiological process, and haloperidol drug p. 335
Beuy Joob, Viroj Wiwanitkit
DOI:10.4103/ijp.IJP_688_19  PMID:33078737
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Decreased mortality among hospitalized coronavirus disease 2019 patients who underwent anticoagulant therapy with heparin p. 337
Vityala Yethindra, Tugolbai Tagaev
DOI:10.4103/ijp.IJP_584_20  PMID:33078738
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Chlorpromazine-induced lenticular opacity p. 339
Kavitha Srinivasan, Megha Gopalakrishna
DOI:10.4103/ijp.IJP_691_20  PMID:33078739
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