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» Table of Contents
September-October 2021
Volume 53 | Issue 5
Page Nos. 353-423
Online since Wednesday, November 24, 2021
Accessed 35,834 times.
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EDITORIAL
Impact of Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory practices (GLP) in India
p. 353
Ekta Kapoor, Neeraj Sharma, Rupa Joshi, Bikash Medhi
DOI
:10.4103/ijp.ijp_685_21
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CLINICAL RESEARCH ARTICLES
A randomized comparative study of methylcobalamin, methylcobalamin plus pregabalin and methylcobalamin plus duloxetine in patients of painful diabetic neuropathy
p. 358
Chetna Sharma, Inderpal Kaur, Harpreet Singh, Inderpal Singh Grover, Jatinder Singh
DOI
:10.4103/ijp.ijp_1159_20
CONTEXT:
Diabetic neuropathy affects 10.5%–32.2% of diabetic population posing clinical burden onto society.
AIMS:
We aimed to study the efficacy, safety, and tolerability of methylcobalamin, methylcobalamin plus pregabalin, and methylcobalamin plus duloxetine in patients of painful diabetic neuropathy.
SETTINGS AND DESIGN:
It is a prospective, randomized, open-label, interventional, and parallel-group study done in patients of painful diabetic neuropathy.
MATERIALS AND METHODS:
A total of 100 patients were recruited and randomized to three study groups A, B, and C on methylcobalamin, methylcobalamin and pregabalin, and methylcobalamin and duloxetine, respectively. Patients were assessed at day 0 and 4, 8, and 12 weeks. The tuning fork test, monofilament test, Thermal Sensitivity testing, and Visual Analog Scale (VAS) were used to analyze vibration, pressure, thermal sensitivity, and pain.
STATISTICAL ANALYSIS USED:
The results are expressed as mean ± standard deviation. Appropriate statistical methods were used to calculate
P
value (<0.05 – significant).
RESULTS:
The increase in number of patients with vibration perception is 11.6%, 37.9%, and 41.4%; pressure sensation is 7.6%, 37.9%, and 37.9%; and thermal sensitivity is 15.4%, 31.1%, and 37.9% in Groups A, B, and C, respectively. The decrease in VAS scores is 0.58 ± 0.14, 3.82 ± 0.05, and 4.17 ± 0.48 in Groups A, B, and C correspondingly. The adverse effects reported in Groups A, B, and C are 0%, 6.9%, and 10.3%, respectively.
CONCLUSIONS:
Group C is more efficacious when compared to Groups A and B while Group B is safer.
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Pentaglobin (immunoglobulin M-enriched immunoglobulin) as adjuvant therapy for premature and very low-birth-weight neonates with sepsis
p. 364
Kawthar F Nassir, Yasir Ibrahim AL-Saddi, Hassan M Abbas, Qutaiba Ahmed Al Khames Aga, Luma Ahmed Al Khames Aga, Ameer A Oudah
DOI
:10.4103/ijp.ijp_881_20
OBJECTIVES:
The purpose of this research was to determine the effectiveness of Pentaglobin® as adjuvant therapy in the treatment of sepsis in preterm newborns.
MATERIALS AND METHODS:
It was a prospective, observational, randomized study for 272 premature neonates and very low birth weight (VLBW) that were diagnosed with sepsis carried at neonatal intensive care units. The patients randomized into control group who received standard sepsis antibiotic treatments, and an intervention group who received Pentaglobin® 5 ml/kg daily for 3 consecutive days as an adjunct therapy to a standard sepsis antibiotic treatment.
RESULTS:
Multiple organisms that isolated from culture specimens were Gram-negative bacteria, Gram-positive, and candida (56.25%, 42.28%, and 1.47%, respectively). The disease duration was distinctively longer in patients who were treated by the standard antibiotic protocol (mean ± standard deviation [SD]: 30.76 ± 3.97, odds ratio [OR]: 30.76, 95% confidence interval [CI]: 30.051, 31.473) comparing to the patients who received Pentaglobin adjuvant therapy (mean ± SD: 26.48 ± 5.55, OR: 26.48, 95% CI: 25.489, 27.477) (
P
< 0.000). Patients treated by standard antibiotic protocol were associated to a substantially increased risk of death (11.76%, hazard ratio 4.400, 95% CI: 1.432, 13.529,
P
= 0.009).
CONCLUSION:
Neonatal sepsis is more common in premature and VLBW newborns, and Pentaglobin® management of newborn nosocomial sepsis might be used in addition to other therapies.
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Topical steroid containing combinations: Burden of adverse effects and why the recent regulatory action may not be enough
p. 371
Ratinder Jhaj, Dinesh Prasad Asati, Deepa Chaudhary, Balakrishnan Sadasivam
DOI
:10.4103/ijp.IJP_728_19
OBJECTIVES AND METHODS:
In September 2018, the government of India banned 328 fixed dose combinations (FDCs), 24 of which are combinations containing topical steroids. To assess what impact can be expected from this regulatory action, we analyzed reports of adverse drug events due to topical corticosteroids at a hospital-based pharmacovigilance center between January 2017 and August 2018.
RESULTS:
Among 34 different steroid-containing FDCs responsible for 485 reports of ADEs with topical steroids, only three preparations, accounting for 50.10% of ADEs, come under the umbrella of the recent ban. Clobetasone propionate (68.87%) and betamethasone (28.45%) were the corticosteroids most frequently associated with adverse events. Most of the steroid preparations (87.84%) had been bought without a prescription for the treatment of dermatophytoses (76.70%). Males (77.73%) were predominantly affected, and nearly half (47.43%) of the patients were between 21 and 30 years of age. Skin atrophy (50.10%), striae (25.54%), and hypopigmentation (19.79%) were the major ADEs.
CONCLUSION:
Nearly half of the cutaneous adverse effects were due to topical steroid combinations which are still widely available over the counter.
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EXPERIMENTAL RESEARCH ARTICLE
Evaluation of anticancer activity of
Clerodendrum viscosum
leaves against breast carcinoma
p. 377
Anil Khushalrao Shendge, Tapasree Basu, Nripendranath Mandal
DOI
:10.4103/ijp.IJP_565_19
INTRODUCTION:
The use of natural resources as medicines for cancer therapies has been described throughout history in the form of traditional medicines. However, many resources are still unidentified for their potent biological activities.
Clerodendrum viscosum
is a hill glory bower reported as a remedy against oxidative stress, skin diseases, and intestinal infections.
MATERIALS AND METHODS:
We have collected the
C.
v
iscosum
leaves and used for the preparation of 70% methanolic extract (CVLME). Then, CVLME has been confirmed for anticancer properties on various cancer cell lines by evaluating cytotoxicity, cell cycle analysis, induction of ROS and apoptosis, and nuclear fragmentation. Further, the phytochemical analysis of CVLME was evaluated through high-performance liquid chromatography.
RESULTS:
Cell proliferation assay revealed the selective cytotoxicity of CVLME against breast cancer cell line (MCF-7). The FACS-based cell cycle analysis showed increased subG1 (apoptosis) population dose dependently. Further, the apoptosis-inducing effect of CVLME was confirmed by annexin staining. Flow cytometry and confocal microscopy revealed the selective ROS generation upon CVLME treatment. The confocal-based morphological study also revealed condensed and fragmented nuclear structure in CVLME-treated MCF-7 cells. Phytochemical investigations further indicated the presence of tannic acid, catechin, rutin, and reserpine which might be the reason for the anticancer activity of CVLME.
CONCLUSION:
The above-combined results revealed the anticancer effect of CVLME, which may be due to the selective induction of ROS in breast carcinoma.
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SHORT COMMUNICATION
Antidiabetic activity of
Commiphora mukul
and
Phyllanthus emblica
and Computational analysis for the identification of active principles with dipeptidyl peptidase IV inhibitory activity
p. 384
Ipseeta Ray Mohanty, C Selvaa Kumar, Manjusha Borde
DOI
:10.4103/ijp.IJP_69_19
The medicinal plants may serve as natural alternatives to synthetic antidiabetic medications such as dipeptidyl peptidase-IV (DPP-IV) inhibitors, which are commonly prescribed in clinical practise. The medicinal plants:
Commiphora mukul
and
Phyllanthus emblica
have considerable DPP-IV inhibitory efficacy, according to our findings. The present study is an extension of the previous study conducted in our laboratory and was designed to confirm the antidiabetic effects of
C. mukul
and
P. emblica
in the streptozotocin diabetes model and elucidate the active principles responsible for DPP-IV inhibition.
C. mukul
(Guggul) and
P. emblica
(Amla) have the ability to inhibit DPP-IV and have anti-diabetic properties in a Type 2 diabetes mellitus experimental model. The binding sites and affinity of the active principles of
C. mukul
(Gluggusterone E, Gluggusterone Z) and
P. emblica
(Pzrogallol, beta-glucogallin, and gallic acid) responsible for DPP-IV enzyme inhibition were identified using
in silico
studies and compared to Vildagliptin, a synthetic DPP-IV inhibitor. The Vildagliptin and therapy groups had significantly lower glycated hemoglobin and DPP-IV levels. The anti-diabetic effect of
C. mukul
and
P. emblica
is due to their DPP-IV inhibitory action. The DPP-IV inhibitory action of Gluggusterone E, Gluggusterone Z, and beta-Glucogallin was found to be superior to Vildagliptin in docking tests.
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DRUG WATCH
Pseudogynecomastia: A chance occurrence with acitretin
p. 388
Seema Rani, Soumya Sachdeva
DOI
:10.4103/ijp.ijp_982_20
Psoriatic involvement of nails manifests in the form of irregular, deep and large pits, splinter hemorrhages, subungual hyperkeratosis, oil drop spot, and onycholysis of the nail bed. Retinoids are one of the treatment modalities for nail psoriasis. Pseudogynecomastia is an uncommonly reported side effect of retinoids. We hereby describe an 11-year-old adolescent who developed pseudogynecomastia posttreatment with acitretin for nail psoriasis.
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Sulfasalazine-induced drug rash with eosinophilia and systemic symptoms syndrome in a seronegative spondyloarthritis patient: A Case report
p. 391
Naresh Sah, Balakeshwa Ramaiah, Raju Koneri
DOI
:10.4103/ijp.IJP_129_18
The objectives were to evaluate drug rash with eosinophilia and systemic symptoms syndrome due to sulfasalazine and to carry out the pharmacoeconomic assessment associated with this adverse drug reaction (ADR). A 37-year woman was presented with rashes, fever, cough, and dyspnea. In the past 3 months, she was on sulfasalazine for inflammatory polyarthritis and seronegative spondyloarthritis. The diagnosis was based on raised eosinophils count, breathing difficulty, and typical pattern of rashes. Significant improvement was seen after discontinuation of sulfasalazine and with the initiation of parenteral corticosteroids. The casualty of this ADR was “probable” based on RegiSCAR, WHO, and Naranjo casualty assessment scales. Preventability, severity was assessed and total cost for management of the ADR was found to be ' 12,126. Thus, ADRs not only adds to patient sufferings but also increase the economic burden. Health-care providers need to be made aware of potentially fatal ADRs associated with sulfa drugs and should be keen to report such ADRs to drug safety authorities.
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REVIEW ARTICLES
Evidences suggesting a possible role of Vitamin D in COVID 19: The missing link
p. 394
Shruti Singh, CM Singh, Alok Ranjan, Sanjeev Kumar, Dheeraj Kumar Singh
DOI
:10.4103/ijp.IJP_654_20
The severe acute respiratory syndrome coronavirus 2 is spreading like wildfire with no specific recommended treatment in sight. While some risk factors such as the presence of comorbidities, old age, and ethnicity have been recognized, not a lot is known about who the virus will strike first or impact more. In this hopeless scenario, exploration of time-tested facts about viral infections, in general, seems to be a sound basis to prop further research upon. The fact that immunity and its various determinants (e.g., micronutrients, sleep, and hygiene) have a crucial role to play in the defense against invading organisms, may be a good starting point for commencing research into these as yet undisclosed territories. Herein, the excellent immunomodulatory, antiviral, and anti-inflammatory roles of Vitamin D necessitate thorough investigation, particularly in COVID-19 perspective. This article reviews mechanisms and evidence suggesting the role Vitamin D plays in people infected by the newly identified COVID-19 virus. For this review, we searched the databases of Medline, PubMed, and Embase. We studied several meta-analyses and randomized controlled trials evaluating the role of Vitamin D in influenza and other contagious viral infections. We also reviewed the circumstantial and anecdotal evidence connecting Vitamin D with COVID-19 emerging recently. Consequently, it seems logical to conclude that the immune-enhancing, antiviral, anti-inflammatory, and lung-protective role of Vitamin D can be potentially lifesaving. Hence, Vitamin D deserves exhaustive exploration through rigorously designed and controlled scientific trials. Using Vitamin D as prophylaxis and/or chemotherapeutic treatment of COVID-19 infection is an approach worth considering. In this regard, mass assessment and subsequent supplementation can be tried, especially considering the mechanistic evidence in respiratory infections, low potential for toxicity, and widespread prevalence of the deficiency of Vitamin D affecting many people worldwide.
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Demystifying therapeutic potential of medicinal plants against chikungunya virus
p. 403
Sukender Kumar, Chanchal Garg, Samander Kaushik, Harpal Singh Buttar, Munish Garg
DOI
:10.4103/ijp.IJP_81_20
Viral infections are posing a great threat to humanity for the last few years. Among these, Chikungunya which is a mosquito-borne viral infection has produced enormous epidemics around the world after been rebounded. Although this infection shows a low mortality rate, patients suffer from fever, arthralgia, and maculopapular rashes, which reduce the quality of life for several weeks to years. The currently available treatments only provide symptomatic relief based on analgesics, antipyretics, and anti-inflammatory drugs which are nonspecific without satisfactory results. Medicinal plants are a widely accepted source of new molecules for the treatment of infectious diseases including viral infections. The scientific reports, primarily focusing on the anti-chikungunya activity of plant extracts, natural origin pure compounds, and their synthetic analog published from 2011 to 2021, were selected from PubMed, Google Scholar, and Scopus by using related keywords like anti-chikungunya plants, natural antivirals for Chikungunya. The present review decodes scientific reports on medicinal plants against chikungunya virus (CHIKV) infection and demystifies the potential phytoconstituents which reveals that the screening of flavonoids containing plants and phytochemicals showing efficacy against other arbovirus infections, may prove as a potential lead for drug development against CHIKV. The present article also outlines pathogenesis, clinical aspects, molecular virology, and diagnostic approaches of CHIKV infection.
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LETTERS TO THE EDITOR
Oxcarbazepine-induced systemic lupus erythematosus: A rare and serious adverse drug reaction to a common anticonvulsant
p. 412
Anwita Sinha, Arun Hegde, Prateek Kinra, Shekhar Neema, Anchit Raj Singh
DOI
:10.4103/ijp.IJP_445_20
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COVID-19 associated mucormycosis, host-iron assimilation: Probiotics can be a novel therapy
p. 415
Ankit Bhardwaj, Vandana Roy
DOI
:10.4103/ijp.ijp_406_21
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Rhino-orbital-cerebral mucormycosis in COVID-19 patients – Taming the black evil with pharmacological weapons
p. 417
Kirandeep Kaur, Bharat Gurnani
DOI
:10.4103/ijp.ijp_392_21
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Sharing experience: Hydroxychloroquine in preexposure prophylaxis against COVID-19
p. 420
Chanda Kulkarni, Adil Sadiq, Arya Gigi, Ambili Devassia, Georgeena George
DOI
:10.4103/ijp.ijp_508_21
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OBITUARYS
Obituary
p. 422
Santanu Kumar Tripathi
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Obituary
p. 423
SK Kulkarni
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