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   Table of Contents - Current issue
Coverpage
July-August 2022
Volume 54 | Issue 4
Page Nos. 241-298

Online since Thursday, October 6, 2022

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EDITORIAL  

New generation vaccine: Novel approaches of vaccine design and delivery and current challenges of vaccine development p. 241
Seema Bansal, Ajay Prakash, Bikash Medhi
DOI:10.4103/ijp.ijp_555_22  
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RESEARCH ARTICLES Top

Efficacy and safety of oral insulin versus placebo for patients with diabetes mellitus: A systematic review and meta-analysis Highly accessed article p. 244
Saili Dharadhar, Amit Sharma, Debasis Dey
DOI:10.4103/ijp.ijp_1135_20  
OBJECTIVE: Compliance to insulin injections is poor due to difficulty in subcutaneous administration. Hence, there is a need of an oral formulation of insulin. Oral insulin is currently under investigation. The present analysis aimed to evaluate oral insulin versus placebo for patients with diabetes mellitus (type-1 and type-2). MATERIALS AND METHODS: Results from PUBMED and MEDLINE were searched and compiled from January 1, 2000 to January 9, 2020. Postprandial blood glucose excursions (2PPG), glycated hemoglobin (HbA1c), C-peptide levels, and immune antibody (IAA) levels were compared between the arms. In addition, time to diabetes and safety of oral insulin were discussed. RESULTS: Thirteen out of 1778 trials were included to the analysis. Oral insulin was found to induce significant reduction in mean 2PPG excursion (standardized mean difference [SMD]: −1.94, 95% CI: −3.20 to −0.68, I2 = 91.81, P < 0.005) and mean IAA levels (SMD:-0.49, 95% CI: −0.82 to -0.16, I2 = 27.12, P < 0.005) compared with placebo. Mean C-peptide levels were notably lower in the oral insulin arm. However, the difference was not statistically significant. No significant difference was observed in mean HbA1c levels. The rate of development of type-1 diabetes was not significantly influenced by oral insulin. No deaths or treatment-related serious adverse events were reported. CONCLUSION: Oral insulin provided significant benefits for acute maintenance of diabetes mellitus. It elicited lower immune response and was well tolerated. This new formulation has potential to augment the management of diabetes mellitus. More studies are required to assess its long-term effects.
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A retrospective review of a 2-year strong antimicrobial stewardship program in a tertiary care institute in Mumbai p. 253
Sanjith Saseedharan, Nausheen Shaffi, Sonal Rambhad, Vaijyanti Kadam, Elizabeth J Mathew
DOI:10.4103/ijp.IJP_466_20  
BACKGROUND INFORMATION: Many institutes have implemented a strict antimicrobial stewardship (AMS) program in the postantibiotic era. AIM: To investigate how the resistance pattern changes after implementation of a stringent AMS programme. METHODOLOGY: It employs a defined daily dose methodology (DDD). The formulae listed below are used to compute this for two periods: October 2015 to October 2017 (Period 1) and October 2017 to October 2019 (Period 2) (Period 2). DDD = Antibiotics used in total (g) per year [INLINE:1] The length of stay was determined using the data from the hospital's information system (HIS). The patterns of resistance to the limited antibiotics are vancomycin, linezolid, tigecycline, and colistin. In both Periods 1 and 2, skin and soft-tissue infections, urinary tract infections, bloodstream infections, and respiratory tract infections were studied in both periods. RESULTS: In the year from October 2015 to October 2017, 4569 patients received limited antibiotics out of a total of 14,544 admissions. The average length of stay was 7.48 days in Period 1, however, it was reduced to 3.96 days in Period 2 out of 15,199 patients. In vitro isolate sensitivities to vancomycin, linezolid, tigecycline, and colistin were increased. CONCLUSION: Some of the most common antibiotics were used less frequently. This appears to be linked to a shorter stay in the hospital and increased antibiotic susceptibility.
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In search for a panacea for coronavirus disease-19: Analysis of ongoing clinical trials for the management of coronavirus disease-19 pandemic in India p. 258
Nidhi Maheshwari, Vandana Roy
DOI:10.4103/ijp.ijp_700_21  
OBJECTIVE: To analyze the clinical trials that are registered on the Clinical Trial Registry of India (CTRI) portal for a year, for the treatment, prevention, and supportive therapy of coronavirus disease-19 (COVID-19). MATERIALS AND METHODS: All the trials registered on CTRI (since January 2020 till January 2021) for therapeutic, preventive, and supportive interventions for COVID-19 were searched with the keywords “Coronavirus,” “COVID-19,” “SARS-COV-2,” and “2019-nCoV”. These registered studies were analyzed as follows: Trials under different systems of Medicine-Allopathy/Homeopathy/Ayurveda/Unani/Yoga/Naturopathy. The Allopathy trials were further analyzed in detail: Intervention, design, comparator, number of subjects, duration, and approvals taken. RESULTS: A total of 1597 records were found. After excluding the overlaps, behavioral and other studies conducted to understand the diagnosis, epidemiology, a total of 419 registered studies were included for further analysis. Out of these 419 studies, 166 (39.6%) were in Ayurveda, 154 (36.7%) in Allopathy, 33 (7.8%) in Homeopathy, 30 (7%) in Unani/Siddha, 18 (4.3%) in Yoga and Naturopathy and 18 (4.3%) in Nutraceuticals. A total of 264 interventions had been registered in 419 clinical trials. Sixty-seven interventions were being studied under allopathy in 154 studies. Same product was being evaluated in differently designed protocols with different endpoints. Maximum number of trials and subjects were for Hydroxychloroquine 25 (17,998), Ivermectin 11 (2820), Convalescent Plasma 11 (3982), Remdesivir 8 (3725), Tocilizumab 6 (884), and Azithromycin 6 (582). CONCLUSIONS: In response to the COVID-19 pandemic, Indian researchers came forward from all the systems of medicine to evaluate interventions for prophylaxis or treatment of the disease. The involvement of AYUSH systems of medicine was specifically more in this regard. A wide variation and heterogeneity in doses and outcomes were observed in trial designs which might make it difficult to generalize the study results when they are made available. Urgent analyses of studies involving interventions on the treatment advisory of the Government may help the healthcare providers take more informed decisions for managing COVID-19 patients in India.
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Simultaneous determination of lactulose, sucrose, sucralose, and mannitol using high-performance liquid chromatography-refractive index to estimate intestinal permeability in patients with active ulcerative colitis p. 270
Pooja Sarotra, Usha Dutta, Hina Gupta, KP Ravindranathan Kartha, Rakesh Kochhar, Ajay Prakash, Phulen Sarma, Jimil Shah, Bikash Medhi
DOI:10.4103/ijp.ijp_90_22  
OBJECTIVES: The intestinal permeability (IP) of sugars and their derivatives has been widely used to assess mucosal damage in gastrointestinal diseases. Ulcerative colitis (UC) is a recurring and relapsing disease that causes inflammation of the gut. IP of sugars can be evaluated and correlated with the flare of UC. MATERIALS AND METHODS: A prospective study was conducted on 91 patients with active UC at the tertiary care center in North India. Mayo grading system assessed disease activity, and IP was assessed by measuring sucrose, lactulose, mannitol, and sucralose in urine samples from UC patients. A high-performance liquid chromatography (HPLC) method to detect all of these sugars simultaneously using a refractive index detector was developed and further validated in patients with UC. RESULTS: The analytical recovery rate of the tested sugars ranged from 95% to 146% in the urine matrix. The limit of detection and limit of quantification were 78.838 mg/L and 262.79 mg/L for sucrose, 84.994 mg/L and 283.31 mg/L for lactulose, 74.789 mg/L and 249.30 mg/L for mannitol, and 50.908 mg/L and 169.69 mg/L for sucralose. CONCLUSION: The standardized HPLC method is sensitive and suitable for the simultaneous detection and determination of different sugar moieties in the urine sample. Patients with UC can be evaluated indirectly for the flare by estimating the recovery rate of sugars through gut permeability. The procedure is noninvasive and thus improves the quality of life of chronically ill patients.
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Immunological factors associated with discordant virological response postcombination antiretroviral therapy in pediatric human immunodeficiency virus infection p. 278
Ravinder Singh, Shesh Prakash Maurya, Namrata Das, Sushil Kumar Kabra, Rakesh Lodha, Bimal Kumar Das
DOI:10.4103/ijp.ijp_616_21  
OBJECTIVES: Evaluation of immunological factors responsible for discordant virological responses postcombination antiretroviral therapy (cART) in human immunodeficiency virus (HIV)-positive children aged <5 years. MATERIALS AND METHODS: Immunological profiling of enrolled 30 HIV-positive children was done at enrollment, 6 and 12 months. Flow cytometric analysis was performed for enumeration of counts and percentage of CD4+, CD8+, and CD19+ cells; expression of CD19, CD86, PD-1, CD3, CD8 and CD28 on lymphocytes was evaluated using whole blood staining technique with monoclonal antibodies. HIV-1 viral load was quantified using a real-time polymerase chain reaction. Serum levels of immunoglobulin G (IgG), immunoglobulin A (IgA), immunoglobulin (IgM), and interleukin (IL)-7 were quantitated using quantitative enzyme-linked immunosorbent assay kits. The HIV-infected children were categorized into virological responders (VRs; HIV-1 plasma viral load <47 copies/mL) and virological nonresponders (VNRs; HIV-1 plasma viral load >1000 copies/mL) following 1-year cART. RESULTS: The frequency of CD28+ CTLs cells was higher (P < 0.0001), and the frequency of CD28-CTLs cells was lower (P < 0.0001) in VRs than VNRs. CD28+ and CD28-CTLs cells correlated with HIV-1 plasma viremia (r = −0.4695, P = 0.01; r = 0.40, P = 0.03, respectively). VRs had higher CD19 percentage (P = 0.04) and count (P = 0.01) than VNRs. CD19+ B cells in the VRs had lower expression of CD86 (P = 0.03) and PD-1 (P = 0.002) than VNRs. VR had lower levels of serum IgG (P = 0.03), IgM (P = 0.04), and IL-7 (P = 0.01) than VNRs. CONCLUSIONS: High baseline B-cell counts, lower serum IgG, IgM, IL-7 levels, lower activation and exhaustion of B cells, and higher frequency of CD28+ CTLs are associated with positive virological response, whereas elevated CD28-CTLs are associated with the poor virological outcomes in HIV-infected children.
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REVIEW ARTICLE Top

The rise of E-pharmacy in India: Benefits, challenges, and the road ahead p. 282
Alison C Dcruz, Vinay N Mokashi, Sreedhar Ranganath Pai, Dharmagadda Sreedhar
DOI:10.4103/ijp.ijp_445_21  
The recent worldwide pandemic has prompted several companies to turn to the online market. The pharmaceutical industry is one such significant and crucial in India. There has been an upsurge in online pharmacies throughout the Indian subcontinent over the last 3–5 years. This unique development of online or “E-pharmacy” field has been carefully examined and presented in this article. The distinction between online and offline pharmacies, the advantages and challenges faced by E-pharmacies, the driving forces that led to the growth of the E-pharmacy sector in India, and the various emerging Indian E-pharmacy companies are covered. A comprehensive review of the legal system under which the E-pharmacy industry operates is also briefed. The reader will also learn about the various initiatives implemented by the Government in support of the E-pharmacy sector in India.
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LETTERS TO THE EDITOR Top

Systems approach to strengthen faculty development program in India to address Competency-Based Medical Education: A roadmap p. 292
Indranil Saha, Bobby Paul
DOI:10.4103/ijp.ijp_287_22  
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Severe progressive dermatomyositis in a patient with metastatic ovarian cancer using bevacizumab p. 295
Dilek Mentesoglu, Sibel Dogan Gunaydin, Sibel Ersoy-Evans, Nilgun Atakan, Ozay Gokoz, Omer Karadag, Saadettin Kilickap
DOI:10.4103/ijp.ijp_11_22  
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Celecoxib-tramadol co-crystal: Efficacy in acute postoperative pain p. 297
Abhijit Sukumaran Nair
DOI:10.4103/ijp.ijp_141_22  
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