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1.
Ann Neurol ; 2024 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-38874304

RESUMO

OBJECTIVE: Approximately half of ischemic strokes (IS) in cancer patients are cryptogenic, with many presumed cardioembolic. We evaluated whether there were specific miRNA and mRNA transcriptome architectures in peripheral blood of IS patients with and without comorbid cancer, and between cardioembolic versus noncardioembolic IS etiologies in comorbid cancer. METHODS: We studied patients with cancer and IS (CS; n = 42), stroke only (SO; n = 41), and cancer only (n = 28), and vascular risk factor-matched controls (n = 30). mRNA-Seq and miRNA-Seq data, analyzed with linear regression models, identified differentially expressed genes in CS versus SO and in cardioembolic versus noncardioembolic CS, and miRNA-mRNA regulatory pairs. Network-level analyses identified stroke etiology-specific responses in CS. RESULTS: A total of 2,085 mRNAs and 31 miRNAs were differentially expressed between CS and SO. In CS, 122 and 35 miRNA-mRNA regulatory pairs, and 5 and 3 coexpressed gene modules, were associated with cardioembolic and noncardioembolic CS, respectively. Complement, growth factor, and immune/inflammatory pathways showed differences between IS etiologies in CS. A 15-gene biomarker panel assembled from a derivation cohort (n = 50) correctly classified 81% of CS and 71% of SO participants in a validation cohort (n = 33). Another 15-gene panel correctly identified etiologies for 13 of 13 CS-cardioembolic and 11 of 11 CS-noncardioembolic participants upon cross-validation; 11 of 16 CS-cryptogenic participants were predicted cardioembolic. INTERPRETATION: We discovered unique mRNA and miRNA transcriptome architecture in CS and SO, and in CS with different IS etiologies. Cardioembolic and noncardioembolic etiologies in CS showed unique coexpression networks and potential master regulators. These may help distinguish CS from SO and identify IS etiology in cryptogenic CS patients. ANN NEUROL 2024.

2.
Artigo em Inglês | MEDLINE | ID: mdl-38889288

RESUMO

OBJECTIVES: Immune checkpoint inhibitor (ICI) associated inflammatory arthritis (ICI-IA) occurs in 4-6% of ICI-treated patients based on one observational study. We identified cases of ICI-IA using administrative claims to study its incidence and characteristics at the population level. METHODS: We used the Medicare 5% sample to identify patients initiating ICIs. Cancer patients were identified by having ≥ 2 ICD-9/10-CM diagnosis codes from an oncologist for lung cancer, melanoma, or renal/urothelial cancer. ICI-IA was defined as having two Medicare claims ≥ 30 days apart with combinations of ICD-9/10-CM diagnosis codes that favored specificity. ICI-IA was identified in patients with a musculoskeletal diagnosis after ICI initiation, who had i.) no inflammatory arthritis or inflammatory rheumatic disease before ICI initiation ever, and ii) no musculoskeletal complaint in the one year prior to ICI. We examined DMARD utilization and visits to rheumatology in patients with ICI-IA. Landmark analysis and a time varying Cox proportional hazards model for overall survival was constructed. RESULTS: The incidence of ICI-IA was 7.2 (6.1-8.4) per 100 patient years. Patients with ICI-IA were mean (SD) age 73.5(7.0) years, 48% women, 91% white. Median(IQR) time from ICI initiation to first ICI-IA diagnosis was 124(56, 252) days. Only 24(16%) received care from a rheumatologist, and 24(16%) were prescribed a DMARD (46% by a rheumatologist). The HR for mortality in patients with ICI-IA was 0.86 (95% CI 0.59-1.26, p= 0.45). CONCLUSIONS: The incidence of ICI-IA identified in claims data is similar to that reported in observational studies, however, few patients are treated with a DMARD or see a rheumatologist. There was no difference in overall survival between ICI-treated patients with and without ICI-IA.

4.
Nat Commun ; 14(1): 8435, 2023 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-38114518

RESUMO

We previously reported the results of a randomized phase II trial (NCT02904954) in patients with early-stage non-small cell lung cancer (NSCLC) who were treated with either two preoperative cycles of the anti-PD-L1 antibody durvalumab alone or combined with immunomodulatory doses of stereotactic radiation (DRT). The trial met its primary endpoint of major pathological response, which was significantly higher following DRT with no new safety signals. Here, we report on the prespecified secondary endpoint of disease-free survival (DFS) regardless of treatment assignment and the prespecified exploratory analysis of DFS in each arm of the trial. DFS at 2 and 3 years across patients in both arms of the trial were 73% (95% CI: 62.1-84.5) and 65% (95% CI: 52.5-76.9) respectively. For the exploratory endpoint of DFS in each arm of the trial, three-year DFS was 63% (95% CI: 46.0-80.4) in the durvalumab monotherapy arm compared to 67% (95% CI: 49.6-83.4) in the dual therapy arm. In addition, we report post hoc exploratory analysis of progression-free survival as well as molecular correlates of response and recurrence through high-plex immunophenotyping of sequentially collected peripheral blood and gene expression profiles from resected tumors in both treatment arms. Together, our results contribute to the evolving landscape of neoadjuvant treatment regimens for NSCLC and identify easily measurable potential biomarkers of response and recurrence.


Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Carcinoma de Pequenas Células do Pulmão , Humanos , Anticorpos Monoclonais/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Terapia Neoadjuvante , Carcinoma de Pequenas Células do Pulmão/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Ensaios Clínicos Fase II como Assunto
5.
J Clin Oncol ; 41(35): 5448-5472, 2023 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-37820295

RESUMO

PURPOSE: To provide evidence-based recommendations to practicing clinicians on the management of patients with small-cell lung cancer. METHODS: An Expert Panel of medical oncology, thoracic surgery, radiation oncology, pulmonary, community oncology, research methodology, and advocacy experts were convened to conduct a literature search, which included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2022. Outcomes of interest included response rates, overall survival, disease-free survival or recurrence-free survival, and quality of life. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS: The literature search identified 95 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS: Evidence-based recommendations were developed to address systemic therapy options, timing of therapy, treatment in patients who are older or with poor performance status, role of biomarkers, and use of myeloid-supporting agents in patients with small-cell lung cancer.Additional information is available at www.asco.org/thoracic-cancer-guidelines.


Assuntos
Neoplasias Pulmonares , Carcinoma de Pequenas Células do Pulmão , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Oncologia/métodos , Ontário , Qualidade de Vida , Carcinoma de Pequenas Células do Pulmão/terapia
6.
Int J Clin Pediatr Dent ; 16(Suppl 1): S57-S62, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37663219

RESUMO

Background: The purpose of this in vitro study was to assess the effect of Tooth Mousse Plus, Remin Pro, and Fluor Protector Gel on enamel erosion, measuring mean weight loss after exposure to a demineralizing agent. Materials and methods: A total of 60 sound-extracted permanent incisors were sectioned and enamel specimens were randomly distributed to different groups. The initial weight of all specimens was registered. The samples were randomly divided into four groups (n = 30). Group I specimens were treated with tap water (control). Groups II, III, and IV were treated with Tooth Mousse, Remin Pro, and Fluor Protector Gel application. After that, specimens were placed all together in a plastic container with 6 mL of a soft drink and immersed for 8 minutes at room temperature, dried, and weighed. Specimens were weighed after each immersion period and mean weight loss was calculated. The data was analyzed for probability distribution using the Kolmogorov-Smirnov test. The intergroup comparison was done using a one-way analysis of variance (ANOVA) followed by post hoc analysis. Results: According to pairwise comparisons in post hoc analysis, the weight of specimens at baseline was significantly greater than the weight of specimens on day 12. The difference in the mean weight of the specimen from baseline to day 12 was 2.833 mg for group I, 2.367 mg for group II, 1.467 mg for group III, and 2.133 mg for group IV. Conclusion: Tooth Mousse Plus, Remin Pro, and Fluor Protector Gel have no significant effect on dental erosion. How to cite this article: Shukla K, Saxena A, Joshi J, et al. A Comparative Study of the Effect of Tooth Mousse Plus Remin Pro and Fluor Protector Gel on Enamel Erosion: An In Vitro Study. Int J Clin Pediatr Dent 2023;16(S-1):S57-S62.

7.
Cancer Med ; 12(17): 18269-18280, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37551156

RESUMO

PURPOSE: Most patients with cancer lack the prognostic understanding necessary to make informed decisions. We tested the feasibility and acceptability of the Oncolo-GIST ("Giving Information Strategically and Transparently, GIST") intervention and explored its associations with patients' improved prognostic understanding. METHODS: The Oncolo-GIST intervention distills prognostic discussions into easy-to-understand talking points. Patients with metastatic cancers that progressed on ≥1 line of chemotherapy and not expected to survive 12 months (n = 31) were recruited from October 2020 through November 2022. We compared patients who discussed their progressive scans with an oncologist trained in the GIST technique or not (i.e., usual care). A primary outcome was prognostic understanding (e.g., patients reporting a life-expectancy of months) assessed within a week of the scan discussion visit. RESULTS: Oncologists (n = 4) appeared receptive to the Oncolo-GIST intervention and scored nearly perfectly on post-training tests of material mastery after a < 2-h tutorial. Post-scan discussion visit, 100% of patients who met with an Oncolo-GIST-trained clinician understood that their cancer was considered incurable (a 31% improvement from pre-visit) compared with 91% of patients meeting with usual care oncologists (an 18% improvement); 33% of patients who met with an Oncolo-GIST-trained oncologist understood that they likely had months, not years, compared to 18% in the usual care group. No statistically significant differences emerged for these changes, nor for therapeutic alliance, anxiety, or depression scores between groups. CONCLUSION: Oncolo-GIST appears to be an easily learned approach to improve prognostic understanding that neither undermines therapeutic alliances nor increases patients' anxiety or depressive symptoms. Efficacy testing in a larger trial is warranted.


Assuntos
Neoplasias , Humanos , Prognóstico , Projetos Piloto , Neoplasias/terapia , Ansiedade/etiologia , Transtornos de Ansiedade
8.
Cureus ; 15(6): e40488, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37461795

RESUMO

Introduction  An odontogenic keratocyst (OKC) is a benign intraosseous lesion with potential to demonstrate aggressive and invasive behavior. The aim of this retrospective study was to analyze the imaging features of the OKC using cone-beam computed tomography (CBCT) and to evaluate the association between the internal structure of the lesion and the effect of the lesion on surrounding structures. Methods Overall, 32 CBCT scans of histopathologically diagnosed cases of OKC were analyzed retrospectively. The following variables were analyzed: anatomic location of the lesions (mandible body (right/left), ramus (right/left), mandible body+ramus (right/left), maxilla (right/left), and both jaws), the internal structure of the lesion (unilocular/multilocular), and the effect of the lesion on the surrounding anatomical structures (involvement of the inferior alveolar nerve canal (IANC), displacement of the IANC, cortical expansion, displacement of the tooth, resorption of the root, associated impacted tooth, associated missing tooth). We also looked for the association between the internal structure and the effect of the lesion on anatomic structures. Results Out of 32 cases, 29 (90.6%) cases involved the mandible alone. Statistically significant association (p-value 0.005) was present between the internal structure and mean age of presentation as well as between the internal structure and impacted tooth (p-value 0.027). The association between the internal structure and other variables was statistically not significant. Conclusions The radiographic features of OKCs can be variable, and these lesions have a considerable effect on the tooth, IANC, and cortical bone. Significant association was found between the internal structure, age, and impacted tooth. Since OKCs have a high recurrence rate, CBCT is advised for evaluating the extent and location of any cortical perforations.

9.
Int J Clin Pediatr Dent ; 16(2): 333-337, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37519966

RESUMO

Aim: To evaluate the relationship between body mass index (BMI) and dental development in the children in age-group of 6-13 years of Malwa region. Materials and methods: A total of 250 orthopantomograms (OPGs) of children aged 6-13 years (130 males and 120 females) collected from the Department of Paediatric and Preventive Dentistry, Government College of Dentistry, Indore, Madhya Pradesh, India, who came for their routine dental treatment. The chronological age, height, and weight were recorded, followed by calculating the BMI of each patient using Centers for Disease Control and Prevention (CDC) growth charts. The dental age was calculated using Cameriere's method. The comparison of the dental and chronological age was done using Wilcoxon signed-rank test. Results: The dental age of underweight patients was significantly lesser than that of the normal, overweight, and obese patients (p-value of <0.05). The dental age of the obese patients were greatest and significantly greater than that of the underweight, normal, and overweight patients (p-value of <0.05). Conclusion: Dental age is significantly associated with the BMI of children aged 6-13 years. The dental age of obese and overweight children is significantly greater than the chronological age. Clinical significance: Predicting the stage of dental development and eruption periods in children with mixed dentition can help with the sequencing and timing of orthodontic, prosthodontic, and surgical procedures. How to cite this article: Selkari V, Saxena A, Parihar A, et al. Evaluation of Relationship between Body Mass Index (BMI) and Dental Development in the Children in Age-group of 6-13 years of Malwa Region: A Cross-sectional Study. Int J Clin Pediatr Dent 2023;16(2):333-337.

10.
Semin Cancer Biol ; 93: 123-128, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37236329

RESUMO

Small cell lung cancer (SCLC) is a recalcitrant cancer with an urgent need for novel therapeutics, preclinical models, and elucidation of the molecular pathways responsible for its rapid resistance. Recently, there have been many significant advancements in our knowledge of SCLC that led to the development of novel treatments. This review will go over the recent attempts to provide new molecular subcategorization of SCLC, recent breakthroughs in various systemic treatments including immunotherapy, targeted therapy, cellular therapy, as well as advancements in radiation therapy.


Assuntos
Neoplasias Pulmonares , Carcinoma de Pequenas Células do Pulmão , Humanos , Carcinoma de Pequenas Células do Pulmão/terapia , Carcinoma de Pequenas Células do Pulmão/tratamento farmacológico , Neoplasias Pulmonares/terapia , Neoplasias Pulmonares/tratamento farmacológico , Imunoterapia
11.
Prev Chronic Dis ; 20: E39, 2023 05 18.
Artigo em Inglês | MEDLINE | ID: mdl-37200503

RESUMO

INTRODUCTION: India is facing a shortage of staff nurses; thus, a better understanding of nurses' workloads is essential for improving and implementing noncommunicable disease (NCD) control strategies. We estimated the proportion of time spent by staff nurses on hypertension and other NCD activities in primary care facilities in 2 states in India. METHODS: We conducted a cross-sectional study in 6 purposively selected primary care facilities in Punjab and Madhya Pradesh during July through September 2021. We used a standardized stopwatch to collect data for time spent on direct hypertension activities (measuring blood pressure, counseling, recording blood pressure measurement, and other NCD-related activities), indirect hypertension activities (data management, patient follow-up calls), and non-NCD activities. We used the Mann-Whitney U test to compare the median time spent on activities between facilities using paper-based records and the Simple mobile device-based app (open-source software). RESULTS: Six staff nurses were observed for 213 person-hours. Nurses spent 111 person-hours (52%; 95% CI, 45%-59%) on direct hypertension activities and 30 person-hours (14%; 95% CI, 10%-19%) on indirect hypertension activities. The time spent on blood pressure measurement (34 minutes) and documentation (35 minutes) was the maximum time on any given day. Facilities that used paper records spent more median time (39 [IQR, 26-62] minutes) for indirect hypertension activities than those using the Simple app (15 [IQR, 11-19] minutes; P < .001). CONCLUSION: Our study found that hypertension activities required more than half of nurses' time in India's primary care facilities. Digital systems can help to reduce the time spent on indirect hypertension activities.


Assuntos
Hipertensão , Humanos , Estudos Transversais , Hipertensão/epidemiologia , Atenção Primária à Saúde , Índia/epidemiologia
12.
Semin Cancer Biol ; 90: 45-56, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36787870

RESUMO

The addition of immune checkpoint blockade (ICB) therapy to standard chemotherapy has been shown to improve survival in patients with metastatic small cell lung cancer. However, the benefit is modest and there remains an unmet need for novel therapeutic approaches to enhance the effectiveness of immunotherapy in this disease, both in the early and late stages. Ionizing radiation, which is a standard treatment for small cell lung cancer, is known to trigger immunogenic cell death in tumor cells, making it an attractive partner for ICB therapies in multiple solid tumor types. However, the optimal radiation dosage and fractionation scheme, target sites for radiation, and sequencing of radiation in relation to ICB treatment are still unclear. In this review we discuss the molecular biology underlying radiation-induced tumor immunity as well as pre-clinical and clinical studies combining radiation with ICB treatments, with a focus on translational and clinical trials in small cell lung cancer.


Assuntos
Neoplasias Pulmonares , Carcinoma de Pequenas Células do Pulmão , Humanos , Carcinoma de Pequenas Células do Pulmão/tratamento farmacológico , Carcinoma de Pequenas Células do Pulmão/genética , Carcinoma de Pequenas Células do Pulmão/radioterapia , Inibidores de Checkpoint Imunológico/uso terapêutico , Imunoterapia , Terapia Combinada , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/radioterapia
13.
Diabetes Metab Syndr ; 17(1): 102692, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36584552

RESUMO

BACKGROUND AND AIMS: There is a bidirectional relationship between COVID-19 and diabetes. The primary objective of this study was to estimate the prevalence of patients newly detected to have diabetes (NDD) who recovered from COVID-19 in India whilst comparing NDD with patients without diabetes (ND) and those who have known to have diabetes (KD) in terms of glycemic status pre- and post-COVID with disease severity. MATERIALS & METHODOLOGY: There were 2212 participants enrolled from 15 sites, with 1630 active participants after the respective execution of selection criteria. Data collection was done using a specialized Case Record Form (CRF). Planned statistical analysis and descriptive statistics were concluded for significance between patient groups on various parameters. RESULT: The differences in age between the study groups were statistically significant. The average blood glucose at COVID-19 onset was significantly higher in KD than in NDD. Significantly more proportion of NDD (83%) had been hospitalized for COVID management when compared to KD (45%) and ND (55%). The NDD group received higher doses of steroids than the other two groups. On average, patients in the NDD group who received at least one vaccination (one dose or two doses) had a higher High-Resolution Computed Tomography (HRCT) score. Patients who had not been vaccinated in ND and KD groups experienced a higher HRCT score. CONCLUSION: Prospective metabolism studies in post-acute COVID-19 will be required to understand the etiology, prognosis, and treatment opportunities.


Assuntos
COVID-19 , Diabetes Mellitus , Humanos , Estudos Retrospectivos , Estudos Prospectivos , Glicemia , Índia/epidemiologia
14.
J Assoc Physicians India ; 71(10): 45-48, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-38716523

RESUMO

Background and objective: The prevalence rate of hyperuricemia (HU) is comparatively higher in Asian countries than in the Western regions. Patients with coexisting HU and hypertension (HTN) are at greater risk of uncontrolled HTN, metabolic syndrome, and complications. This study aims to determine the prevalence of HU in individuals with HTN from the major geographical regions across India. Materials and methods: A cross-sectional, multicentric, observational study conducted in primary and secondary care centers from urban areas across different regions in India. Primary inclusion criteria were either a history of HTN or blood pressure systolic blood pressure (SBP) ≥140 and diastolic blood pressure (DBP) ≥ 90 mm Hg. A structured Google form was circulated among the participating healthcare practitioners from various participating centers to record the demographic, clinical, and biochemical parameters of patients visiting the respective centers. The data was consolidated and analyzed using Microsoft Excel. Screening for HU among individuals with HTN was based on two criteria-(1) self-reported diagnosed history of HU or (2) based on serum uric acid (SUA) levels >7 and > 6 mg/dL for men and women, respectively. The data were analyzed and represented using GraphPad Prism version 9. Results: Among the study population from 12 participating centers across different regions in India, 1,528 individuals had HTN. The mean age of the study participants was 57.4 ± 10.5 years with a male-to-female ratio of 1:1. The total prevalence rate of HU among individuals with HTN is 22.5% (N = 345). Gender-wise analysis indicated that 51.5% (177) of the males and 48.5% (168) of the females had HU. Among the patients with HTN and HU, 75% were overweight with a body mass index (BMI) of ≥25 kg/m2. The region-wise prevalence rate HU are North-17.4% (60), South-18% (62), Central-12.2% (42), East-29.6% (102), and West-22.9% (79). Conclusion: India's overall HU prevalence rate (22.5%) was comparable to that in other Asian countries (10-30%). However, the prevalence of HU among HTN patients varies between different regions of India (12.2-29.6%). Results from the participating centers located in an urban setting indicated that the eastern region had the highest HU prevalence (29.6%) and the Central region had the lowest HU prevalence rate (12.2%). The varying prevalence rate can be attributed to the diversity in geographical factors, genetic background or (family history of HU), sociocultural habits, and metabolic perturbations. Understanding this prevalence rate diversity can help strengthen the HU prevention measures to improve quality of life. How to cite this article: Patni B, Singh AN, Singh NK, et al. Prevalence of Hyperuricemia in Indian Population with Hypertension. J Assoc Physicians India 2023;71(10):45-48.


Assuntos
Hipertensão , Hiperuricemia , Humanos , Hiperuricemia/epidemiologia , Índia/epidemiologia , Hipertensão/epidemiologia , Masculino , Prevalência , Feminino , Pessoa de Meia-Idade , Estudos Transversais , Adulto , Idoso , Ácido Úrico/sangue
15.
Front Oncol ; 13: 1274163, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38318324

RESUMO

Cancer of unknown primary (CUP) represents a significant diagnostic and therapeutic challenge, being the third to fourth leading cause of cancer death, despite advances in diagnostic tools. This article presents a successful approach using a novel genomic analysis in the evaluation and treatment of a CUP patient, leveraging whole-exome sequencing (WES) and RNA sequencing (RNA-seq). The patient, with a history of multiple primary tumors including urothelial cancer, exhibited a history of rapid progression on empirical chemotherapy. The application of our approach identified a molecular target, characterized the tumor expression profile and the tumor microenvironment, and analyzed the origin of the tumor, leading to a tailored treatment. This resulted in a substantial radiological response across all metastatic sites and the predicted primary site of the tumor. We argue that a comprehensive genomic and molecular profiling approach, like the BostonGene© Tumor Portrait, can provide a more definitive, personalized treatment strategy, overcoming the limitations of current predictive assays. This approach offers a potential solution to an unmet clinical need for a standardized approach in identifying the tumor origin for the effective management of CUP.

16.
Annu Int Conf IEEE Eng Med Biol Soc ; 2022: 1839-1842, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-36086557

RESUMO

The retinal vascular system adapts and reacts rapidly to ocular diseases such as glaucoma, diabetic retinopathy and age-related macular degeneration. Here we present a combination of methods to further extract vascular information from [Formula: see text] wide-field optical coherence tomography angiography (OCTA). An integrated U-Net for the segmentation and classification of arteries and veins reached a segmentation IoU of 0.7095±0.0224, and classification IoU of 0.8793±0.1049 and 0.8928±0.0929 respectively. A correcting algorithm which uses topological information was created to correct the misclassification and connectivity of the vessels, which showed an average increase of 8.29% in IoU. Finally, the vessel morphometry of branch orders was extracted, where this allows the direct comparison of artery/vein, arterioles/venules and capillaries.


Assuntos
Vasos Retinianos , Tomografia de Coerência Óptica , Angiofluoresceinografia/métodos , Armazenamento e Recuperação da Informação , Retina , Vasos Retinianos/diagnóstico por imagem , Tomografia de Coerência Óptica/métodos
17.
Indian J Ophthalmol ; 70(8): 3008-3014, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35918962

RESUMO

Purpose: The present study compares the efficacy, safety, and immunogenicity of Lupin's biosimilar ranibizumab with that of Lucentis® in patients with neovascular age-related macular degeneration. Methods: This prospective, double-blind, multi-centric phase-III study was conducted across 19 centers in India. A total of 202 patients with neovascular age-related macular degeneration were randomized (1:1) to receive either Lupin's biosimilar ranibizumab or Lucentis®, 0.5 mg, as an intravitreous injection once every month for 3 months. The primary efficacy endpoint was the proportion of patients who lost fewer than 15 letters from baseline in best-corrected visual acuity. The safety profile included assessment of adverse events, ophthalmic examination, physical and systemic examination, and vital parameters. The immunogenicity assessment was based on evaluation of anti-drug antibodies. Results: Overall, 174 patients (87 [86.14%] in each group) completed the study. The demographics and baseline characteristics were comparable between the treatment groups. The proportion of patients losing fewer than 15 letters from baseline best corrected visual acuity score in the study eye was comparable between two groups. The difference between Lupin's ranibizumab and Lucentis® for the proportion of patients who lost fewer than 15 letters was within the predefined equivalence margin (intention-to-treat population: 1.0%; 95% confidence interval [CI], -3.3% to 5.4% and per protocol population: 1.2%; 95% CI, -3.2% to 6.4%). The incidence of treatment-emergent adverse events was comparable, and 11 (10.89%) patients in Lupin's ranibizumab and 19 (18.81%) patients in Lucentis® group had at least one treatment-emergent adverse event. The immunogenicity incidence as assessed by proportion of patients with positive anti-drug antibodies was numerically lower in Lupin's ranibizumab (4.95%) than Lucentis® (12.87%). Conclusion: Lupin's biosimilar ranibizumab demonstrated therapeutic equivalence, desirable safety, and favorable immunogenicity profile compared to Lucentis®.


Assuntos
Medicamentos Biossimilares , Degeneração Macular , Degeneração Macular Exsudativa , Inibidores da Angiogênese , Anticorpos Monoclonais Humanizados , Humanos , Injeções Intravítreas , Degeneração Macular/induzido quimicamente , Estudos Prospectivos , Ranibizumab , Resultado do Tratamento , Acuidade Visual , Degeneração Macular Exsudativa/diagnóstico , Degeneração Macular Exsudativa/tratamento farmacológico
18.
J Thromb Haemost ; 20(9): 2046-2057, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35652416

RESUMO

BACKGROUND: Patients with cancer and acute ischemic stroke (AIS) face high rates of recurrent thromboembolism or death. OBJECTIVES: To examine whether hematologic and embolic biomarkers soon after AIS are associated with subsequent adverse clinical outcomes. METHODS: We prospectively enrolled 50 adults with active solid tumor cancer and AIS at two hospitals from 2016 to 2020. Blood was collected 72-120 h after stroke onset. A 30-min transcranial Doppler (TCD) microemboli detection study was performed. The exposure variables were hematologic markers of coagulation (D-dimer, thrombin-antithrombin), platelet (P-selectin), and endothelial activation (thrombomodulin, soluble intercellular adhesion molecule-1 [sICAM-1], soluble vascular cell adhesion molecule-1 [sVCAM-1]), and the presence of TCD microemboli. The primary outcome was a composite of recurrent arterial/venous thromboembolism or death. We used Cox regression to evaluate associations between biomarkers and subsequent outcomes. RESULTS: During an estimated median follow-up time of 48 days (IQR, 18-312), 43 (86%) participants developed recurrent thromboembolism or death, including 28 (56%) with recurrent thromboembolism, of which 13 were recurrent AIS (26%). In unadjusted analysis, D-dimer (HR 1.6; 95% CI 1.2-2.0), P-selectin (HR 1.9; 95% CI 1.4-2.7), sICAM-1 (HR 2.2; 95% CI 1.6-3.1), sVCAM-1 (HR 1.6; 95% CI 1.2-2.1), and microemboli (HR 2.2; 95% CI 1.1-4.5) were associated with the primary outcome, whereas thrombin-antithrombin and thrombomodulin were not. D-dimer was the only marker associated with recurrent AIS (HR 1.2; 95% CI 1.0-1.5). Results were generally consistent in analyses adjusted for important prognostic variables. CONCLUSIONS: Markers of hypercoagulability and embolic disease may be associated with adverse clinical outcomes in cancer-related stroke.


Assuntos
AVC Isquêmico , Neoplasias , Tromboembolia , Adulto , Antitrombinas , Biomarcadores , Humanos , AVC Isquêmico/diagnóstico , Neoplasias/complicações , Selectina-P , Trombina , Trombomodulina
19.
Clin Lung Cancer ; 23(3): e238-e242, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-34580031

RESUMO

INTRODUCTION: The COVID-19 pandemic reached New York City in early March 2020 resulting in an 11-week lockdown period to mitigate further spread. It has been well documented that cancer care was drastically affected as a result. Given New York City's early involvement, we attempted to identify any stage shift that may have occurred in the diagnoses of non-small cell lung cancer (NSCLC) at our institution as a result of these lockdowns. PATIENTS AND METHODS: We conducted a retrospective review of a prospective database of lung cancer patients at our institution from July 1, 2019 until March 31, 2021. Patients were grouped by calendar year quarter in which they received care. Basic demographics and clinical staging were compared across quarters. RESULTS: Five hundred and fifty four patients were identified that underwent treatment during the time period of interest. During the lockdown period, there was a 50% reduction in the mean number of patients seen (15 ± 3 vs. 28 ± 7, P = .004). In the quarter following easing of restrictions, there was a significant trend towards earlier stage (cStage I/II) disease. In comparison to quarters preceding the pandemic lockdown, there was a significant increase in the proportion of patients with Stage IV disease in the quarters following phased reopening (P = .026). CONCLUSION: After a transient but significant increase in Stage I/II disease with easing of restrictions there was a significant increase in patients with Stage IV disease. Extended longitudinal studies must be conducted to determine whether COVID-19 lockdowns will lead to further increases in the proportion of patients with advanced NSCLC.


Assuntos
COVID-19 , Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , COVID-19/epidemiologia , COVID-19/prevenção & controle , Carcinoma Pulmonar de Células não Pequenas/epidemiologia , Controle de Doenças Transmissíveis , Humanos , Neoplasias Pulmonares/epidemiologia , Cidade de Nova Iorque/epidemiologia , Pandemias/prevenção & controle , SARS-CoV-2
20.
Glob Heart ; 16(1): 82, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34909373

RESUMO

Background: Hypertension is the leading risk factor for cardiovascular disease in India, but less than 10% of the estimated people with hypertension have blood pressure under control. The India Hypertension Control Initiative (IHCI) was implemented to strengthen hypertension management and control in public sector health facilities. Since late March 2020, lockdown due to the COVID-19 pandemic limited healthcare access and disrupted the provision of essential health services. IHCI quickly implemented adaptive interventions to improve access to medications. Objectives: To estimate the availability of antihypertensive drugs in peripheral public sector facilities during the lockdown and the proportion of patients who received drugs through community drug distribution, i.e., through Health and Wellness Centers (HWCs)/Sub-Centers (SCs), the most peripheral public sector health facilities for primary care, and home delivery. Methods: We collected data from 29 IHCI districts of 5 states (Kerala, Madhya Pradesh, Maharashtra, Punjab, and Telangana) during April-May 2020. The population included individuals diagnosed with hypertension and enrolled under IHCI in all public sector primary care health facilities. We contacted a convenience sample of more than one-third of the functional HWC/SC and analyzed the proportion of facilities and patients who received drugs. We also contacted a convenience sample of patients telephonically to estimate their self-reported availability of drugs. Conclusion: Of the 4245 HWC/SC, more than one-third were contacted telephonically, and 85-88% had received antihypertensive medications for community-level distribution. Among 721,675 patients registered until March 2020, 38.4% had received drug refills through HWC/SC or home delivery by frontline workers during the lockdown. We demonstrated the feasibility of community-level drug distribution for patients with hypertension during the COVID-19 lockdown in India. The adaptive strategy of community-based drug distribution through HWC/SC and home delivery appears feasible and may help improve access to hypertension care during the COVID-19 pandemic and beyond.


Assuntos
COVID-19 , Hipertensão , Controle de Doenças Transmissíveis , Continuidade da Assistência ao Paciente , Humanos , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Índia/epidemiologia , Pandemias/prevenção & controle , SARS-CoV-2
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