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1.
MethodsX ; 13: 102813, 2024 Dec.
Article in English | MEDLINE | ID: mdl-39040212

ABSTRACT

The increasing pressures of environmental regulation and the introduction of new policy frameworks by various nations have accelerated the popularization of industrial solid waste management and recovery, underscoring the transition towards a circular economy. This paradigm shift emphasizes the importance of material recovery, reuse, and recycling of industrial waste to minimize environmental impact and enhance sustainability. Despite the availability of individual approaches for waste recovery, there exists a significant gap in the systematic selection of optimal recovery pathways that facilitate the reintegration of materials into the production cycle. Addressing this gap, our study introduces a novel optimization model designed to identify the most efficient material circularity routes that leverage both the technical and biological cycles of the circular economy framework. Utilizing the Genetic Algorithm optimization tool in MATLAB, our model prioritizes pathways that maximize material recovery and profit generation simultaneously. This dual-objective function serves as the cornerstone of our analysis, ensuring a balanced approach to environmental sustainability and economic viability. The model's efficacy was tested on pre-calculated quantities of fabric waste generated by the Biyagama Export Processing Zone, providing a practical case study for its application. Our findings reveal diverse scenarios under which the model can allocate varying weights to each objective, demonstrating its flexibility and utility as a decision-making tool for stakeholders in the waste management sector. The results indicate that the model is not only capable of optimizing waste circularity pathways for maximum material recovery and profit generation but also offers a customizable framework that can adapt to the specific priorities of different stakeholders. This research contributes to the existing body of knowledge by filling a critical gap in the selection of sustainable waste recovery pathways, offering a practical, optimized, and scalable solution that can significantly advance the goals of the circular economy in the industrial sector.•Decision-making model for stakeholders in the waste management sector.•Model selects the best material recovery pathways.•Textile industrial fabric waste stream used as a pilot to test the model's effectiveness.

2.
Clin Psychopharmacol Neurosci ; 22(2): 370-375, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38627084

ABSTRACT

Objective: : This study tried to observe clinical benefit of aripiprazole augmentation (ARPA) treatment for major depressive disorder with anxious distress (MDDA) in routine practice. Methods: : Retrospective chart review (n = 41) was conducted for clinical benefit of ARPA in patients with MDDA in routine practice. The primary endpoint was the mean change of Hamilton Anxiety Rating scale (HAMA) total scores from baseline to the endpoint. Additional secondary endpoints were also retrieved. Results: : The changes of primary endpoint HAMA (t = 5.731, -4.6, p = 0.001), and secondary endpoints including Hamilton Depression Rating scale (HAMD, t = 4.284, -3.4, p < 0.001), Clinical Global Impression-Clinical Benefit (CGI-CB, -0.9, t = 1.821, p = 0.026), and Clinical Global Impression Score-Severity (CGI-S, t = 3.556, -0.4, p < 0.001) scores were also significantly improved during the study. No significant adverse events were observed. Conclusion: : This study has shown additional benefit of ARPA treatment for MDDA patients in routine practice. However, adequately-powered and well-controlled studies are necessary for generalization of the present findings.

3.
Mar Pollut Bull ; 202: 116366, 2024 May.
Article in English | MEDLINE | ID: mdl-38621355

ABSTRACT

Ocean acidification has become increasingly severe in coastal areas. It poses emerging threats to coastal organisms and influences ecological functioning. Donax faba, a dominant clam in the intertidal zone of the Bay of Bengal, plays an important role in the coastal food web. This clam has been widely consumed by the local communities and also acts as a staple diet for shorebirds and crustaceans. In this paper, we investigated how acidified conditions will influence the physiology, biochemical constituents, and energetics of Donax faba. Upon incubation for 2 months in lowered pH 7.7 ± 0.05 and control 8.1 ± 0.05 conditions, we found a delayed growth in the acidified conditions followed by decrease in calcium ions in the clam shell. Although not significant, we found the digestive enzymes showed a downward trend. Total antioxidant was significantly increased in the acidified condition compared to the control. Though not significant, the expression level of MDA and antioxidant enzymes (SOD, CAT, GST, GPX, and APX) showed increasing trend in acidified samples. Among nutrients such as amino acids and fatty acids, there was no significant difference between treatments, however, showed a downward trend in the acidified conditions compared to control. Among the minerals, iron and zinc showed significant increase in the acidified conditions. The above results suggest that the clam growth, and physiological energetics may have deleterious effects if exposed for longer durations at lowered pH condition thereby affecting the organisms involved in the coastal food web.


Subject(s)
Bivalvia , Food Chain , Seawater , Animals , Hydrogen-Ion Concentration , Seawater/chemistry , Bivalvia/physiology , Antioxidants/metabolism , Oceans and Seas , Ocean Acidification
4.
Front Immunol ; 15: 1330373, 2024.
Article in English | MEDLINE | ID: mdl-38596679

ABSTRACT

Introduction: Indole-3-carbinol (I3C) is found in cruciferous vegetables and used as a dietary supplement. It is known to act as a ligand for aryl hydrocarbon receptor (AhR). In the current study, we investigated the role of AhR and the ability of I3C to attenuate LPS-induced Acute Respiratory Distress Syndrome (ARDS). Methods: To that end, we induced ARDS in wild-type C57BL/6 mice, Ccr2gfp/gfp KI/KO mice (mice deficient in the CCR2 receptor), and LyZcreAhRfl/fl mice (mice deficient in the AhR on myeloid linage cells). Additionally, mice were treated with I3C (65 mg/kg) or vehicle to investigate its efficacy to treat ARDS. Results: I3C decreased the neutrophils expressing CXCR2, a receptor associated with neutrophil recruitment in the lungs. In addition, LPS-exposed mice treated with I3C revealed downregulation of CCR2+ monocytes in the lungs and lowered CCL2 (MCP-1) protein levels in serum and bronchoalveolar lavage fluid. Loss of CCR2 on monocytes blocked the recruitment of CXCR2+ neutrophils and decreased the total number of immune cells in the lungs during ARDS. In addition, loss of the AhR on myeloid linage cells ablated I3C-mediated attenuation of CXCR2+ neutrophils and CCR2+ monocytes in the lungs from ARDS animals. Interestingly, scRNASeq showed that in macrophage/monocyte cell clusters of LPS-exposed mice, I3C reduced the expression of CXCL2 and CXCL3, which bind to CXCR2 and are involved in neutrophil recruitment to the disease site. Discussion: These findings suggest that CCR2+ monocytes are involved in the migration and recruitment of CXCR2+ neutrophils during ARDS, and the AhR ligand, I3C, can suppress ARDS through the regulation of immune cell trafficking.


Subject(s)
Indoles , Monocytes , Respiratory Distress Syndrome , Mice , Animals , Monocytes/metabolism , Lipopolysaccharides/pharmacology , Neutrophils/metabolism , Receptors, Aryl Hydrocarbon/metabolism , Ligands , Mice, Inbred C57BL , Lung/metabolism , Respiratory Distress Syndrome/chemically induced , Respiratory Distress Syndrome/drug therapy , Respiratory Distress Syndrome/metabolism
6.
J Pharm Bioallied Sci ; 16(Suppl 1): S409-S411, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38595452

ABSTRACT

Conditions affecting the upper digestive system are often seen in clinical practice and are associated with a high rate of death and disability. Histopathological confirmation is one of the foundations for good treatment planning and the definite diagnosis of illnesses of the upper gastrointestinal tract. The numerous methods employed in the diagnosis of gastrointestinal lesions have come a long way in the previous 25 years. The identification and diagnosis of gastrointestinal lesions have been substantially aided by the development of endoscopy, endoscopic biopsy, and other surgical techniques. This research aimed to examine the variety of gastrointestinal tract (GI) lesions and to draw connections between the clinical and pathological manifestations of these conditions. Materials and Methods: A two-year cross-sectional study was conducted in the Department of Pathology, from June 2018 to May 2020, which included surgical specimens of 140 cases from the upper gastrointestinal tract, of which 111 cases were biopsy, and 29 cases were resected surgical specimens. The data were analyzed using SPSS software. Furthermore, P values, sensitivity, specificity, positive predictive value, and negative predictive value were calculated. Results: This study was a two-year cross-sectional study conducted in the Department of Pathology during the period of June 2018-May 2020.

7.
J Leukoc Biol ; 115(6): 1070-1083, 2024 05 29.
Article in English | MEDLINE | ID: mdl-38366630

ABSTRACT

FICZ (6-formylindolo[3,2-b]carbazole) is a potent aryl hydrocarbon receptor agonist that has a poorly understood function in the regulation of inflammation. In this study, we investigated the effect of aryl hydrocarbon receptor activation by FICZ in a murine model of autoimmune hepatitis induced by concanavalin A. High-throughput sequencing techniques such as single-cell RNA sequencing and assay for transposase accessible chromatin sequencing were used to explore the mechanisms through which FICZ induces its effects. FICZ treatment attenuated concanavalin A-induced hepatitis, evidenced by decreased T-cell infiltration, decreased circulating alanine transaminase levels, and suppression of proinflammatory cytokines. Concanavalin A revealed an increase in natural killer T cells, T cells, and mature B cells upon concanavalin A injection while FICZ treatment reversed the presence of these subsets. Surprisingly, concanavalin A depleted a subset of CD55+ B cells, while FICZ partially protected this subset. The immune cells showed significant dysregulation in the gene expression profiles, including diverse expression of migratory markers such as CCL4, CCL5, and CXCL2 and critical regulatory markers such as Junb. Assay for transposase accessible chromatin sequencing showed more accessible chromatin in the CD3e promoter in the concanavalin A-only group as compared to the naive and concanavalin A-exposed, FICZ-treated group. While there was overall more accessible chromatin of the Adgre1 (F4/80) promoter in the FICZ-treated group, we observed less open chromatin in the Itgam (CD11b) promoter in Kupffer cells, supporting the ability of FICZ to reduce the infiltration of proinflammatory cytokine producing CD11b+ Kupffer cells. Taken together, these data demonstrate that aryl hydrocarbon receptor activation by FICZ suppresses liver injury through the limitation of CD3+ T-cell activation and CD11b+ Kupffer cell infiltration.


Subject(s)
CD11b Antigen , Carbazoles , Concanavalin A , Kupffer Cells , Lymphocyte Activation , Receptors, Aryl Hydrocarbon , T-Lymphocytes , Animals , Concanavalin A/pharmacology , Carbazoles/pharmacology , Kupffer Cells/metabolism , Kupffer Cells/drug effects , Kupffer Cells/pathology , Lymphocyte Activation/drug effects , Receptors, Aryl Hydrocarbon/metabolism , Mice , CD11b Antigen/metabolism , T-Lymphocytes/drug effects , T-Lymphocytes/immunology , T-Lymphocytes/metabolism , Hepatitis, Autoimmune/pathology , Hepatitis, Autoimmune/drug therapy , Hepatitis, Autoimmune/immunology , Hepatitis, Autoimmune/metabolism , Hepatitis, Autoimmune/etiology , Mice, Inbred C57BL , Ligands , Male , Cytokines/metabolism
8.
Chemosphere ; 353: 141541, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38423149

ABSTRACT

Plastics are a vital component of our daily lives in the contemporary globalization period; they are present in all facets of modern life. Because the bulk of synthetic plastics utilized in the market are non-biodegradable by nature, the issues associated with their contamination are unavoidable in an era dominated by polymers. Polyethylene terephthalate (PET), which is extensively used in industries such as automotive, packaging, textile, food, and beverages production represents a major share of these non-biodegradable polymer productions. Given its extensive application across various sectors, PET usage results in a considerable amount of post-consumer waste, majority of which require disposal after a certain period. However, the recycling of polymeric waste materials has emerged as a prominent topic in research, driven by growing environmental consciousness. Numerous studies indicate that products derived from polymeric waste can be converted into a new polymeric resource in diverse sectors, including organic coatings and regenerative medicine. This review aims to consolidate significant scientific literatures on the recycling PET waste for electrochemical device applications. It also highlights the current challenges in scaling up these processes for industrial application.


Subject(s)
Plastics , Polyethylene Terephthalates , Recycling , Polymers , Product Packaging
9.
PLoS One ; 19(1): e0296643, 2024.
Article in English | MEDLINE | ID: mdl-38180969

ABSTRACT

BACKGROUND AND OBJECTIVES: Patient-reported measures of encounters in healthcare settings and consideration of their preferences could provide valuable inputs to improve healthcare quality. Although there are increasing reports of user experiences regarding health care in India in recent times, there is a lack of evidence from Indian healthcare settings on the care provided for patients with chronic diseases. METHODS: We selected diabetes mellitus and cancer as representatives of two common conditions requiring different care pathways. We conducted a scoping review of studies reporting experiences or preferences of patients/caregivers for these conditions, in PubMed, Global Index Medicus and grey literature, from the year 2000 onwards. Both published and emergent themes were derived from the data and summarised as a narrative synthesis. RESULTS: Of 95 included studies (49 diabetes, 46 cancer), 73% (65) were exclusively quantitative surveys, 79% included only patients (75), and 59.5% (44) were conducted in government centres. Studies were concentrated in a few states in India, with the underrepresentation of vulnerable population groups and representative studies. There was a lack of standardised tools and comprehensive approaches for assessing experiences and preferences of patients and caregivers, concerning diabetes and cancers in India. The commonest type of care assessed was therapeutic (74), with 14 cancer studies on diagnosis and nine on palliative care. Repeated visits to crowded centres, drug refill issues, unavailability of specific services in government facilities, and expensive private care characterised diabetes care, while cancer care involved delayed diagnosis and treatment, communication, and pain management issues. CONCLUSIONS: There is a need for robust approaches and standardised tools to measure responsiveness of the healthcare system to patient needs, across geographical and population subgroups in India. Health system reforms are needed to improve access to high-quality care for treatment and palliation of cancer and management of chronic diseases such as diabetes.


Subject(s)
Diabetes Mellitus , Noncommunicable Diseases , Humans , Caregivers , Noncommunicable Diseases/epidemiology , Noncommunicable Diseases/therapy , India/epidemiology , Chronic Disease , Diabetes Mellitus/epidemiology , Diabetes Mellitus/therapy
10.
Clin Ther ; 46(1): 50-58, 2024 01.
Article in English | MEDLINE | ID: mdl-38036337

ABSTRACT

PURPOSE: Weight gain and associated negative cardiometabolic effects can occur as a result of mental illness or treatment with second-generation antipsychotics (SGAs), leading to increased rates of morbidity and mortality. In this analysis, we evaluated the effect of the SGA cariprazine on weight and metabolic parameters in a real-world, retrospective, observational dataset. METHODS: Electronic health records from the Optum Humedica database (October 1, 2014-December 31, 2020) were analyzed during the 12-month period before starting cariprazine (baseline) and for up to 12 months following cariprazine initiation; approved and off-label indications were included. Body weight trajectories were estimated in the overall patient cohort and at 3-, 6-, and 12-month timepoints (primary objective). Changes in hemoglobin A1c (HbA1c), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides were also evaluated (secondary objectives). Percentages of patients with clinically relevant shifts in body weight, total cholesterol, and fasting triglycerides were also determined. Discontinuation rates for metabolic regulating medications were calculated. Average predicted values were estimated by linear mixed-effects regression models. FINDINGS: A total of 2,301 patients were included; average duration of follow-up was 133.7 days. Average predicted weight change for patients during the cariprazine overall follow-up period was +2.4 kg, with predicted weight changes of +0.8 kg (n = 811), +1.1 kg (n = 350), and +1.4 kg (n = 107) at months 3, 6, and 12, respectively. Overall, the majority of patients did not experience clinically significant (≥7%) weight gain (82.8%) or loss (90.5%) after starting cariprazine. Average predicted HbA1c levels (n = 189) increased during baseline (0.15%/year) and decreased during cariprazine treatment (-0.2%/year). Average predicted triglyceride levels (n = 257) increased during baseline (15.0 mg/dL/year) and decreased during cariprazine treatment (-0.7 mg/dL/year). Predicted LDL (n = 247) and HDL (n = 255) values decreased during baseline (-7.3 and -1.1 mg/dL/year, respectively); during cariprazine treatment, LDL increased by 5.6 mg/dL/year and HDL decreased by -0.6 mg/dL/year. During follow-up, most patients did not shift from normal/borderline to high total cholesterol (<240 to ≥240 mg/dL; 522 [90.2%]) or fasting triglyceride (<200 to ≥200 mg/dL; 143 [88.8%] patients) levels; shifts from high to normal/borderline levels occurred in 44 (61.1%) patients for total cholesterol and 38 (57.6%) patients for fasting triglycerides. After starting cariprazine, the discontinuation rate per 100 patient-years was 60.4 for antihyperglycemic medication and 87.4 for hyperlipidemia medication. IMPLICATIONS: These real-world results support short-term clinical trial findings describing a neutral weight and metabolic profile associated with cariprazine treatment and they expand the dataset to include long-term follow-up.


Subject(s)
Electronic Health Records , Hyperlipidemias , Humans , Retrospective Studies , Glycated Hemoglobin , Triglycerides , Weight Gain , Cholesterol
11.
Article in English | WPRIM (Western Pacific) | ID: wpr-1042671

ABSTRACT

Objective@#This study tried to observe clinical benefit of aripiprazole augmentation (ARPA) treatment for major depressive disorder with anxious distress (MDDA) in routine practice. @*Methods@#Retrospective chart review (n = 41) was conducted for clinical benefit of ARPA in patients with MDDA in routine practice. The primary endpoint was the mean change of Hamilton Anxiety Rating scale (HAMA) total scores from baseline to the endpoint. Additional secondary endpoints were also retrieved. @*Results@#The changes of primary endpoint HAMA (t = 5.731, −4.6, p = 0.001), and secondary endpoints including Hamilton Depression Rating scale (HAMD, t = 4.284, −3.4, p < 0.001), Clinical Global Impression-Clinical Benefit (CGI-CB, −0.9, t = 1.821, p = 0.026), and Clinical Global Impression Score-Severity (CGI-S, t = 3.556, −0.4, p < 0.001) scores were also significantly improved during the study. No significant adverse events were observed. @*Conclusion@#This study has shown additional benefit of ARPA treatment for MDDA patients in routine practice. However, adequately-powered and well-controlled studies are necessary for generalization of the present findings.

12.
Indian J Public Health ; 67(3): 399-407, 2023.
Article in English | MEDLINE | ID: mdl-37929382

ABSTRACT

Background: Our aim was to study the regional differences in dietary patterns in India and their association with population-level nutrition-related health indicators such as the prevalence of anemia, overweight, undernutrition, and hyperglycemia. Objectives: To identify and characterize the dietary patterns from publicly available nationally representative survey data on food consumption conducted by the National Sample Survey Office (NSSO) to study the regional differences in dietary patterns. Methods: Dietary patterns were identified by factor analysis of per capita food consumption data from the household consumer expenditure survey (2011). Mean factor scores of dietary patterns were calculated for each district separately for urban and rural regions. Ecological association of factor scores with the district-level percentage prevalence of health indicators from the National Family Health Survey-4 (2015-2016) data was done by the Spatial Durbin Model of spatial regression analysis. Results: Factor analyses revealed four dietary patterns which were similar in terms of the food items that characterized the factors for both rural and urban regions. Direct effects of dietary patterns by spatial regression analyses were observed with several health outcomes after adjusting for differences in socioeconomic development. Prevalence of anemia was positively associated with "Milk and wheat-rich diet" among men in the rural regions but negatively associated with other dietary patterns. Prevalence of overweight and high blood glucose was positively associated with "Rice and meat-rich diet" and "Coconut and seafood rich diet" in the rural regions. "Refined oil and tur dal-rich diet" was positively associated with the prevalence of overweight and hypertension in urban regions and negatively associated with underweight and anemia in men in rural and urban regions. Conclusions: Spatial regression analyses revealed several important associations between dietary patterns and health outcomes, mostly in rural regions and some in urban regions. These results suggest the role of the major food items consumed in different regions and their impact on health outcomes in India and may have implications in tailoring dietary modifications accordingly.


Subject(s)
Anemia , Overweight , Male , Humans , Overweight/epidemiology , India/epidemiology , Diet , Regression Analysis , Anemia/epidemiology , Rural Population , Outcome Assessment, Health Care
13.
Med J Armed Forces India ; 79(5): 606-607, 2023.
Article in English | MEDLINE | ID: mdl-37719897
14.
Pharm Nanotechnol ; 2023 Sep 11.
Article in English | MEDLINE | ID: mdl-37702161

ABSTRACT

Nanotechnology is a new science and business endeavour with worldwide economic benefits. Growing knowledge of nanomaterial fabrication techniques has increased the focus on nanomaterial preparation for various purposes. Nanofibers are one-dimensional nanomaterials having distinct physicochemical properties and characteristics. Nanofibers are nanomaterial types with a cross-sectional dimension of tens to hundreds of nanometres. They may create high porosity mesh networks with significant interconnections among pores, making them suitable for advanced applications. Electrospinning stands out for its ease of use, flexibility, low cost, and variety among the approaches described in the literature. The most common method for making nanofibers is electrospinning. This article extensively describes and summarizes the impact of various process variables on the fabrication of nanofibers. Special attention has been given to scientific and patent prospection to confirm the research interests in nanofibers.

15.
Interv Cardiol Clin ; 12(4): 469-487, 2023 10.
Article in English | MEDLINE | ID: mdl-37673492

ABSTRACT

Acute kidney injury (AKI) is a frequently occurring complication of cardiovascular interventions, and associated with adverse outcomes. Therefore, a clear definition of AKI is of paramount importance to enable timely recognition and treatment. Historically, changes in the serum creatinine and urine output have been used to define AKI, and the criteria have evolved over time with better understanding of the impact of AKI on the outcomes. However, the reliance on serum creatinine for these AKI definitions carries numerous limitations including delayed rise, inability to differentiate between hemodynamics versus structural injury and assay variability to name a few.


Subject(s)
Acute Kidney Injury , Cardiovascular Surgical Procedures , Terminology as Topic , Humans , Acute Kidney Injury/blood , Acute Kidney Injury/diagnosis , Biomarkers/blood , Cardiovascular Surgical Procedures/adverse effects , Creatinine/blood , Severity of Illness Index
16.
Pharm Nanotechnol ; 2023 Sep 01.
Article in English | MEDLINE | ID: mdl-37680159

ABSTRACT

Biosensors have been one of the most fascinating topics for scientists for a long time. This is because biological moieties are multifaceted and are unswervingly related to the presence of a healthy atmosphere. The biosensor approach has also endured profound changes in recent years. Biosensors have been emphasized for various applications, including food quality estimation, surveillance systems, and health and metabolic abnormality diagnostics. The advances in nanotechnology have led to a considerable potential to enhance biosensors' sensitivity, robustness, and anti-interference capabilities. Several new nanomaterials (such as nanoparticles, nanotubes, nanorods, and nanowires) have been fabricated due to the evolution of nanotechnology, and their unique features are gradually being identified, allowing for much faster detection and reproducibility. Biosensor performance has also been enhanced substantially as a result of their use. Because of their capacity to detect a wide range of compounds at deficient concentrations, nanobiosensors have sparked much interest. This article discusses biosensors based on various nanomaterials, their evolution, accompanying features, and their applications in multiple fields.

18.
Clin Psychopharmacol Neurosci ; 21(3): 594-598, 2023 Aug 31.
Article in English | MEDLINE | ID: mdl-37424426

ABSTRACT

Objective: This study tried to observe additional benefit of agomelatine (AGO) treatment for major depressive disorder (MDD) in routine practice. Methods: Retrospective chart review (n = 63) was conducted for additional benefit of combination with or switching to AGO in MDD patients without full remission. The primary endpoint was the mean change of Clinical Global Impression-Clinical Benefit (CGI-CB) total scores from baseline to the endpoint. Additional secondary endpoints were also collected. Results: The changes of CGI-CB (Z = -3.073, p = 0.002) and Montgomery-Åsberg Depression Rating Scale (Z = -3.483, p < 0.001) total scores were significantly decreased from baseline to the endpoint, respectively. At the endpoint, the remission rate was 22.6% (n = 18) and 28.6% of patient had improvement in CGI-CB total scores at the endpoint. No significant adverse events were observed. Conclusion: This study has shown additional benefit of AGO treatment as combination or switching agent for MDD patients without full remission in routine practice. However, adequately-powered and well-controlled studies are necessary for generalization of the present findings.

19.
Cancer Chemother Pharmacol ; 91(6): 457-468, 2023 06.
Article in English | MEDLINE | ID: mdl-37093266

ABSTRACT

PURPOSE: Very few studies have demonstrated the rituximab biosimilarity in terms of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity in patients with diffuse large B-cell lymphoma (DLBCL) in India. Therefore, we compared the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of our biosimilar rituximab with the reference rituximab (Ristova, Roche products [India] Pvt. Ltd) in patients with DLBCL in India. METHODS: A phase 3, randomized, assessor-blind, parallel-group, two-arm study was conducted across 28 sites in India. A total of 153 newly diagnosed DLBCL patients were randomized to receive either biosimilar rituximab or reference rituximab. The study drugs were administered at a dose of 375 mg/m2 by intravenous infusion every 3 weeks for six cycles. The primary end point was objective response rate (ORR) at the end of Cycle 6. Secondary end points included: pharmacokinetic, pharmacodynamics, immunogenicity, and safety assessment. RESULTS: The ORR at the end of Cycle 6 was 82.14% in the biosimilar rituximab and 85.71% in the reference rituximab group. The risk difference (90% CIs) was - 3.57 (- 14.80, 7.66). It met the non-inferiority margin of - 20%. The pharmacokinetic and pharmacodynamic parameters were comparable between the two treatment groups. The incidence rate of immunogenicity was very low and similar in both the treatment groups. The safety profile of both the treatments was comparable with no major difference in terms of nature, frequency and severity of TEAEs. CONCLUSION: The study demonstrated the biosimilarity between the biosimilar rituximab and the reference rituximab. Our biosimilar rituximab could add to the cost-effective treatment alternatives for patients with DLBCL in India.


Subject(s)
Biosimilar Pharmaceuticals , Lymphoma, Large B-Cell, Diffuse , Humans , Rituximab/adverse effects , Biosimilar Pharmaceuticals/adverse effects , Lymphoma, Large B-Cell, Diffuse/drug therapy , Lymphoma, Large B-Cell, Diffuse/pathology , Infusions, Intravenous , India , Treatment Outcome
20.
MethodsX ; 10: 102011, 2023.
Article in English | MEDLINE | ID: mdl-36643803

ABSTRACT

SARS-CoV-2 is a public pandemic health concern globally. Nasopharyngeal and oropharyngeal swab samples are used for Covid-19 viral detection. Sample collection procedure was tedious and uncomfortable and unsuitable for biochemical and CBC analysis in swab samples. Biochemistry and CBC tests are key determinant in management of Covid-19 patients. We developed a LAMP test to detect viral RNA in blood samples. LAMP is required four specific primers targeting the internal transcribed S-region and loop primers for viral RNA amplification. RNA was extracted from blood samples by TRIzol method. LAMP reaction was performed at 60 °C for 1 hour and amplicons were visualized in HNB dye. No cross-reactivity was seen with HBV, HCV, and HIV infected sample. Out of 40 blood samples, 33 samples were positive for LAMP and Q-PCR analysis, one sample was positive for LAMP and negative for Q-PCR, two samples were negative for LAMP but positive for Q-PCR, and four blood samples were negative for LAMP and Q-PCR. LAMP method has an accuracy of 92.50%, with sensitivity and specificity of 94.28% and 80%, respectively. Thus, LAMP diagnostic test has proved reliable, fast, inexpensive and can be useful for detection where the limited resources available.•LAMP method is a potential tool for detection of SARS-CoV-2.•Blood samples are the key determinant for routine diagnostics as well as molecular diagnostics.•LAMP assay is an appropriate diagnostics method which offers greater simplicity, low cost, sensitivity, and specificity than other methods in molecular diagnostics.

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